Axura

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Axura 10 mg film-coated tablets 
 
Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets 
 
Axura 20 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Axura 10 mg film-coated tablets 
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. 
 
Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets 
Each filmcoated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine. 
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. 
Each film-coated tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine. 
Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine. 
 
Axura 20 mg film-coated tablets 
Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine. 
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet. 
 
Axura 10 mg film-coated tablets 
Pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one 
side and "M M" on the other side. 
The tablet can be divided into equal doses. 
 
Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets 
The 5 mg film-coated tablets are white to off-white, oval-oblong film-coated tablets with imprint ‘5’ on 
one side and imprint ‘MEM’ on the other side. 
The 10 mg film-coated tablets are pale yellow to yellow, oval shaped film-coated tablet with breaking 
line and engravings "1-0" on one side and "M M" on the other side. The tablet can be divided into 
equal doses. 
The 15 mg film-coated tablets are orange to grey-orange, oval-oblong film-coated tablets with imprint 
‘15’ on one side and imprint ‘MEM’ on the other side. 
The 20 mg film-coated tablets are pale red to grey-red, oval-oblong film-coated tablets with imprint ‘20’ 
on one side and imprint ‘MEM’ on the other side. 
 
Axura 20 mg film-coated tablets 
Pale red to grey-red, oval-oblong film-coated tablets with imprint “20” on one side and imprint “MEM” 
on the other side. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of patients with moderate to severe Alzheimer’s disease. 
 



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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. 
 
Axura 10 mg film-coated tablets 
 
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 tablet (15 mg) per day for 7 days. 
 
From Week 4 on: 
The patient should take two 10 mg film-coated tablets (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 (two 10 mg tablets once a day) as described above. 
 
Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets 
 
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, oval-oblong) for 7 days. 
 
Week 2 (day 8-14): 
The patient should take one 10 mg film-coated tablet per day (pale yellow to yellow, oval shaped) for 
7 days. 
 



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Week 3 (day 15-21): 
The patient should take one 15 mg film-coated tablet per day (grey-orange, oval-oblong) for 7 days. 
 
Week 4 (day 22-28): 
The patient should take one 20 mg film-coated tablet per day (grey-red, oval-oblong) for 7 days. 
 
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. 
 
Axura 20 mg film-coated tablets 
 
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. 
For up-titration other tablet strengths are available. 
 
Week 1 (day 1-7): 
The patient should take one 5 mg film-coated tablet per day for 7 days. 
 
Week 2 (day 8-14): 
The patient should take one 10 mg film-coated tablet per day for 7 days. 
 
Week 3 (day 15-21): 
The patient should take one 15 mg film-coated tablet per day for 7 days. 
 
From Week 4 on: 
The patient should take 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 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 Axura is not recommended in patients with severe hepatic impairment. 
 
Paediatric population 
The safety and efficacy of Axura in children aged below 18 years has not been established. 
No data are available. 
 



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Method of administration 
 
Axura should be administered once a day and should be taken at the same time every day. The 
film-coated tablets can be taken with or without food. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Caution is recommended in patients with epilepsy, former history of convulsions or patients with 
predisposing factors for epilepsy. 
 
Concomitant use of N-methyl-D-aspartate(NMDA)-antagonists such as amantadine, ketamine or 
dextromethorphan should be avoided. These compounds act at the same receptor system as 
memantine, and therefore adverse reactions (mainly central nervous system (CNS)-related) may be 
more frequent or more pronounced (see also section 4.5). 
 
Some factors that may raise urine pH (see section 5.2 “Elimination”) may necessitate careful 
monitoring of the patient. These factors include drastic changes in diet, e.g. from a carnivore to a 
vegetarian diet, or a massive ingestion of alkalising gastric buffers. Also, urine pH may be elevated by 
states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria. 
 
In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart 
failure (NYHA III-IV), or uncontrolled hypertension were excluded. As a consequence, only limited 
data are available and patients with these conditions should be closely supervised. 
 
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. 



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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 
 
For memantine, no clinical data on exposed pregnancies are available. 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 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, Axura 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 Axura and 
1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Axura 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 Axura 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%). 
 
The following Adverse Reactions listed in the Table below have been accumulated in clinical studies 
with Axura and since its introduction in the market. Within each frequency grouping, undesirable 
effects are presented in order of decreasing seriousness. 
 
Tabulated list of adverse reactions 
 
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). 
 
SYSTEM ORGAN CLASS FREQUENCY ADVERSE REACTION 
Infections and infestations Uncommon Fungal infections 
Immune systeme disorders Common Drug hypersensitivity 
Psychiatric disorders Common Somnolence 
 Uncommon Confusion 
 Uncommon Hallucinations1 
 Not known Psychotic reactions2 
Nervous system disorders Common Dizziness 



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SYSTEM ORGAN CLASS FREQUENCY ADVERSE REACTION 
 Common Balance disorder 
 Uncommon Gait abnormal 
 Very rare  Seizures 
Cardiac disorders Uncommon Cardiac failure 
Vascular disorders Common Hypertension 
 Uncommon Venous 

thrombosis/thromboembolism  
Respiratory, thoracic and mediastinal 
disorders 

Common Dyspnoea 

Gastrointestinal disorders Common Constipation 
 Uncommon Vomiting 
 Not known Pancreatitis2 
Hepatobiliary disorders Common Elevated liver function test 
 Not known Hepatitis 
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 events have been reported in patients treated with Axura. 
 
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 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. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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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: 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). 
 



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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 
 
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. 
 



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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 
 
Axura 10 mg film-coated tablets 
 
Tablet core 
Microcrystalline cellulose 
Croscarmellose sodium 
Colloidal anhydrous silica 
Magnesium stearate 
 
Tablet coating 
Hypromellose 
Macrogol 400 
Titanium dioxide (E 171) 
Iron oxide yellow (E 172) 
 
Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets 
 
Tablet cores for 5/10/15/20 mg film-coated tablets 
Microcrystalline cellulose 
Croscarmellose sodium 
Colloidal anhydrous silica 
Magnesium stearate 
 
Tablet coating for 5/10/15/20 mg film-coated tablets 
Hypromellose 
Macrogol 400 
Titanium dioxide (E 171) 
 
Additional for 10 mg film-coated tablets: 
Iron oxide yellow (E 172) 
 
Additional for 15 mg and 20 mg film-coated tablets: 
Iron oxide yellow and red (E 172) 
 
Axura 20 mg film-coated tablets 
 
Tablet core 
Microcrystalline cellulose 
Croscarmellose sodium 
Colloidal anhydrous silica 
Magnesium stearate 



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Tablet coating 
Hypromellose 
Macrogol 400 
Titanium dioxide (E 171) 
Iron oxide yellow and red (E 172) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
4 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container 
 
Axura 10 mg film-coated tablets 
Blister packs containing either 7, 10, 14 or 20 tablets per blister strip (Alu/PP). Pack sizes of 14, 28, 
30, 42, 50, 56, 98, 100, 112, and multipacks containing 840 (20 x 42), 980 (10 x 98) or 1000 
(20 x 50) tablets are presented. 
 
Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets 
Each pack contains 28 film-coated tablets in 4 PVDC/PE/PVC/Al-blister or PP/Al-blisters with 7 film-
coated tablets of 5 mg, 7 film-coated tablets of 10 mg, 7 film-coated tablets of 15 mg and 7 film-coated 
tablets of 20 mg. 
 
Axura 20 mg film-coated tablets 
Blister packs containing 14 film-coated tablets per PVDC/PE/PVC/Al-blister or PP/Al-blister strip. 
Pack sizes of 14, 28, 42, 56, 98 or multipacks containing 840 (20 x 42) film-coated tablets are 
presented. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Merz Pharmaceuticals GmbH 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
Axura 10 mg film-coated tablets 
EU/1/02/218/001 
EU/1/02/218/002 
EU/1/02/218/003 



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EU/1/02/218/007 
EU/1/02/218/008 
EU/1/02/218/009 
EU/1/02/218/010 
EU/1/02/218/012 
EU/1/02/218/013 
EU/1/02/218/014 
EU/1/02/218/015 
EU/1/02/218/030 
 
Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets 
EU/1/02/218/016 
EU/1/02/218/023 
 
Axura 20 mg film-coated tablets 
EU/1/02/218/017 
EU/1/02/218/018 
EU/1/02/218/019 
EU/1/02/218/020 
EU/1/02/218/021 
EU/1/02/218/022 
EU/1/02/218/024 
EU/1/02/218/025 
EU/1/02/218/026 
EU/1/02/218/027 
EU/1/02/218/028 
EU/1/02/218/029 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 17 May 2002 
Date of latest renewal: 17 May 2007 
 
 
10. DATE OF REVISION OF THE TEXT 
 
MM/YYYY 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency (EMA) http://www.ema.europa.eu. 
 

http://www.emea.europa.eu/


 13 

1. NAME OF THE MEDICINAL PRODUCT 
 
Axura 5 mg/pump actuation, oral solution 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
1 g of solution contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. 
 
Each pump actuation delivers 0.5 ml solution which contains 5 mg of memantine hydrochloride which is 
equivalent to 4.16 mg memantine. 
 
Excipients: Each one millilitre of solution contains 100 mg sorbitol (E 420) and 0.5 mg potassium, see 
section 4.4. 
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Oral solution. 
The solution is clear and colourless to light yellowish. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of 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 once daily. 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 0.5 ml solution (5 mg) equivalent to one pump actuation per day for 7 days. 
 
Week 2 (day 8-14): 
The patient should take 1 ml solution (10 mg) equivalent to two pump actuations per day for 7 days. 
 



 14 

Week 3 (day 15-21): 
The patient should take 1.5 ml solution (15 mg) equivalent to three pump actuations per day for 7 days. 
 
From Week 4 on: 
The patient should take 2 ml solution (20 mg) equivalent to four pump actuations once a day. 
 
Maintenance dose 
The recommended maintenance dose is 20 mg (2 ml solution, equivalent to four pump actuations) 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 (2 ml solution, equivalent to four pump actuations) 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 (1 ml solution, equivalent to two pump actuations). 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 (1 ml solution, equivalent to two pump actuations) 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 Axura in patients with severe hepatic impairment is not recommended. 
 
Paediatric population 
The safety and efficacy of Axura in children aged below 18 years has not been established. 
No data are available. 
 
Method of administration 
 
Axura should be taken once daily at the same time each day. The solution can be taken with or without 
food. The solution must not be poured or pumped into the mouth directly from the bottle or the pump, 
but should be dosed onto a spoon or into a glass of water using the pump. For detailed instructions on 
the preparation and handling of the product see section 6.6. 
 
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 other 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. 
 



 15 

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: The oral solution contains sorbitol. Patients with rare hereditary problems of fructose 
intolerance should not take this medicine. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Due to the pharmacological effects and the mechanism of action of memantine the following 
interactions may occur: 
 
• The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and 

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

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

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

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

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

 
In single-dose pharmacokinetic (PK) studies in young healthy subjects no relevant active 
substance-active substance interaction of memantine with glyburide/metformin or donepezil was 
observed. 
 
In a clinical study in young healthy subjects no relevant effect of memantine on the pharmacokinetics 
of galantamine was observed. 
 
Memantine did not inhibit CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, flavin containing monooxygenase, 
epoxide hydrolase or sulphation in vitro. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
For memantine, no clinical data on exposed pregnancies are available. 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. 
 



 16 

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, Axura has minor or moderate influence on the 
ability to drive and use machines such that outpatients should be warned to take special care. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
In clinical trials in mild to severe dementia, involving 1,784 patients treated with Axura and 
1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Axura 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 Axura 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%). 
 
The following Adverse Reactions listed in the Table below have been accumulated in clinical studies 
with Axura and since its introduction in the market. Within each frequency grouping, undesirable 
effects are presented in order of decreasing seriousness. 
 
Tabulated list of adverse reactions 
 
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). 
 
SYSTEM ORGAN CLASS FREQUENCY ADVERSE REACTION 
Infections and infestations Uncommon Fungal infections 
Immune systeme disorders Common Drug hypersensitivity 
Psychiatric disorders Common Somnolence 
 Uncommon Confusion 
 Uncommon Hallucinations1 
 Not known Psychotic reactions2 
Nervous system disorders Common Dizziness 
 Common Balance disorder 
 Uncommon Gait abnormal 
 Very rare  Seizures 
Cardiac disorders Uncommon Cardiac failure 
Vascular disorders Common Hypertension 
 Uncommon Venous 

thrombosis/thromboembolism  
Respiratory, thoracic and mediastinal 
disorders 

Common Dyspnoea 

Gastrointestinal disorders Common Constipation 
 Uncommon Vomiting 
 Not known Pancreatitis2 
Hepatobiliary disorders Common Elevated liver function test 
 Not known Hepatitis 
General disorders and administration 
site conditions 

Common Headache 

 Uncommon Fatigue 
1 Hallucinations have mainly been observed in patients with severe Alzheimer´s disease. 



 17 

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 events have been reported in patients treated with Axura. 
 
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 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: 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. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 18 

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. 
 



 19 

Elimination 
 
Memantine is eliminated in a monoexponential manner with a terminal t½ of 60 to 100 hours. In 
volunteers with normal kidney function, total clearance (Cltot) amounts to 170 ml/min/1.73 m² and part 
of total renal clearance is achieved by tubular secretion. 
 
Renal handling also involves tubular reabsorption, probably mediated by cation transport proteins. The 
renal elimination rate of memantine under alkaline urine conditions may be reduced by a factor of 7 to 
9 (see section 4.4). Alkalisation of urine may result from drastic changes in diet, e.g. from a carnivore 
to a vegetarian diet, or from the massive ingestion of alkalising gastric buffers. 
 
Linearity 
 
Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg. 
 
Pharmacokinetic/pharmacodynamic relationship 
 
At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant) 
of memantine, which is 0.5 µmol in human frontal cortex. 
 
5.3 Preclinical safety data 
 
In short term studies in rats memantine like other NMDA-antagonists have induced neuronal 
vacuolisation and necrosis (Olney lesions) only after doses leading to very high peak serum 
concentrations. Ataxia and other preclinical signs have preceded the vacuolisation and necrosis. As the 
effects have neither been observed in long term studies in rodents nor in non-rodents, the clinical 
relevance of these findings is unknown. 
 
Ocular changes were inconsistently observed in repeat dose toxicity studies in rodents and dogs, but 
not in monkeys. Specific ophthalmoscopic examinations in clinical studies with memantine did not 
disclose any ocular changes. 
 
Phospholipidosis in pulmonary macrophages due to accumulation of memantine in lysosomes was 
observed in rodents. This effect is known from other active substances with cationic amphiphilic 
properties. There is a possible relationship between this accumulation and the vacuolisation observed 
in lungs. This effect was only observed at high doses in rodents. The clinical relevance of these 
findings is unknown. 
 
No genotoxicity has been observed following testing of memantine in standard assays. There was no 
evidence of any carcinogenicity in life long studies in mice and rats. Memantine was not teratogenic in 
rats and rabbits, even at maternally toxic doses, and no adverse effects of memantine were noted on 
fertility. In rats, foetal growth reduction was noted at exposure levels, which are identical or slightly 
higher than at human exposure. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Potassium sorbate 
Sorbitol E 420 
Purified water 
 
6.2 Incompatibilities 
 
Not applicable. 
 



 20 

6.3 Shelf life 
 
4 years. 
 
Once opened, the contents of the bottle should be used within 3 months. 
 
6.4 Special precautions for storage 
 
Do not store above 30ºC. 
 
The bottle with the mounted pump may only be kept and transported in a vertical position. 
 
6.5 Nature and contents of container 
 
50 ml (and 10 x 50 ml) in brown glass bottles (Hydrolytic Class II) and 100 ml in brown glass bottles 
(Hydrolytic Class III). 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
No special requirements. 
 
Prior to first use the dosing pump has to be screwed on the bottle. For removing the screw cap from 
the bottle the cap must be turned anticlockwise and unscrewed completely (fig. 1). 

 
 
Mounting the dosing pump on the bottle: 
 
The dosing pump has to be removed from the plastic bag (fig. 2) and placed on top of the bottle, 
sliding the plastic dip tube carefully into the bottle. Then the dosing pump needs to be hold onto the 
neck of the bottle and screwed clockwise until it is firmly attached (fig 3). For the intended use the 
dosing pump is only screwed on once when starting the use, and should never be unscrewed. 
 



 21 

 
 
Use of the dosing pump for dispensing: 
 
The dosing pump head has two positions and is easy to turn – anticlockwise (unlocked position) and 
clockwise (locked position). The dosing pump head should not be pushed down while in the locked 
position. The solution may only be dispensed in the unlocked position. To do this, the dosing pump 
head has to be turned in the direction of the arrow about one eighth of a turn, until a resistance is felt 
(fig. 4). 

 
The dosing pump is then ready for use. 
 
Preparing the dosing pump: 
 
When used for the first time, the dosing pump does not dispense the correct amount of oral solution. 
Therefore, the pump must be prepared (primed) by pushing the dosing pump head down completely 
five times in succession (fig. 5). 

 
The solution thus dispensed is discarded. The next time the dosing pump head is pushed downwards 
completely (equivalent to one pump actuation), it dispenses the correct dose (1 pump actuation is 
equivalent to 0.5 ml oral solution, and contains 5 mg of the active substance memantine hydrochloride; 
fig. 6). 



 22 

 
 
Correct use of the dosing pump: 
 
The bottle should be placed on a flat, horizontal surface, for example a table top, and only use it in a 
vertical position.. A glass with a little water or a spoon should be hold below the nozzle and the dosing 
pump head has to be pushed down in a firm but calm and steady manner (not too slowly) right down to 
the stop (fig. 7, fig. 8). 

 
The dosing pump head can then be released and is ready for the next pump actuation. 
 
The dosing pump may only be used with the memantine hydrochloride solution in the bottle provided, 
not for other substances or containers. If the pump does not function as described during intended use 
and according to instruction, the patient should consult the treating physician or a pharmacist. The 
dosing pump should be locked after use. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Merz Pharmaceuticals GmbH 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/218/005 
EU/1/02/218/006 
EU/1/02/218/011 
 
 



 23 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 17 May 2002 
Date of latest renewal: 17 May 2007 
 
 
10. DATE OF REVISION OF THE TEXT 
 
MM/YYYY 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency (EMA) http://www.ema.europa.eu. 
 

http://www.emea.europa.eu/


 24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER 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 
 



 25 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Merz Pharma GmbH & Co. KGaA 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
 
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 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) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
 



 26 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



 27 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



 28 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR BLISTER PACK 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Axura 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 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 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 
 
Oral use. Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



 29 

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 
 
Merz Pharmaceuticals GmbH 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/218/012 14 film-coated tablets 
EU/1/02/218/007 28 film-coated tablets 
EU/1/02/218/001 30 film-coated tablets 
EU/1/02/218/013 42 film-coated tablets 
EU/1/02/218/002 50 film-coated tablets 
EU/1/02/218/008 56 film-coated tablets 
EU/1/02/218/014 98 film-coated tablets 
EU/1/02/218/003 100 film-coated tablets 
EU/1/02/218/009 112 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot {number} 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Axura 10 mg tablets 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



 30 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR 42, 50 AND 98 TABLETS AS INTERMEDIATE PACK / COMPONENT OF A 
MULTIPACK (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Axura 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 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
42 film-coated tablets 
Component of a multipack, can’t be sold separately. 
50 film-coated tablets 
Component of a multipack, can’t be sold separately. 
98 film-coated tablets 
Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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



 31 

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 
 
Merz Pharmaceuticals GmbH 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/218/010 1000 film-coated tablets (20 packs of 50) 
EU/1/02/218/015 980 film-coated tablets (10 packs of 98) 
EU/1/02/218/030 840 film-coated tablets (20 packs of 42) 
 
 
13. BATCH NUMBER 
 
Lot {number} 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Axura 10 mg tablets 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



 32 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER WRAPPER LABEL ON MULTIPACKS (20 x 42 TABLETS, 20 x 50 TABLETS AND 
10 x 98 TABLETS) WRAPPED IN FOIL (INCLUDING BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Axura 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 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack 840 (20 packs of 42) film-coated tablets 
Multipack 980 (10 packs of 98) film-coated tablets 
Multipack 1000 (20 packs of 50) film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



 33 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Merz Pharmaceuticals GmbH 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/218/010 1000 film-coated tablets (20 packs of 50) 
EU/1/02/218/015 980 film-coated tablets (10 packs of 98) 
EU/1/02/218/030 840 film-coated tablets (20 packs of 42) 
 
 
13. BATCH NUMBER 
 
Lot {number} 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



 34 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOR TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Axura 10 mg film-coated tablets 
Memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Merz Pharmaceuticals GmbH 
 
 
3. EXPIRY DATE 
 
EXP {MM/YYYY} 
See embossed stamp. 
 
 
4. BATCH NUMBER 
 
Lot {number} 
See embossed stamp. 
 
 
5. OTHER 
 



 35 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
CARTON AND LABEL FOR BOTTLE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Axura 5 mg/pump actuation, oral solution 
Memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pump actuation delivers 0.5 ml solution which contains 5 mg of memantine hydrochloride which is 
equivalent to 4.16 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
The solution also contains potassium sorbate and sorbitol (E 420). 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Oral solution 
50 ml 
100 ml 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. Read the package leaflet before 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 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30ºC. 



 36 

When opened, use within 3 months. 
 
 
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 
 
Merz Pharmaceuticals GmbH 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/218/005 50 ml 
EU/1/02/218/006 100 ml 
 
 
13. BATCH NUMBER 
 
Lot {number} 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Axura 5 mg/pump actuation, oral solution 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



 37 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
CARTON AND LABEL FOR 50 ml BOTTLE AS INTERMEDIATE PACK / COMPONENT 
OF A MULTIPACK (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Axura 5 mg/pump actuation, oral solution 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pump actuation delivers 0.5 ml solution which contains 5 mg of memantine hydrochloride which is 
equivalent to 4.16 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
The solution also contains potassium sorbate and sorbitol (E 420). 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
50 ml oral solution 
Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. Read the package leaflet before 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 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30ºC. 



 38 

When opened, use within 3 months. 
 
 
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 
 
Merz Pharmaceuticals GmbH 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/218/011 500 ml (10 bottles of 50 ml) 
 
 
13. BATCH NUMBER 
 
Lot {number} 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Axura 5 mg/pump actuation, oral solution 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



 39 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER WRAPPER LABEL ON MULTIPACKS (10 x 50 ml) WRAPPED IN FOIL 
(INCLUDING BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Axura 5 mg/pump actuation, oral solution 
memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pump actuation delivers 0.5 ml solution which contains 5 mg of memantine hydrochloride which is 
equivalent to 4.16 mg memantine. 
 
 
3. LIST OF EXCIPIENTS 
 
The solution also contains potassium sorbate and sorbitol (E 420). 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack 500 ml, comprising 10 packs, each containing 1 bottle with 50 ml oral solution. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. Read the package leaflet before 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 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30ºC. 
When opened, use within 3 months. 
 



 40 

 
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 
 
Merz Pharmaceuticals GmbH 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/218/011 500 ml (10 bottles of 50 ml) 
 
 
13. BATCH NUMBER 
 
Lot {number} 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



 41 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR 28 TABLETS - TREATMENT INITIATION PACK – 4 WEEK TREATMENT 
SCHEDULE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Axura 5 mg film-coated tablets 
Axura 10 mg film-coated tablets 
Axura 15 mg film-coated tablets 
Axura 20 mg film-coated tablets 
Memantine hydrochloride 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine. 
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. 
Each film-coated tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine. 
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 
 
Each pack of 28 film-coated tablets for a 4 week treatment schedule contains: 
7 x Axura 5 mg 
7 x Axura 10 mg 
7 x Axura 15 mg 
7 x Axura 20 mg 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. Read the package leaflet before 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 
 
 



 42 

8. EXPIRY DATE 
 
EXP 
 
 
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 
 
Merz Pharmaceuticals GmbH 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/218/016 28 film-coated tablets 
EU/1/02/218/023 28 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot {number} 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Axura 5 mg, 10 mg, 15 mg, 20 mg tablets 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



 43 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INNER CARTON FOR BLISTER PACK; front and backside 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Axura 5 mg 
Axura 10 mg 
Axura 15 mg 
Axura 20 mg 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Memantine hydrochloride 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 film-coated tablets. Axura 5 mg 
7 film-coated tablets. Axura 10 mg 
7 film-coated tablets. Axura 15 mg 
7 film-coated tablets. Axura 20 mg 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
One tablet daily 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

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

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
 



 44 

12. MARKETING AUTHORISATION NUMBER(S) 
 
 
13. BATCH NUMBER 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
Week 1, 2, 3, 4 
Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



 45 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INNER CARTON FOR BLISTER PACK; frontside 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Axura 5 mg 
Axura 10 mg 
Axura 15 mg 
Axura 20 mg 
film-coated tablets 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Memantine hydrochloride 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Each pack of 28 film- coated tablets for a 4 week treatment schedule contains: 
7 x Axura 5 mg 
7 x Axura 10 mg 
7 x Axura 15 mg 
7 x Axura 20 mg 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
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 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 46 

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 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/218/016 28 film-coated tablets 
EU/1/02/218/023 28 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot {number} 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



 47 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOR TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Axura 5 mg, 10 mg, 15 mg, 20 mg film-coated tablets 
Memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Merz Pharmaceuticals GmbH 
 
 
3. EXPIRY DATE 
 
EXP {MM/YYYY} 
See embossed stamp. 
 
 
4. BATCH NUMBER 
 
Lot {number} 
See embossed stamp. 
 
 
5. OTHER 
 
 



 48 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR BLISTER PACK 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Axura 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 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
14 film-coated tablets 
28 film-coated tablets 
42 film-coated tablets 
56 film-coated tablets 
98 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. Read the package leaflet before use. 
 
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 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



 49 

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 
 
Merz Pharmaceuticals GmbH 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/218/017 14 film-coated tablets 
EU/1/02/218/018 28 film-coated tablets 
EU/1/02/218/019 42 film-coated tablets 
EU/1/02/218/020 56 film-coated tablets 
EU/1/02/218/021 98 film-coated tablets 
EU/1/02/218/024 14 film-coated tablets 
EU/1/02/218/025 28 film-coated tablets 
EU/1/02/218/026 42 film-coated tablets 
EU/1/02/218/027 56 film-coated tablets 
EU/1/02/218/028 98 film-coated tablets 
 
 
13. BATCH NUMBER 
 
Lot {number} 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Axura 20 mg tablets 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



 50 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR 42 TABLETS AS INTERMEDIATE PACK / COMPONENT OF A  
MULTIPACK (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Axura 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 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
42 film-coated tablets 
Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. Read the package leaflet before 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 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



 51 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Merz Pharmaceuticals GmbH 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/218/022 840 film-coated tablets (20 packs of 42) 
EU/1/02/218/029 840 film-coated tablets (20 packs of 42) 
 
 
13. BATCH NUMBER 
 
Lot {number} 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Axura 20 mg tablets 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



 52 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER WRAPPER LABEL ON MULTIPACKS (20x 42 TABLETS) WRAPPED IN FOIL 
(INCLUDING BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Axura 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 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Multipack 840 (20 packs of 42) film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use. Read the package leaflet before 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 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



 53 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Merz Pharmaceuticals GmbH 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/218/022 840 film-coated tablets (20 packs of 42) 
EU/1/02/218/029 840 film-coated tablets (20 packs of 42) 
 
 
13. BATCH NUMBER 
 
Lot {number} 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



 54 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER FOR TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Axura 20 mg film-coated tablets 
Memantine hydrochloride 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Merz Pharmaceuticals GmbH 
 
 
3. EXPIRY DATE 
 
EXP {MM/YYYY} 
See embossed stamp. 
 
 
4. BATCH NUMBER 
 
Lot {number} 
See embossed stamp. 
 
 
5. OTHER 
 
Mon → Tue → Wed → Thu → Fri → Sat → Sun 



 55 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



 56 

Package leaflet: Information for the user 
 

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

of Axura tablets (listed in section 6). 
 
Warning and precautions 
Talk to your doctor or pharmacist before taking Axura 
- 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 Axura 
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 
Axura is not recommended for children and adolescents under the age of 18 years. 
 
Other medicines and Axura 
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
In particular, Axura 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 Axura. 
 
Axura 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 Axura 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, Axura may change your reactivity, making driving or operating machinery inappropriate. 
 
 
3. How to take Axura 
 
Always take Axura exactly as your doctor has told you. Check with your doctor or pharmacist if you 
are not sure. 
 



 58 

Dosage 
The recommended dose of Axura 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 tablet 
 

week 4  
and beyond 

two 10 mg tablets once a 
day 

 
 
The usual starting dose is half a tablet once a day (1x 5 mg) for the first week. This is increased to one 
tablet once a day (1x 10 mg) in the second week and to 1 and a half tablet once a day in the third 
week. From the fourth week on, the usual dose is 2 tablets once a day (1x 20 mg). 
 
Dosage in patients with impaired kidney function 
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In 
this case, monitoring of your kidney function should be performed by your doctor at specified 
intervals. 
 
Administration 
Axura 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 Axura as long as it is of benefit to you. Your doctor should assess your treatment on a 
regular basis. 
 
If you take more Axura than you should 
- In general, taking too much Axura 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 Axura, contact your doctor or get medical advice, as you may 

need medical attention. 
 
If you forget to take Axura 
- If you find you have forgotten to take your dose of Axura, 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 users): 
• Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, 

shortness of breath, high blood pressure and drug hypersensitivity 
 



 59 

Uncommon (may affect up to 1 in 100 users): 
• Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure 

and venous blood clotting (thrombosis/thromboembolism) 
 
Very rare (may affect up to 1 in 10,000 users): 
• 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 Axura. 
 
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 Axura 
 
Keep out of the sight and reach of children. 
 
Do not use Axura after the expiry date which is stated on the carton and the blister after EXP. The 
expiry date refers to the last day of that month. 
 
This medicinal product 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. Content of the pack and other information 
 
What Axura contains 
The active substance is memantine hydrochloride. Each film-coated tablet contains 10 mg of 
memantine hydrochloride equivalent to 8.31 mg memantine. 
 
The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous 
silica, and magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium 
dioxide (E 171) and iron oxide yellow (E 172) all in the tablet coating. 
 
What Axura looks like and contents of the pack 
Axura film-coated tablets are presented as pale yellow to yellow, oval shaped film-coated tablet with 
breaking line and engravings "1-0" on one side and "M M" on the other side. 
 
Axura film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 30 tablets, 42 tablets, 
50 tablets, 56 tablets, 98 tablets, 100 tablets, 112 tablets and multipacks of 840 (20 packs of 42) 
tablets, 980 (10 packs of 98) tablets or 1000 (20 packs of 50) tablets. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Merz Pharmaceuticals GmbH 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 60 

Germany 
 
Manufacturer 
Merz Pharma GmbH + Co. KGaA 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
Merz Pharmaceuticals GmbH 
Tél/Tel: +49 (0)69 1503 – 0 
 

Lietuva 
H. Abbe Pharma GmbH 
Tel.: +370 52 711710 
 

България 
Merz Pharmaceuticals GmbH 
Tel.: +49 (0)69 1503 – 0 
 

Luxembourg/Luxemburg 
HANFF Global Health Solutions s.à r.l. 
Tel: +352 45 07 07-1 

Česká republika 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Magyarország 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Danmark 
Merz Pharmaceuticals GmbH 
Tlf: +49 (0)69 1503 – 0 
 

Malta 
Clinipharm Co. Ltd 
Tel: +356 21 43 74 15 
 

Deutschland 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 - 0 

Nederland 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Eesti 
H. Abbe Pharma GmbH 
Tel.: +372 6 460980 
 

Norge 
Merz Pharmaceuticals GmbH 
Tlf: +49 (0)69 1503 – 0 
 

Ελλάδα 
Merz Pharmaceuticals GmbH 
Τηλ: +49 (0)69 1503 - 0 
 

Österreich 
Merz Pharma Austria GmbH 
Tel: +43 1 869 16 04-0 
 

España 
Merz Pharma España S.L. 
Tel: +34 91 657 47 84 
 

Polska 
Centrala Farmaceutyczna CEFARM SA 
Tel: +48 22 634 02 22 

France 
Merz Pharmaceuticals GmbH 
Tél: +49 (0)69 1503 – 0 
 

Portugal 
Merz Pharma España S.L. 
Tel: +34 91 657 47 84 
 

Hrvatska 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

România 
Merz Pharmaceuticals GmbH 
Tel.: +49 (0)69 1503 – 0 
 

Ireland 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Slovenija 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 - 0 

Ísland 
Merz Pharmaceuticals GmbH 

Slovenská republika 
Merz Pharmaceuticals GmbH 



 61 

Sími.: +49 (0)69 1503 – 0 
 

Tel: +49 (0)69 1503 – 0 
 

Italia 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 - 0 

Suomi/Finland 
Merz Pharmaceuticals GmbH 
Puh/Tel: +49 (0)69 1503 – 0 
 

Κύπρος 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 - 0 

Sverige 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Latvija 
H. Abbe Pharma GmbH 
Tel.: +371 67 103203 
 

United Kingdom 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 

 
 
This leaflet was last revised in MM/YYYY. 
Detailed information on this medicine is available on the European Medicines Agency (EMA) web 
side: http://www.ema.europa.eu. 
 

http://www.emea.europa.eu/


 62 

Package leaflet: Information for the user 
 

Axura 5 mg/pump actuation, oral solution 
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 Axura is and what it is used for 
2. What you need to know before you take Axura 
3. How to take Axura 
4. Possible side effects 
5. How to store Axura 
6. Content of the pack and other information 
 
 
1. What Axura is and what it is used for 
 
How does Axura work 
Axura contains the active substance memantine hydrochloride. 
Axura 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. Axura belongs to a group of medicines called NMDA-
receptor antagonists. Axura acts on these NMDA-receptors improving the transmission of nerve 
signals and the memory. 
 
What is Axura used for 
Axura is used for the treatment of patients with moderate to severe Alzheimer’s disease. 
 
 
2. What you need to know before you take Axura 
 
Do not take Axura 
- if you are allergic (hypersensitive) to memantine hydrochloride or any of the other ingredients 

of Axura oral solution (listed in section 6). 
 
Warning and precautions 
Talk to your doctor or pharmacist before taking Axura 
- 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 Axura 
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 



 63 

(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 
Axura is not recommended for children and adolescents under the age of 18 years. 
 
Other medicines and Axura 
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
In particular, Axura 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 Axura. 
 
Axura 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 Axura 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, Axura may change your reactivity, making driving or operating machinery inappropriate. 
 
Axura contains sorbitol 
This medicinal product contains sorbitol. If you have been told by your doctor that you have an 
intolerance to some sugars, contact your doctor before taking this medicinal product. Your doctor will 
advise you. 
 
Furthermore, this medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially 
potassium-free. 
 
 



 64 

3. How to take Axura 
 
Always take Axura exactly as your doctor has told you. Check with your doctor or pharmacist if you 
are not sure. 
 
Dosage 
One pump actuation contains 5mg memantine hydrochloride. 
The recommended dose of Axura for adults and older people is four pump actuations, equivalent to 
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 
 

one pump actuation 

week 2 
 

two pump actuations 

week 3 
 

three pump actuations 

week 4 
and beyond 

four pump actuations 

 
The usual starting dose is one pump actuation (1 x 5 mg) once daily for the first week. This dose is 
increased in the second week to two pump actuations once daily (1 x 10 mg), and in the third week to 
three pump actuations (1 x 15 mg) once daily. From the fourth week the recommended dose is four 
pump actuations once daily (1 x 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 
Axura 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 solution should be taken with a little water. The 
solution can be taken with or without food. 
For detailed instructions on the preparation and handling of the product see end of this leaflet. 
 
Duration of treatment 
Continue to take Axura as long as it is of benefit to you. Your doctor should assess your treatment on a 
regular basis. 
 
If you take more Axura than you should 
- In general, taking too much Axura 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 Axura, contact your doctor or get medical advice, as you may 

need medical attention. 
 
If you forget to take Axura 
- If you find you have forgotten to take your dose of Axura, 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. 
 
 



 65 

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 users): 
• Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorder, 

shortness of breath, high blood pressure and drug hypersensitivity 
 
Uncommon (may affect up to 1 in 100 users): 
• Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure 

and venous blood clotting (thrombosis/thromboembolism) 
 
Very rare (may affect up to 1 in 10,000 users): 
• 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 Axura. 
 
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 Axura 
 
Keep out of the sight and reach of children. 
 
Do not use Axura after the expiry date which is stated on the carton and the bottle label after the EXP. 
The expiry date refers to the last day of that month. 
 
Do not store above 30°C. 
 
Once opened, the contents of the bottle should be used within 3 months. 
 
The bottle with the mounted pump must be kept and transported in an upright position only. 
 
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 to protect the environment. 
 
 
6. Content of the pack and other information 
 
What Axura contains 
The active substance is memantine hydrochloride. 
 
Each pump actuation delivers 0.5 ml solution which contains 5 mg of memantine hydrochloride which is 
equivalent to 4.16 mg memantine. 
 
The other ingredients are: potassium sorbate, sorbitol (E 420) and purified water. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 66 

What Axura looks like and contents of the pack 
Axura oral solution is presented as a clear, colourless to light yellowish solution. 
 
Axura oral solution is available in bottles of 50 ml, 100 ml or a multipack of 500 ml (10 x 50 ml). 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Merz Pharmaceuticals GmbH 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
Manufacturer 
Merz Pharma GmbH + Co. KGaA 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
Merz Pharmaceuticals GmbH 
Tél/Tel: +49 (0)69 1503 – 0 
 

Lietuva 
H. Abbe Pharma GmbH 
Tel.: +370 52 711710 
 

България 
Merz Pharmaceuticals GmbH 
Tel.: +49 (0)69 1503 – 0 
 

Luxembourg/Luxemburg 
HANFF Global Health Solutions s.à r.l. 
Tél: +352 45 07 07-1 

Česká republika 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Magyarország 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Danmark 
Merz Pharmaceuticals GmbH 
Tlf: +49 (0)69 1503 – 0 
 

Malta 
Clinipharm Co. Ltd 
Tel: +356 21 43 74 15 
 

Deutschland 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 - 0 

Nederland 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Eesti 
H. Abbe Pharma GmbH 
Tel.: +372 6 460980 
 

Norge 
Merz Pharmaceuticals GmbH 
Tlf: +49 (0)69 1503 – 0 
 

Ελλάδα 
Merz Pharmaceuticals GmbH 
Τηλ: +49 (0)69 1503 - 0 
 

Österreich 
Merz Pharma Austria GmbH 
Tel: +43 1 869 16 04-0 
 

España 
Merz Pharma España S.L. 
Tel: +34 91 657 47 84 
 

Polska 
Centrala Farmaceutyczna CEFARM SA 
Tel: +48 22 634 02 22 

France 
Merz Pharmaceuticals GmbH 
Tél: +49 (0)69 1503 – 0 

Portugal 
Merz Pharma España S.L.  
Tel: +34 91 657 47 84 



 67 

  
Hrvatska 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

România 
Merz Pharmaceuticals GmbH 
Tel.: +49 (0)69 1503 – 0 
 

Ireland 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Slovenija 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 - 0 

Ísland 
Merz Pharmaceuticals GmbH 
Sími.: +49 (0)69 1503 – 0 
 

Slovenská republika 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Italia 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 - 0 

Suomi/Finland 
Merz Pharmaceuticals GmbH 
Puh/Tel: +49 (0)69 1503 – 0 
 

Κύπρος 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 - 0 

Sverige 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Latvija 
H. Abbe Pharma GmbH 
Tel.: +371 67 103203 
 

United Kingdom 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 

 
 
This leaflet was last revised in MM/YYYY. 
Detailed information on this medicine is available on the European Medicines Agency (EMA) web 
side: http://www.ema.europa.eu. 
 
 
Instruction for proper use of the pump 
 
The solution must not be poured or pumped directly into the mouth from the bottle or pump. Measure 
the dose onto a spoon or into a glass of water, using the pump. 
 
Take the screw cap off the bottle: 
 
The cap must be turned anticlockwise, unscrewed completely and removed (fig. 1). 

 

http://www.emea.europa.eu/


 68 

Mounting the dosing pump on the bottle: 
 
Take the dosing pump out of the plastic bag (fig. 2) and place it on top of the bottle. Slide the plastic 
dip tube carefully into the bottle. Hold the dosing pump onto the neck of the bottle and screw it 
clockwise until it fits firmly (fig. 3). The dosing pump is only screwed on once when starting the use, 
and should never be unscrewed. 

 
 
How the dosing pump works: 
 
The dosing pump head has two positions and is easy to turn: 
- anticlockwise to unlock and  
- clockwise to lock. 
 
The dosing pump head should not be pushed down while in the locked position. The solution may only 
be dispensed in the unlocked position. To unlock, turn the pump head in the direction of the arrow 
until it cannot be turned any further (about one eighth of a turn, fig. 4). The dosing pump is then ready 
for use. 

 
 
Preparing the dosing pump: 
 
When used for the first time, the dosing pump does not dispense the correct amount of oral solution. 
Therefore, the pump must be prepared (primed) by pushing the dosing pump head down completely 
five times in succession (fig. 5). 



 69 

 
The solution thus dispensed is discarded. The next time the dosing pump head is pushed downwards 
completely (equivalent to one pump actuation), it dispenses the correct dose (fig. 6). 

 
Correct use of the dosing pump: 
 
Place the bottle on a flat, horizontal surface, for example a table top, and only use it in a upright 
position. Hold a glass with a little water or a spoon below the nozzle. Push down the dosing pump 
head in a firm but calm and steady manner - not too slowly (fig. 7, fig. 8). 

 
The dosing pump head can then be released and is ready for the next pump actuation. 
 
The dosing pump must only be used with the Axura solution in the bottle provided, not for other 
substances or containers. If the pump does not function properly, consult your doctor or a 
pharmacist.Lock the dosing pump after using Axura. 
 



 70 

Package leaflet: Information for the user 
 

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

of Axura tablets (listed in section 6). 
 
Warning and precautions 
Talk to your doctor or pharmacist before taking Axura 
- 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 Axura 
reassessed by your doctor on a regular basis. 
 



 71 

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 
Axura is not recommended for children and adolescents under the age of 18 years. 
 
Other medicines and Axura 
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
In particular, Axura 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 Axura. 
 
Axura 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 Axura 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, Axura may change your reactivity, making driving or operating machinery inappropriate. 
 
 
3. How to take Axura 
 
The Axura treatment initiation pack is only to be used for the beginning of the treatment with Axura. 
 
Always take Axura exactly as your doctor has told you. Check with your doctor or pharmacist if you 



 72 

are not sure. 
 
Dosage 
The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Axura 
dose during the first 3 weeks of treatment. The treatment scheme is also indicated on the treatment 
initiation pack. Take one tablet once a day. 
 
Week 1 (day 1-7): 
Take one 5 mg tablet once a day (white to off-white, oval-oblong) for 7 days. 
 
Week 2 (day 8-14): 
Take one 10 mg tablet once a day (pale yellow to yellow, oval shaped) for 7 days. 
 
Week 3 (day 15-21):  
Take one 15 mg tablet once a day (grey-orange, oval-oblong) for 7 days. 
 
Week 4 (day 22-28):  
Take one 20 mg tablet per day (grey-red, oval-oblong) 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 
Axura 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 Axura as long as it is of benefit to you. Your doctor should assess your treatment on a 
regular basis. 
 
If you take more Axura than you should 
- In general, taking too much Axura 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 Axura, contact your doctor or get medical advice, as you may 

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

usual time. 
- Do not take a double dose to make up for a forgotten dose. 
 



 73 

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 users): 
• 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 users): 
• Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure 

and venous blood clotting (thrombosis/thromboembolism) 
 
Very rare (may affect up to 1 in 10,000 users): 
• 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 Axura. 
 
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 Axura 
 
Keep out of the sight and reach of children. 
 
Do not use Axura after the expiry date which is stated on the carton and the blister after EXP. The 
expiry date refers to the last day of that month. 
 
This medicinal product 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. Content of the pack and other information 
 
What Axura contains 
The active substance is memantine hydrochloride. Each tablet contains 5/10/15/20 mg of memantine 
hydrochloride equivalent to 4.15/8.31/12.46/16.62 mg memantine. 
 
The other ingredients for Axura 5/10/15 and 20 mg film-coated tablets are microcrystalline cellulose, 
croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, all in the tablet core; and 
hypromellose, macrogol 400, titanium dioxide (E 171) and additional for Axura 10 mg film-coated 
tablets is iron oxide yellow (E 172) and for Axura 15 mg and Axura 20 mg film-coated tablets are iron 
oxide yellow and red (E 172), all in the tablet coating. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 74 

 
What Axura looks like and contents of the pack 
Axura 5 mg film-coated tablets are presented as white to off-white, oval-oblong with imprint ‘5’ on one 
side and imprint ‘MEM’ on the other side. 
Axura 10 mg film-coated tablets are presented as pale yellow to yellow, oval shaped film-coated tablet 
with breaking line and engravings "1-0" on one side and "M M" on the other side The tablet can be 
divided into equal halves. 
Axura 15 mg film-coated tablets are presented as orange to grey-orange, oval-oblong with imprint ‘15’ 
on one side and imprint ‘MEM’ on the other side. 
Axura 20 mg film-coated tablets are presented as are pale red to grey-red, oval-oblong with imprint ‘20’ 
on one side and imprint ‘MEM’ on the other side. 
 
One treatment initiation pack contains 28 tablets in 4 blisters with 7 tablets of Axura 5 mg, 7 tablets of 
Axura 10 mg, 7 tablets of Axura 15 mg and 7 tablets of Axura 20 mg. 
 
Marketing Authorisation Holder 
Merz Pharmaceuticals GmbH 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
Manufacturer 
Merz Pharma GmbH + Co. KGaA 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
Merz Pharmaceuticals GmbH 
Tél/Tel: +49 (0)69 1503 – 0 
 

Lietuva 
H. Abbe Pharma GmbH 
Tel.: +370 52 711710 
 

България 
Merz Pharmaceuticals GmbH 
Tel.: +49 (0)69 1503 – 0 
 

Luxembourg/Luxemburg 
HANFF Global Health Solutions s.à r.l. 
Tél: +352 45 07 07-1 

Česká republika 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Magyarország 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Danmark 
Merz Pharmaceuticals GmbH 
Tlf: +49 (0)69 1503 – 0 
 

Malta 
Clinipharm Co. Ltd 
Tel: +356 21 43 74 15 
 

Deutschland 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 - 0 

Nederland 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Eesti 
H. Abbe Pharma GmbH 
Tel.: +372 6 460980 
 

Norge 
Merz Pharmaceuticals GmbH 
Tlf: +49 (0)69 1503 – 0 
 

Ελλάδα 
Merz Pharmaceuticals GmbH 
Τηλ: +49 (0)69 1503 - 0 

Österreich 
Merz Pharma Austria GmbH 
Tel: +43 1 869 16 04-0 



 75 

  
España 
Merz Pharma España S.L. 
Tel: +34 91 657 47 84 
 

Polska 
Centrala Farmaceutyczna CEFARM SA 
Tel: +48 22 634 02 22 

France 
Merz Pharmaceuticals GmbH 
Tél: +49 (0)69 1503 – 0 
 

Portugal 
Merz Pharma España S.L.  
Tel: +34 91 657 47 84 
 

Hrvatska 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

România 
Merz Pharmaceuticals GmbH 
Tel.: +49 (0)69 1503 – 0 
 

Ireland 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Slovenija 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 - 0 

Ísland 
Merz Pharmaceuticals GmbH 
Sími.: +49 (0)69 1503 – 0 
 

Slovenská republika 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Italia 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 - 0 

Suomi/Finland 
Merz Pharmaceuticals GmbH 
Puh/Tel: +49 (0)69 1503 – 0 
 

Κύπρος 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 - 0 

Sverige 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Latvija 
H. Abbe Pharma GmbH 
Tel.: +371 67 103203 
 

United Kingdom 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 

 
 
This leaflet was last revised in MM/YYYY. 
Detailed information on this medicine is available on the European Medicines Agency (EMA) web 
side: http://www.ema.europa.eu. 
 

http://www.emea.europa.eu/


 76 

Package leaflet: Information for the user 
 

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

of Axura tablets (listed in section 6). 
 
Warning and precautions 
Talk to your doctor or pharmacist before taking Axura 
- 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 Axura 
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. 
 



 77 

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 
Axura is not recommended for children and adolescents under the age of 18 years. 
 
Other medicines and Axura 
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
In particular, Axura 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 Axura. 
 
Axura 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 Axura 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, Axura may change your reactivity, making driving or operating machinery inappropriate.  
 
 
3. How to take Axura 
 
Always take Axura exactly as your doctor has told you. Check with your doctor or pharmacist if you 
are not sure. 
 
Dosage 
The recommended dose of Axura for adults and older people is 20 mg once a day. 
 



 78 

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 Axura 5 mg film-coated tablets once a day. This 
dose will be increased weekly by 5 mg until the recommended (maintenance) dose is reached. The 
recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the 
4th week. 
 
Dosage in patients with impaired kidney function 
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In 
this case, monitoring of your kidney function should be performed by your doctor at specified 
intervals. 
 
Administration 
Axura 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 Axura as long as it is of benefit to you. Your doctor should assess your treatment on a 
regular basis. 
 
If you take more Axura than you should 
- In general, taking too much Axura 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 Axura, contact your doctor or get medical advice, as you may 

need medical attention. 
 
If you forget to take Axura 
- If you find you have forgotten to take your dose of Axura, 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 product, 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 users): 
• 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 users): 
• Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure 

and venous blood clotting (thrombosis/thromboembolism) 
 
Very rare (may affect up to 1 in 10,000 users): 
• 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 



 79 

have been reported in patients treated with Axura. 
 
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 Axura 
 
Keep out of the sight and reach of children. 
 
Do not use Axura after the expiry date which is stated on the carton and the blister after EXP. The 
expiry date refers to the last day of that month. 
 
This medicinal product does not require any special storage conditions. 
 
Do not throw away 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. Content of the pack and other information 
 
What Axura contains 
The active substance is memantine hydrochloride. Each film-coated tablet contains 20 mg of 
memantine hydrochloride equivalent to 16.62 mg memantine. 
 
The other ingredients are  microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous 
silica, magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide 
(E 171), iron oxide yellow and red (E 172), all in the tablet coating. 
 
What Axura looks like and contents of the pack 
Axura film-coated tablets are presented as pale red to grey-red, oval-oblong film-coated tablets with 
imprint ‘20’ on one side and imprint ‘MEM’ on the other side. 
 
Axura film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 42 tablets, 56 tablets, 
98 tablets or in multipacks of 840 (20 x 42) tablets. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Merz Pharmaceuticals GmbH 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
Manufacturer 
Merz Pharma GmbH + Co. KGaA 
Eckenheimer Landstr. 100 
D-60318 Frankfurt/Main 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 80 

België/Belgique/Belgien 
Merz Pharmaceuticals GmbH 
Tél/Tel: +49 (0)69 1503 – 0 
 

Lietuva 
H. Abbe Pharma GmbH 
Tel.: +370 52 711710 
 

България 
Merz Pharmaceuticals GmbH 
Tel.: +49 (0)69 1503 – 0 
 

Luxembourg/Luxemburg 
HANFF Global Health Solutions s.à r.l. 
Tél: +352 45 07 07-1 

Česká republika 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Magyarország 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Danmark 
Merz Pharmaceuticals GmbH 
Tlf: +49 (0)69 1503 – 0 
 

Malta 
Clinipharm Co. Ltd 
Tel: +356 21 43 74 15 
 

Deutschland 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 - 0 

Nederland 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Eesti 
H. Abbe Pharma GmbH 
Tel.: +372 6 460980 
 

Norge 
Merz Pharmaceuticals GmbH 
Tlf: +49 (0)69 1503 – 0 
 

Ελλάδα 
Merz Pharmaceuticals GmbH 
Τηλ: +49 (0)69 1503 - 0 
 

Österreich 
Merz Pharma Austria GmbH 
Tel: +43 1 869 16 04-0 
 

España 
Merz Pharma España S.L. 
Tel: +34 91 657 47 84 
 

Polska 
Centrala Farmaceutyczna CEFARM SA 
Tel: +48 22 634 02 22 

France 
Merz Pharmaceuticals GmbH 
Tél: +49 (0)69 1503 – 0 
 

Portugal 
Merz Pharma España S.L. 
Tel: +34 91 657 47 84 
 

Hrvatska 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

România 
Merz Pharmaceuticals GmbH 
Tel.: +49 (0)69 1503 – 0 
 

Ireland 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Slovenija 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 - 0 

Ísland 
Merz Pharmaceuticals GmbH 
Sími.: +49 (0)69 1503 – 0 
 

Slovenská republika 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Italia 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 - 0 

Suomi/Finland 
Merz Pharmaceuticals GmbH 
Puh/Tel: +49 (0)69 1503 – 0 
 

Κύπρος 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 - 0 

Sverige 
Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 
 

Latvija United Kingdom 



 81 

H. Abbe Pharma GmbH 
Tel.: +371 67 103203 
 

Merz Pharmaceuticals GmbH 
Tel: +49 (0)69 1503 – 0 

 
 
This leaflet was last revised in MM/YYYY. 
Detailed information on this medicine is available on the European Medicines Agency (EMA) web 
side: http://www.ema.europa.eu. 
 

http://www.emea.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER 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