Marixino (previously Maruxa)

Основна информация

  • Търговско наименование:
  • Marixino (previously Maruxa)
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Marixino (previously Maruxa)
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Other anti-dementia drugs
  • Терапевтична област:
  • Alzheimer Disease
  • Терапевтични показания:
  • Treatment of patients with moderate to severe Alzheimer’s disease.
  • Каталог на резюме:
  • Revision: 6

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/002658
  • Дата Оторизация:
  • 28-04-2013
  • EMEA код:
  • EMEA/H/C/002658
  • Последна актуализация:
  • 12-05-2020

Доклад обществена оценка

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.

EMA/514457/2013

EMEA/H/C/002658

EPAR summary for the public

Marixino

memantine

This is a summary of the European public assessment report (EPAR) for Marixino. It explains how the

Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is

not intended to provide practical advice on how to use Marixino.

For practical information about using Marixino, patients should read the package leaflet or contact their

doctor or pharmacist.

What is Marixino and what is it used for?

Marixino is a medicine used to treat patients with moderate to severe Alzheimer’s disease, a type of

dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour. It

contains the active substance memantine hydrochloride.

Marixino is a ‘generic medicine’. This means that Marixino is similar to a ‘reference medicine’ already

authorised in the European Union (EU) called Ebixa. For more information on generic medicines, see

the question-and-answer document here.

How is Marixino used?

Marixino is available as 10 mg and 20 mg tablets and can only be obtained with a prescription.

Treatment should be started and supervised by a doctor who has experience in the diagnosis and

treatment of Alzheimer’s disease. Treatment should only be started if a caregiver is available who will

regularly monitor the use of Marixino by the patient.

Marixino should be given once a day at the same time every day. To prevent side effects, the dose of

Marixino is gradually increased over the first three weeks of treatment: during the first week, the dose

is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four

onwards, the recommended maintenance dose is 20 mg once a day. The tolerance and dose should be

assessed within 3 months after starting treatment, and from then on the benefits of continuing

Previously known as Maruxa.

Marixino

EMA/514457/2013

Page 2/3

treatment with Marixino should be reassessed on a regular basis. The dose may need to be reduced in

patients who have moderate or severe problems with their kidneys.

For more information, see the package leaflet.

How does Marixino work?

The active substance in Marixino, memantine, is an antidementia medicine. The cause of Alzheimer’s

disease is unknown, but memory loss in the disease is believed to be due to a disturbance of message

signals in the brain.

Memantine works by blocking special types of receptor called NMDA receptors to which the

neurotransmitter glutamate normally attaches. Neurotransmitters are chemicals in the nervous system

that allow nerve cells to communicate with one another. Changes in the way glutamate transmits

signals within the brain have been linked to the memory loss seen in Alzheimer’s disease. In addition,

overstimulation of the NMDA receptors may result in cell damage or death. By blocking NMDA

receptors, memantine improves the transmission of signals in the brain and reduces the symptoms of

Alzheimer’s disease.

How has Marixino been studied?

The company provided data on the medicine’s solubility, composition and absorption in the body. No

additional studies in patients were required as Marixino was shown to have comparable quality and is

considered to be bioequivalent to the reference medicine, Ebixa. ‘Bioequivalent’ means that the

medicines are expected to produce the same levels of the active substance in the body.

What are the benefits and risks of Marixino?

Because Marixino is a generic medicine and is bioequivalent to the reference medicine, its benefits and

risks are taken as being the same as the reference medicine’s.

Why is Marixino approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance

with EU requirements, Marixino has been shown to have comparable quality and to be bioequivalent to

Ebixa. Therefore, the CHMP’s view was that, as for Ebixa, the benefit outweighs the identified risk. The

Committee recommended that Marixino be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of

Marixino?

Safety information has been included in the summary of product characteristics and the package leaflet

for Marixino, including the appropriate precautions to be followed by healthcare professionals and

patients.

Other information about Marixino

The European Commission granted a marketing authorisation valid throughout the European Union for

Maruxa on 29 April 2013. The name of the medicine was changed to Marixino on 9 August 2013.

The full EPAR for Marixino can be found on the Agency’s website: ema.europa.eu/Find

medicine/Human medicines/European public assessment reports. For more information about

Marixino

EMA/514457/2013

Page 3/3

treatment with Marixino, read the package leaflet (also part of the EPAR) or contact your doctor or

pharmacist.

The full EPAR for the reference medicine can also be found on the Agency’s website.

This summary was last updated in 08-2013.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

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

What Marixino is and what it is used for

What you need to know before you take Marixino

How to take Marixino

Possible side effects

How to store Marixino

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.

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

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor

before talking this medicinal product.

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

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.

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.

See section 2 "Marixino contains lactose".

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:

België/Belgique/Belgien

Lietuva

KRKA Belgium, SA.

Tél/Tel: + 32 (0) 487 50 73 62

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.: + 361 (0) 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

KRKA Sverige AB

Sími: + 46 (0)8 643 67 66 (SE)

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

Kipa Pharmacal Ltd.

Τηλ: + 357 24 651 882

Sverige

KRKA Sverige AB

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

Latvija

KRKA Latvija SIA

United Kingdom

Consilient Health (UK) Ltd.

Tel: + 371 6 733 86 10

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

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

What Marixino is and what it is used for

What you need to know before you take Marixino

How to take Marixino

Possible side effects

How to store Marixino

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.

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

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor

before talking this medicinal product.

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 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 4

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

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".

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.

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.: + 361 (0) 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

KRKA Sverige AB

Sími: + 46 (0)8 643 67 66 (SE)

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

Kipa Pharmacal Ltd.

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

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