MARIXINO 10 mg Фильм-Coated Таблетки

Содержание инструкции

1. Marixino 10 mg film-coated tablets
   1. What is Marixino and what is it 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. Package contents and other information
2. Marixino 20 mg film-coated tablets
   1. What is Marixino and what is it 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

Marixino 10 mg film-coated tablets

memantine hydrochloride

Read this leaflet carefully before you start 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 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 is Marixino and what is it 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 results from
an alteration 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 defined as NMDA receptor antagonists.
Marixino acts on these NMDA receptors, improving the transmission of
nerve signals 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 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 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 should be carefully monitored and the clinical benefits of Marixino re-evaluated by the doctor at regular intervals. In case of renal dysfunction (kidney problems), the doctor must carefully monitor kidney function and, if necessary, adjust the dose of memantine accordingly. Avoid concomitant use of medicines such as amantadine (for the treatment of Parkinson's disease), ketamine (a substance generally used as an anesthetic), dextromethorphan

(generally used for cough treatment) and other NMDA receptor antagonists.

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 medicine.
In particular, Marixino may alter the effects of the following medicines and it may be necessary to adjust
the dose:

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

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you 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 should not breastfeed.

Driving and using machines
Your doctor will advise you about whether it is safe to drive or use machines with your condition.
In addition, Marixino may alter your responsiveness, making it inadvisable to drive
vehicles or use machines.

Marixino contains lactose and sodium
If you have been diagnosed with intolerance to certain sugars, contact your doctor 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 following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.

Dosage
The recommended dose of Marixino for adults and the elderly is 20 mg once a day. To reduce
the risk of side effects, reach this dose gradually following this daily dosage scheme:

The usual starting dose is half a tablet once a day (1 x 5 mg) for the first week. The
dosage 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 in the third week. From the fourth week onwards, the usual dose
is equal to two tablets once a day (1 x 20 mg).

Dosage in patients with reduced kidney function
In case of reduced kidney function, your doctor may decide on a dosage regimen suitable for your
condition. In this case, monitoring of kidney function at regular intervals must be performed
by your doctor as specified.

Administration
Marixino must be administered orally once a day. To benefit, you must
take the medicine regularly every day at the same time. Take the tablets with a little
water. The film-coated tablets of 10 mg can be divided into equal doses. The tablets
can be taken with or without food.

Duration of treatment
Continue taking Marixino as long as you benefit from it. Your doctor will evaluate the treatment at regular
intervals.

If you take more Marixino than you should

• In general, an overdose of Marixino is not harmful. You may experience a greater number of symptoms described in section 4 “Possible side effects”.
• In case of a significant overdose of Marixino, contact your doctor as their 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 a missed dose.

If you have any doubts 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 observed side effects are mild to moderate.

Common (may affect up to 1 in 10 people):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, hypertension and hypersensitivity to the drug. 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):
• Convulsions Not known (frequency cannot be estimated from available data):
• Pancreatitis, 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 get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system detailed in Annex V.
By reporting side effects you can help to 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 the box after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 ingredient 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: 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, of oval shape, 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 of 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 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 further information on this medicinal product, 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.: + 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.

Slovenija
KRKA, d.d., Novo mesto
Tel: + 353 1 293 91 80 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 Fynland 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
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu

Marixino 20 mg film-coated tablets

memantine hydrochloride

Read this leaflet carefully before you start 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 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 is Marixino and what is it used for

Marixino contains the active ingredient memantine hydrochloride. It belongs to a group of medicines
known as anti-dementia medications. Memory loss in Alzheimer's dementia results from
an alteration 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 defined as NMDA receptor antagonists.
Marixino acts on these NMDA receptors, improving the transmission of
nerve signals 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 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 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 should be carefully monitored and the clinical benefits of Marixino re-evaluated by the doctor at regular intervals. In case of renal dysfunction (kidney problems), the doctor must carefully monitor kidney function and, if necessary, adjust the dose of memantine accordingly. Avoid concomitant use of medicines such as amantadine (for the treatment of Parkinson's disease), ketamine (a substance generally used as an anesthetic), dextromethorphan

(generally used for cough treatment) and other NMDA receptor antagonists.

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 medicine.
In particular, Marixino may alter the effects of the following medicines and it may be necessary to adjust
the dose:

• amantadine, ketamine, dextromethorphan
• dantrolene, baclofen
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
• hydrochlorothiazide (or combinations with hydrochlorothiazide)
• anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
• anticonvulsants (substances used to prevent and treat seizures)
• barbiturates (substances generally used to induce sleep)
• dopamine 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 the medical staff that you are taking Marixino.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you 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 should not breastfeed.

Driving and using machines
Your doctor will advise you about whether it is safe to drive or use machines with your condition.
In addition, Marixino may alter your readiness to react, making it inadvisable to drive
vehicles or use machines.

Marixino contains lactose and sodium
If your doctor has told you that you have an intolerance to some sugars, contact your doctor 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 following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.

Dosage
The recommended dose of Marixino for adults and the elderly is 20 mg once a day.
To reduce the risk of undesirable effects, reach this dose gradually following this
daily dosage scheme. For increasing the titration, tablets with other
dosages are available.
At the beginning of treatment, you will start using half a 10 mg tablet once a day (1 x 5
mg). This dose will be increased weekly by 5 mg until reaching the recommended dose (maintenance). The recommended maintenance dose is 20 mg once a day, which is reached
at the beginning of the fourth week.

Dosage in patients with reduced renal function
In case of reduced renal function, the doctor may decide on a dosage regimen suitable for your
conditions. In this case, monitoring of renal function at regular intervals must be performed
by the doctor as specified.

Administration
Marixino must be administered orally once a day. To benefit, you must
take the medicine regularly every day at the same time. Take the tablets with a little
water. The 10 mg tablet can be divided into two equal doses. The tablets can be
taken with or without food.

Duration of treatment
Continue taking Marixino as long as you benefit from it. The doctor will evaluate the treatment at regular
intervals.

If you take more Marixino than you should

• In general, an overdose of Marixino is not harmful. You may experience a greater number of symptoms described in paragraph 4 “Possible undesirable effects”.
• In case of a significant overdose of Marixino, contact your doctor as their 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 compensate for a missed dose. If you have any doubts about the use of 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 observed side effects are from mild to moderate.

Common (may affect up to 1 in 10 people)

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, hypertension and hypersensitivity to the drug. 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)
• Convulsions. Not known (frequency cannot be estimated based on the available data):
• Pancreatitis, liver inflammation (hepatitis), psychotic reactions.

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the packaging 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 any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Marixino contains

• The active ingredient is memantine hydrochloride. Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg of memantine.
• The other ingredients (excipients) are: Tablet core: lactose monohydrate, 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, biconvex (tablet length
15.7-16.4 mm, thickness 4.7-5.7 mm).
Marixino film-coated tablets are available in blister packs of 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 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 further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

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

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

България
КРКА България ЕООД
Teл.: + 359 (0)2 962 34 50

Luxembourg/Luxemburg
KRKA Belgium S.A.
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 S.A.
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
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu