Marixino

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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS



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1. NAME OF THE MEDICINAL PRODUCT

Marixino 10 mg film-coated tablets
Marixino 20 mg film-coated tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Marixino 10 mg film-coated tablets

Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.

Marixino 20 mg film-coated tablets

Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.

Excipient with known effect: lactose monohydrate

Marixino 10 mg film-coated tablets
Each film-coated tablet contains 51.45 mg lactose monohydrate.

Marixino 20 mg film-coated tablets
Each film-coated tablet contains 102.90 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablet

Marixino 10 mg film-coated tablets

White, oval, biconvex film-coated tablet, scored on one side (tablet length: 12.2–12.9 mm, thickness:
3.5–4.5 mm). The tablet can be divided into equal doses.

Marixino 20 mg film-coated tablets

White, oval, biconvex film-coated tablet (tablet length: 15.7–16.4 mm, thickness: 4.7–5.7 mm).

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Treatment of adult patients with moderate to severe Alzheimer’s disease.

4.2 Posology and method of administration

Treatment should be initiated and supervised by a physician experienced in the diagnosis and 
treatment of Alzheimer’s dementia. 

Posology

Therapy should only be started if a caregiver is available who will regularly monitor the intake of the 
medicinal product by the patient. Diagnosis should be made according to current guidelines. The 
tolerance and dosing of memantine should be reassessed on a regular basis, preferably within three 



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months after start of treatment. Thereafter, the clinical benefit of memantine and the patient’s 
tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. 
Maintenance treatment can be continued for as long as a therapeutic benefit is favourable and the 
patient tolerates treatment with memantine. Discontinuation of memantine should be considered when 
evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment.

Adults
Dose titration
The maximum daily dose is 20 mg per day. In order to reduce the risk of undesirable effects, the 
maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows:

Week 1 (day 1-7)
The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days.

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

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

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

Maintenance dose
The recommended maintenance dose is 20 mg per day.

Elderly
On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 
20 mg per day (two 10 mg film-coated tablets or one 20 mg film-coated tablet once a day) as 
described above.

Renal impairment
In patients with mildly impaired renal function (creatinine clearance 50 – 80 ml/min) no dose 
adjustment is required. In patients with moderate renal impairment (creatinine clearance 
30 - 49 ml/min) daily dose should be 10 mg per day. If tolerated well after at least 7 days of treatment, 
the dose could be increased up to 20 mg/day according to standard titration scheme. In patients with 
severe renal impairment (creatinine clearance 5 – 29 ml/min) daily dose should be 10 mg per day.

Hepatic impairment
In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B), no 
dose adjustment is needed. No data on the use of memantine in patients with severe hepatic 
impairment are available. Administration of Marixino is not recommended in patients with severe 
hepatic impairment.

Paediatric population
No data available.

Method of administration

Marixino should be administered orally once a day and should be taken at the same time every day. 
The film-coated tablets can be taken with or without food.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1



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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.

Lactose
This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total 
lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 
"sodium-free".

4.5 Interaction with other medicinal products and other forms of interaction

Due to the pharmacological effects and the mechanism of action of memantine the following 
interactions may occur:
- The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and 

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

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

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

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

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

In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant active 
substance-active substance interaction of memantine with glyburide/metformin or donepezil was 
observed.

In a clinical study in young healthy subjects, no relevant effect of memantine on the pharmacokinetics 
of galantamine was observed.



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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

There are no or limited amount of data from the use of memantine in pregnant women. Animal studies 
indicate a potential for reducing intrauterine growth at exposure levels, which are identical or slightly 
higher than at human exposure (see section 5.3). The potential risk for humans is unknown. 
Memantine should not be used during pregnancy unless clearly necessary.

Breast-feeding

It is not known whether memantine is excreted in human breast milk but, taking into consideration the 
lipophilicity of the substance, this probably occurs. Women taking memantine should not breast-feed.

Fertility

No adverse reactions of memantine were noted on non-clinical male and female fertility.

4.7 Effects on ability to drive and use machines

Moderate to severe Alzheimer’s disease usually causes impairment of driving performance and 
compromises the ability to use machinery. Furthermore, Marixino has minor to moderate influence on 
the ability to drive and use machines such that outpatients should be warned to take special care.

4.8 Undesirable effects

Summary of the safety profile

In clinical trials in mild to severe dementia, involving 1,784 patients treated with memantine and 
1,595 patients treated with placebo, the overall incidence rate of adverse reactions with memantine did 
not differ from those with placebo; the adverse reactions were usually mild to moderate in severity. 
The most frequently occurring adverse reactions with a higher incidence in the memantine group than 
in the placebo group were dizziness (6.3 % vs 5.6 %, respectively), headache (5.2 % vs 3.9 %), 
constipation (4.6 % vs 2.6 %), somnolence (3.4 % vs 2.2 %) and hypertension (4.1 % vs 2.8 %).

Tabulated list of adverse reactions

The following Adverse Reactions listed in the table below have been accumulated in clinical studies 
with memantine and since its introduction in the market.

Adverse reactions are ranked according to system organ class, using the following convention:very 
common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to 
< 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). Within 
each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

SYSTEM ORGAN CLASS FREQUENCY ADVERSE REACTION

Infections and infestations Uncommon Fungal infections

Immune system disorders Common Drug hypersensitivity

Psychiatric disorders Common Somnolence

Uncommon Confusion



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Uncommon Hallucinations1

Not known Psychotic reactions2

Nervous System disorders Common Dizziness

Common Balance disorders

Uncommon Gait abnormal

Very rare Seizures

Cardiac disorders Uncommon Cardiac failure

Vascular disorders Common Hypertension

Uncommon Venous thrombosis/thromboembolism

Respiratory, thoracic and mediastinal 
disorders

Common Dyspnoea

Gastrointestinal disorders Common Constipation

Uncommon Vomiting

Not known Pancreatitis2

Hepatobiliary disorders Common Elevated liver function test

Not known Hepatitis

General disorders and administration 
site conditions

Common Headache

Uncommon Fatigue

1 Hallucinations have mainly been observed in patients with severe Alzheimer’s disease.
2 Isolated cases reported in post-marketing experience.

Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. In 
post-marketing experience these reactions have been reported in patients treated with memantine.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V.

4.9 Overdose

Only limited experience with overdose is available from clinical studies and post-marketing 
experience.

Symptoms

Relative large overdoses (200 mg and 105 mg/day for 3 days, respectively) have been associated with 
either only symptoms of tiredness, weakness and/or diarrhoea or no symptoms. In the overdose cases 
below 140 mg or unknown dose the patients revealed symptoms from central nervous system 
(confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) 
and/or of gastrointestinal origin (vomiting and diarrhoea).

In the most extreme case of overdose, the patient survived the oral intake of a total of 2000 mg 
memantine with effects on the central nervous system (coma for 10 days, and later diplopia and 
agitation). The patient received symptomatic treatment and plasmapheresis. The patient recovered 



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without permanent sequelae.

In another case of a large overdose, the patient also survived and recovered. The patient had received 
400 mg memantine orally. The patient experienced central nervous system symptoms such as 
restlessness, psychosis, visual hallucinations, proconvulsiveness, somnolence, stupor, and 
unconsciousness.

Treatment

In the event of overdose, treatment should be symptomatic. No specific antidote for intoxication or 
overdose is available. Standard clinical procedures to remove active substance material, e.g. gastric 
lavage, carbo medicinalis (interruption of potential entero-hepatic recirculation), acidification of urine, 
forced diuresis should be used as appropriate.

In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful 
symptomatic clinical treatment should be considered.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Psychoanaleptics, other anti-dementia drugs, ATC code: N06DX01.

There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular at 
NMDA-receptors, contributes to both expression of symptoms and disease progression in 
neurodegenerative dementia.

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 %, 



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p < 0.0001).

5.2 Pharmacokinetic properties

Absorption

Memantine has an absolute bioavailability of approximately 100 %. Tmax is between 3 and 8 hours. 
There is no indication that food influences the absorption of memantine.

Distribution

Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70 to 
150 ng/ml (0.5 – 1 μmol) with large interindividual variations. When daily doses of 5 to 30 mg were 
administered, a mean cerebrospinal fluid (CSF)/serum ratio of 0.52 was calculated. The volume of 
distribution is around 10 l/kg. About 45 % of memantine is bound to plasma-proteins.

Biotransformation

In man, about 80 % of the circulating memantine-related material is present as the parent compound. 
Main human metabolites are N-3,5-dimethyl-gludantan, the isomeric mixture of 4- and 6-hydroxy-
memantine, and 1-nitroso-3,5-dimethyl-adamantane. None of these metabolites exhibit NMDA-
antagonistic activity. No cytochrome P 450 catalysed metabolism has been detected in vitro.

In a study using orally administered 14C-memantine, a mean of 84 % of the dose was recovered within 
20 days, more than 99 % being excreted renally.

Elimination

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

Tablet core
Lactose monohydrate
Microcrystalline cellulose (E460)
Anyhydrous colloidal silica
Talc (E553b)
Magnesium stearate (E470b)

Film coating
Methacrylic acid - ethyl acrylate copolymer (1:1)
Sodyum laurilsulfate
Polysorbate 80
Talc (E553b)
Triacetin
Simeticone

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

5 years

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Blister (PVC/PVDC-Alu foil): 14, 28, 30, 42, 50, 56, 60, 70, 84, 90, 98, 100 and 112 film-coated 
tablets, in a carton box.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.



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7. MARKETING AUTHORISATION HOLDER

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

8. MARKETING AUTHORISATION NUMBER(S)

Marixino 10 mg film-coated tablets

14 film-coated tablets: EU/1/13/820/001
28 film-coated tablets: EU/1/13/820/002
30 film-coated tablets: EU/1/13/820/003
42 film-coated tablets: EU/1/13/820/004
50 film-coated tablets: EU/1/13/820/005
56 film-coated tablets: EU/1/13/820/006
60 film-coated tablets: EU/1/13/820/007
70 film-coated tablets: EU/1/13/820/008
84 film-coated tablets: EU/1/13/820/009
90 film-coated tablets: EU/1/13/820/010
98 film-coated tablets: EU/1/13/820/011
100 film-coated tablets: EU/1/13/820/012
112 film-coated tablets: EU/1/13/820/013

Marixino 20 mg film-coated tablets

14 film-coated tablets: EU/1/13/820/014
28 film-coated tablets: EU/1/13/820/015
30 film-coated tablets: EU/1/13/820/016
42 film-coated tablets: EU/1/13/820/017
50 film-coated tablets: EU/1/13/820/018
56 film-coated tablets: EU/1/13/820/019
60 film-coated tablets: EU/1/13/820/020
70 film-coated tablets: EU/1/13/820/021
84 film-coated tablets: EU/1/13/820/022
90 film-coated tablets: EU/1/13/820/023
98 film-coated tablets: EU/1/13/820/024
100 film-coated tablets: EU/1/13/820/025
112 film-coated tablets: EU/1/13/820/026

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 29 April 2013
Date of latest renewal: 18 January 2018

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu.



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ANNEX II

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND 
USE

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION

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



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A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers responsible for batch release

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
SLOVENIA

TAD Pharma GmbH
Heinz-Lohmann-Straße 5
27472 Cuxhaven
GERMANY

The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch.

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

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

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION

 Periodic safety update reports (PSURs)

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

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

 Risk management plan (RMP)

Not applicable. 



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ANNEX III

LABELLING AND PACKAGE LEAFLET



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A. LABELLING



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

CARTON BOX 

1. NAME OF THE MEDICINAL PRODUCT

Marixino 10 mg film-coated tablets
memantine hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.

3. LIST OF EXCIPIENTS

Contains lactose.
See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

14 film-coated tablets
28 film-coated tablets
30 film-coated tablets
42 film-coated tablets
50 film-coated tablets
56 film-coated tablets
60 film-coated tablets
70 film-coated tablets
84 film-coated tablets
90 film-coated tablets
98 film-coated tablets
100 film-coated tablets
112 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Once daily

Read the package leaflet before use.

Oral use

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

Keep out of the sight and reach of children.



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7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/820/001 14 film-coated tablets
EU/1/13/820/002 28 film-coated tablets
EU/1/13/820/003 30 film-coated tablets
EU/1/13/820/004 42 film-coated tablets
EU/1/13/820/005 50 film-coated tablets
EU/1/13/820/006 56 film-coated tablets
EU/1/13/820/007 60 film-coated tablets
EU/1/13/820/008 70 film-coated tablets
EU/1/13/820/009 84 film-coated tablets
EU/1/13/820/010 90 film-coated tablets
EU/1/13/820/011 98 film-coated tablets
EU/1/13/820/012 100 film-coated tablets
EU/1/13/820/013 112 film-coated tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Marixino 10 mg



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17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN



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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER (PVC/PVDC-Alu FOIL)

1. NAME OF THE MEDICINAL PRODUCT

Marixino 10 mg film-coated tablets
memantine hydrochloride

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

CARTON BOX

1. NAME OF THE MEDICINAL PRODUCT

Marixino 20 mg film-coated tablets
memantine hydrochloride

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.

3. LIST OF EXCIPIENTS

Contains lactose.
See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

14 film-coated tablets
28 film-coated tablets
30 film-coated tablets
42 film-coated tablets
50 film-coated tablets
56 film-coated tablets
60 film-coated tablets
70 film-coated tablets
84 film-coated tablets
90 film-coated tablets
98 film-coated tablets
100 film-coated tablets
112 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Once daily

Read the package leaflet before use.

Oral use

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

Keep out of the sight and reach of children.



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7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

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

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/13/820/014 14 film-coated tablets
EU/1/13/820/015 28 film-coated tablets
EU/1/13/820/016 30 film-coated tablets
EU/1/13/820/017 42 film-coated tablets
EU/1/13/820/018 50 film-coated tablets
EU/1/13/820/019 56 film-coated tablets
EU/1/13/820/020 60 film-coated tablets
EU/1/13/820/021 70 film-coated tablets
EU/1/13/820/022 84 film-coated tablets
EU/1/13/820/023 90 film-coated tablets
EU/1/13/820/024 98 film-coated tablets
EU/1/13/820/025 100 film-coated tablets
EU/1/13/820/026 112 film-coated tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Marixino 20 mg



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17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN



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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER (PVC/PVDC-Alu FOIL)

1. NAME OF THE MEDICINAL PRODUCT

Marixino 20 mg film-coated tablets
memantine hydrochloride

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER



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B. PACKAGE LEAFLET



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Package leaflet: Information for the patient

Marixino 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 Marixino is and what it is used for
2. What you need to know before you take Marixino
3. How to take Marixino
4. Possible side effects
5. How to store Marixino
6. Contents of the pack and other information

1. What Marixino is and what it is used for

Marixino contains the active substance memantine hydrochloride. It belongs to a group of medicines 
known as anti-dementia medicines. Memory loss in Alzheimer’s disease is due to a disturbance of 
message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors 
that are involved in transmitting nerve signals important in learning and memory. Marixino belongs to 
a group of medicines called NMDA-receptor antagonists. Marixino acts on these NMDA-receptors 
improving the transmission of nerve signals and the memory.

Marixino is used for the treatment of patients with moderate to severe Alzheimer’s disease.

2. What you need to know before you take Marixino

Do not take Marixino
- if you are allergic to memantine or any of the other ingredients of this medicine (listed in 

section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Marixino:
- 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 Marixino 
reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your 
kidney function and if necessary adapt the memantine doses accordingly.

The use of medicinal products called amantadine (for the treatment of Parkinson’s disease), ketamine 
(a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and 
other NMDA-antagonists at the same time should be avoided.



25

Children and adolescents
Marixino is not recommended for children and adolescents under the age of 18 years.

Other medicines and Marixino
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.

In particular, Marixino 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 Marixino.

Marixino 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 Marixino 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, 
Marixino may change your reactivity, making driving or operating machinery inappropriate.

Marixino contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially "sodium-
free".

3. How to take Marixino

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure. 

Dosage
The recommended dose of Marixino for adults and older people is 20 mg once a day. In order to 



26

reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:

Week 1 Half a 10 mg tablet
Week 2 One 10 mg tablet
Week 3 One and a half 10 mg tablets
Week 4 Two 10 mg tablets 

The usual starting dose is half a tablet once a day (1 x 5 mg) for the first week. This is increased to one 
tablet once a day (1 x 10 mg) in the second week and to 1 and a half tablets once a day (1 x 15 mg) in 
the third week. From the fourth week on, the usual dose is two tablets once a day (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
Marixino 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 10 mg film-coated tablet can be divided into equal doses. The tablets can be taken with or without 
food.

Duration of treatment
Continue to take Marixino as long as it is of benefit to you. Your doctor should assess your treatment 
on a regular basis.

If you take more Marixino than you should
- In general, taking too much Marixino 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 Marixino, contact your doctor or get medical advice, as you may 

need medical attention.

If you forget to take Marixino
- If you find you have forgotten to take your dose of Marixino, wait and take your next dose at 

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects are mild to moderate.

Common (may affect up to 1 in 10 people):
- Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, 

shortness of breath, high blood pressure and drug hypersensitivity.

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

and venous blood clotting (thrombosis/thromboembolism).

Very Rare (may affect up to 1 in 10,000 people):
- Seizures.



27

Not known (frequency cannot be estimated from the available data):
- Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions

Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events 
have been reported in patients treated with memantine.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine.

5. How to store Marixino

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The 
expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Marixino contains
- The active substance is memantine hydrochloride.

Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg 
memantine.

- The other ingredients (excipients) are:
Tablet core: lactose monohydrate, microcrystalline cellulose (E460), anhydrous colloidal silica, 
talc (E553b), magnesium stearate (E470b).
Film coating: methacrylic acid - ethyl acrylate copolymer (1:1), sodium laurilsulfate, 
polysorbate 80, talc (E553b), triacetin, simeticone.

What Marixino looks like and contents of the pack
White, oval, biconvex film-coated tablets, scored on one side (tablet length: 12.2–12.9 mm, thickness:
3.5–4.5 mm). The tablet can be divided into equal doses.

Marixino film-coated tablets are available in boxes of 14, 28, 30, 42, 50, 56, 60, 70, 84, 90, 98, 100 
and 112 film-coated tablets in blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:



28

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62

Lietuva
UAB KRKA Lietuva
Tel: + 370 5 236 27 40

България
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Malta
E. J. Busuttil Ltd.
Tel: + 356 21 445 885

Deutschland
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Nederland
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)

Eesti
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658

Norge
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα
QUALIA PHARMA S.A.
Τηλ: + 30 210 6256177

Österreich
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

España
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 81

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 293 91 80

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: + 358 20 754 5330

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882

Sverige
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

Latvija United Kingdom



29

KRKA Latvija SIA
Tel: + 371 6 733 86 10

Consilient Health (UK) Ltd.
Tel: + 44 (0)203 751 1888

This leaflet was last revised in 

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.



30

Package leaflet: Information for the patient

Marixino 20 mg film-coated tablets
memantine hydrochloride

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

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

effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Marixino is and what it is used for
2. What you need to know before you take Marixino
3. How to take Marixino
4. Possible side effects
5. How to store Marixino
6. Contents of the pack and other information

1. What Marixino is and what it is used for

Marixino contains the active substance memantine hydrochloride. It belongs to a group of medicines 
known as anti-dementia medicines. Memory loss in Alzheimer’s disease is due to a disturbance of 
message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors 
that are involved in transmitting nerve signals important in learning and memory. Marixino belongs to 
a group of medicines called NMDA-receptor antagonists. Marixino acts on these NMDA-receptors 
improving the transmission of nerve signals and the memory.

Marixino is used for the treatment of patients with moderate to severe Alzheimer’s disease.

2. What you need to know before you take Marixino

Do not take Marixino
- if you are allergic to memantine or any of the other ingredients of this medicine (listed in 

section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Marixino:
- 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 Marixino 
reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your 
kidney function and if necessary adapt the memantine doses accordingly.

The use of medicinal products called amantadine (for the treatment of Parkinson’s disease), ketamine 
(a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and 
other NMDA-antagonists at the same time should be avoided.



31

Children and adolescents
Marixino is not recommended for children and adolescents under the age of 18 years.

Other medicines and Marixino
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.

In particular, Marixino 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 Marixino.

Marixino 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 Marixino 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, 
Marixino may change your reactivity, making driving or operating machinery inappropriate.

Marixino contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially "sodium-
free".

3. How to take Marixino

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 
if you are not sure. 

Dosage
The recommended dose of Marixino for adults and older people is 20 mg once a day.



32

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 half a 10 mg tablet once a day (1 x 5 mg). 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
Marixino 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 10 mg film-coated tablet can be divided into equal doses. The tablets can be taken with or without 
food.

Duration of treatment
Continue to take Marixino as long as it is of benefit to you. Your doctor should assess your treatment 
on a regular basis.

If you take more Marixino than you should
- In general, taking too much Marixino 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 Marixino, contact your doctor or get medical advice, as you may 

need medical attention.

If you forget to take Marixino
- If you find you have forgotten to take your dose of Marixino, wait and take your next dose at 

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects are mild to moderate.

Common (may affect up to 1 in 10 people):
- Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, 

shortness of breath, high blood pressure and drug hypersensitivity.

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

and venous blood clotting (thrombosis/thromboembolism).

Very Rare (may affect up to 1 in 10,000 people):
- Seizures.

Not known (frequency cannot be estimated from the available data):
- Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions



33

Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events 
have been reported in patients treated with memantine.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine.

5. How to store Marixino

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The 
expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Marixino contains
- The active substance is memantine hydrochloride.

Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg 
memantine.

- The other ingredients (excipients) are:
Tablet core: lactose monohydrate, microcrystalline cellulose (E460), anhydrous colloidal silica, 
talc (E553b), magnesium stearate (E470b).
Film coating: methacrylic acid - ethyl acrylate copolymer (1:1), sodium laurilsulfate, 
polysorbate 80, talc (E553b), triacetin, simeticone.
See section 2 "Marixino contains lactose and sodium".

What Marixino looks like and contents of the pack
White, oval, biconvex film-coated tablet (tablet length: 15.7–16.4 mm, thickness: 4.7–5.7 mm).

Marixino film-coated tablets are available in boxes of 14, 28, 30, 42, 50, 56, 60, 70, 84, 90, 98, 100 
and 112 film-coated tablets in blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder 
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:

België/Belgique/Belgien
KRKA Belgium, SA.

Lietuva
UAB KRKA Lietuva



34

Tél/Tel: + 32 (0) 487 50 73 62 Tel: + 370 5 236 27 40

България
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Malta
E. J. Busuttil Ltd.
Tel: + 356 21 445 885

Deutschland
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Nederland
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)

Eesti
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658

Norge
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα
QUALIA PHARMA S.A.
Τηλ: + 30 210 6256177

Österreich
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

España
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 81

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 100

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 293 91 80

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: + 358 20 754 5330

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882

Sverige
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

United Kingdom
Consilient Health (UK) Ltd.
Tel: + 44 (0)203 751 1888



35

This leaflet was last revised in 

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.


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