Memantine ratiopharm

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



2 

 
1. NAME OF THE MEDICINAL PRODUCT 
 
Memantine ratiopharm 10 mg film-coated tablets 
Memantine ratiopharm 20 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Memantine ratiopharm 10 mg  
 
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg 
memantine. 
 
Memantine ratiopharm 20 mg 
 
Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg 
memantine. 
 
Excipients with known effect: 
 
Memantine ratiopharm 10 mg  
 
Lactose (80 mg/film-coated tablet) and soya lecithin (0.13 mg/film-coated tablet). 
 
Memantine ratiopharm 20 mg 
 
Lactose (160 mg/film-coated tablet) and soya lecithin (0.26 mg/film-coated tablet). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet) 
 
Memantine ratiopharm 10 mg  
 
White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with 
“10” on the other side. The tablet can be divided into equal doses. 
 
Memantine ratiopharm 20 mg 
 
White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with 
“20” on the other side. The tablet can be divided into equal doses. 
 
 
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.  



3 

 
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 half a 10 mg film-coated tablet (5 mg) per day for 

7 days. 
Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet (10 mg) per day for 

7 days. 
Week 3 (day 15-21): The patient should take one and a half 10 mg film-coated tablets (15 mg) per 

day for 7 days. 
From Week 4 on: The patient should take two 10 mg film-coated tablets (20 mg) or one 20 mg 

film-coated tablet 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 (two 10 mg film-coated tablets or one 20 mg film-coated tablet 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 Memantine ratiopharm is not recommended in patients 
with severe hepatic impairment. 
 
Paediatric population 
No data available. 
 
Method of administration 
 
Memantine ratiopharm 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 



4 

 
Hypersensitivity to the active substance, peanut or soya 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. 
 
Excipients 
 
Memantine ratiopharm contains lactose. Patients with rare hereditary problems of galactose 
intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this 
medicine. 
Memantine ratiopharm contains soya lecithin, see section 4.3. 
 
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. 
 



5 

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 
compromises the ability to use machinery. Furthermore, Memantine ratiopharm has minor to 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. 
 
Infections and infestations Uncommon Fungal infections 
Immune system disorders Common Drug hypersensitivity 
Psychiatric disorders Common 

Uncommon 
Uncommon 
Not known 

Somnolence 
Confusion 
Hallucinations1 
Psychotic reactions2 



6 

Nervous system disorders Common 
Common 
Uncommon 
Very rare 

Dizziness 
Balance disorders 
Gait abnormal 
Seizures 

Cardiac disorders Uncommon Cardiac failure 
Vascular disorders Common 

Uncommon 
Hypertension 
Venous 
thrombosis/thromboembolism 

Respiratory, thoracic and 
mediastinal disorders 

Common 
 

Dyspnoea 

Gastrointestinal disorders Common 
Uncommon 
Not known 

Constipation 
Vomiting 
Pancreatitis2 

Hepatobiliary disorders Common 
Not known 

Elevated liver function test 
Hepatitis 

General disorders and 
administration site conditions 

Common 
Uncommon 

Headache 
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 2000 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. 



7 

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. 
 
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 studies 
 
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 



8 

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. 
 
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. 
 



9 

 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core 
 
Cellulose microcrystalline (E 460) 
Starch pregelatinised (E 1404) 
Lactose anhydrous 
Colloidal anhydrous silica (E 551) 
Magnesium stearate (E 470b) 
 
Coating 
 
Polysorbate 80 (E 433) 
Polyvinyl alcohol (E 1203) 
Titanium dioxide (E 171) 
Talc (E 553b) 
Soya lecithin (E 322) 
Xanthan gum (E 415) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
 
HDPE bottles: 
Shelf life after first opening: 6 months 
 
6.4 Special precautions for storage 
 
Blister packs 
 
Do not store above 25°C. 
 
HDPE bottles 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
10 mg film-coated tablets 
 
PVC/PVDC-Aluminium foil blister packs 
Pack sizes of 10, 14, 21, 28, 30, 42, 50, 56, 98, 100, 112 film-coated tablets. 
 
HDPE (high-density polyethylene) bottles with PP (polypropylene) caps 
Pack sizes of 100 film-coated tablets. 
 
20 mg film-coated tablets 
 
PVC/PVDC-Aluminium foil blister packs 
Pack sizes of 10, 14, 21, 28, 30, 42, 56, 98, 100 film-coated tablets. 



10 

 
HDPE (high-density polyethylene) bottles with PP (polypropylene) caps 
Pack sizes of 100 film-coated tablets. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/836/001 
EU/1/13/836/002 
EU/1/13/836/003 
EU/1/13/836/004 
EU/1/13/836/005 
EU/1/13/836/006 
EU/1/13/836/007 
EU/1/13/836/008 
EU/1/13/836/009 
EU/1/13/836/010 
EU/1/13/836/011 
EU/1/13/836/012 
EU/1/13/836/013 
EU/1/13/836/014 
EU/1/13/836/015 
EU/1/13/836/016 
EU/1/13/836/017 
EU/1/13/836/018 
EU/1/13/836/019 
EU/1/13/836/020 
EU/1/13/836/021 
EU/1/13/836/022 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 13 June 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. 



11 

 
1. NAME OF THE MEDICINAL PRODUCT 
 
Memantine ratiopharm 5 mg film-coated tablets 
Memantine ratiopharm 10 mg film-coated tablets 
Memantine ratiopharm 15 mg film-coated tablets 
Memantine ratiopharm 20 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Memantine ratiopharm 5 mg 
 
Each film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine. 
 
Memantine ratiopharm 10 mg 
 
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg 
memantine. 
 
Memantine ratiopharm 15 mg 
 
Each film-coated tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg 
memantine. 
 
Memantine ratiopharm 20 mg 
 
Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg 
memantine. 
 
Excipients with known effect: 
 
Memantine ratiopharm 5 mg 
 
Lactose (40 mg/film-coated tablet) and soya lecithin (0.065 mg/film-coated tablet). 
 
Memantine ratiopharm 10 mg 
 
Lactose (80 mg/film-coated tablet) and soya lecithin (0.13 mg/film-coated tablet). 
 
Memantine ratiopharm 15 mg 
 
Lactose (120 mg/film-coated tablet) and soya lecithin (0.195 mg/film-coated tablet). 
 
Memantine ratiopharm 20 mg 
 
Lactose (160 mg/film-coated tablet) and soya lecithin (0.26 mg/film-coated tablet). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet) 
 



12 

Memantine ratiopharm 5 mg 
 
White to off-white, capsule shaped, biconvex tablets plain on one side and debossed with “5” on the 
other side. 
 
Memantine ratiopharm 10 mg 
 
White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with 
“10” on the other side. 
 
Memantine ratiopharm 15 mg 
 
White to off-white, capsule shaped, biconvex tablets plain on one side and debossed with “15” on the 
other side. 
 
Memantine ratiopharm 20 mg 
 
White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with 
“20” on the other side. 
 
The 10 mg and 20 mg tablet can be divided into equal doses. 
 
 
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 to off-white, capsule shaped, 
biconvex tablets plain on one side and debossed with “5” on the other side) for 7 days. 
 
Week 2 (day 8-14): 



13 

The patient should take one 10 mg film-coated tablet per day (white to off-white, capsule shaped, 
biconvex tablets with a break score on one side and debossed with “10” on the other side.) for 7 days. 
 
Week 3 (day 15-21): 
The patient should take one 15 mg film-coated tablet per day (white to off-white, capsule shaped, 
biconvex tablets plain on one side and debossed with “15” on the other side.) for 7 days. 
 
Week 4 (day 22-28): 
The patient should take one 20 mg film-coated tablet per day (white to off-white, capsule shaped, 
biconvex tablets with a break score on one side and debossed with “20” on the other side.) 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 Memantine ratiopharm is not recommended in patients 
with severe hepatic impairment. 
 
Paediatric population 
No data available. 
 
Method of administration 
 
Memantine ratiopharm 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, peanut or soya 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 



14 

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. 
 
Excipients 
 
Memantine ratiopharm contains lactose. Patients with rare hereditary problems of galactose 
intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this 
medicine. 
Memantine ratiopharm contains soya lecithin, see section 4.3. 
 
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. 
 



15 

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 
compromises the ability to use machinery. Furthermore, Memantine ratiopharm has minor to 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. 
 
Infections and infestations Uncommon Fungal infections 
Immune system disorders Common Drug hypersensitivity 
Psychiatric disorders Common 

Uncommon 
Uncommon 
Not known 

Somnolence 
Confusion 
Hallucinations1 
Psychotic reactions2 

Nervous system disorders Common 
Common 
Uncommon 
Very rare 

Dizziness 
Balance disorders 
Gait abnormal 
Seizures 

Cardiac disorders Uncommon Cardiac failure 
Vascular disorders Common 

Uncommon 
Hypertension 
Venous 
thrombosis/thromboembolism 

Respiratory, thoracic and 
mediastinal disorders 

Common 
 

Dyspnoea 

Gastrointestinal disorders Common 
Uncommon 
Not known 

Constipation 
Vomiting 
Pancreatitis2 

Hepatobiliary disorders Common 
Not known 

Elevated liver function test 
Hepatitis 



16 

General disorders and 
administration site conditions 

Common 
Uncommon 

Headache 
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 2000 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. 
 
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. 
 



17 

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 studies 
 
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. 
 
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 
 



18 

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 core 
 
Cellulose microcrystalline (E 460) 
Starch pregelatinised (E 1404) 
Lactose anhydrous 
Colloidal anhydrous silica (E 551) 
Magnesium stearate (E 470b) 
 
Coating 
 



19 

Polysorbate 80 (E 433) 
Polyvinyl alcohol (E 1203) 
Titanium dioxide (E 171) 
Talc (E 553b) 
Soya lecithin (E 322) 
Xanthan gum (E 415) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
Do not store above 25°C. 
 
6.5 Nature and contents of container 
 
PVC/PVDC-Aluminium foil blister packs 
Pack sizes of 28 (7 +7 +7 + 7) film-coated tablets. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/836/023 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 13 June 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. 
 



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 

 



21 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
 
HBM Pharma s.r.o. 
Sklabinská 30 
SL-03680 Martin 
Slovakia 
 
Merckle GmbH 
Ludwig-Merckle-Strasse 3 
D-89143 Blaubeuren-Weiler 
Germany 
 
Teva Pharmaceutical Works Private Limited Company 
Pallagi út 13 
HU-4042 Debrecen 
Hungary 
 
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 

 
 Risk Management Plan (RMP) 
 
Not applicable. 
 



22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 



24 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer packaging (Blister) 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Memantine ratiopharm 10 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose and soya lecithin. Read the package leaflet before use. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
10 film-coated tablets 
14 film-coated tablets 
21 film-coated tablets 
28 film-coated tablets 
30 film-coated tablets 
42 film-coated tablets 
50 film-coated tablets 
56 film-coated tablets 
98 film-coated tablets 
100 film-coated tablets 
112 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Oral use 
 
Once daily 
 
 
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 



25 

 
 
 
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 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/836/001 10 film-coated tablets 
EU/1/13/836/002 14 film-coated tablets 
EU/1/13/836/003 21 film-coated tablets 
EU/1/13/836/004 28 film-coated tablets 
EU/1/13/836/005 30 film-coated tablets 
EU/1/13/836/006 42 film-coated tablets 
EU/1/13/836/007 50 film-coated tablets 
EU/1/13/836/008 56 film-coated tablets 
EU/1/13/836/009 98 film-coated tablets 
EU/1/13/836/010 100 film-coated tablets 
EU/1/13/836/011 112 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 



26 

16. INFORMATION IN BRAILLE 
 
Memantine ratiopharm 10 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



27 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Memantine ratiopharm 10 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
ratiopharm 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 



28 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer packaging (Blister) 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Memantine ratiopharm 20 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose and soya lecithin. Read the package leaflet before use. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
10 film-coated tablets 
14 film-coated tablets 
21 film-coated tablets 
28 film-coated tablets 
30 film-coated tablets 
42 film-coated tablets 
56 film-coated tablets 
98 film-coated tablets 
100 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Oral use 
 
Once daily 
 
 
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 
 
 



29 

 
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 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/836/013 10 film-coated tablets 
EU/1/13/836/014 14 film-coated tablets 
EU/1/13/836/015 21 film-coated tablets 
EU/1/13/836/016 28 film-coated tablets 
EU/1/13/836/017 30 film-coated tablets 
EU/1/13/836/018 42 film-coated tablets 
EU/1/13/836/019 56 film-coated tablets 
EU/1/13/836/020 98 film-coated tablets 
EU/1/13/836/021 100 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Memantine ratiopharm 20 mg 
 



30 

 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



31 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
memantine ratiopharm 20 mg film-coated tablets 
 
Memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
ratiopharm 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 
 



32 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer packaging (HDPE bottle) 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Memantine ratiopharm 10 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose and soya lecithin. Read the package leaflet before use. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
100 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Oral 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 
 
Shelf life after first opening: 6 months. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 



33 

 
 
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 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/836/012 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Memantine ratiopharm 10 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



34 

 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
Label (HDPE bottle) 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Memantine ratiopharm 10 mg tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose and soya lecithin. Read the package leaflet before use. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
100  tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Oral 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 
 
Shelf life after first opening: 6 months. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 



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 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/836/012 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 
 



36 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer packaging (HDPE bottle) 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Memantine ratiopharm 20 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose and soya lecithin. Read the package leaflet before use. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
100 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Oral use 
 
Once daily 
 
 
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 
 
Shelf life after first opening: 6 months. 
 
 
9. SPECIAL STORAGE CONDITIONS 



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 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/836/022 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Memantine ratiopharm 20 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



38 

 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
Label (HDPE bottle) 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Memantine ratiopharm 20 mg tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose and soya lecithin. Read the package leaflet before use. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
100  tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Oral use 
 
Once daily 
 
 
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 
 
Shelf life after first opening: 6 months. 
 
 



39 

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 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/836/022 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 
 



40 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer packaging for 4 week treatment initiation pack (28 tablets, week 1-4) 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Memantine ratiopharm 5 mg 
Memantine ratiopharm 10 mg 
Memantine ratiopharm 15 mg 
Memantine ratiopharm 20 mg 
film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 5 mg or 10 mg or 15 mg or 20 mg of memantine hydrochloride 
equivalent to 4.15 mg or 8.31 mg or 12.46 mg or 16.62 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose and soya lecithin. Read the package leaflet before use. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Treatment initiation pack 
 
Each pack of 28 film-coated tablets for a 4 week treatment schedule contains: 
7 x 5 mg and 7 x 10 mg and 7 x 15 mg and 7 x 20 mg film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Oral use 
 
Once daily 
 
For continuation of your treatment please consult your doctor. 
 
 
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 
 
 



41 

 
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 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/836/023 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Memantine ratiopharm 5 mg 
Memantine ratiopharm 10 mg 
Memantine ratiopharm 15 mg 
Memantine ratiopharm 20 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 



42 

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



43 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer packaging for 4 week treatment initiation pack ( 5 mg, 7 tablets, week 1) 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Memantine ratiopharm 5 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 5 mg memantine hydrochloride equivalent to 4.15 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose and soya lecithin. Read the package leaflet before use. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
7 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Oral use 
 
Take only one tablet per day 
 
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 
 
 



44 

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 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/836/023 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Memantine ratiopharm 5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 
 



45 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Memantine ratiopharm 5 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
ratiopharm 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 



46 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer packaging for 4 week treatment initiation pack ( 10 mg, 7 tablets, week 2) 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Memantine ratiopharm 10 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose and soya lecithin. Read the package leaflet before use. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
7 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Oral use 
 
Take only one tablet per day 
 
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 
 
 



47 

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 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/836/023 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Memantine ratiopharm 10 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
' 
 
 



48 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Memantine ratiopharm 10 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
ratiopharm 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 



49 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer packaging for 4 week treatment initiation pack ( 15 mg, 7 tablets, week 3) 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Memantine ratiopharm 15 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 15 mg memantine hydrochloride equivalent to 12.46 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose and soya lecithin. Read the package leaflet before use. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
7 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Oral use 
 
Take only one tablet per day 
 
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 
 
 



50 

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 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/836/023 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Memantine ratiopharm 15 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 
 



51 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Memantine ratiopharm 15 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
ratiopharm 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 



52 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Outer packaging for 4 week treatment initiation pack ( 20 mg, 7 tablets, week 4) 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Memantine ratiopharm 20 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose and soya lecithin. Read the package leaflet before use. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
 
7 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
Oral use 
 
Take only one tablet per day 
 
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 
 
 



53 

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 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/836/023 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Memantine ratiopharm 20 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 
 



54 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blister 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Memantine ratiopharm 20 mg film-coated tablets 
 
memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
ratiopharm 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 
 



55 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



56 

Package leaflet: Information for the patient 
 

Memantine ratiopharm 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 Memantine ratiopharm is and what it is used for 
2. What you need to know before you take Memantine ratiopharm 
3. How to take Memantine ratiopharm 
4. Possible side effects 
5. How to store Memantine ratiopharm 
6. Contents of the pack and other information 
 
 
1. What Memantine ratiopharm is and what it is used for 
 
How does Memantine ratiopharm work 
Memantine ratiopharm contains the active substance memantine hydrochloride. It 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. Memantine ratiopharm belongs to a group of medicines 
called NMDA-receptor antagonists. Memantine ratiopharm acts on these NMDA-receptors improving 
the transmission of nerve signals and the memory. 
 
What is Memantine ratiopharm used for 
Memantine ratiopharm is used for the treatment of patients with moderate to severe Alzheimer’s 
disease. 
 
2. What you need to know before you take Memantine ratiopharm 
 
Do not take Memantine ratiopharm: 
● if you are allergic to memantine hydrochloride, peanut or soya or any of the other ingredients of 

this medicine (listed in section 6). 
 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Memantine ratiopharm: 
● 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 Memantine 
ratiopharm 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. 
 



57 

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 
Memantine ratiopharm is not recommended for children and adolescents under the age of 18 years. 
 
Other medicines and Memantine ratiopharm 
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any 
other medicines. 
 
In particular, Memantine ratiopharm 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 Memantine ratiopharm. 
 
Memantine ratiopharm 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. 
 
The use of memantine in pregnant women is not recommended. 
 
Women taking Memantine ratiopharm 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, Memantine ratiopharm may change your reactivity, making driving or operating machinery 
inappropriate. 
 
Memantine ratiopharm contains lactose and soya lecithin 
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to 
some sugars, contact your doctor before taking this medicinal product. 
This medicine contains soya lecithin. If you are allergic to peanut or soya, do not take this medicinal 
product. 
 
 



58 

3. How to take Memantine ratiopharm 
 
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 Memantine ratiopharm for adults and older patients is 20 mg once a day. 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 one and a half tablets once a day in the third 
week. From the fourth week on, the usual dose is two tablets once a day (1x 20 mg). 
 
The tablet can be divided into equal doses. 
 
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 
Memantine ratiopharm 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 Memantine ratiopharm as long as it is of benefit to you. Your doctor should assess 
your treatment on a regular basis. 
 
If you take more Memantine ratiopharm than you should 
● In general, taking too much Memantine ratiopharm 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 Memantine ratiopharm, contact your doctor or get medical advice, 

as you may need medical attention. 
 
If you forget to take Memantine ratiopharm 
● If you find you have forgotten to take your dose of Memantine ratiopharm, 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. 



59 

 
Common (affects 1 to 10 users in 100): 
● Headache, sleepiness, constipation, elevated liver function tests, 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 or pharmacist. 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 Memantine ratiopharm 
 
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 the blister pack after 
EXP. The expiry date refers to the last day of that month. 
 
Blister packs 
Do not store above 25°C. 
 
HDPE bottles 
This medicinal product does not require any special storage conditions. 
Shelf life after first opening of the container: 6 months 
 
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 Memantine ratiopharm 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 
Cellulose microcrystalline (E 460), starch pregelatinised (E 1404), lactose anhydrous, colloidal 
anhydrous silica (E 551), magnesium stearate (E 470b). 
Coating 
Polysorbate 80 (E 433), polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b), 
soya lecithin (E 322), xanthan gum (E 415). 

 



60 

What Memantine ratiopharm looks like and contents of the pack 
White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with 
“10” on the other side. 
 
Memantine ratiopharm is available in packs of 10, 14, 21, 28, 30, 42, 50, 56, 98, 100 and 112 film-
coated tablets. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
Manufacturer 
Merckle GmbH 
Ludwig-Merckle-Straße 3 
89143 Blaubeuren 
Germany 
 
TEVA Pharmaceutical Works Private Limited Company 
Pallagi út 13, 4042 Debrecen 
Hungary 
 
HBM Pharma s.r.o. 
Slabinská 30, 03680 Martin 
Slovakia 
 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 

België/Belgique/Belgien 
Teva Pharma Belgium N.V./S.A./AG 
Tél/Tel: +32 3 820 73 73 
 

Lietuva 
UAB “Sicor Biotech” 
Tel: +370 5 266 0203 
 

България 
Тева Фармасютикълс България ЕООД 
Teл: +359 2 489 95 82 
 

Luxembourg/Luxemburg 
ratiopharm GmbH 
Allemagne/Deutschland 
Tél/Tel: +49 731 402 02 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: +420 251 007 111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel.: +36 1 288 64 00 
 

Danmark 
Teva Denmark A/S 
Tlf: +45 44 98 55 11 
 

Malta 
Teva Pharmaceuticals Ireland 
L-Irlanda 
Tel: +353 51 321 740 
 

Deutschland 
ratiopharm GmbH 
Tel: +49 731 402 02 
 

Nederland 
Teva Nederland B.V. 
Tel: +31 800 0228 400 
 



61 

Eesti 
UAB “Sicor Biotech” Eesti filiaal 
Tel: +372 661 0801 
 

Norge 
Teva Norway AS 
Tlf: +47 66 77 55 90 
 

Ελλάδα 
Teva Ελλάς Α.Ε. 
Τηλ: +30 210 72 79 099 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1 97 007 0 
 

España 
ratiopharm España, S.A. 
Tel: +34 91 567 29 70 
 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel.: +48 22 345 93 00 
 

France 
Teva Santé 
Tél: +33 1 55 91 78 00 
 

Portugal 
ratiopharm, Comércio e Indústria de 
Produtos Farmacêuticos, Lda 
Tel: +351 21 476 75 50 
 

Hrvatska 
Pliva Hrvatska d.o.o 
Tel: + 385 1 37 20 000 
 

România 
Teva Pharmaceuticals S.R.L 
Tel: +40 21 230 65 24 
 

Ireland 
Teva Pharmaceuticals Ireland 
Tel: +353 51 321740 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 1 58 90 390 
 

Ísland 
Alvogen ehf 
Sími: +354 522 2900 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 2 57 26 79 11 
 

Italia 
Teva Italia S.r.l. 
Tel: +39 02 89 17 98 1 
 

Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 20 180 5900 
 

Κύπρος 
Teva Ελλάς Α.Ε., Ελλάδα 
Τηλ: +30 210 72 79 099 
 

Sverige 
Teva Sweden AB 
Tel: +46 42 12 11 00 
 

Latvija 
UAB “Sicor Biotech” filiāle Latvijā 
Tel: +371 673 23 666 
 

United Kingdom 
Teva UK Limited 
Tel: +44 1977 628500 
 

 
 
This leaflet was last revised in  
 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 



62 

Package leaflet: Information for the patient 
 

Memantine ratiopharm 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 Memantine ratiopharm is and what it is used for 
2. What you need to know before you take Memantine ratiopharm 
3. How to take Memantine ratiopharm 
4. Possible side effects 
5. How to store Memantine ratiopharm 
6. Contents of the pack and other information 
 
 
1. What Memantine ratiopharm is and what it is used for 
 
How does Memantine ratiopharm work 
Memantine ratiopharm contains the active substance memantine hydrochloride. It 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. Memantine ratiopharm belongs to a group of medicines 
called NMDA-receptor antagonists. Memantine ratiopharm acts on these NMDA-receptors improving 
the transmission of nerve signals and the memory. 
 
What is Memantine ratiopharm used for 
Memantine ratiopharm is used for the treatment of patients with moderate to severe Alzheimer’s 
disease. 
 
2. What you need to know before you take Memantine ratiopharm 
 
Do not take Memantine ratiopharm: 
● if you are allergic to memantine hydrochloride, peanut or soya or any of the other ingredients of 

this medicine (listed in section 6). 
 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Memantine ratiopharm: 
● 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 Memantine 
ratiopharm 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. 
 



63 

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 
Memantine ratiopharm is not recommended for children and adolescents under the age of 18 years. 
 
Other medicines and Memantine ratiopharm 
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any 
other medicines. 
 
In particular, Memantine ratiopharm 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 Memantine ratiopharm. 
 
Memantine ratiopharm 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. 
 
The use of memantine in pregnant women is not recommended. 
 
Women taking Memantine ratiopharm 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, Memantine ratiopharm may change your reactivity, making driving or operating machinery 
inappropriate. 
 
Memantine ratiopharm contains lactose and soya lecithin 
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to 
some sugars, contact your doctor before taking this medicinal product. 
This medicine contains soya lecithin. If you are allergic to peanut or soya, do not take this medicinal 
product. 
 
 



64 

3. How to take Memantine ratiopharm 
 
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 Memantine ratiopharm for adults and older patients is 20 mg once a day. 
 
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 5 mg 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. 
 
The tablet can be divided into equal doses. 
 
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 
Memantine ratiopharm 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 Memantine ratiopharm as long as it is of benefit to you. Your doctor should assess 
your treatment on a regular basis. 
 
If you take more Memantine ratiopharm than you should 
● In general, taking too much Memantine ratiopharm 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 Memantine ratiopharm, contact your doctor or get medical advice, 

as you may need medical attention. 
 
If you forget to take Memantine ratiopharm 
● If you find you have forgotten to take your dose of Memantine ratiopharm, 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 tests, 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) 



65 

 
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 or pharmacist. 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 Memantine ratiopharm 
 
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 the blister pack after 
EXP. The expiry date refers to the last day of that month. 
 
Blister packs 
Do not store above 25°C. 
 
HDPE bottles 
This medicinal product does not require any special storage conditions. 
Shelf life after first opening of the container: 6 months 
 
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 Memantine ratiopharm 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 
Cellulose microcrystalline (E 460), starch pregelatinised (E 1404), lactose anhydrous, colloidal 
anhydrous silica (E 551), magnesium stearate (E 470b). 
Coating 
Polysorbate 80 (E 433), polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b), 
soya lecithin (E 322), xanthan gum (E 415). 

 
What Memantine ratiopharm looks like and contents of the pack 
White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with 
“20” on the other side. 
 
Memantine ratiopharm is available in packs of 10, 14, 21, 28, 30, 42, 56, 98 and 100 film-coated 
tablets. 
 
Not all pack sizes may be marketed. 



66 

 
Marketing Authorisation Holder 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
Manufacturer 
Merckle GmbH 
Ludwig-Merckle-Straße 3 
89143 Blaubeuren 
Germany 
 
TEVA Pharmaceutical Works Private Limited Company 
Pallagi út 13, 4042 Debrecen 
Hungary 
 
HBM Pharma s.r.o. 
Slabinská 30, 03680 Martin 
Slovakia 
 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 

België/Belgique/Belgien 
Teva Pharma Belgium N.V./S.A./AG 
Tél/Tel: +32 3 820 73 73 
 

Lietuva 
UAB “Sicor Biotech” 
Tel: +370 5 266 0203 
 

България 
Тева Фармасютикълс България ЕООД 
Teл: +359 2 489 95 82 
 

Luxembourg/Luxemburg 
ratiopharm GmbH 
Allemagne/Deutschland 
Tél/Tel: +49 731 402 02 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: +420 251 007 111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel.: +36 1 288 64 00 
 

Danmark 
Teva Denmark A/S 
Tlf: +45 44 98 55 11 
 

Malta 
Teva Pharmaceuticals Ireland 
L-Irlanda 
Tel: +353 51 321 740 
 

Deutschland 
ratiopharm GmbH 
Tel: +49 731 402 02 
 

Nederland 
Teva Nederland B.V. 
Tel: +31 800 0228 400 
 

Eesti 
UAB “Sicor Biotech” Eesti filiaal 
Tel: +372 661 0801 
 

Norge 
Teva Norway AS 
Tlf: +47 66 77 55 90 
 

Ελλάδα 
Teva Ελλάς Α.Ε. 
Τηλ: +30 210 72 79 099 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1 97 007 0 
 



67 

España 
ratiopharm España, S.A. 
Tel: +34 91 567 29 70 
 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel.: +48 22 345 93 00 
 

France 
Teva Santé 
Tél: +33 1 55 91 78 00 
 

Portugal 
ratiopharm, Comércio e Indústria de 
Produtos Farmacêuticos, Lda 
Tel: +351 21 476 75 50 
 

Hrvatska 
Pliva Hrvatska d.o.o 
Tel: + 385 1 37 20 000 
 

România 
Teva Pharmaceuticals S.R.L 
Tel: +40 21 230 65 24 
 

Ireland 
Teva Pharmaceuticals Ireland 
Tel: +353 51 321740 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 1 58 90 390 
 

Ísland 
Alvogen ehf 
Sími: +354 522 2900 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 2 57 26 79 11 
 

Italia 
Teva Italia S.r.l. 
Tel: +39 02 89 17 98 1 
 

Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 20 180 5900 
 

Κύπρος 
Teva Ελλάς Α.Ε., Ελλάδα 
Τηλ: +30 210 72 79 099 
 

Sverige 
Teva Sweden AB 
Tel: +46 42 12 11 00 
 

Latvija 
UAB “Sicor Biotech” filiāle Latvijā 
Tel: +371 673 23 666 
 

United Kingdom 
Teva UK Limited 
Tel: +44 1977 628500 
 

 
 
This leaflet was last revised in  
 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 



68 

Package leaflet: Information for the patient 
 

Memantine ratiopharm 5 mg film-coated tablets 
Memantine ratiopharm 10 mg film-coated tablets 
Memantine ratiopharm 15 mg film-coated tablets 
Memantine ratiopharm 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 Memantine ratiopharm is and what it is used for 
2. What you need to know before you take Memantine ratiopharm 
3. How to take Memantine ratiopharm 
4. Possible side effects 
5. How to store Memantine ratiopharm 
6. Contents of the pack and other information 
 
 
1. What Memantine ratiopharm is and what it is used for 
 
How does Memantine ratiopharm work 
Memantine ratiopharm contains the active substance memantine hydrochloride. It 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. Memantine ratiopharm belongs to a group of medicines 
called NMDA-receptor antagonists. Memantine ratiopharm acts on these NMDA-receptors improving 
the transmission of nerve signals and the memory. 
 
What is Memantine ratiopharm used for 
Memantine ratiopharm is used for the treatment of patients with moderate to severe Alzheimer’s 
disease. 
 
2. What you need to know before you take Memantine ratiopharm 
 
Do not take Memantine ratiopharm: 
● if you are allergic to memantine hydrochloride, peanut or soya or any of the other ingredients of 

this medicine (listed in section 6). 
 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Memantine ratiopharm: 
● 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 Memantine 
ratiopharm reassessed by your doctor on a regular basis. 
 



69 

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 
● other NMDA-antagonists 
at the same time should be avoided. 
 
Children and adolescents 
Memantine ratiopharm is not recommended for children and adolescents under the age of 18 years. 
 
Other medicines and Memantine ratiopharm 
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any 
other medicines. 
 
In particular, Memantine ratiopharm 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 Memantine ratiopharm. 
 
Memantine ratiopharm 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. 
 
The use of memantine in pregnant women is not recommended. 
 
Women taking Memantine ratiopharm 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, Memantine ratiopharm may change your reactivity, making driving or operating machinery 
inappropriate. 
 
Memantine ratiopharm contains lactose and soya lecithin 
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to 
some sugars, contact your doctor before taking this medicinal product. 
This medicine contains soya lecithin. If you are allergic to peanut or soya, do not take this medicinal 
product. 



70 

 
 
3. How to take Memantine ratiopharm 
 
The Memantine ratiopharm treatment initiation pack is only to be used for the beginning of the 
treatment with Memantine ratiopharm. 
 
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 treatment dose of 20 mg per day is achieved by a gradual increase of the 
Memantine ratiopharm dose during the first 3 weeks of treatment. Take one tablet once a day. 
 
Week 1 (day 1-7): 
Take one 5 mg tablet once a day (white to off-white, capsule shaped, biconvex, plain on one side and 
debossed with “5” on the other side) for 7 days. 
 
Week 2 (day 8-14): 
Take one 10 mg tablet once a day (white to off-white, capsule shaped, biconvex, with a break score on 
one side and debossed with “10” on the other side) for 7 days. 
 
Week 3 (day 15-21): 
Take one 15 mg tablet once a day (white to off-white, capsule shaped, biconvex, plain on one side and 
debossed with “15” on the other side) for 7 days. 
 
Week 4 (day 22-28): 
Take one 20 mg tablet once day (white to off-white, capsule shaped, biconvex, with a break score on 
one side and debossed with “20” on the other side) 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 
Memantine ratiopharm 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 Memantine ratiopharm as long as it is of benefit to you. Your doctor should assess 
your treatment on a regular basis. 
 



71 

If you take more Memantine ratiopharm than you should 
● In general, taking too much Memantine ratiopharm 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 Memantine ratiopharm, contact your doctor or get medical advice, 

as you may need medical attention. 
 
If you forget to take Memantine ratiopharm 
● If you find you have forgotten to take your dose of Memantine ratiopharm, 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 tests, 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 or pharmacist. 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 Memantine ratiopharm 
 
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 the blister pack 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. 
 
 



72 

6. Contents of the pack and other information 
 
What Memantine ratiopharm contains 
- The active substance is memantine hydrochloride. 

Each film-coated tablet contains 5 mg memantine hydrochloride equivalent to 4.15 mg 
memantine. 
Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg 
memantine. 
Each film-coated tablet contains 15 mg memantine hydrochloride equivalent to 12.46 mg 
memantine. 
Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg 
memantine. 

- The other ingredients are: 
Tablet core 
Cellulose microcrystalline (E 460), starch pregelatinised (E 1404), lactose anhydrous, colloidal 
anhydrous silica (E 551), magnesium stearate (E 470b). 
Coating 
Polysorbate 80 (E 433), polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b), 
soya lecithin (E 322), xanthan gum (E 415). 

 
What Memantine ratiopharm looks like and contents of the pack 
The 5 mg film-coated tablets are white to off-white, capsule shaped, biconvex tablets plain on one side 
and debossed with “5” on the other side. 
The 10 mg film-coated tablets are white to off-white, capsule shaped, biconvex tablets with a break 
score on one side and debossed with “10” on the other side. 
The 15 mg film-coated tablets are white to off-white, capsule shaped, biconvex tablets plain on one 
side and debossed with “15” on the other side. 
The 20 mg film-coated tablets are white to off-white, capsule shaped, biconvex tablets with a break 
score on one side and debossed with “20” on the other side. 
 
Memantine ratiopharm is available in packs with 28 (7 +7 +7 + 7) film-coated tablets. 
 
Marketing Authorisation Holder 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
Manufacturer 
Merckle GmbH 
Ludwig-Merckle-Straße 3 
89143 Blaubeuren 
Germany 
 
TEVA Pharmaceutical Works Private Limited Company 
Pallagi út 13, 4042 Debrecen 
Hungary 
 
HBM Pharma s.r.o. 
Slabinská 30, 03680 Martin 
Slovakia 
 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 



73 

België/Belgique/Belgien 
Teva Pharma Belgium N.V./S.A./AG 
Tél/Tel: +32 3 820 73 73 
 

Lietuva 
UAB “Sicor Biotech” 
Tel: +370 5 266 0203 
 

България 
Тева Фармасютикълс България ЕООД 
Teл: +359 2 489 95 82 
 

Luxembourg/Luxemburg 
ratiopharm GmbH 
Allemagne/Deutschland 
Tél/Tel: +49 731 402 02 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: +420 251 007 111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel.: +36 1 288 64 00 
 

Danmark 
Teva Denmark A/S 
Tlf: +45 44 98 55 11 
 

Malta 
Teva Pharmaceuticals Ireland 
L-Irlanda 
Tel: +353 51 321 740 
 

Deutschland 
ratiopharm GmbH 
Tel: +49 731 402 02 
 

Nederland 
Teva Nederland B.V. 
Tel: +31 800 0228 400 
 

Eesti 
UAB “Sicor Biotech” Eesti filiaal 
Tel: +372 661 0801 
 

Norge 
Teva Norway AS 
Tlf: +47 66 77 55 90 
 

Ελλάδα 
Teva Ελλάς Α.Ε. 
Τηλ: +30 210 72 79 099 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1 97 007 0 
 

España 
ratiopharm España, S.A. 
Tel: +34 91 567 29 70 
 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel.: +48 22 345 93 00 
 

France 
Teva Santé 
Tél: +33 1 55 91 78 00 
 

Portugal 
ratiopharm, Comércio e Indústria de 
Produtos Farmacêuticos, Lda 
Tel: +351 21 476 75 50 
 

Hrvatska 
Pliva Hrvatska d.o.o 
Tel: + 385 1 37 20 000 
 

România 
Teva Pharmaceuticals S.R.L 
Tel: +40 21 230 65 24 
 

Ireland 
Teva Pharmaceuticals Ireland 
Tel: +353 51 321740 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 1 58 90 390 
 

Ísland 
Alvogen ehf. 
Sími: +354 522 2900 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 2 57 26 79 11 
 

Italia 
Teva Italia S.r.l. 
Tel: +39 02 89 17 98 1 
 

Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 20 180 5900 
 

Κύπρος 
Teva Ελλάς Α.Ε., Ελλάδα 

Sverige 
Teva Sweden AB 



74 

Τηλ: +30 210 72 79 099 
 

Tel: +46 42 12 11 00 
 

Latvija 
UAB “Sicor Biotech” filiāle Latvijā 
Tel: +371 673 23 666 
 

United Kingdom 
Teva UK Limited 
Tel: +44 1977 628500 
 

 
 
This leaflet was last revised in  
 
 
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 MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET