Memantine Mylan

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT  
 
Memantine Mylan 10 mg film-coated tablets 
Memantine Mylan 20 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION  
 
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg 
memantine. 
Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg 
memantine. 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet. 
 
Memantine Mylan 10 mg film-coated tablets 
A dark yellow film-coated, tapered oblong shaped, biconvex tablet debossed with “ME” on the left of 
the score and “10” on the right of the score on one side of the tablet and a score on the other side. 
The tablet can be divided into equal doses. 
 
Memantine Mylan 20 mg film-coated tablets 
A red film-coated, oval, biconvex, bevelled edge tablet debossed with “ME” on one side of the tablet 
and “20” on the other side. 
 
 
4. CLINICAL PARTICULARS  
 
4.1 Therapeutic indications 
 
Treatment of adult patients with moderate to severe Alzheimer’s disease. 
 
4.2 Posology and method of administration 
 
Treatment should be initiated and supervised by a physician experienced in the diagnosis and 
treatment of Alzheimer’s dementia. 
 
Posology 
 
Therapy should only be started if a caregiver is available who will regularly monitor the intake of the 
medicinal product by the patient. Diagnosis should be made according to current guidelines. The 
tolerance and dosing of memantine should be reassessed on a regular basis, preferably within three 
months after start of treatment. Thereafter, the clinical benefit of memantine and the patient’s 
tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. 
Maintenance treatment can be continued for as long as a therapeutic benefit is favourable and the 
patient tolerates treatment with memantine. Discontinuation of memantine should be considered when 
evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment. 
 
Adults 
 
Dose titration 
The maximum daily dose is 20 mg per day. In order to reduce the risk of undesirable effects, the 
maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows: 



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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 Mylan is not recommended in patients with 
severe hepatic impairment. 
 
Paediatric population 
No data available. 
 
Method of administration 
Memantine Mylan should be administered orally once a day and should be taken at the same time 
every day. The film-coated tablets can be taken with or without food. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Caution is recommended in patients with epilepsy, former history of convulsions or patients with 
predisposing factors for epilepsy. 
 
Concomitant use of N-methyl-D-aspartate (NMDA)-antagonists such as amantadine, ketamine or 
dextromethorphan should be avoided. These compounds act at the same receptor system as 
memantine, and therefore adverse reactions (mainly central nervous system (CNS)-related) may be 
more frequent or more pronounced (see also section 4.5). 
 



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Some factors that may raise urine pH (see section 5.2 “Elimination”) may necessitate careful 
monitoring of the patient. These factors include drastic changes in diet, e.g. from a carnivore to a 
vegetarian diet, or a massive ingestion of alkalising gastric buffers. Also, urine pH may be elevated by 
states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria. 
 
In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart 
failure (NYHA III-IV), or uncontrolled hypertension were excluded. As a consequence, only limited 
data are available and patients with these conditions should be closely supervised. 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 
‘sodium-free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Due to the pharmacological effects and the mechanism of action of memantine the following 
interactions may occur: 
 
• The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and 

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

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

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

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

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

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



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Fertility 
No adverse effects of memantine were noted on non-clinical male and female fertility studies. 
 
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 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. 
 

System organ class Frequency Adverse reaction 
Infections and infestations Uncommon Fungal infections 

 
Immune system disorders Common Drug hypersensitivity 

 
Psychiatric disorders Common Somnolence 

 
Uncommon Confusion 

 
Uncommon Hallucinations1 

 
Not known Psychotic reactions2 

 
Nervous system disorders Common Dizziness 

 
Common  
 

Balance disorders 

Uncommon Gait abnormal 
 

Very rare Seizures 
 

Cardiac disorders Uncommon Cardiac failure 
 

Vascular disorders Common Hypertension 
 



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Uncommon Venous 
thrombosis/thromboembolism 
 

Respiratory, thoracic and 
mediastinal disorders 
 

Common Dyspnoea 
 

Gastrointestinal disorders Common Constipation 
 

Uncommon Vomiting 
 

Not known Pancreatitis2 
 

Hepatobiliary disorders 
 

Common Elevated liver function test 
 

Not known 
 

Hepatitis 

General disorders and 
administration 
site conditions 
 

Common Headache 
 

Uncommon  
 

Fatigue 

1 Hallucinations have mainly been observed in patients with severe Alzheimer´s disease. 
2 Isolated cases reported in post-marketing experience. 
 
Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. In post-
marketing experience these reactions have been reported in patients treated with memantine. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V*. 
 
4.9 Overdose 
 
Only limited experience with overdose is available from clinical studies and post-marketing 
experience. 
 
Symptoms 
Relative large overdoses (200 mg and 105 mg/day for 3 days, respectively) have been associated with 
either only symptoms of tiredness, weakness and/or diarrhoea or no symptoms. In the overdose cases 
below 140 mg or unknown dose the patients revealed symptoms from central nervous system 
(confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) 
and/or of gastrointestinal origin (vomiting and diarrhoea). 
 
In the most extreme case of overdose, the patient survived the oral intake of a total of 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 



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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. 
 
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 



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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 
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. 
 
 



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6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet cores for 10/20 mg film-coated tablets: 
Cellulose, microcrystalline 
Croscarmellose sodium 
Magnesium stearate 
Talc 
Silica, colloidal anhydrous 
 
Tablet coat for 10/20 mg film-coated tablets: 
Polydextrose (E1200) 
Hypromellose 3cP (E464) 
Hypromellose 6cP (E464) 
Hypromellose 50cP (E464) 
 
Macrogol 400 (E1521) 
Macrogol 8000 (E1521) 
 
Iron oxide red (E172) 
 
Additional for 10 mg film-coated tablets: 
Titanium dioxide (E171) 
Iron oxide yellow (E172) 
Indigo carmine aluminium lake (E132) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
Clear PVC-PVdC film with push through aluminium foil lidding blisters in pack sizes of 7, 10, 14, 28, 
28 x 1, 30, 42, 50, 56, 56 x 1, 60, 70, 84, 98, 98 x 1, 100, 100 x 1 or 112 film-coated tablets. The pack 
sizes 28 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets are presented in clear PVC-PVdC film with 
push through aluminium foil lidding perforated unit dose blisters. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER  
 
Mylan S.A.S. 



10 

117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
8. MARKETING AUTHORISATION NUMBERS  
 
EU/1/13/827/001 
EU/1/13/827/002 
EU/1/13/827/003 
EU/1/13/827/004 
EU/1/13/827/005 
EU/1/13/827/006 
EU/1/13/827/007 
EU/1/13/827/008 
EU/1/13/827/009 
EU/1/13/827/010 
EU/1/13/827/011 
EU/1/13/827/012 
EU/1/13/827/013 
EU/1/13/827/014 
EU/1/13/827/015 
EU/1/13/827/016 
EU/1/13/827/017 
EU/1/13/827/018 
EU/1/13/827/019 
EU/1/13/827/020 
EU/1/13/827/021 
EU/1/13/827/022 
EU/1/13/827/023 
EU/1/13/827/024 
EU/1/13/827/025 
EU/1/13/827/026 
EU/1/13/827/027 
EU/1/13/827/028 
EU/1/13/827/029 
EU/1/13/827/030 
EU/1/13/827/031 
EU/1/13/827/032 
EU/1/13/827/033 
EU/1/13/827/034 
EU/1/13/827/035 
EU/1/13/827/036 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHO RISATION  
 
Date of first authorisation: 22 April 2013 
Date of latest renewal: 08 January 2018 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 

  



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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 

 
 

 



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A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE  
 
Name and address of the manufacturers responsible for batch release 
 
McDermott Laboratories Ltd. T/A Gerard Laboratories 
Unit 35 Baldoyle Industrial Estate 
Grange Road 
Dublin 13 
Ireland 
 
Mylan Hungary Kft. 
H-2900 Komárom  
Mylan utca. 1 
Hungary  
 
Generics [UK] Limited 
Station Close 
Potters Bar 
Hertfordshire 
EN6 1TL 
UK 
 
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 medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETI NG 
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 SA FE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 
 
Not applicable. 

 
   



13 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

ANNEX III   
 

LABELLING AND PACKAGE LEAFLET 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



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A. LABELLING  
 

  



15 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT  
 
Memantine Mylan 10 mg film-coated tablets 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg 
memantine. 
 
 
3. LIST OF EXCIPIENTS  
 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS  
 
Film-coated tablet 
 
7 film-coated tablets 
10 film-coated tablets 
14 film-coated tablets 
28 film-coated tablets 
28 x 1 film-coated tablets 
30 film-coated tablets 
42 film-coated tablets 
50 film-coated tablets 
56 film-coated tablets 
56 x 1 film-coated tablets 
60 film-coated tablets 
70 film-coated tablets 
84 film-coated tablets 
98 film-coated tablets 
98 x 1 film-coated tablets 
100 film-coated tablets 
100 x 1 film-coated tablets 
112 film-coated tablets 
 
 
5. METHOD AND ROUTE 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. 



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7. OTHER SPECIAL WARNING(S), IF NECESSARY  
 
 
 
8. EXPIRY DATE  
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS  
 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PROD UCTS, IF 
APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION  HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBERS  
 
EU/1/13/827/001 7 film-coated tablets 
EU/1/13/827/002 10 film-coated tablets 
EU/1/13/827/003 14 film-coated tablets 
EU/1/13/827/004 28 film-coated tablets 
EU/1/13/827/005 28 x 1 film-coated tablets 
EU/1/13/827/006 30 film-coated tablets 
EU/1/13/827/007 42 film-coated tablets 
EU/1/13/827/008 50 film-coated tablets 
EU/1/13/827/009 56 film-coated tablets 
EU/1/13/827/010 56 x 1 film-coated tablets 
EU/1/13/827/011 60 film-coated tablets 
EU/1/13/827/012 70 film-coated tablets 
EU/1/13/827/013 84 film-coated tablets 
EU/1/13/827/014 98 film-coated tablets 
EU/1/13/827/015 98 x 1 film-coated tablets 
EU/1/13/827/016 100 film-coated tablets 
EU/1/13/827/017 100 x 1 film-coated tablets 
EU/1/13/827/018 112 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 



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14. GENERAL CLASSIFICATION FOR SUPPLY  
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE  
 
Memantine Mylan 10 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE  
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  
 
PC: 
SN: 
NN: 
  



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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS  
 
BLISTER 

 
 
1. NAME OF THE MEDICINAL PRODUCT  

 
Memantine Mylan 10 mg film-coated tablets 
memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 
Mylan S.A.S. 
 
 
3. EXPIRY DATE 

 
EXP 
 
 
4. BATCH NUMBER 

 
Lot 
 
 
5. OTHER 

  



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT  
 
Memantine Mylan 20 mg film-coated tablets 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg 
memantine. 
 
 
3. LIST OF EXCIPIENTS  
 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS  
 
Film-coated tablet 
 
7 film-coated tablets 
10 film-coated tablets 
14 film-coated tablets 
28 film-coated tablets 
28 x 1 film-coated tablets 
30 film-coated tablets 
42 film-coated tablets 
50 film-coated tablets 
56 film-coated tablets 
56 x 1 film-coated tablets 
60 film-coated tablets 
70 film-coated tablets 
84 film-coated tablets 
98 film-coated tablets 
98 x 1 film-coated tablets 
100 film-coated tablets 
100 x 1 film-coated tablets 
112 film-coated tablets 
 
 
5. METHOD AND ROUTE 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. 



20 

 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY  
 
 
 
8. EXPIRY DATE  
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS  
 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PROD UCTS, IF 
APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION  HOLDER 
 
Mylan S.A.S. 
117 Allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBERS  
 
EU/1/13/827/019 7 film-coated tablets 
EU/1/13/827/020 10 film-coated tablets 
EU/1/13/827/021 14 film-coated tablets 
EU/1/13/827/022 28 film-coated tablets 
EU/1/13/827/023 28 x 1 film-coated tablets 
EU/1/13/827/024 30 film-coated tablets 
EU/1/13/827/025 42 film-coated tablets 
EU/1/13/827/026 50 film-coated tablets 
EU/1/13/827/027 56 film-coated tablets 
EU/1/13/827/028 56 x 1 film-coated tablets 
EU/1/13/827/029 60 film-coated tablets 
EU/1/13/827/030 70 film-coated tablets 
EU/1/13/827/031 84 film-coated tablets 
EU/1/13/827/032 98 film-coated tablets 
EU/1/13/827/033 98 x 1 film-coated tablets 
EU/1/13/827/034 100 film-coated tablets 
EU/1/13/827/035 100 x 1 film-coated tablets 
EU/1/13/827/036 112 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 



21 

 
14. GENERAL CLASSIFICATION FOR SUPPLY  
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE  
 
Memantine Mylan 20 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE  
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  
 
PC: 
SN: 
NN:  



22 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS  
 
BLISTER 

 
 
1. NAME OF THE MEDICINAL PRODUCT  

 
Memantine Mylan 20 mg film-coated tablets 
memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 
Mylan S.A.S. 

 
 

3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 

 
Lot 
 
 
5. OTHER 

 
Mon → Tue → Wed → Thu → Fri → Sat → Sun  
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 



23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
B. PACKAGE LEAFLET 



24 

Package leaflet: Information for the patient 
 

Memantine Mylan 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 Mylan is and what it is used for 
2. What you need to know before you take Memantine Mylan 
3. How to take Memantine Mylan 
4. Possible side effects 
5. How to store Memantine Mylan 
6. Contents of the pack and other information 
 
 
1. What Memantine Mylan is and what it is used for 
 
Memantine Mylan contains the active substance memantine. 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 Mylan belongs to a group of medicines called 
NMDA-receptor antagonists. Memantine Mylan acts on these NMDA-receptors improving the 
transmission of nerve signals and the memory. 
 
Memantine Mylan is used for the treatment of patients with moderate to severe Alzheimer’s disease. 
 
 
2. What you need to know before you take Memantine Mylan 
 
Do not take Memantine Mylan: 
- if you are allergic to memantine 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 Mylan 
- 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 
Mylan reassessed by your doctor on a regular basis. 
 
If you suffer from renal impairment (kidney problems), your doctor should closely monitor your 
kidney function and if necessary adapt the memantine doses accordingly. 
 
The use of medicinal products called amantadine (for the treatment of Parkinson’s disease), ketamine 
(a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and 
other NMDA-antagonists at the same time should be avoided. 



25 

 
Children and adolescents 
Memantine Mylan is not recommended for children and adolescents under the age of 18 years. 
 
Other medicines and Memantine Mylan 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
In particular, Memantine Mylan 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 Mylan. 
 
Memantine Mylan with food and drink 
You should inform your doctor if you have recently changed or intend to change your diet 
substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal 
tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction 
(poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your 
doctor may need to adjust the dose of your medicine. 
 
Pregnancy and breast-feeding  
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine.  
 
Pregnancy 
The use of memantine in pregnant women is not recommended. 
 
Breast-feeding 
Women taking Memantine Mylan 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 Mylan may change your reactivity, making driving or operating machinery 
inappropriate. 
 
Memantine Mylan contains sodium  
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’. 
 
 
3. How to take Memantine Mylan 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
Dosage 



26 

The recommended dose of Memantine Mylan for adults and older people 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 10 mg tablet once a day (5 mg) for the first week. This is increased to 
one 10 mg tablet once a day (10 mg) in the second week and to 1 and a half 10 mg tablets once a day 
in the third week. From the fourth week on, the usual dose is two 10 mg tablets once a day (20 mg). 
 
Dosage in patients with impaired kidney function 
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In 
this case, monitoring of your kidney function should be performed by your doctor at specified 
intervals. 
 
Administration 
Memantine Mylan 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 divided into equal doses and can be taken with or without food. 
 
Duration of treatment 
Continue to take Memantine Mylan as long as it is of benefit to you. Your doctor should assess your 
treatment on a regular basis. 
 
If you take more Memantine Mylan than you should 
- In general, taking too much Memantine Mylan 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 Mylan, contact your doctor or get medical advice, as 

you may need medical attention. 
 
If you forget to take Memantine Mylan 
- If you find you have forgotten to take your dose of Memantine Mylan, 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 (may affect up to 1 in 10 people): 

• Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, 
shortness of breath, high blood pressure and drug hypersensitivity 

 
Uncommon (may affect up to 1 in 100 people): 

• Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure 
and venous blood clotting (thrombosis/thromboembolism) 



27 

 
Very rare (may affect up to 1 in 10,000 people): 

• 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 hydrochloride. 
 
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 Mylan 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The 
expiry date refers to the last day of that month. 
 
This medicine does not require any special storage conditions. 
 
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 Mylan contains 
- The active substance is memantine. Each film-coated tablet contains 10 mg of memantine 

hydrochloride equivalent to 8.31 mg memantine.  
- The other ingredients are microcrystalline cellulose, croscarmellose sodium (see section 2 

‘Memantine Mylan contains sodium’), magnesium stearate, talc and colloidal anyhdrous silica, 
all in the tablet core; polydextrose (E1200), titanium dioxide (E171), hypromellose 3cP (E464), 
hypromellose 6cP (E464), hypromellose 50cP (E464), iron oxide yellow (E172), macrogol 400 
(E1521), macrogol 8000, indigo carmine aluminium lake (E132) and iron oxide red (E172), all 
in the tablet coating.  

 
What Memantine Mylan looks like and contents of the pack 
A dark yellow film-coated, tapered oblong shaped, biconvex tablet marked with “ME” on the left of 
the score and “10” on the right of the score on one side of the tablet and a score on the other side. 
The tablet can be divided into equal doses. 
 
Memantine Mylan film-coated tablets are available in blister packs of 7, 10, 14, 28, 28 x 1, 30, 42, 50, 
56, 56 x 1, 60, 70, 84, 98, 98 x 1, 100, 100 x 1 or 112 film-coated tablets.  
The pack sizes 28 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets are presented in unit dose blisters. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder  
 
Mylan S.A.S. 
117 Allée des Parcs, 69800 Saint-Priest, France. 



28 

 
Manufacturer 
 
McDermott Laboratories Ltd. T/A Gerard Laboratories 
Unit 35 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland. 
 
Mylan Hungary Kft. 
H-2900 Komárom, Mylan utca. 1, Hungary. 
 
Generics [UK] Limited 
Station Close, Potters Bar, Hertfordshire EN6 1TL, United Kingdom. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
Mylan bvba/sprl 
Tél/Tel: + 32 (0)2 658 61 00 
 

Lietuva 
BGP Products UAB  
Tel: +370 5 205 1288 

България 
Майлан ЕООД 
Teл.: +359 2 44 55 400 
 

Luxembourg/Luxemburg 
Mylan bvba/sprl 
Tel: + 32 (0)2 658 61 00 
(Belgique/Belgien) 
 

Česká republika 
Mylan Healthcare CZ s.r.o. 
Tel: +420 222 004 400 
 

Magyarország 
Mylan EPD Kft 
Tel: + 36 1 465 2100 
 

Danmark 
Mylan Denmark ApS 
Tel: +45 28 11 69 32 
 

Malta 
V.J. Salomone Pharma Ltd 
Tel: + 356 21 22 01 74 

Deutschland 
Mylan Healthcare GmbH  
Tel: +49 800 0700 800 
 

Nederland 
Mylan BV 
Tel: +31 (0)20 426 3300 

Eesti 
BGP Products Switzerland GmbH Eesti 
filiaal  
Tel: +372 6363 052 
 

Norge 
Mylan Healthcare Norge AS 
Tel: +47 66 75 33 00 
 

Ελλάδα  
Generics Pharma Hellas ΕΠΕ  
Τηλ:  +30 210 993 6410 
 

Österreich 
Arcana Arzneimittel GmbH 
Tel: +43 1 416 2418 
 

España 
Mylan Pharmaceuticals, S.L 
Tel: + 34 900 102 712 
 

Polska 
Mylan Healthcare Sp. z o.o. 
Tel: + 48 22 546 64 00 
 

France 
Mylan S.A.S 
Tel: + 33 4 37 25 75 00 
 

Portugal 
Mylan, Lda. 
Tel: + 351 21 412 72 56 
 

Hrvatska 
Mylan Hrvatska d.o.o. 
Tel: +385 1 23 50 599 
 

România 
BGP Products SRL 
Tel: +40 372 579 000 
 



29 

Ireland 
Mylan Ireland Limited 
Tel: +353 (0) 87 1694982 
 

Slovenija 
Mylan Healthcare d.o.o. 
Tel: + 386 1 23 63 180 
 

Ísland 
Icepharma hf 
Tel: +354 540 8000 
 

Slovenská republika 
Mylan s.r.o. 
Tel: +421 2 32 199 100 

Italia 
Mylan Italia S.r.l. 
Tel: + 39 02 612 46921 
 

Suomi/Finland 
Mylan Finland OY 
Puh/Tel: +358 20 720 9555 
 

Κύπρος 
Varnavas Hadjipanayis Ltd. 
Τηλ: +357 2220 7700 
 

Sverige 
Mylan AB  
Tel: + 46 855 522 750 
 

Latvija 
Mylan Healthcare SIA 
Tel: +371 676 055 80 
 

United Kingdom 
Generics [UK] Ltd 
Tel: +44 1707 853000 

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



30 

Package leaflet: Information for the patient 
 

Memantine Mylan 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 Mylan is and what it is used for 
2. What you need to know before you take Memantine Mylan 
3. How to take Memantine Mylan 
4. Possible side effects 
5. How to store Memantine Mylan 
6. Contents of the pack and other information 
 
 
1. What Memantine Mylan is and what it is used for 
 
Memantine Mylan contains the active substance memantine. 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 Mylan belongs to a group of medicines called 
NMDA-receptor antagonists. Memantine Mylan acts on these NMDA-receptors improving the 
transmission of nerve signals and the memory. 
 
Memantine Mylan is used for the treatment of patients with moderate to severe Alzheimer’s disease. 
 
 
2. What you need to know before you take Memantine Mylan 
 
Do not take Memantine Mylan: 
- if you are allergic to memantine 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 Mylan 
- 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 
Mylan reassessed by your doctor on a regular basis. 
 
If you suffer from renal impairment (kidney problems), your doctor should closely monitor your 
kidney function and if necessary adapt the memantine doses accordingly. 
 
The use of medicinal products called amantadine (for the treatment of Parkinson’s disease), ketamine 
(a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and 
other NMDA-antagonists at the same time should be avoided. 



31 

 
 
Children and adolescents 
Memantine Mylan is not recommended for children and adolescents under the age of 18 years. 
 
Other medicines and Memantine Mylan 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
In particular, Memantine Mylan 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 Mylan. 
 
Memantine Mylan with food and drink  
You should inform your doctor if you have recently changed or intend to change your diet 
substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal 
tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction 
(poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your 
doctor may need to adjust the dose of your medicine. 
 
Pregnancy and breast-feeding  
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine.  
 
Pregnancy 
The use of memantine in pregnant women is not recommended. 
 
Breast-feeding 
Women taking Memantine Mylan 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 Mylan may change your reactivity, making driving or operating machinery 
inappropriate. 
 
Memantine Mylan contains sodium  
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-
free’. 
 
 
3. How to take Memantine Mylan 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
Dosage 



32 

The recommended dose of Memantine Mylan for adults and older people 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. 
 
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 

one 20 mg tablet once a day 

 
The usual starting dose is half a 10 mg tablet once a day (5 mg) for the first week. This is increased to 
one 10 mg tablet once a day (10 mg) in the second week and to 1 and a half 10 mg tablets once a day 
in the third week. From the fourth week on, the usual dose is one 20 mg tablet once a day (20 mg). 
 
Dosage in patients with impaired kidney function 
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In 
this case, monitoring of your kidney function should be performed by your doctor at specified 
intervals. 
 
Administration 
Memantine Mylan 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 Mylan as long as it is of benefit to you. Your doctor should assess your 
treatment on a regular basis. 
 
If you take more Memantine Mylan than you should 
- In general, taking too much Memantine Mylan 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 Mylan, contact your doctor or get medical advice, as 

you may need medical attention. 
 
If you forget to take Memantine Mylan 
- If you find you have forgotten to take your dose of Memantine Mylan, 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 (may affect up to 1 in 10 people): 

• Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, 
shortness of breath, high blood pressure and drug hypersensitivity 

 
Uncommon (may affect up to 1 in 100 people): 

• Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure 
and venous blood clotting (thrombosis/thromboembolism) 



33 

 
Very rare (may affect up to 1 in 10,000 people): 

• 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 hydrochloride. 
 
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 Mylan 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The 
expiry date refers to the last day of that month. 
 
This medicine does not require any special storage conditions. 
 
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 Mylan contains 
- The active substance is memantine. Each film-coated tablet contains 20 mg of memantine 

hydrochloride equivalent to 16.62 mg memantine. 
- The other ingredients are microcrystalline cellulose, croscarmellose sodium (see section 2 

‘Memantine Mylan contains sodium’), magnesium stearate, talc and colloidal anyhdrous silica, 
all in the tablet core; polydextrose (E1200), hypromellose 3cP (E464), hypromellose 6cP 
(E464), hypromellose 50cP (E464), iron oxide red (E172), macrogol 400 (E1521), macrogol 
8000, all in the tablet coating.   

 
What Memantine Mylan looks like and contents of the pack 
A red film-coated, oval, biconvex, beveled edge tablet marked with “ME” on one side of the tablet and 
“20” on the other side. 
 
Memantine Mylan film-coated tablets are available in blister packs of 7, 10, 14, 28, 28 x 1, 30, 42, 50, 
56, 56 x 1, 60, 70, 84, 98, 98 x 1, 100, 100 x 1 or 112 film-coated tablets.  
The pack sizes 28 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets are presented in unit dose blisters. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
 
Mylan S.A.S. 
117 Allée des Parcs, 69800 Saint-Priest, France. 
 
Manufacturer 



34 

 
McDermott Laboratories Ltd. T/A Gerard Laboratories 
Unit 35 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland. 
 
Mylan Hungary Kft. 
H-2900 Komárom, Mylan utca. 1, Hungary. 
 
Generics [UK] Limited 
Station Close, Potters Bar, Hertfordshire EN6 1TL, United Kingdom. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
Mylan bvba/sprl 
Tél/Tel: + 32 (0)2 658 61 00 
 

Lietuva 
BGP Products UAB 
Tel: +370 5 205 1288 
 

България 
Майлан ЕООД 
Teл.: +359 2 44 55 400 
 

Luxembourg/Luxemburg 
Mylan bvba/sprl 
Tel: + 32 (0)2 658 61 00 
(Belgique/Belgien) 
 

Česká republika 
Mylan Healthcare CZ s.r.o. 
Tel: +420 222 004 400 
 

Magyarország 
Mylan EPD Kft 
Tel: + 36 1 465 2100 
 

Danmark 
Mylan Denmark ApS 
Tel: +45 28 11 69 32 
 

Malta 
V.J. Salomone Pharma Ltd 
Tel: + 356 21 22 01 74 
 

Deutschland 
Mylan Healthcare GmbH  
Tel: +49 800 0700 800 
 

Nederland 
Mylan BV 
Tel: + 31 (0)20 426 3300 

Eesti 
BGP Products Switzerland GmbH Eesti 
filiaal 
Tel: +372 6363 052 
 

Norge 
Mylan Healthcare Norge AS 
Tel: +47 66 75 33 00 
 

Ελλάδα  
Generics Pharma Hellas ΕΠΕ  
Τηλ:  +30 210 993 6410 
 

Österreich 
Arcana Arzneimittel GmbH 
Tel: +43 1 416 2418 
 

España 
Mylan Pharmaceuticals, S.L 
Tel: + 34 900 102 712 
 

Polska 
Mylan Healthcare Sp. z o.o. 
Tel: + 48 22 546 64 00 
 

France 
Mylan S.A.S 
Tel: + 33 4 37 25 75 00 
 

Portugal 
Mylan, Lda. 
Tel: + 351 21 412 72 56 
 

Hrvatska 
Mylan Hrvatska d.o.o. 
Tel: +385 1 23 50 599 
 

România 
BGP Products SRL 
Tel: +40 372 579 000 
 

Ireland 
Mylan Ireland Limited 

Slovenija 
Mylan Healthcare d.o.o. 



35 

Tel: +353 (0) 87 1694982 
 

Tel: + 386 1 23 63 180 
 

Ísland 
Icepharma hf 
Tel: +354 540 8000 
 

Slovenská republika 
Mylan s.r.o. 
Tel: +421 2 32 199 100 

Italia 
Mylan Italia S.r.l. 
Tel: + 39 02 612 46921 
 

Suomi/Finland 
Mylan Finland OY 
Puh/Tel: +358 20 720 9555 
 

Κύπρος 
Varnavas Hadjipanayis Ltd 
Τηλ: +357 2220 7700 
 

Sverige 
Mylan AB  
Tel: + 46 855 522 750 
 

Latvija 
Mylan Healthcare SIA 
Tel: +371 676 055 80 
 

United Kingdom 
Generics [UK] Ltd 
Tel: +44 1707 853000 

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


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