Marixino

Package leaflet: Information for the user

Marixino 10 mg film-coated tablets

memantine hydrochloride
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Marixino is and what it is used for
2. What you need to know before taking 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 drugs. Memory loss in Alzheimer's dementia is due to
a disruption in the transmission of nerve signals in the brain. The brain contains so-called
N-Methyl-D-Aspartate (NMDA) receptors involved in the transmission of nerve signals important for
learning and memory. Marixino belongs to a group of medicines known as NMDA receptor antagonists. Marixino acts on these NMDA receptors, improving nerve signal transmission and memory.
Marixino is used for the treatment of patients with moderate to severe Alzheimer's disease.

2. What you need to know before taking Marixino

Do not take Marixino

• if you are allergic (hypersensitive) to memantine or to 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 had a myocardial infarction (heart attack) or if you suffer from congestive heart failure or uncontrolled hypertension (high blood pressure). In these situations, treatment must be closely monitored and the clinical benefits of Marixino should be regularly reassessed by your doctor. If you have renal impairment (kidney problems), your doctor must closely monitor kidney function and, if necessary, adjust the dose of memantine accordingly. Avoid concomitant use of medicines such as amantadine (used to treat Parkinson's disease), ketamine (a substance generally used as an anaesthetic), or dextromethorphan

(generally used to treat cough) and other NMDA receptor antagonists.
Children and adolescents
Marixino is not recommended for children and adolescents under 18 years of age.
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 alter the effects of the following medicines, and dose adjustment may be necessary:

• amantadine, ketamine, dextromethorphan
• dantrolene, baclofen
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
• hydrochlorothiazide (or combinations containing hydrochlorothiazide)
• anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
• anticonvulsants (substances used to prevent and treat epileptic 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 are admitted to hospital, inform medical staff that you are taking Marixino.

Marixino with food and drink
Talk to your doctor if you have recently changed or plan to substantially change your
diet (for example, from a normal diet to a strictly vegetarian diet) or if you suffer
from renal tubular acidosis (RTA, an excess of acid-forming substances in the blood due to
kidney dysfunction (insufficient kidney function)) or severe urinary tract infections, as your
doctor may need to adjust the dose of the medicine accordingly.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The use of memantine during pregnancy is not recommended.
Breastfeeding
Women taking Marixino must not breastfeed.
Driving and using machines
Your doctor will advise you on whether it is safe for you to drive or operate machinery given your condition.
Moreover, Marixino may affect your reaction time, making it advisable not to drive or
use machinery.
Marixino contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Marixino

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Dosage
The recommended dose of Marixino for adults and elderly patients is 20 mg once daily. To reduce
the risk of undesirable effects, reach this dose gradually according to the following daily dosage schedule:

The usual starting dose is half a tablet once daily (1 x 5 mg) for the first week. The dosage is increased to one tablet once daily (1 x 10 mg) in the second week and to one and a half tablets once daily in the third week. From the fourth week onwards, the usual dose is two tablets once daily (1 x 20 mg).
Dosage in patients with reduced renal function
If you have reduced kidney function, your doctor may decide on a dosage regimen suitable for your condition. In such cases, regular monitoring of kidney function must be performed by your doctor as specified.
Administration
Marixino should be taken orally once daily. To obtain benefit, you must take the medicine regularly every day at the same time. Swallow the tablets with some water. The 10 mg film-coated tablets may be divided into equal doses. The tablets may be taken with or without food.
Duration of treatment
Continue taking Marixino for as long as you benefit from it. Your doctor will review your treatment at regular intervals.
If you take more Marixino than you should

• In general, overdosing on Marixino is not harmful. A higher number of symptoms described in section 4 "Possible side effects" may occur.
• In case of a significant overdose of Marixino, contact your doctor as medical intervention may be necessary.

If you forget to take Marixino

• If you forget to take a dose of Marixino, take the next dose at the usual scheduled time.
• Do not take a double dose to make up for the forgotten dose.

If you have any questions about 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 side effects observed are mild to moderate.
Common (may affect up to 1 in 10 people):

• Headache, drowsiness, constipation, increased liver function tests, dizziness, balance disorders, shortness of breath, hypertension and drug hypersensitivity.

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

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbances, 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), 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed in Annex 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 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 dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Marixino contains

• The active substance is memantine hydrochloride. Each film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
• The other ingredients (excipients) are: Tablet core: lactose, microcrystalline cellulose (E460), anhydrous colloidal silica, talc (E553b), magnesium stearate (E470b). Tablet coating: methacrylic acid-ethyl acrylate copolymer (1:1), sodium lauryl sulfate, polysorbate 80, talc (E553b), triacetin, simethicone. See section 2 “Marixino contains lactose and sodium”.

Description of the appearance of Marixino and the contents of the pack
Film-coated tablets, white in colour, oval-shaped, biconvex, with a score line on one side (tablet length 12.2–12.9 mm, thickness: 3.5–4.5 mm). The tablet can be divided into two equal doses.
Marixino film-coated tablets are available in blister packs containing 14, 28, 30, 42, 50, 56, 60, 70, 84, 90, 98, 100 and 112 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
KRKA Belgium, SA. UAB KRKA Lietuva
Tél/Tel: + 32 (0) 487 50 73 62 Tel: + 370 5 236 27 40

България Luxembourg/Luxemburg
КРКА България ЕООД KRKA Belgium, SA.
Teл.: + 359 (02) 962 34 50 Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika Magyarország
KRKA ČR, s.r.o. KRKA Magyarország Kereskedelmi Kft.
Tel: + 420 (0) 221 115 150 Tel.: + 36 (1) 355 8490

Danmark Malta
KRKA Sverige AB E. J. Busuttil Ltd.
Tlf: + 46 (0)8 643 67 66 (SE) Tel: + 356 21 445 885

Deutschland Nederland
TAD Pharma GmbH KRKA Belgium, SA.
Tel: + 49 (0) 4721 606-0 Tel: + 32 (0) 487 50 73 62 (BE)

Eesti Norge
KRKA, d.d., Novo mesto Eesti filiaal KRKA Sverige AB
Tel: + 372 (0) 6 671 658 Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα Österreich
QUALIA PHARMA S.A. KRKA Pharma GmbH, Wien
Τηλ: + 30 210 6256177 Tel: + 43 (0)1 66 24 300

España Polska
KRKA Farmacéutica, S.L. KRKA-POLSKA Sp. z o.o.
Tel: + 34 911 61 03 81 Tel.: + 48 (0)22 573 7500

France Portugal
KRKA France Eurl KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tél: + 33 (0)1 57 40 82 25 Tel: + 351 (0)21 46 43 650

Hrvatska România
KRKA - FARMA d.o.o. KRKA Romania S.R.L., Bucharest
Tel: + 385 1 6312 100 Tel: + 4 021 310 66 05

Ireland Slovenija
KRKA Pharma Dublin, Ltd. KRKA, d.d., Novo mesto
Tel: + 353 1 293 91 80 Tel: + 386 (0) 1 47 51 100

Ísland Slovenská republika
LYFIS ehf. KRKA Slovensko, s.r.o.
Sími: + 354 534 3500 Tel: + 421 (0) 2 571 04 501

Italia Suomi/Finland
KRKA Farmaceutici Milano S.r.l. KRKA Fynland Oy
Tel: + 39 02 3300 8841 Puh/Tel: + 358 20 754 5330

Κύπρος Sverige
KI.PA. (PHARMACAL) LIMITED KRKA Sverige AB
Τηλ: + 357 24 651 882 Tel: + 46 (0)8 643 67 66 (SE)

Latvija United Kingdom
KRKA Latvija SIA Consilient Health (UK) Ltd.
Tel: + 371 6 733 86 10 Tel: + 44 (0)203 751 1888

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

Package leaflet: Information for the user

Marixino 20 mg film-coated tablets

memantine hydrochloride
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Marixino is and what it is used for
2. What you need to know before taking 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 drugs. Memory loss in Alzheimer's dementia is due to an impairment in nerve
signal transmission in the brain. The brain contains so-called N-Methyl-D-Aspartate (NMDA) receptors
involved in nerve signal transmission important for learning and memory. Marixino belongs to a group
of medicines known as NMDA receptor antagonists. Marixino acts on these NMDA receptors, improving
nerve signal transmission and memory.
Marixino is used for the treatment of patients with moderate to severe Alzheimer's disease.

2. What you need to know before taking Marixino

Do not take Marixino

• if you are allergic (hypersensitive) to memantine or to 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 had a myocardial infarction (heart attack) or if you suffer from congestive heart failure or uncontrolled hypertension (high blood pressure). In these situations, treatment must be closely monitored and the clinical benefits of Marixino reassessed by the doctor at regular intervals. If you have renal impairment (kidney problems), your doctor must carefully monitor kidney function and, if necessary, adjust the dose of memantine accordingly. Avoid concomitant use of medicines such as amantadine (used for Parkinson’s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (commonly used to treat cough), and other NMDA receptor antagonists.

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

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 alter the effects of the following medicines, and dose adjustment may be necessary:

• amantadine, ketamine, dextromethorphan
• dantrolene, baclofen
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
• hydrochlorothiazide (or combinations containing hydrochlorothiazide)
• anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
• anticonvulsants (substances used to prevent and treat epileptic 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 hospitalised, inform medical staff that you are taking Marixino.

Marixino with food and drink
Talk to your doctor if you have recently changed or plan to substantially change your diet (e.g. switching from a normal diet to a strictly vegetarian diet), or if you suffer from renal tubular acidosis (RTA, an excess of acid-forming substances in the blood due to kidney dysfunction (insufficient kidney function)) or severe urinary tract infections, as your doctor may need to adjust the dose of the medicine accordingly.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
The use of memantine during pregnancy is not recommended.

Breastfeeding
Women taking Marixino must not breastfeed.

Driving and using machines
Your doctor will advise you on whether it is safe for you to drive or operate machinery given your condition.
Moreover, Marixino may affect your reaction time, making it advisable to avoid driving vehicles or operating machinery.

Marixino contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Marixino

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose of Marixino for adults and elderly patients is 20 mg once daily.
To reduce the risk of undesirable effects, this dose should be reached gradually according to the following daily dosage schedule. For dose titration, tablets with other strengths are available.
At the beginning of treatment, you will start by taking half a 10 mg tablet once daily (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 daily, which is achieved at the beginning of the fourth week.
Dosage in patients with reduced renal function
If you have reduced kidney function, your doctor may decide on a dosage regimen suitable for your condition. In this case, regular monitoring of kidney function must be performed by your doctor as specified.
Administration
Marixino should be taken orally once daily. To obtain benefit, you must take the medicine regularly every day at the same time. Swallow the tablets with some water. The 10 mg tablet may be divided into two equal doses. Tablets may be taken with or without food.
Duration of treatment
Continue taking Marixino for as long as you benefit from it. Your doctor will review your treatment at regular intervals.
If you take more Marixino than you should

• In general, overdose of Marixino is not harmful. A higher number of symptoms described in section 4 "Possible side effects" may occur.
• In case of a significant overdose of Marixino, contact your doctor, as medical intervention may be necessary.

If you forget to take Marixino

• If you forget to take a dose of Marixino, take the next dose at the scheduled time.
• Do not take a double dose to make up for the missed dose. If you have any doubts about how to use this medicine, consult 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 side effects observed are mild to moderate.

Common (may affect up to 1 in 10 people)

• Headache, somnolence, constipation, increased liver function tests, dizziness, balance disorders, shortness of breath, hypertension, and drug hypersensitivity.

Uncommon (may affect up to 1 in 100 people)

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbances, heart failure, and venous blood coagulation (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), psychotic reactions.

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex 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 stated on the blister and on the 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 dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Marixino contains

• The active substance is memantine hydrochloride. Each film-coated tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
• The other components (excipients) are: Tablet core: monohydrate lactose, microcrystalline cellulose (E460), anhydrous colloidal silica, talc (E553b), magnesium stearate (E470b). Tablet coating: methacrylate-ethyl acrylate copolymer (1:1), sodium lauryl sulfate, polysorbate 80, talc (E553b), triacetin, simethicone. See section 2 “Marixino contains lactose and sodium”.

Description of the appearance of Marixino and contents of the pack
Film-coated tablets, white in colour, oval-shaped and biconvex (tablet length 15.7–16.4 mm, thickness 4.7–5.7 mm).
Marixino film-coated tablets are available in blister packs containing 14, 28, 30, 42, 50, 56, 60, 70, 84, 90, 98, 100, and 112 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

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

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

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

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

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

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

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

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

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

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

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

Ísland
LYFIS ehf.
Sími: + 354 534 3500

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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