Nemdatine

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 5 mg film-coated tablets 
Nemdatine 10 mg film-coated tablets 
Nemdatine 15 mg film-coated tablets 
Nemdatine 20 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Nemdatine 5 mg 
 
Each film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine. 
 
Nemdatine 10 mg 
 
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg 
memantine. 
 
Nemdatine 15 mg 
 
Each film-coated tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg 
memantine. 
 
Nemdatine 20 mg 
 
Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg 
memantine. 
 
Excipient(s) with known effect: 
 
Nemdatine 5 mg film-coated tablets 
 
Each film-coated tablet contains 0.47 mg lactose monohydrate. 
 
Nemdatine 10 mg film-coated tablets 
 
Each film-coated tablet contains 0.95 mg lactose monohydrate. 
 
Nemdatine 15 mg film-coated tablets 
 
Each film-coated tablet contains 1.42 mg lactose monohydrate. 
 
Nemdatine 20 mg film-coated tablets 
 
Each film-coated tablet contains 1.89 mg lactose monohydrate. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet). 
 
Nemdatine 5 mg film-coated tablets 
 
White, oval shaped, biconvex film-coated tablet, 8 mm x 4.5 mm in size, with the marking “M5” 



3 

engraved on one side. 
 
Nemdatine 10 mg film-coated tablets 
 
White, capsule-shaped, biconvex film-coated tablet, 9.8 mm x 4.9 mm in size, with score line and the 
marking “M 10” engraved on the scored side. 
 
The tablet can be divided into equal doses. 
 
Nemdatine 15 mg film-coated tablets 
 
Orange, oval shaped, biconvex film-coated tablet, 11.4 mm x 6.4 mm in size, with the marking “M15” 
engraved on one side. 
 
Nemdatine 20 mg film-coated tablets 
 
Dark pink, oval shaped, biconvex film-coated tablet, 12.6 mm x 7 mm in size, with the marking 
“M20” engraved on one side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of adult patients with moderate to severe Alzheimer’s disease. 
 
4.2 Posology and method of administration 
 
Treatment should be initiated and supervised by a physician experienced in the diagnosis and 
treatment of Alzheimer’s dementia. 
 
Posology 
 
Therapy should only be started if a caregiver is available who will regularly monitor the intake of the 
medicinal product by the patient. Diagnosis should be made according to current guidelines. The 
tolerance and dosing of memantine should be reassessed on a regular basis, preferably within three 
months after start of treatment. Thereafter, the clinical benefit of memantine and the patient’s 
tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. 
Maintenance treatment can be continued for as long as a therapeutic benefit is favourable and the 
patient tolerates treatment with memantine. Discontinuation of memantine should be considered when 
evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment. 
 
Adults 
 
Dose titration 
 
The maximum daily dose is 20 mg per day. In order to reduce the risk of undesirable effects, the 
maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows. 
 
Week 1 (day 1-7): 
The patient should take one 5 mg film-coated tablet (5 mg) or half a 10 mg film-coated tablet (5 mg) 
per day for 7 days. 
 
Week 2 (day 8-14): 
The patient should take two 5 mg film-coated tablets (10 mg) or one 10 mg film-coated tablet (10 mg) 
per day for 7 days. 
 



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Week 3 (day 15-21): 
The patient should take three 5 mg film-coated tablets (15 mg) or one 15 mg film-coated tablet 
(15 mg) per day for 7 days. 
 
From Week 4 on: 
The patient should take four 5 mg film-coated tablets (20 mg), two 10 mg film-coated tablets (20 mg) 
or one 20 mg film-coated tablet (20 mg) per day. 
 
Maintenance dose 
 
The recommended maintenance dose is 20 mg per day. 
 
Elderly 
On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 
20 mg per day (four 5 mg film-coated tablets (20 mg), two 10 mg film-coated tablets (20 mg) or one 
20 mg film-coated tablet (20 mg) once a day) as described above. 
 
Renal impairment 
In patients with mildly impaired renal function (creatinine clearance 50 − 80 ml/min) no dose 
adjustment is required. In patients with moderate renal impairment (creatinine clearance 30 –
 49 ml/min) daily dose should be 10 mg per day. If tolerated well after at least 7 days of treatment, the 
dose could be increased up to 20 mg/day according to standard titration scheme. In patients with 
severe renal impairment (creatinine clearance 5 – 29 ml/min) daily dose should be 10 mg per day. 
 
Hepatic impairment 
In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B), no 
dose adjustment is needed. No data on the use of memantine in patients with severe hepatic 
impairment are available. Administration of Nemdatine is not recommended in patients with severe 
hepatic impairment. 
 
Paediatric population 
No data are available. 
 
Method of administration 
 
Nemdatine should be administered orally once a day and should be taken at the same time every day.  
The film-coated tablets can be taken with or without food. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Caution is recommended in patients with epilepsy, former history of convulsions or patients with 
predisposing factors for epilepsy. 
 
Concomitant use of N-methyl-D-aspartate (NMDA)-antagonists such as amantadine, ketamine or 
dextromethorphan should be avoided. These compounds act at the same receptor system as 
memantine, and therefore adverse reactions (mainly central nervous system (CNS)-related) may be 
more frequent or more pronounced (see also section 4.5). 
 
Some factors that may raise urine pH (see section 5.2 ‘Elimination’) may necessitate careful 
monitoring of the patient. These factors include drastic changes in diet, e.g. from a carnivore to a 
vegetarian diet, or a massive ingestion of alkalising gastric buffers. Also, urine pH may be elevated by 
states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria. 
 



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In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart 
failure (NYHA III-IV), or uncontrolled hypertension were excluded. As a consequence, only limited 
data are available and patients with these conditions should be closely supervised. 
 
This medicinal product contains lactose. Patients with rare hereditary problems of galactose 
intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this 
medicine. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Due to the pharmacological effects and the mechanism of action of memantine the following 
interactions may occur: 
 
- The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and 

anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as 
memantine. The effects of barbiturates and neuroleptics may be reduced. Concomitant 
administration of memantine with the antispasmodic agents, dantrolene or baclofen, can modify 
their effects and a dose adjustment may be necessary. 

- Concomitant use of memantine and amantadine should be avoided, owing to the risk of 
pharmacotoxic psychosis. Both compounds are chemically related NMDA-antagonists. The 
same may be true for ketamine and dextromethorphan (see also section 4.4). There is one 
published case report on a possible risk also for the combination of memantine and phenytoin. 

- Other active substances such as cimetidine, ranitidine, procainamide, quinidine, quinine and 
nicotine that use the same renal cationic transport system as amantadine may also possibly 
interact with memantine leading to a potential risk of increased plasma levels. 

- There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when 
memantine is co-administered with HCT or any combination with HCT. 

- In post-marketing experience, isolated cases with international normalized ratio (INR) increases 
have been reported in patients concomitantly treated with warfarin. Although no causal 
relationship has been established, close monitoring of prothrombin time or INR is advisable for 
patients concomitantly treated with oral anticoagulants. 

 
In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant active substance-
active substance interaction of memantine with glyburide/metformin or donepezil was observed. 
 
In a clinical study in young healthy subjects, no relevant effect of memantine on the pharmacokinetics 
of galantamine was observed. 
 
Memantine did not inhibit CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, flavin containing monooxygenase, 
epoxide hydrolase or sulphation in vitro. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data from the use of memantine in pregnant women. Animal studies 
indicate a potential for reducing intrauterine growth at exposure levels, which are identical or slightly 
higher than at human exposure (see section 5.3). The potential risk for humans is unknown. 
Memantine should not be used during pregnancy unless clearly necessary. 
 
Breast-feeding 
 
It is not known whether memantine is excreted in human breast milk but, taking into consideration the 
lipophilicity of the substance, this probably occurs. Women taking memantine should not breast-feed. 
 
Fertility 
 



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No adverse reactions of memantine were noted on male and female fertility. 
 
4.7 Effects on ability to drive and use machines 
 
Moderate to severe Alzheimer’s disease usually causes impairment of driving performance and 
compromises the ability to use machinery. Furthermore, Nemdatine has minor or moderate influence 
on the ability to drive and use machines such that outpatients should be warned to take special care. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
In clinical trials in mild to severe dementia, involving 1,784 patients treated with memantine and 
1,595 patients treated with placebo, the overall incidence rate of adverse reactions with memantine did 
not differ from those with placebo; the adverse reactions were usually mild to moderate in severity. 
The most frequently occurring adverse reactions with a higher incidence in the memantine group than 
in the placebo group were dizziness (6.3 % vs. 5.6 %, respectively), headache (5.2 % vs. 3.9 %), 
constipation (4.6 % vs. 2.6 %), somnolence (3.4 % vs. 2.2 %) and hypertension (4.1 % vs. 2.8 %). 
 
Tabulated list of adverse reactions 
 
The following Adverse Reactions listed in the table below have been accumulated in clinical studies 
with memantine and since its introduction in the market. 
 
Adverse reactions are ranked according to system organ class, using the following convention: very 
common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to 
< 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). Within 
each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
 
SYSTEM ORGAN CLASS FREQUENCY ADVERSE REACTION 

Infections and infestations Uncommon Fungal infections 

Immune system disorders Common Drug hypersensitivity 

Psychiatric disorders Common Somnolence 

Uncommon Confusion 

Uncommon Hallucinations1 

Not known Psychotic reactions2 

Nervous system disorders Common Dizziness 

Common Balance disorders 

Uncommon Gait abnormal 

Very rare Seizures 

Cardiac disorders Uncommon Cardiac failure 

Vascular disorders Common Hypertension 

Uncommon Venous thrombosis/thromboembolism 

Respiratory, thoracic and mediastinal 
disorders 

Common Dyspnoea 

Gastrointestinal disorders Common Constipation 

Uncommon Vomiting 



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Not known Pancreatitis2 

Hepatobiliary disorders Common Elevated liver function test 

Not known Hepatitis 

General disorders and administration 
site conditions 

Common Headache 

Uncommon Fatigue 
1 Hallucinations have mainly been observed in patients with severe Alzheimer´s disease. 
2 Isolated cases reported in post-marketing experience. 
 
Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. In 
post-marketing experience these reactions have been reported in patients treated with memantine. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Only limited experience with overdose is available from clinical studies and post-marketing 
experience. 
 
Symptoms 
 
Relative large overdoses (200 mg and 105 mg/day for 3 days, respectively) have been associated with 
either only symptoms of tiredness, weakness and/or diarrhoea or no symptoms. In the overdose cases 
below 140 mg or unknown dose the patients revealed symptoms from central nervous system 
(confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) 
and/or of gastrointestinal origin (vomiting and diarrhoea). 
 
In the most extreme case of overdose, the patient survived the oral intake of a total of 2,000 mg 
memantine with effects on the central nervous system (coma for 10 days, and later diplopia and 
agitation). The patient received symptomatic treatment and plasmapheresis. The patient recovered 
without permanent sequelae. 
 
In another case of a large overdose, the patient also survived and recovered. The patient had received 
400 mg memantine orally. The patient experienced central nervous system symptoms such as 
restlessness, psychosis, visual hallucinations, proconvulsiveness, somnolence, stupor, and 
unconsciousness. 
 
Treatment 
 
In the event of overdose, treatment should be symptomatic. No specific antidote for intoxication or 
overdose is available. Standard clinical procedures to remove active substance material, e.g. gastric 
lavage, carbo medicinalis (interruption of potential entero-hepatic recirculation), acidification of urine, 
forced diuresis should be used as appropriate. 
 
In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful 
symptomatic clinical treatment should be considered. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 



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5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Psychoanaleptics, other Anti-dementia drugs, ATC code: N06DX01. 
 
Mechanism of action 
 
There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular at 
NMDA-receptors, contributes to both expression of symptoms and disease progression in 
neurodegenerative dementia. 
 
Memantine is a voltage-dependent, moderate-affinity uncompetitive NMDA-receptor antagonist. It 
modulates the effects of pathologically elevated tonic levels of glutamate that may lead to neuronal 
dysfunction. 
 
Clinical efficacy and safety  
 
A pivotal monotherapy study in a population of patients suffering from moderate to severe 
Alzheimer’s disease (mini mental state examination (MMSE) total scores at baseline of 3 − 14) 
included a total of 252 outpatients. The study showed beneficial effects of memantine treatment in 
comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based 
impression of change (CIBIC-plus): p = 0.025; Alzheimer´s disease cooperative study – activities of 
daily living (ADCS-ADLsev): p = 0.003; severe impairment battery (SIB): p = 0.002). 
 
A pivotal monotherapy study of memantine in the treatment of mild to moderate Alzheimer’s disease 
(MMSE total scores at baseline of 10 to 22) included 403 patients. Memantine-treated patients showed 
a statistically significantly better effect than placebo-treated patients on the primary endpoints: 
Alzheimer´s disease assessment scale (ADAS-cog) (p = 0.003) and CIBIC-plus (p = 0.004) at week 24 
(last observation carried forward (LOCF)). In another monotherapy study in mild to moderate 
Alzheimer’s disease a total of 470 patients (MMSE total scores at baseline of 11 − 23) were 
randomised. In the prospectively defined primary analysis statistical significance was not reached at 
the primary efficacy endpoint at week 24. 
 
A meta-analysis of patients with moderate to severe Alzheimer’s disease (MMSE total scores < 20) 
from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies 
with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically 
significant effect in favour of memantine treatment for the cognitive, global, and functional domains. 
When patients were identified with concurrent worsening in all three domains, results showed a 
statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated 
patients as memantine-treated patients showed worsening in all three domains (21 % vs. 11 %, 
p < 0.0001). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Memantine has an absolute bioavailability of approximately 100 %. Tmax is between 3 and 8 hours. 
There is no indication that food influences the absorption of memantine. 
 
Distribution 
 
Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70 to 
150 ng/ml (0.5 – 1 μmol) with large interindividual variations. When daily doses of 5 to 30 mg were 
administered, a mean cerebrospinal fluid (CSF)/serum ratio of 0.52 was calculated. The volume of 
distribution is around 10 l/kg. About 45 % of memantine is bound to plasma-proteins. 
 
Biotransformation 
 



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In man, about 80 % of the circulating memantine-related material is present as the parent compound. 
Main human metabolites are N-3,5-dimethyl-gludantan, the isomeric mixture of 4- and 6-hydroxy-
memantine, and 1-nitroso-3,5-dimethyl-adamantane. None of these metabolites exhibit NMDA-
antagonistic activity. No cytochrome P 450 catalysed metabolism has been detected in vitro. 
 
In a study using orally administered 14C-memantine, a mean of 84 % of the dose was recovered within 
20 days, more than 99 % being excreted renally. 
 
Elimination 
 
Memantine is eliminated in a monoexponential manner with a terminal t½ of 60 to 100 hours. In 
volunteers with normal kidney function, total clearance (Cltot) amounts to 170 ml/min/1.73 m² and part 
of total renal clearance is achieved by tubular secretion. 
 
Renal handling also involves tubular reabsorption, probably mediated by cation transport proteins. The 
renal elimination rate of memantine under alkaline urine conditions may be reduced by a factor of 7 to 
9 (see section 4.4). Alkalisation of urine may result from drastic changes in diet, e.g. from a carnivore 
to a vegetarian diet, or from the massive ingestion of alkalising gastric buffers. 
 
Linearity 
 
Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg. 
 
Pharmacokinetic/pharmacodynamic relationship 
 
At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant) 
of memantine, which is 0.5 μmol in human frontal cortex. 
 
5.3 Preclinical safety data 
 
In short term studies in rats, memantine like other NMDA-antagonists have induced neuronal 
vacuolisation and necrosis (Olney lesions) only after doses leading to very high peak serum 
concentrations. Ataxia and other preclinical signs have preceded the vacuolisation and necrosis. As the 
effects have neither been observed in long term studies in rodents nor in non-rodents, the clinical 
relevance of these findings is unknown. 
 
Ocular changes were inconsistently observed in repeat dose toxicity studies in rodents and dogs, but 
not in monkeys. Specific ophthalmoscopic examinations in clinical studies with memantine did not 
disclose any ocular changes. 
 
Phospholipidosis in pulmonary macrophages due to accumulation of memantine in lysosomes was 
observed in rodents. This effect is known from other active substances with cationic amphiphilic 
properties. There is a possible relationship between this accumulation and the vacuolisation observed 
in lungs. This effect was only observed at high doses in rodents. The clinical relevance of these 
findings is unknown. 
 
No genotoxicity has been observed following testing of memantine in standard assays. There was no 
evidence of any carcinogenicity in life long studies in mice and rats. Memantine was not teratogenic in 
rats and rabbits, even at maternally toxic doses, and no adverse effects of memantine were noted on 
fertility. In rats, foetal growth reduction was noted at exposure levels, which are identical or slightly 
higher than at human exposure. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 



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Tablet cores for 5, 10, 15 and 20 mg film-coated tablets 
 
Microcrystalline cellulose 
Crospovidone Type A 
Talc 
Magnesium stearate 
 
Tablet coat for 5, 10, 15 and 20 mg film-coated tablets 
 
Hypromellose 6cP 
Titanium dioxide (E171) 
Lactose monohydrate 
Macrogol 3350 
Triacetin 
 
Additional for 15 mg film-coated tablets 
 
Iron oxide yellow, red and black (E172) 
 
Additional for 20 mg film-coated tablets 
 
Iron oxide red and yellow (E172) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
Blisters: 2 years. 
 
HDPE bottles: use within 100 days after opening. 
 
6.4 Special precautions for storage 
 
Do not store above 25°C. 
 
6.5 Nature and contents of container 
 
PVC/PVDC-Aluminium blisters. 
 
Nemdatine 10 mg and 20 mg film-coated tablets: 
HDPE bottle. 
 
Pack sizes 
Nemdatine 5 mg film-coated tablets: 
Blister packs: 42 and 98 film-coated tablets.  
 
Nemdatine 10 mg film-coated tablets: 
Blister packs: 28, 30, 42, 50, 56, 60, 98 and 112 film-coated tablets.  
HDPE bottle: 100 film-coated tablets. 
 
Nemdatine 15 mg film-coated tablets: 
Blister packs: 7, 42 and 98 film-coated tablets.  
 
Nemdatine 20 mg film-coated tablets: 
Blister packs: 28, 42, 56 and 98 film-coated tablets.  



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HDPE bottle: 100 film-coated tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf.  
Reykjavíkurvegi 76-78 
220 Hafnarfjörður 
Iceland 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/824/001 
EU/1/13/824/002 
EU/1/13/824/003 
EU/1/13/824/004 
EU/1/13/824/005 
EU/1/13/824/006 
EU/1/13/824/007 
EU/1/13/824/008 
EU/1/13/824/009 
EU/1/13/824/010 
EU/1/13/824/019 
EU/1/13/824/011 
EU/1/13/824/012 
EU/1/13/824/013 
EU/1/13/824/014 
EU/1/13/824/015 
EU/1/13/824/016 
EU/1/13/824/017 
EU/1/13/824/020 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 22 April 2013 
Date of latest renewal: 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 5 mg film-coated tablets 
Nemdatine 10 mg film-coated tablets 
Nemdatine 15 mg film-coated tablets 
Nemdatine 20 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Nemdatine 5 mg 
 
Each film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine. 
 
Nemdatine 10 mg 
 
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg 
memantine. 
 
Nemdatine 15 mg 
 
Each film-coated tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg 
memantine. 
 
Nemdatine 20 mg 
 
Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg 
memantine. 
 
Excipient(s) with known effect: 
 
Nemdatine 5 mg film-coated tablets 
 
Each film-coated tablet contains 0.47 mg lactose monohydrate. 
 
Nemdatine 10 mg film-coated tablets 
 
Each film-coated tablet contains 0.95 mg lactose monohydrate. 
 
Nemdatine 15 mg film-coated tablets 
 
Each film-coated tablet contains 1.42 mg lactose monohydrate. 
 
Nemdatine 20 mg film-coated tablets 
 
Each film-coated tablet contains 1.89 mg lactose monohydrate. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet). 
 
Nemdatine 5 mg film-coated tablets 
 
White, oval shaped, biconvex film-coated tablets, 8 mm x 4.5 mm in size, with the marking “M5” 



13 

engraved on one side. 
 
Nemdatine 10 mg film-coated tablets 
 
White, capsule-shaped, biconvex film-coated tablets, 9.8 mm x 4.9 mm in size, with score line and the 
marking “M 10” engraved on the scored side. The tablet can be divided into equal doses. 
 
Nemdatine 15 mg film-coated tablets 
 
Orange, oval shaped, biconvex film-coated tablets, 11.4 mm x 6.4 mm in size, with the marking 
“M15” engraved on one side. 
 
Nemdatine 20 mg film-coated tablets 
 
Dark pink, oval shaped, biconvex film-coated tablets, 12.6 mm x 7 mm in size, with the marking 
“M20” engraved on one side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of adult patients with moderate to severe Alzheimer’s disease. 
 
4.2 Posology and method of administration 
 
Treatment should be initiated and supervised by a physician experienced in the diagnosis and 
treatment of Alzheimer’s dementia. 
 
Posology 
 
Therapy should only be started if a caregiver is available who will regularly monitor the intake of the 
medicinal product by the patient. Diagnosis should be made according to current guidelines. The 
tolerance and dosing of memantine should be reassessed on a regular basis, preferably within three 
months after start of treatment. Thereafter, the clinical benefit of memantine and the patient’s 
tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. 
Maintenance treatment can be continued for as long as a therapeutic benefit is favourable and the 
patient tolerates treatment with memantine. Discontinuation of memantine should be considered 
when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment. 
 
Adults 
 
Dose titration 
 
The recommended starting dose is 5 mg per day which is stepwise increased over the first 4 weeks of 
treatment reaching the recommended maintenance dose as follows: 
 
Week 1 (day 1-7): 
The patient should take one 5 mg film-coated tablet per day (white, oval-shaped) for 7 days. 
 
Week 2 (day 8-14): 
The patient should take one 10 mg film-coated tablet per day (white, capsule shaped) for 7 days. 
 
Week 3 (day 15-21): 
The patient should take one 15 mg film-coated tablet per day (orange, oval shaped) for 7 days. 
 
Week 4 (day 22-28): 



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The patient should take one 20 mg film-coated tablet per day (dark pink, oval shaped) for 7 days. 
 
The maximum daily dose is 20 mg per day. 
 
Maintenance dose 
 
The recommended maintenance dose is 20 mg per day. 
 
Elderly 
On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 
20 mg per day (20 mg once a day) as described above. 
 
Renal impairment 
In patients with mildly impaired renal function (creatinine clearance 50 − 80 ml/min) no dose 
adjustment is required. In patients with moderate renal impairment (creatinine clearance 30 –
 49 ml/min) daily dose should be 10 mg per day. If tolerated well after at least 7 days of treatment, the 
dose could be increased up to 20 mg/day according to standard titration scheme. In patients with 
severe renal impairment (creatinine clearance 5 – 29 ml/min) daily dose should be 10 mg per day. 
 
Hepatic impairment 
In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B), no 
dose adjustment is needed. No data on the use of memantine in patients with severe hepatic 
impairment are available. Administration of Nemdatine is not recommended in patients with severe 
hepatic impairment. 
 
Paediatric population 
No data are available. 
 
Method of administration 
 
Nemdatine should be administered orally once a day and should be taken at the same time every day. 
The film-coated tablets can be taken with or without food. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Caution is recommended in patients with epilepsy, former history of convulsions or patients with 
predisposing factors for epilepsy. 
 
Concomitant use of N-methyl-D-aspartate (NMDA)-antagonists such as amantadine, ketamine or 
dextromethorphan should be avoided. These compounds act at the same receptor system as 
memantine, and therefore adverse reactions (mainly central nervous system (CNS)-related) may be 
more frequent or more pronounced (see also section 4.5). 
 
Some factors that may raise urine pH (see section 5.2 ‘Elimination’) may necessitate careful 
monitoring of the patient. These factors include drastic changes in diet, e.g. from a carnivore to a 
vegetarian diet, or a massive ingestion of alkalising gastric buffers. Also, urine pH may be elevated by 
states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria. 
 
In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart 
failure (NYHA III-IV), or uncontrolled hypertension were excluded. As a consequence, only limited 
data are available and patients with these conditions should be closely supervised. 
 
This medicinal product contains lactose. Patients with rare hereditary problems of galactose 



15 

intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this 
medicine. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Due to the pharmacological effects and the mechanism of action of memantine the following 
interactions may occur: 
 
- The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and 

anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as 
memantine. The effects of barbiturates and neuroleptics may be reduced. Concomitant 
administration of memantine with the antispasmodic agents, dantrolene or baclofen, can modify 
their effects and a dose adjustment may be necessary. 

- Concomitant use of memantine and amantadine should be avoided, owing to the risk of 
pharmacotoxic psychosis. Both compounds are chemically related NMDA-antagonists. The 
same may be true for ketamine and dextromethorphan (see also section 4.4). There is one 
published case report on a possible risk also for the combination of memantine and phenytoin. 

- Other active substances such as cimetidine, ranitidine, procainamide, quinidine, quinine and 
nicotine that use the same renal cationic transport system as amantadine may also possibly 
interact with memantine leading to a potential risk of increased plasma levels. 

- There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when 
memantine is co-administered with HCT or any combination with HCT. 

- In post-marketing experience, isolated cases with international normalized ratio (INR) increases 
have been reported in patients concomitantly treated with warfarin. Although no causal 
relationship has been established, close monitoring of prothrombin time or INR is advisable for 
patients concomitantly treated with oral anticoagulants. 

 
In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant active substance-
active substance interaction of memantine with glyburide/metformin or donepezil was observed. 
 
In a clinical study in young healthy subjects, no relevant effect of memantine on the pharmacokinetics 
of galantamine was observed. 
 
Memantine did not inhibit CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, flavin containing monooxygenase, 
epoxide hydrolase or sulphation in vitro. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data from the use of memantine in pregnant women. Animal studies 
indicate a potential for reducing intrauterine growth at exposure levels, which are identical or slightly 
higher than at human exposure (see section 5.3). The potential risk for humans is unknown. 
Memantine should not be used during pregnancy unless clearly necessary. 
 
Breast-feeding 
 
It is not known whether memantine is excreted in human breast milk but, taking into consideration the 
lipophilicity of the substance, this probably occurs. Women taking memantine should not breast-feed. 
 
Fertility 
 
No adverse reactions of memantine were noted on male and female fertility. 
 
4.7 Effects on ability to drive and use machines 
 
Moderate to severe Alzheimer’s disease usually causes impairment of driving performance and 



16 

compromises the ability to use machinery. Furthermore, Nemdatine has minor or moderate influence 
on the ability to drive and use machines such that outpatients should be warned to take special care. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
In clinical trials in mild to severe dementia, involving 1,784 patients treated with memantine and 
1,595 patients treated with placebo, the overall incidence rate of adverse reactions with memantine did 
not differ from those with placebo; the adverse reactions were usually mild to moderate in severity. 
The most frequently occurring adverse reactions with a higher incidence in the memantine group than 
in the placebo group were dizziness (6.3 % vs. 5.6 %, respectively), headache (5.2 % vs. 3.9 %), 
constipation (4.6 % vs. 2.6 %), somnolence (3.4 % vs. 2.2 %) and hypertension (4.1 % vs. 2.8 %). 
 
Tabulated list of adverse reactions 
 
The following Adverse Reactions listed in the table below have been accumulated in clinical studies 
with memantine and since its introduction in the market. 
 
Adverse reactions are ranked according to system organ class, using the following convention: very 
common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to 
< 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). Within 
each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
 
SYSTEM ORGAN CLASS FREQUENCY ADVERSE REACTION 

Infections and infestations Uncommon Fungal infections 

Immune system disorders Common Drug hypersensitivity 

Psychiatric disorders Common Somnolence 

Uncommon Confusion 

Uncommon Hallucinations1 

Not known Psychotic reactions2 

Nervous system disorders Common Dizziness 

Common Balance disorders 

Uncommon Gait abnormal 

Very rare Seizures 

Cardiac disorders Uncommon Cardiac failure 

Vascular disorders Common Hypertension 

Uncommon Venous thrombosis/thromboembolism 

Respiratory, thoracic and mediastinal 
disorders 

Common Dyspnoea 

Gastrointestinal disorders Common Constipation 

Uncommon Vomiting 

Not known Pancreatitis2 

Hepatobiliary disorders Common Elevated liver function test 

Not known Hepatitis 



17 

General disorders and administration 
site conditions 

Common Headache 

Uncommon Fatigue 
1 Hallucinations have mainly been observed in patients with severe Alzheimer´s disease. 
2 Isolated cases reported in post-marketing experience. 
 
Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. In 
post-marketing experience these reactions have been reported in patients treated with memantine. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Only limited experience with overdose is available from clinical studies and post-marketing 
experience. 
 
Symptoms 
 
Relative large overdoses (200 mg and 105 mg/day for 3 days, respectively) have been associated with 
either only symptoms of tiredness, weakness and/or diarrhoea or no symptoms. In the overdose cases 
below 140 mg or unknown dose the patients revealed symptoms from central nervous system 
(confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) 
and/or of gastrointestinal origin (vomiting and diarrhoea). 
 
In the most extreme case of overdose, the patient survived the oral intake of a total of 2,000 mg 
memantine with effects on the central nervous system (coma for 10 days, and later diplopia and 
agitation). The patient received symptomatic treatment and plasmapheresis. The patient recovered 
without permanent sequelae. 
 
In another case of a large overdose, the patient also survived and recovered. The patient had received 
400 mg memantine orally. The patient experienced central nervous system symptoms such as 
restlessness, psychosis, visual hallucinations, proconvulsiveness, somnolence, stupor, and 
unconsciousness. 
 
Treatment 
 
In the event of overdose, treatment should be symptomatic. No specific antidote for intoxication or 
overdose is available. Standard clinical procedures to remove active substance material, e.g. gastric 
lavage, carbo medicinalis (interruption of potential entero-hepatic recirculation), acidification of urine, 
forced diuresis should be used as appropriate. 
 
In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful 
symptomatic clinical treatment should be considered. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Psychoanaleptics, other Anti-dementia drugs, ATC code: N06DX01. 
 
Mechanism of action 



18 

 
There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular at 
NMDA-receptors, contributes to both expression of symptoms and disease progression in 
neurodegenerative dementia. 
 
Memantine is a voltage-dependent, moderate-affinity uncompetitive NMDA-receptor antagonist. It 
modulates the effects of pathologically elevated tonic levels of glutamate that may lead to neuronal 
dysfunction. 
 
Clinical efficacy and safety 
 
A pivotal monotherapy study in a population of patients suffering from moderate to severe 
Alzheimer’s disease (mini mental state examination (MMSE) total scores at baseline of 3 − 14) 
included a total of 252 outpatients. The study showed beneficial effects of memantine treatment in 
comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based 
impression of change (CIBIC-plus): p = 0.025; Alzheimer´s disease cooperative study – activities of 
daily living (ADCS-ADLsev): p = 0.003; severe impairment battery (SIB): p = 0.002). 
 
A pivotal monotherapy study of memantine in the treatment of mild to moderate Alzheimer’s disease 
(MMSE total scores at baseline of 10 to 22) included 403 patients. Memantine-treated patients showed 
a statistically significantly better effect than placebo-treated patients on the primary endpoints: 
Alzheimer´s disease assessment scale (ADAS-cog) (p = 0.003) and CIBIC-plus (p = 0.004) at week 24 
(last observation carried forward (LOCF)). In another monotherapy study in mild to moderate 
Alzheimer’s disease a total of 470 patients (MMSE total scores at baseline of 11 − 23) were 
randomised. In the prospectively defined primary analysis statistical significance was not reached at 
the primary efficacy endpoint at week 24. 
 
A meta-analysis of patients with moderate to severe Alzheimer’s disease (MMSE total scores < 20) 
from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies 
with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically 
significant effect in favour of memantine treatment for the cognitive, global, and functional domains. 
When patients were identified with concurrent worsening in all three domains, results showed a 
statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated 
patients as memantine-treated patients showed worsening in all three domains (21 % vs. 11 %, 
p < 0.0001). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Memantine has an absolute bioavailability of approximately 100 %. Tmax is between 3 and 8 hours. 
There is no indication that food influences the absorption of memantine. 
 
Distribution 
 
Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70 to 
150 ng/ml (0.5 – 1 μmol) with large interindividual variations. When daily doses of 5 to 30 mg were 
administered, a mean cerebrospinal fluid (CSF)/serum ratio of 0.52 was calculated. The volume of 
distribution is around 10 l/kg. About 45 % of memantine is bound to plasma-proteins. 
 
Biotransformation 
 
In man, about 80 % of the circulating memantine-related material is present as the parent compound. 
Main human metabolites are N-3,5-dimethyl-gludantan, the isomeric mixture of 4- and 6-hydroxy-
memantine, and 1-nitroso-3,5-dimethyl-adamantane. None of these metabolites exhibit NMDA-
antagonistic activity. No cytochrome P 450 catalysed metabolism has been detected in vitro. 
 



19 

In a study using orally administered 14C-memantine, a mean of 84 % of the dose was recovered within 
20 days, more than 99 % being excreted renally. 
 
Elimination 
 
Memantine is eliminated in a monoexponential manner with a terminal t½ of 60 to 100 hours. In 
volunteers with normal kidney function, total clearance (Cltot) amounts to 170 ml/min/1.73 m² and part 
of total renal clearance is achieved by tubular secretion. 
 
Renal handling also involves tubular reabsorption, probably mediated by cation transport proteins. The 
renal elimination rate of memantine under alkaline urine conditions may be reduced by a factor of 7 to 
9 (see section 4.4). Alkalisation of urine may result from drastic changes in diet, e.g. from a carnivore 
to a vegetarian diet, or from the massive ingestion of alkalising gastric buffers. 
 
Linearity 
 
Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg. 
 
Pharmacokinetic/pharmacodynamic relationship 
 
At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant) 
of memantine, which is 0.5 μmol in human frontal cortex. 
 
5.3 Preclinical safety data 
 
In short term studies in rats, memantine like other NMDA-antagonists have induced neuronal 
vacuolisation and necrosis (Olney lesions) only after doses leading to very high peak serum 
concentrations. Ataxia and other preclinical signs have preceded the vacuolisation and necrosis. As the 
effects have neither been observed in long term studies in rodents nor in non-rodents, the clinical 
relevance of these findings is unknown. 
 
Ocular changes were inconsistently observed in repeat dose toxicity studies in rodents and dogs, but 
not in monkeys. Specific ophthalmoscopic examinations in clinical studies with memantine did not 
disclose any ocular changes. 
 
Phospholipidosis in pulmonary macrophages due to accumulation of memantine in lysosomes was 
observed in rodents. This effect is known from other active substances with cationic amphiphilic 
properties. There is a possible relationship between this accumulation and the vacuolisation observed 
in lungs. This effect was only observed at high doses in rodents. The clinical relevance of these 
findings is unknown. 
 
No genotoxicity has been observed following testing of memantine in standard assays. There was no 
evidence of any carcinogenicity in life long studies in mice and rats. Memantine was not teratogenic in 
rats and rabbits, even at maternally toxic doses, and no adverse effects of memantine were noted on 
fertility. In rats, foetal growth reduction was noted at exposure levels, which are identical or slightly 
higher than at human exposure. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet cores for 5, 10, 15 and 20 mg film-coated tablets 
 
Microcrystalline cellulose 
Crospovidone Type A 
Talc 



20 

Magnesium stearate 
 
Tablet coat for 5 mg and 10 mg film-coated tablets 
 
Hypromellose 6cP 
Titanium dioxide (E171) 
Lactose monohydrate 
Macrogol 3350 
Triacetin 
 
Tablet coat for 15 mg film-coated tablets 
 
Hypromellose 6cP 
Lactose monohydrate 
Titanium dioxide (E171) 
Macrogol 3350 
Triacetin 
Iron oxide yellow, red and black (E172) 
 
Tablet coat for 20 mg film-coated tablets 
 
Hypromellose 6cP 
Titanium dioxide (E171) 
Lactose monohydrate 
Macrogol 3350 
Triacetin 
Iron oxide red and yellow (E172) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years. 
 
6.4 Special precautions for storage 
 
Do not store above 25°C. 
 
6.5 Nature and contents of container 
 
PVC/PVDC-Aluminium blisters. 
 
Each pack contains 28 film-coated tablets (7 film-coated tablets of 5 mg, 7 film-coated tablets of 
10 mg, 7 film-coated tablets of 15 mg and 7 film-coated tablets of 20 mg) in a wallet pack or as a pack 
of 4 blisters in 4 separate immediate cartons and one outer carton. 
 
6.6 Special precautions for disposal  
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf.  
Reykjavíkurvegi 76-78 



21 

220 Hafnarfjörður 
Iceland 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/824/018 
EU/1/13/824/021 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 22 April 2013 
Date of latest renewal: 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 

  



22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 

 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE  

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 



23 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

Name and address of the manufacturer(s) responsible for batch release 

Actavis hf. 
Reykjavikurvegur 78, 
200 Hafnarfjörður 
Iceland 
 
Actavis Group PTC ehf. 
Reykjavikurvegur 76-78 
220 Hafnarfjordur 
Iceland 
 
Actavis Ltd 
BLB016 Bulebel Industrial Estate, 
Zejtun ZTN 3000 
Malta 
 

Manufacturing Packaging Farmaca (MPF) B.V 
Neptunus 12, 
Heerenveen, 8448CN, 
Netherlands 
 
Manufacturing Packaging Farmaca (MPF) B.V 
Appelhof 13, 
Oudehaske, 8465RX, 
Netherlands 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

Medicinal product subject to restricted prescription (see Annex I: Summary of Product 
Characteristics, section 4.2).  

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION  

 

• Periodic safety update reports  
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT 



24 

 

• Risk Management Plan (RMP) 
 

Not applicable. 

  



25 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



26 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 



27 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR BLISTER PACK 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 5 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
42 film-coated tablets 
98 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
 
 



28 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf.  
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/824/001 42 film-coated tablets 
EU/1/13/824/002 98 film-coated tablets 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Nemdatine 5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



29 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOR TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 5 mg tablets 
 
memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis Group PTC ehf. Logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 

  



30 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR BLISTER PACK 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 10 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 film-coated tablets 
30 film-coated tablets 
42 film-coated tablets 
50 film-coated tablets 
56 film-coated tablets 
60 film-coated tablets 
98 film-coated tablets 
112 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



31 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf.  
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/824/003 28 film-coated tablets 
EU/1/13/824/004 30 film-coated tablets 
EU/1/13/824/005 42 film-coated tablets 
EU/1/13/824/006 50 film-coated tablets 
EU/1/13/824/007 56 film-coated tablets 
EU/1/13/824/008 60 film-coated tablets 
EU/1/13/824/009 98 film-coated tablets 
EU/1/13/824/010 112 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Nemdatine 10 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



32 

 



33 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOR TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 10 mg tablets 
 
memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis Group PTC ehf. Logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 



34 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR BOTTLE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 10 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
100 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
 
Use within 100 days after opening. 
 
 



35 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf.  
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/824/019 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Nemdatine 10 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



36 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
LABEL FOR BOTTLE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 10 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
100 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
 
Use within 100 days after opening. 
 
 



37 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis Group PTC ehf. Logo] 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/824/019 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 



38 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR BLISTER PACK 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 15 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 film-coated tablets 
42 film-coated tablets 
98 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
 
 



39 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf.  
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/824/011 7 film-coated tablets 
EU/1/13/824/012 42 film-coated tablets 
EU/1/13/824/013 98 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Nemdatine 15 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



40 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOR TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 15 mg tablets 
 
memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis Group PTC ehf. Logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 



41 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON AND WALLET FOR 28 TABLETS – TREATMENT INITIATION PACK – 
4 WEEK TREATMENT SCHEDULE – Frontside 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 5 mg 
Nemdatine 10 mg 
Nemdatine 15 mg 
Nemdatine 20 mg 
film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 5, 10, 15 or 20 mg of memantine hydrochloride equivalent to 4.15, 8.31, 12.46 or 
16.62 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 film-coated tablets 
 
Treatment initiation pack. 
Each pack of 28 film-coated tablets for a 4 week treatment schedule contains: 
7 film-coated tablets of Nemdatine 5 mg 
7 film-coated tablets of Nemdatine 10 mg 
7 film-coated tablets of Nemdatine 15 mg 
7 film-coated tablets of Nemdatine 20 mg 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 



42 

 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf.  
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/824/018 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Nemdatine 5 mg, 10 mg, 15 mg, 20 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



43 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON AND WALLET FOR 28 TABLETS – TREATMENT INITIATION PACK – 
4 WEEK TREATMENT SCHEDULE – Inside 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 5 mg 
Nemdatine 10 mg 
Nemdatine 15 mg 
Nemdatine 20 mg 
film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
memantine hydrochloride 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Each pack with 28 film-coated tablets for a 4 week treatment schedule contains: 
Week 1: 7 film-coated tablets of Nemdatine 5 mg 
Week 2: 7 film-coated tablets of Nemdatine 10 mg 
Week 3: 7 film-coated tablets of Nemdatine 15 mg 
Week 4: 7 film-coated tablets of Nemdatine 20 mg 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
 
Read the package leaflet before use. 
 
One tablet daily. 
 
For continuation of your treatment please consult your doctor. 
 
Nemdatine 5 mg 
Week 1 
Day 1, 2, 3, 4, 5, 6, 7 
 
Nemdatine 10 mg 
Week 2 
Day 8, 9, 10, 11, 12, 13, 14 
 
Nemdatine 15 mg 
Week 3 
Day 15, 16, 17, 18, 19, 20, 21 
 



44 

Nemdatine 20 mg 
Week 4 
Day 22, 23, 24, 25, 26, 27, 28 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis Group PTC ehf. Logo] 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/824/018 
 
 
13. BATCH NUMBER 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 



45 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOR TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT 
SCHEDULE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 5 mg tablets 
 
memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis Group PTC ehf. Logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 



46 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOR TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT 
SCHEDULE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 10 mg tablets 
 
memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis Group PTC ehf. Logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 



47 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOR TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT 
SCHEDULE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 15 mg tablets 
 
memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis Group PTC ehf. Logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 



48 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOR TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT 
SCHEDULE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 20 mg tablets 
 
memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis Group PTC ehf. Logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 



49 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING. 
 
CARTON FOR BLISTER PACK 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 20 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 film-coated tablets 
42 film-coated tablets 
56 film-coated tablets 
98 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
 



50 

 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf.  
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/824/014 28 film-coated tablets 
EU/1/13/824/015 42 film-coated tablets 
EU/1/13/824/016 56 film-coated tablets 
EU/1/13/824/017 98 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Nemdatine 20 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 



51 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOR TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 20 mg tablets 
 
memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis Group PTC ehf. Logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Mon. 
Tue. 
Wed. 
Thu. 
Fri. 
Sat. 
Sun. 



52 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING. 
 
CARTON FOR BOTTLE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 20 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
100 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
 
Use within 100 days after opening. 
 
 



53 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf.  
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/824/020 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Nemdatine 20 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



54 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING. 
 
LABEL FOR BOTTLE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 20 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
100 tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
 
Use within 100 days after opening. 
 
 



55 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis Group PTC ehf. Logo] 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/824/020 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 



56 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR 28 TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT 
SCHEDULE – OUTER CARTON (WITH BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 5 mg 
Nemdatine 10 mg 
Nemdatine 15 mg 
Nemdatine 20 mg 
film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 5, 10, 15 or 20 mg of memantine hydrochloride equivalent to 4.15, 8.31, 12.46 or 
16.62 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Treatment initiation pack. 
 
Treatment initiation pack with 28 (4x7) film-coated tablets for a 4 week treatment schedule: 
7 film-coated tablets of Nemdatine 5 mg 
7 film-coated tablets of Nemdatine 10 mg 
7 film-coated tablets of Nemdatine 15 mg 
7 film-coated tablets of Nemdatine 20 mg 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
 
Read the package leaflet before use. 
 
For continuation of your treatment please consult your doctor. 
 
Week 1: Take one tablet daily of Nemdatine 5 mg. 
 
Week 2: Take one tablet daily of Nemdatine 10 mg. 
 
Week 3: Take one tablet daily of Nemdatine 15 mg. 
 
Week 4: Take one tablet daily of Nemdatine 20 mg. 
 
 



57 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf.  
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/824/021 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Nemdatine 5 mg, 10 mg, 15 mg, 20 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 



58 

 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 



59 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR 7 TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT 
SCHEDULE –IMMEDIATE CARTON (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 5 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
 
Read the package leaflet before use. 
 
One tablet daily. 
 
For continuation of your treatment please consult your doctor. 
 
Week 1 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



60 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf.  
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/824/021 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Nemdatine 5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 



61 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOR TABLETS FOR TREATMENT INITIATION PACK 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 5 mg tablets 
 
memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis Group PTC ehf. Logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Week 1 
 
Mon. 
Tue. 
Wed. 
Thu. 
Fri. 
Sat. 
Sun. 
 

 



62 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR 7 TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT 
SCHEDULE –IMMEDIATE CARTON (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 10 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
 
Read the package leaflet before use. 
 
One tablet daily. 
 
For continuation of your treatment please consult your doctor. 
 
Week 2 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



63 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf.  
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/824/021 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Nemdatine 10 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 



64 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOR TABLETS FORTREATMENT INITIATION PACK 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 10 mg tablets 
 
memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis Group PTC ehf. Logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Week 2 
 
Mon. 
Tue. 
Wed. 
Thu. 
Fri. 
Sat. 
Sun. 
 
 



65 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR 7 TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT 
SCHEDULE –IMMEDIATE CARTON (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 15 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
 
Read the package leaflet before use. 
 
One tablet daily. 
 
For continuation of your treatment please consult your doctor. 
 
Week 3 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



66 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf.  
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/824/021 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Nemdatine 15 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 



67 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOR TABLETS FOR TREATMENT INITIATION PACK 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 15 mg tablets 
 
memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis Group PTC ehf. Logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Week 3 
 
Mon. 
Tue. 
Wed. 
Thu. 
Fri. 
Sat. 
Sun. 
 



68 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING. 
 
CARTON FOR 7 TABLETS – TREATMENT INITIATION PACK – 4 WEEK TREATMENT 
SCHEDULE –IMMEDIATE CARTON (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 20 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. 
 
Read the package leaflet before use. 
 
One tablet daily. 
 
For continuation of your treatment please consult your doctor. 
 
Week 4 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



69 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf.  
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/13/824/021 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Nemdatine 20 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 



70 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOR TABLETS FOR TREATMENT INITIATION PACK 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nemdatine 20 mg tablets 
 
memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis Group PTC ehf. Logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Week 4 
 
Mon. 
Tue. 
Wed. 
Thu. 
Fri. 
Sat. 
Sun. 
 
 

 
  



71 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
  



72 

Package leaflet: Information for the patient 
 

Nemdatine 5 mg film-coated tablets 
memantine hydrochloride 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Nemdatine is and what it is used for 
2. What you need to know before you take Nemdatine 
3. How to take Nemdatine 
4. Possible side effects 
5. How to store Nemdatine 
6. Contents of the pack and other information 
 
 
1. What Nemdatine is and what it is used for 
 
How does Nemdatine work 
Nemdatine contains the active substance memantine hydrochloride. Nemdatine belongs to a group of 
medicines known as anti-dementia medicines. 
Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain 
contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve 
signals important in learning and memory. Nemdatine belongs to a group of medicines called NMDA- 
receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve 
signals and the memory. 
 
What is Nemdatine used for 
Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s disease. 
 
 
2. What you need to know before you take Nemdatine 
 
Do not take Nemdatine 
- if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine 

(listed in section 6). 
 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Nemdatine 
- if you have a history of epileptic seizures 
- if you have recently experienced a myocardial infarction (heart attack), or if you are suffering 

from congestive heart failure or from an uncontrolled hypertension (high blood pressure). 
 
In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine 
reassessed by your doctor on a regular basis. 
If you suffer from renal impairment (kidney problems), your doctor should closely monitor your 
kidney function and if necessary adapt the memantine doses accordingly. 
 
The use of medicinal products called amantadine (for the treatment of Parkinson’s disease), ketamine 
(a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and 



73 

other NMDA-antagonists at the same time should be avoided. 
 
Children and adolescents 
Nemdatine is not recommended for children and adolescents under the age of 18 years. 
 
Other medicines and Nemdatine 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
In particular, Nemdatine may change the effects of the following medicines and their dose may need to 
be adjusted by your doctor: 
- amantadine, ketamine, dextromethorphan 
- dantrolene, baclofen 
- cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine 
- hydrochlorothiazide (or any combination with hydrochlorothiazide) 
- anticholinergics (substances generally used to treat movement disorders or intestinal cramps) 
- anticonvulsants (substances used to prevent and relieve seizures) 
- barbiturates (substances generally used to induce sleep) 
- dopaminergic agonists (substances such as L-dopa, bromocriptine) 
- neuroleptics (substances used in the treatment of mental disorders) 
- oral anticoagulants 
 
If you go into hospital, let your doctor know that you are taking Nemdatine. 
 
Nemdatine with food and drink 
You should inform your doctor if you have recently changed or intend to change your diet 
substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal 
tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction 
(poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your 
doctor may need to adjust the dose of your medicine. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
  
Pregnancy 
The use of memantine in pregnant women is not recommended. 
 
Breast-feeding 
Women taking Nemdatine should not breast-feed. 
 
Driving and using machines 
Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, 
Nemdatine may change your reactivity, making driving or operating machinery inappropriate. 
 
Nemdatine contains lactose monohydrate 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicinal product. 
 
 
3. How to take Nemdatine 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure. 
 
Dosage 
The recommended dose of Nemdatine for adults and older people is 20 mg once a day. 



74 

In order to reduce the risk of side effects this dose is achieved gradually by the following daily 
treatment scheme: 
 
Week 1 One 5 mg tablet 
Week 2 Two 5 mg tablets 
Week 3 Three 5 mg tablets 
Week 4 and beyond Four 5 mg tablets once a day 
 
The usual starting dose is one tablet once a day (1x 5 mg) for the first week. This is increased to two 
tablets once a day (1x 10 mg) in the second week and to three tablets once a day (1x 15 mg) in the 
third week. From the fourth week on, the usual dose is 4 tablets once a day (1x 20 mg). 
 
Dosage in patients with impaired kidney function 
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In 
this case, monitoring of your kidney function should be performed by your doctor at specified 
intervals. 
 
Administration 
Nemdatine should be administered orally once a day. To benefit from your medicine you should take it 
regularly every day at the same time of the day. The tablets should be swallowed with some water. 
The tablets can be taken with or without food. 
 
Duration of treatment  
Continue to take Nemdatine as long as it is of benefit to you. Your doctor should assess your treatment 
on a regular basis. 
 
If you take more Nemdatine than you should 
- In general, taking too much Nemdatine should not result in any harm to you. You may 

experience increased symptoms as described in section 4 ‘Possible side effects’. 
- If you take a large overdose of Nemdatine, contact your doctor or get medical advice, as you 

may need medical attention. 
 
If you forget to take Nemdatine 
- If you find you have forgotten to take your dose of Nemdatine, wait and take your next dose at 

the usual time. 
- Do not take a double dose to make up for a forgotten dose. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
In general, the observed side effects are mild to moderate. 
 
Common (affects 1 to 10 users in 100) 
- Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, 

shortness of breath, high blood pressure and drug hypersensitivity 
 
Uncommon (affects 1 to 10 users in 1,000) 
- Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure 

and venous blood clotting (thrombosis/thromboembolism) 
 
Very Rare (affects less than 1 user in 10,000) 
- Seizures 



75 

 
Not known (frequency cannot be estimated from the available data) 
- Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions 
 
Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events 
have been reported in patients treated with memantine. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Nemdatine 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. 
The expiry date refers to the last day of that month. 
 
Do not store above 25°C. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Nemdatine contains 
- The active substance is memantine hydrochloride. Each film-coated tablet contains 5 mg 

memantine hydrochloride equivalent to 4.15 mg memantine. 
 
- The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc 

and magnesium stearate. Tablet coat (Opadry II White 33G28435): Hypromellose 6cP, titanium 
dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin. 

 
What Nemdatine looks like and contents of the pack 
Nemdatine 5 mg film-coated tablets (tablets) are white, oval shaped, biconvex, 8 mm x 4.5 mm in size, 
with the marking “M5” engraved on one side. 
 
Pack sizes 
Blister packs: 42 and 98 film-coated tablets.  
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Actavis Group PTC ehf. 
Reykjavíkurvegi 76-78 
220 Hafnarfjörður 
Iceland 
 
Manufacturer 
Actavis hf. 
Reykjavíkurvegi 78 
220 Hafnarfjörður 
Iceland 



76 

 
Actavis Group PTC ehf. 
Reykjavikurvegur 76-78 
220 Hafnarfjordur 
Iceland 
 
Actavis Ltd. 
BLB 016 Bulebel Industrial Estate 
Zejtun ZTN 3000 
Malta 
 
Manufacturing Packaging Farmaca (MPF) B.V 
Neptunus 12, 
Heerenveen, 8448CN, 
Netherlands 
 
Manufacturing Packaging Farmaca (MPF) B.V 
Appelhof 13, 
Oudehaske, 8465RX, 
Netherlands 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Actavis Group PTC ehf. 
IJsland/Islande/Island 
Tél/Tel: +354 5503300 
 

Lietuva 
UAB Sicor Biotech 
Tel: +370 52660203 
 

България 
Актавис ЕАД 
Teл: +359 24899585 
 

Luxembourg/Luxemburg 
Actavis Group PTC ehf. 
Islande/Island 
Tél/Tel: +354 5503300 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: +420 251007111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel: +36 12886400 
 

Danmark 
Teva Denmark A/S 
Tlf: +45 44985511 
 

Malta 
Actavis Ltd. 
Tel: +356 21693533 
 

Deutschland 
Actavis Group PTC ehf. 
Island 
Tel: +354 5503300 
 

Nederland 
Aurobindo Pharma B.V. 
Tel: +31 355429933 
 

Eesti 
UAB Sicor Biotech Eesti filiaal 
Tel: +372 6610801 
 

Norge 
Teva Norway AS 
Tlf: +47 66775590 
 

Ελλάδα 
Specifar ABEE 
Τηλ: +30 2105401500 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1970070 
 



77 

España 
Aurovitas Spain, S.A.U. 
Tel: +34 916308645 
 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel: +48 223459300 
 

France 
Actavis Group PTC ehf. 
Islande 
Tél: +354 5503300 
 

Portugal 
Actavis Group PTC ehf. 
Islândia 
Tel: +354 5503300 
 

Hrvatska 
Pliva Hrvatska d.o.o. 
Tel: +385 13720 000 
 

România 
Teva Pharmaceuticals S.R.L. 
Tel: +40 212306524 
 

Ireland 
Actavis Ireland Limited 
Tel: +353 214619040 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 15890390 
 

Ísland 
Actavis Group PTC ehf. 
Sími: +354 5503300 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 257267911 
 

Italia 
Actavis Group PTC ehf. 
Islanda 
Tel: +354 5503300 
 

Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 201805900 
 

Κύπρος 
Specifar ABEE 
Ελλάδα 
Τηλ: +30 2105401500 
 

Sverige 
Teva Sweden AB 
Tel: +46 42121100 
 

Latvija 
UAB Sicor Biotech filiāle Latvijā 
Tel: +371 67323666 
 

United Kingdom 
Actavis UK Limited 
Tel: +44 1271385257 
 

 
This leaflet was last revised in {MM/YYYY} 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/.  



78 

Package leaflet: Information for the patient 
 

Nemdatine 10 mg film-coated tablets 
memantine hydrochloride 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Nemdatine is and what it is used for 
2. What you need to know before you take Nemdatine 
3. How to take Nemdatine 
4. Possible side effects 
5. How to store Nemdatine 
6. Contents of the pack and other information 
 
 
1. What Nemdatine is and what it is used for 
 
How does Nemdatine work 
Nemdatine contains the active substance memantine hydrochloride. Nemdatine belongs to a group of 
medicines known as anti-dementia medicines. 
Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain 
contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve 
signals important in learning and memory. Nemdatine belongs to a group of medicines called NMDA- 
receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve 
signals and the memory. 
 
What is Nemdatine used for 
Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s disease. 
 
 
2. What you need to know before you take Nemdatine 
 
Do not take Nemdatine 
- if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine 

(listed in section 6). 
 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Nemdatine 
- if you have a history of epileptic seizures 
- if you have recently experienced a myocardial infarction (heart attack), or if you are suffering 

from congestive heart failure or from an uncontrolled hypertension (high blood pressure). 
 
In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine 
reassessed by your doctor on a regular basis. 
If you suffer from renal impairment (kidney problems), your doctor should closely monitor your 
kidney function and if necessary adapt the memantine doses accordingly. 
 
The use of medicinal products called amantadine (for the treatment of Parkinson’s disease), ketamine 
(a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and 



79 

other NMDA-antagonists at the same time should be avoided. 
 
Children and adolescents 
Nemdatine is not recommended for children and adolescents under the age of 18 years. 
 
Other medicines and Nemdatine 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
In particular, Nemdatine may change the effects of the following medicines and their dose may need to 
be adjusted by your doctor: 
- amantadine, ketamine, dextromethorphan 
- dantrolene, baclofen 
- cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine 
- hydrochlorothiazide (or any combination with hydrochlorothiazide) 
- anticholinergics (substances generally used to treat movement disorders or intestinal cramps) 
- anticonvulsants (substances used to prevent and relieve seizures) 
- barbiturates (substances generally used to induce sleep) 
- dopaminergic agonists (substances such as L-dopa, bromocriptine) 
- neuroleptics (substances used in the treatment of mental disorders) 
- oral anticoagulants 
 
If you go into hospital, let your doctor know that you are taking Nemdatine. 
 
Nemdatine with food and drink 
You should inform your doctor if you have recently changed or intend to change your diet 
substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal 
tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction 
(poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your 
doctor may need to adjust the dose of your medicine. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
Pregnancy 
The use of memantine in pregnant women is not recommended. 
 
Breast-feeding 
Women taking Nemdatine should not breast-feed. 
 
Driving and using machines 
Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, 
Nemdatine may change your reactivity, making driving or operating machinery inappropriate. 
 
Nemdatine contains lactose monohydrate 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicinal product. 
 
 
3. How to take Nemdatine 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure. 
 
Dosage 
The recommended dose of Nemdatine for adults and older people is 20 mg once a day. 



80 

In order to reduce the risk of side effects this dose is achieved gradually by the following daily 
treatment scheme: 
 
Week 1 Half a 10 mg tablet 
Week 2 One 10 mg tablet 
Week 3 One and a half 10 mg tablets 
Week 4 and beyond Two 10 mg tablets once a day 
 
The usual starting dose is half a tablet once a day (1x 5 mg) for the first week. This is increased to one 
tablet once a day (1x 10 mg) in the second week and to 1 and a half tablets once a day (1x 15 mg) in 
the third week. From the fourth week on, the usual dose is 2 tablets once a day (1x 20 mg). 
 
Dosage in patients with impaired kidney function 
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In 
this case, monitoring of your kidney function should be performed by your doctor at specified 
intervals. 
 
Administration 
Nemdatine should be administered orally once a day. To benefit from your medicine you should take it 
regularly every day at the same time of the day. The tablets should be swallowed with some water. 
The tablets can be taken with or without food. 
 
Duration of treatment 
Continue to take Nemdatine as long as it is of benefit to you. Your doctor should assess your treatment 
on a regular basis. 
 
If you take more Nemdatine than you should 
- In general, taking too much Nemdatine should not result in any harm to you. You may 

experience increased symptoms as described in section 4 ‘Possible side effects’. 
- If you take a large overdose of Nemdatine, contact your doctor or get medical advice, as you 

may need medical attention. 
 
If you forget to take Nemdatine 
- If you find you have forgotten to take your dose of Nemdatine, wait and take your next dose at 

the usual time. 
- Do not take a double dose to make up for a forgotten dose. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
In general, the observed side effects are mild to moderate. 
 
Common (affects 1 to 10 users in 100) 
- Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, 

shortness of breath, high blood pressure and drug hypersensitivity 
 
Uncommon (affects 1 to 10 users in 1,000) 
- Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure 

and venous blood clotting (thrombosis/thromboembolism) 
 
Very Rare (affects less than 1 user in 10,000) 
- Seizures 



81 

 
Not known (frequency cannot be estimated from the available data) 
- Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions 
 
Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events 
have been reported in patients treated with memantine. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Nemdatine 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton, blister and bottle label 
after ‘EXP’. The expiry date refers to the last day of that month. 
 
Do not store above 25°C. 
 
<[For HDPE bottle only:]> 
Use within 100 days after opening. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information  
 
What Nemdatine contains 
- The active substance is memantine hydrochloride. Each film-coated tablet contains 10 mg 

memantine hydrochloride equivalent to 8.31 mg memantine. 
 
- The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc 

and magnesium stearate. Tablet coat (Opadry II White 33G28435): Hypromellose 6cP, titanium 
dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin. 

 
What Nemdatine looks like and contents of the pack 
Nemdatine 10 mg film-coated tablets (tablets) are white, capsule-shaped, biconvex, 9.8 mm x 4.9 mm 
in size, with score line and the marking “M 10” engraved on the scored side  
 
Pack sizes 
Blister packs: 28, 30, 42, 50, 56, 60, 98 and 112 film-coated tablets.  
Bottle: 100 film-coated tablets. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Actavis Group PTC ehf. 
Reykjavíkurvegi 76-78 
220 Hafnarfjörður 
Iceland 
 
Manufacturer 



82 

Actavis hf. 
Reykjavíkurvegi 78 
220 Hafnarfjörður 
Iceland 
 
Actavis Group PTC ehf. 
Reykjavikurvegur 76-78 
220 Hafnarfjordur 
Iceland 
 
Actavis Ltd. 
BLB 016 Bulebel Industrial Estate 
Zejtun ZTN 3000 
Malta 
 
Manufacturing Packaging Farmaca (MPF) B.V 
Neptunus 12, 
Heerenveen, 8448CN, 
Netherlands 
 
Manufacturing Packaging Farmaca (MPF) B.V 
Appelhof 13, 
Oudehaske, 8465RX, 
Netherlands 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Actavis Group PTC ehf. 
IJsland/Islande/Island 
Tél/Tel: +354 5503300 
 

Lietuva 
UAB Sicor Biotech 
Tel: +370 52660203 
 

България 
Актавис ЕАД 
Teл: +359 24899585 
 

Luxembourg/Luxemburg 
Actavis Group PTC ehf. 
Islande/Island 
Tél/Tel: +354 5503300 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: +420 251007111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel: +36 12886400 
 

Danmark 
Teva Denmark A/S 
Tlf: +45 44985511 
 

Malta 
Actavis Ltd. 
Tel: +356 21693533 
 

Deutschland 
Actavis Group PTC ehf. 
Island 
Tel: +354 5503300 
 

Nederland 
Aurobindo Pharma B.V. 
Tel: +31 355429933 
 

Eesti 
UAB Sicor Biotech Eesti filiaal 
Tel: +372 6610801 
 

Norge 
Teva Norway AS 
Tlf: +47 66775590 
 



83 

Ελλάδα 
Specifar ABEE 
Τηλ: +30 2105401500 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1970070 
 

España 
Aurovitas Spain, S.A.U. 
Tel: +34 916308645 
 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel: +48 223459300 
 

France 
Actavis Group PTC ehf. 
Islande 
Tél: +354 5503300 
 

Portugal 
Actavis Group PTC ehf. 
Islândia 
Tel: +354 5503300 
 

Hrvatska 
Pliva Hrvatska d.o.o. 
Tel: +385 13720 000 
 

România 
Teva Pharmaceuticals S.R.L. 
Tel: +40 212306524 
 

Ireland 
Actavis Ireland Limited 
Tel: +353 214619040 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 15890390 
 

Ísland 
Actavis Group PTC ehf. 
Sími: +354 5503300 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 257267911 
 

Italia 
Actavis Group PTC ehf. 
Islanda 
Tel: +354 5503300 
 

Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 201805900 
 

Κύπρος 
Specifar ABEE 
Ελλάδα 
Τηλ: +30 2105401500 
 

Sverige 
Teva Sweden AB 
Tel: +46 42121100 
 

Latvija 
UAB Sicor Biotech filiāle Latvijā 
Tel: +371 67323666 
 

United Kingdom 
Actavis UK Limited 
Tel: +44 1271385257 
 

 
This leaflet was last revised in {MM/YYYY} 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/.  

  



84 

Package leaflet: Information for the patient 
 

Nemdatine 15 mg film-coated tablets 
memantine hydrochloride 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Nemdatine is and what it is used for 
2. What you need to know before you take Nemdatine 
3. How to take Nemdatine 
4. Possible side effects 
5. How to store Nemdatine 
6. Contents of the pack and other information 
 
 
1. What Nemdatine is and what it is used for  
 
How does Nemdatine work 
Nemdatine contains the active substance memantine hydrochloride. Nemdatine belongs to a group of 
medicines known as anti-dementia medicines. 
Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain 
contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve 
signals important in learning and memory. Nemdatine belongs to a group of medicines called NMDA- 
receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve 
signals and the memory. 
 
What is Nemdatine used for 
Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s disease. 
 
 
2. What you need to know before you take Nemdatine 
 
Do not take Nemdatine 
- if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine 

(listed in section 6). 
 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Nemdatine 
- if you have a history of epileptic seizures 
- if you have recently experienced a myocardial infarction (heart attack), or if you are suffering 

from congestive heart failure or from an uncontrolled hypertension (high blood pressure). 
 
In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine 
reassessed by your doctor on a regular basis. 
If you suffer from renal impairment (kidney problems), your doctor should closely monitor your 
kidney function and if necessary adapt the memantine doses accordingly. 
 
The use of medicinal products called amantadine (for the treatment of Parkinson’s disease), ketamine 
(a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and 



85 

other NMDA-antagonists at the same time should be avoided. 
 
Children and adolescents 
Nemdatine is not recommended for children and adolescents under the age of 18 years. 
 
Other medicines and Nemdatine 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
In particular, Nemdatine may change the effects of the following medicines and their dose may need to 
be adjusted by your doctor: 
- amantadine, ketamine, dextromethorphan 
- dantrolene, baclofen 
- cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine 
- hydrochlorothiazide (or any combination with hydrochlorothiazide) 
- anticholinergics (substances generally used to treat movement disorders or intestinal cramps) 
- anticonvulsants (substances used to prevent and relieve seizures) 
- barbiturates (substances generally used to induce sleep) 
- dopaminergic agonists (substances such as L-dopa, bromocriptine) 
- neuroleptics (substances used in the treatment of mental disorders) 
- oral anticoagulants 
 
If you go into hospital, let your doctor know that you are taking Nemdatine. 
 
Nemdatine with food and drink 
You should inform your doctor if you have recently changed or intend to change your diet 
substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal 
tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction 
(poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your 
doctor may need to adjust the dose of your medicine. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
Pregnancy 
The use of memantine in pregnant women is not recommended. 
 
Breast-feeding 
Women taking Nemdatine should not breast-feed. 
 
Driving and using machines 
Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, 
Nemdatine may change your reactivity, making driving or operating machinery inappropriate. 
 
Nemdatine contains lactose monohydrate 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicinal product. 
 
 
3. How to take Nemdatine 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure. 
 
Dosage 
The recommended dose of Nemdatine for adults and older people is 20 mg once a day. 



86 

In order to reduce the risk of side effects this dose is achieved gradually by the following daily 
treatment scheme: 
 
Week 1 One 5 mg tablet 
Week 2 One 10 mg tablet 
Week 3 One 15 mg tablet 
Week 4 and beyond One 20 mg tablet once a day 
 
The usual starting dose is 5 mg memantine once a day for the first week. This is increased to 10 mg 
memantine in the second week and to 15 mg memantine once a day in the third week. From the fourth 
week on, the usual dose is 20 mg memantine once a day. 
 
Dosage in patients with impaired kidney function 
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In 
this case, monitoring of your kidney function should be performed by your doctor at specified 
intervals. 
 
Administration 
Nemdatine should be administered orally once a day. To benefit from your medicine you should take it 
regularly every day at the same time of the day. The tablets should be swallowed with some water. 
The tablets can be taken with or without food. 
 
Duration of treatment 
Continue to take Nemdatine as long as it is of benefit to you. Your doctor should assess your treatment 
on a regular basis. 
 
If you take more Nemdatine than you should 
- In general, taking too much Nemdatine should not result in any harm to you. You may 

experience increased symptoms as described in section 4 ‘Possible side effects’. 
- If you take a large overdose of Nemdatine, contact your doctor or get medical advice, as you 

may need medical attention. 
 
If you forget to take Nemdatine 
- If you find you have forgotten to take your dose of Nemdatine, wait and take your next dose at 

the usual time. 
- Do not take a double dose to make up for a forgotten dose. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
In general, the observed side effects are mild to moderate. 
 
Common (affects 1 to 10 users in 100) 
- Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, 

shortness of breath, high blood pressure and drug hypersensitivity 
 
Uncommon (affects 1 to 10 users in 1,000) 
- Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure 

and venous blood clotting (thrombosis/thromboembolism) 
 
Very Rare (affects less than 1 user in 10,000) 
- Seizures 



87 

 
Not known (frequency cannot be estimated from the available data) 
- Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions 
 
Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events 
have been reported in patients treated with memantine. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Nemdatine 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. 
The expiry date refers to the last day of that month. 
 
Do not store above 25°C. 
 
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 
dispose of medicines no longer required. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Nemdatine contains 
- The active substance is memantine hydrochloride. Each film-coated tablet contains 15 mg 

memantine hydrochloride equivalent to 12.46 mg memantine. 
 
- The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc 

and magnesium stearate. Tablet coat (Opadry II Orange 33G230001): Hypromellose 6cP, 
titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin and iron oxide yellow, 
red and black (E172). 

 
What Nemdatine looks like and contents of the pack 
Nemdatine 15 mg film-coated tablets (tablets) are orange, oval shaped, biconvex, 11.4 mm x 6.4 mm 
in size, with the marking “M15” engraved on one side. 
 
Pack sizes 
Blister packs: 7, 42 and 98 film-coated tablets.  
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Actavis Group PTC ehf. 
Reykjavíkurvegi 76-78 
220 Hafnarfjörður 
Iceland 
 
Manufacturer 
Actavis hf. 
Reykjavíkurvegi 78 
220 Hafnarfjörður 



88 

Iceland 
 
Actavis Group PTC ehf. 
Reykjavikurvegur 76-78 
220 Hafnarfjordur 
Iceland 
 
Actavis Ltd. 
BLB 016 Bulebel Industrial Estate 
Zejtun ZTN 3000 
Malta 
 
Manufacturing Packaging Farmaca (MPF) B.V 
Neptunus 12, 
Heerenveen, 8448CN, 
Netherlands 
 
Manufacturing Packaging Farmaca (MPF) B.V 
Appelhof 13, 
Oudehaske, 8465RX, 
Netherlands 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Actavis Group PTC ehf. 
IJsland/Islande/Island 
Tél/Tel: +354 5503300 
 

Lietuva 
UAB Sicor Biotech 
Tel: +370 52660203 
 

България 
Актавис ЕАД 
Teл: +359 24899585 
 

Luxembourg/Luxemburg 
Actavis Group PTC ehf. 
Islande/Island 
Tél/Tel: +354 5503300 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: +420 251007111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel: +36 12886400 
 

Danmark 
Teva Denmark A/S 
Tlf: +45 44985511 
 

Malta 
Actavis Ltd. 
Tel: +356 21693533 
 

Deutschland 
Actavis Group PTC ehf. 
Island 
Tel: +354 5503300 
 

Nederland 
Aurobindo Pharma B.V. 
Tel: +31 355429933 
 

Eesti 
UAB Sicor Biotech Eesti filiaal 
Tel: +372 6610801 
 

Norge 
Teva Norway AS 
Tlf: +47 66775590 
 

Ελλάδα 
Specifar ABEE 
Τηλ: +30 2105401500 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1970070 
 



89 

España 
Aurovitas Spain, S.A.U. 
Tel: +34 916308645 
 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel: +48 223459300 
 

France 
Actavis Group PTC ehf. 
Islande 
Tél: +354 5503300 
 

Portugal 
Actavis Group PTC ehf. 
Islândia 
Tel: +354 5503300 
 

Hrvatska 
Pliva Hrvatska d.o.o. 
Tel: +385 13720 000 
 

România 
Teva Pharmaceuticals S.R.L. 
Tel: +40 212306524 
 

Ireland 
Actavis Ireland Limited 
Tel: +353 214619040 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 15890390 
 

Ísland 
Actavis Group PTC ehf. 
Sími: +354 5503300 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 257267911 
 

Italia 
Actavis Group PTC ehf. 
Islanda 
Tel: +354 5503300 
 

Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 201805900 
 

Κύπρος 
Specifar ABEE 
Ελλάδα 
Τηλ: +30 2105401500 
 

Sverige 
Teva Sweden AB 
Tel: +46 42121100 
 

Latvija 
UAB Sicor Biotech filiāle Latvijā 
Tel: +371 67323666 
 

United Kingdom 
Actavis UK Limited 
Tel: +44 1271385257 
 

 
This leaflet was last revised in {MM/YYYY} 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/.  

  



90 

Package leaflet: Information for the patient 
 

Nemdatine 5 mg film-coated tablets 
Nemdatine 10 mg film-coated tablets 
Nemdatine 15 mg film-coated tablets 
Nemdatine 20 mg film-coated tablets 

memantine hydrochloride 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Nemdatine is and what it is used for 
2. What you need to know before you take Nemdatine 
3. How to take Nemdatine 
4. Possible side effects 
5. How to store Nemdatine 
6. Contents of the pack and other information 
 
 
1. What Nemdatine is and what it is used for 
 
How does Nemdatine work 
Nemdatine contains the active substance memantine hydrochloride. Nemdatine belongs to a group of 
medicines known as anti-dementia medicines. 
Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain 
contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve 
signals important in learning and memory. Nemdatine belongs to a group of medicines called NMDA- 
receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve 
signals and the memory. 
 
What is Nemdatine used for 
Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s disease. 
 
 
2. What you need to know before you take Nemdatine 
 
Do not take Nemdatine 
- if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine 

(listed in section 6). 
 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Nemdatine 
- if you have a history of epileptic seizures 
- if you have recently experienced a myocardial infarction (heart attack), or if you are suffering 

from congestive heart failure or from an uncontrolled hypertension (high blood pressure). 
 
In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine 
reassessed by your doctor on a regular basis. 
If you suffer from renal impairment (kidney problems), your doctor should closely monitor your 
kidney function and if necessary adapt the memantine doses accordingly. 



91 

 
The use of medicinal products called amantadine (for the treatment of Parkinson’s disease), ketamine 
(a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and 
other NMDA-antagonists at the same time should be avoided. 
 
Children and adolescents 
Nemdatine is not recommended for children and adolescents under the age of 18 years. 
 
Other medicines and Nemdatine 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
In particular, Nemdatine may change the effects of the following medicines and their dose may need to 
be adjusted by your doctor: 
- amantadine, ketamine, dextromethorphan 
- dantrolene, baclofen 
- cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine 
- hydrochlorothiazide (or any combination with hydrochlorothiazide) 
- anticholinergics (substances generally used to treat movement disorders or intestinal cramps) 
- anticonvulsants (substances used to prevent and relieve seizures) 
- barbiturates (substances generally used to induce sleep) 
- dopaminergic agonists (substances such as L-dopa, bromocriptine) 
- neuroleptics (substances used in the treatment of mental disorders) 
- oral anticoagulants 
 
If you go into hospital, let your doctor know that you are taking Nemdatine. 
 
Nemdatine with food and drink 
You should inform your doctor if you have recently changed or intend to change your diet 
substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal 
tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction 
(poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your 
doctor may need to adjust the dose of your medicine. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
Pregnancy 
The use of memantine in pregnant women is not recommended. 
 
Breast-feeding 
Women taking Nemdatine should not breast-feed. 
 
Driving and using machines 
Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, 
Nemdatine may change your reactivity, making driving or operating machinery inappropriate. 
 
Nemdatine contains lactose monohydrate 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicinal product. 
 
 
3. How to take Nemdatine 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure. 



92 

 
The Nemdatine treatment initiation pack is only to be used for the beginning of the treatment with 
Nemdatine. 
 
Dosage 
The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the 
Nemdatine dose during the first 3 weeks of treatment. The treatment scheme is also indicated on the 
treatment initiation pack. Take one tablet once a day. 
 
Week 1 (day 1-7): 
Take one 5 mg tablet once a day (white, oval-shaped) for 7 days. 
 
Week 2 (day 8-14): 
Take one 10 mg tablet once a day (white, capsule shaped) for 7 days. 
 
Week 3 (day 15-21): 
Take one 15 mg tablet once a day (orange, oval shaped) for 7 days. 
 
Week 4 (day 22-28): 
Take one 20 mg tablet per day (dark pink, oval shaped) for 7 days. 
 
Week 1 5 mg tablet 
Week 2 10 mg tablet 
Week 3 15 mg tablet 
Week 4 and beyond 20 mg tablets once a day 

 
Maintenance dose 
The recommended daily dose is 20 mg once a day. 
For continuation of the treatment please consult your doctor. 
 
Dosage in patients with impaired kidney function 
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In 
this case, monitoring of your kidney function should be performed by your doctor at specified 
intervals. 
 
Administration 
Nemdatine should be administered orally once a day. To benefit from your medicine you should take it 
regularly every day at the same time of the day. The tablets should be swallowed with some water. 
The tablets can be taken with or without food. 
 
Duration of treatment 
Continue to take Nemdatine as long as it is of benefit to you. Your doctor should assess your treatment 
on a regular basis. 
 
If you take more Nemdatine than you should 
- In general, taking too much Nemdatine should not result in any harm to you. You may 

experience increased symptoms as described in section 4 ‘Possible side effects’. 
- If you take a large overdose of Nemdatine, contact your doctor or get medical advice, as you 

may need medical attention. 
 
If you forget to take Nemdatine 
- If you find you have forgotten to take your dose of Nemdatine, wait and take your next dose at 

the usual time. 
- Do not take a double dose to make up for a forgotten dose. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 



93 

 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
In general, the observed side effects are mild to moderate. 
 
Common (affects 1 to 10 users in 100) 
- Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, 

shortness of breath, high blood pressure and drug hypersensitivity 
 
Uncommon (affects 1 to 10 users in 1,000) 
- Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure 

and venous blood clotting (thrombosis/thromboembolism) 
 
Very Rare (affects less than 1 user in 10,000) 
- Seizures 
 
Not known (frequency cannot be estimated from the available data) 
- Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions 
 
Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events 
have been reported in patients treated with memantine. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Nemdatine 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. 
The expiry date refers to the last day of that month. 
 
Do not store above 25°C. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Nemdatine contains 
- The active substance is memantine hydrochloride. Each film-coated tablet contains 5, 10, 15, or 

20 mg memantine hydrochloride equivalent to 4.15, 8.31, 12.46 or 16.62 mg memantine. 
 
- The other ingredients for Nemdatine 5, 10, 15 and 20 mg film-coated tablets are: Tablet core: 

Microcrystalline cellulose, crospovidone Type A, talc and magnesium stearate. Tablet coat: 
Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin. 
The 15 mg tablets furthermore contain iron oxide yellow, red and black (E172). The 20 mg 
tablets furthermore contain iron oxide red and yellow (E172). 

 
What Nemdatine looks like and contents of the pack 



94 

Nemdatine 5 mg film-coated tablets (tablets) are white, oval shaped, biconvex, 8 mm x 4.5 mm in size, 
with the marking “M5” engraved on one side. 
Nemdatine 10 mg film-coated tablets (tablets) are white, capsule-shaped, biconvex, 9.8 mm x 4.9 mm 
in size, with score line and the marking “M 10” engraved on the scored side.  
Nemdatine 15 mg film-coated tablets (tablets) are orange, oval shaped, biconvex, 11.4 mm x 6.4 mm 
in size, with the marking “M15” engraved on one side. 
Nemdatine 20 mg film-coated tablets (tablets) are dark pink, oval shaped, biconvex, 12.6 mm x 7 mm 
in size, with the marking “M20” engraved on one side. 
 
One treatment initiation pack contains 28 tablets in 4 blisters in a wallet pack or a multipack of 4 
blisters in 4 separate immediate cartons and one outer carton with 7 tablets of Nemdatine 5 mg, 
7 tablets of Nemdatine 10 mg, 7 tablets of Nemdatine 15 mg and 7 tablets of Nemdatine 20 mg. 
 
Marketing Authorisation Holder 
Actavis Group PTC ehf. 
Reykjavíkurvegi 76-78 
220 Hafnarfjörður 
Iceland 
 
Manufacturer 
Actavis hf. 
Reykjavíkurvegi 78 
220 Hafnarfjörður 
Iceland 
 
Actavis Group PTC ehf. 
Reykjavikurvegur 76-78 
220 Hafnarfjordur 
Iceland 
 
Actavis Ltd. 
BLB 016 Bulebel Industrial Estate 
Zejtun ZTN 3000 
Malta 
 
Manufacturing Packaging Farmaca (MPF) B.V 
Neptunus 12, 
Heerenveen, 8448CN, 
Netherlands 
 
Manufacturing Packaging Farmaca (MPF) B.V 
Appelhof 13, 
Oudehaske, 8465RX, 
Netherlands 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Aurobindo Pharma B.V. 
Nederland/Pays-Bas/Niederlande 
Tél/Tel: +31 355429933 
 

Lietuva 
UAB Sicor Biotech 
Tel: +370 52660203 
 



95 

България 
Актавис ЕАД 
Teл: +359 24899585 
 

Luxembourg/Luxemburg 
Actavis Group PTC ehf. 
Islande/Island 
Tél/Tel: +354 5503300 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: +420 251007111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel: +36 12886400 
 

Danmark 
Teva Denmark A/S 
Tlf: +45 44985511 
 

Malta 
Actavis Ltd. 
Tel: +356 21693533 
 

Deutschland 
Actavis Group PTC ehf. 
Island 
Tel: +354 5503300 
 

Nederland 
Aurobindo Pharma B.V. 
Tel: +31 355429933 
 

Eesti 
UAB Sicor Biotech Eesti filiaal 
Tel: +372 6610801 
 

Norge 
Teva Norway AS 
Tlf: +47 66775590 
 

Ελλάδα 
Specifar ABEE 
Τηλ: +30 2105401500 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1970070 
 

España 
Aurovitas Spain, S.A.U. 
Tel: +34 916308645 
 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel: +48 223459300 
 

France 
Actavis Group PTC ehf. 
Islande 
Tél: +354 5503300 
 

Portugal 
Actavis Group PTC ehf. 
Islândia 
Tel: +354 5503300 
 

Hrvatska 
Pliva Hrvatska d.o.o. 
Tel: +385 13720 000 
 

România 
Teva Pharmaceuticals S.R.L. 
Tel: +40 212306524 
 

Ireland 
Actavis Ireland Limited 
Tel: +353 214619040 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 15890390 
 

Ísland 
Actavis Group PTC ehf. 
Sími: +354 5503300 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 257267911 
 

Italia 
Actavis Group PTC ehf. 
Islanda 
Tel: +354 5503300 
 

Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 201805900 
 

Κύπρος 
Specifar ABEE 
Ελλάδα 
Τηλ: +30 2105401500 
 

Sverige 
Teva Sweden AB 
Tel: +46 42121100 
 



96 

Latvija 
UAB Sicor Biotech filiāle Latvijā 
Tel: +371 67323666 
 

United Kingdom 
Actavis UK Limited 
Tel: +44 1271385257 
 

 
This leaflet was last revised in {MM/YYYY} 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/.  

  



97 

Package leaflet: Information for the patient 
 

Nemdatine 20 mg film-coated tablets 
memantine hydrochloride 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Nemdatine is and what it is used for 
2. What you need to know before you take Nemdatine 
3. How to take Nemdatine 
4. Possible side effects 
5. How to store Nemdatine 
6. Contents of the pack and other information 
 
 
1. What Nemdatine is and what it is used for 
 
How does Nemdatine work 
Nemdatine contains the active substance memantine hydrochloride. Nemdatine belongs to a group of 
medicines known as anti-dementia medicines. 
Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain 
contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve 
signals important in learning and memory. Nemdatine belongs to a group of medicines called NMDA- 
receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve 
signals and the memory. 
 
What is Nemdatine used for 
Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s disease. 
 
 
2. What you need to know before you before you take Nemdatine 
 
Do not take Nemdatine 
- if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine 

(listed in section 6). 
 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Nemdatine 
- if you have a history of epileptic seizures 
- if you have recently experienced a myocardial infarction (heart attack), or if you are suffering 

from congestive heart failure or from an uncontrolled hypertension (high blood pressure). 
 
In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine 
reassessed by your doctor on a regular basis. 
If you suffer from renal impairment (kidney problems), your doctor should closely monitor your 
kidney function and if necessary adapt the memantine doses accordingly. 
 
The use of medicinal products called amantadine (for the treatment of Parkinson’s disease), ketamine 
(a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and 



98 

other NMDA-antagonists at the same time should be avoided. 
 
Children and adolescents 
Nemdatine is not recommended for children and adolescents under the age of 18 years. 
 
Other medicines and Nemdatine 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
In particular, Nemdatine may change the effects of the following medicines and their dose may need to 
be adjusted by your doctor: 
- amantadine, ketamine, dextromethorphan 
- dantrolene, baclofen 
- cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine 
- hydrochlorothiazide (or any combination with hydrochlorothiazide) 
- anticholinergics (substances generally used to treat movement disorders or intestinal cramps) 
- anticonvulsants (substances used to prevent and relieve seizures) 
- barbiturates (substances generally used to induce sleep) 
- dopaminergic agonists (substances such as L-dopa, bromocriptine) 
- neuroleptics (substances used in the treatment of mental disorders) 
- oral anticoagulants 
 
If you go into hospital, let your doctor know that you are taking Nemdatine. 
 
Nemdatine with food and drink 
You should inform your doctor if you have recently changed or intend to change your diet 
substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal 
tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction 
(poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your 
doctor may need to adjust the dose of your medicine. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
Pregnancy 
The use of memantine in pregnant women is not recommended. 
 
Breast-feeding 
Women taking Nemdatine should not breast-feed. 
 
Driving and using machines 
Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, 
Nemdatine may change your reactivity, making driving or operating machinery inappropriate. 
 
Nemdatine contains lactose monohydrate 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicinal product. 
 
 
3. How to take Nemdatine 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure. 
 
Dosage 
The recommended dose of Nemdatine for adults and older people is 20 mg once a day. 



99 

In order to reduce the risk of side effects this dose is achieved gradually by the following daily 
treatment scheme. For up-titration other tablet strengths are available. 
 
At the beginning of treatment you will start by using Nemdatine 5 mg film-coated tablets once a day. 
This dose will be increased weekly by 5 mg until the recommended (maintenance) dose is reached. 
The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the 4th 
week. 
 
Dosage in patients with impaired kidney function 
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In 
this case, monitoring of your kidney function should be performed by your doctor at specified 
intervals. 
 
Administration 
Nemdatine should be administered orally once a day. To benefit from your medicine you should take it 
regularly every day at the same time of the day. The tablets should be swallowed with some water. 
The tablets can be taken with or without food. 
 
Duration of treatment 
Continue to take Nemdatine as long as it is of benefit to you. Your doctor should assess your treatment 
on a regular basis. 
 
If you take more Nemdatine than you should 
- In general, taking too much Nemdatine should not result in any harm to you. You may 

experience increased symptoms as described in section 4 ‘Possible side effects’. 
- If you take a large overdose of Nemdatine, contact your doctor or get medical advice, as you 

may need medical attention. 
 
If you forget to take Nemdatine 
- If you find you have forgotten to take your dose of Nemdatine, wait and take your next dose at 

the usual time. 
- Do not take a double dose to make up for a forgotten dose. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
In general, the observed side effects are mild to moderate. 
 
Common (affects 1 to 10 users in 100) 
- Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, 

shortness of breath, high blood pressure and drug hypersensitivity 
 
Uncommon (affects 1 to 10 users in 1,000) 
- Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure 

and venous blood clotting (thrombosis/thromboembolism) 
 
Very Rare (affects less than 1 user in 10,000) 
- Seizures 
 
Not known (frequency cannot be estimated from the available data) 
- Inflammation of the pancreas, inflammation of the liver (hepatitis)  and psychotic reactions 
 
Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events 



100 

have been reported in patients treated with memantine. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Nemdatine 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton, blister and bottle label 
after ‘EXP’. The expiry date refers to the last day of that month. 
 
Do not store above 25°C. 
 
<[For HDPE bottle only:]> 
Use within 100 days after opening. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Nemdatine contains 
- The active substance is memantine hydrochloride. Each film-coated tablet contains 20 mg 

memantine hydrochloride equivalent to 16.62 mg memantine. 
 
- The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc 

and magnesium stearate. Tablet coat (Opadry II Pink 33G240000): Hypromellose 6cP, titanium 
dioxide (E171), lactose monohydrate, macrogol 3350, triacetin and iron oxide red and yellow 
(E172). 

 
What Nemdatine looks like and contents of the pack 
Nemdatine 20 mg film-coated tablets (tablets) are dark pink, oval shaped, biconvex, 12.6 mm x 7 mm 
in size, with the marking “M20” engraved on one side. 
 
Pack sizes 
Blister packs: 28, 42, 56 and 98 film-coated tablets.  
Bottle: 100 film-coated tablets. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Actavis Group PTC ehf. 
Reykjavíkurvegi 76-78 
220 Hafnarfjörður 
Iceland 
 
Manufacturer 
Actavis hf. 
Reykjavíkurvegi 78 
220 Hafnarfjörður 
Iceland 



101 

 
Actavis Group PTC ehf. 
Reykjavikurvegur 76-78 
220 Hafnarfjordur 
Iceland 
 
Actavis Ltd. 
BLB 016 Bulebel Industrial Estate 
Zejtun ZTN 3000 
Malta 
 
Manufacturing Packaging Farmaca (MPF) B.V 
Neptunus 12, 
Heerenveen, 8448CN, 
Netherlands 
 
Manufacturing Packaging Farmaca (MPF) B.V 
Appelhof 13, 
Oudehaske, 8465RX, 
Netherlands 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Actavis Group PTC ehf. 
IJsland/Islande/Island 
Tél/Tel: +354 5503300 
 

Lietuva 
UAB Sicor Biotech 
Tel: +370 52660203 
 

България 
Актавис ЕАД 
Teл: +359 24899585 
 

Luxembourg/Luxemburg 
Actavis Group PTC ehf. 
Islande/Island 
Tél/Tel: +354 5503300 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: +420 251007111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel: +36 12886400 
 

Danmark 
Teva Denmark A/S 
Tlf: +45 44985511 
 

Malta 
Actavis Ltd. 
Tel: +356 21693533 
 

Deutschland 
Actavis Group PTC ehf. 
Island 
Tel: +354 5503300 
 

Nederland 
Aurobindo Pharma B.V. 
Tel: +31 355429933 
 

Eesti 
UAB Sicor Biotech Eesti filiaal 
Tel: +372 6610801 
 

Norge 
Teva Norway AS 
Tlf: +47 66775590 
 

Ελλάδα 
Specifar ABEE 
Τηλ: +30 2105401500 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1970070 
 



102 

España 
Aurovitas Spain, S.A.U. 
Tel: +34 916308645 
 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel: +48 223459300 
 

France 
Actavis Group PTC ehf. 
Islande 
Tél: +354 5503300 
 

Portugal 
Actavis Group PTC ehf. 
Islândia 
Tel: +354 5503300 
 

Hrvatska 
Pliva Hrvatska d.o.o. 
Tel: +385 13720 000 
 

România 
Teva Pharmaceuticals S.R.L. 
Tel: +40 212306524 
 

Ireland 
Actavis Ireland Limited 
Tel: +353 214619040 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 15890390 
 

Ísland 
Actavis Group PTC ehf. 
Sími: +354 5503300 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 257267911 
 

Italia 
Actavis Group PTC ehf. 
Islanda 
Tel: +354 5503300 
 

Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 201805900 
 

Κύπρος 
Specifar ABEE 
Ελλάδα 
Τηλ: +30 2105401500 
 

Sverige 
Teva Sweden AB 
Tel: +46 42121100 
 

Latvija 
UAB Sicor Biotech filiāle Latvijā 
Tel: +371 67323666 
 

United Kingdom 
Actavis UK Limited 
Tel: +44 1271385257 
 

 
This leaflet was last revised in {MM/YYYY} 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/.  


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET