Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - marixino

Document Subject

Generated Narrative: MedicinalProductDefinition mp5b6e393c6403bed8aaf028ca7b1d8cd4

identifier: http://ema.europa.eu/identifier/14 film-coated tablets: EU/1/13/820/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Marixino 10 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-5b6e393c6403bed8aaf028ca7b1d8cd4

identifier: http://ema.europa.eu/identifier/14 film-coated tablets: EU/1/13/820/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - marixino

Attesters

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

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.

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 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".

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.

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.

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.

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, and 112 film-coated tablets in blisters. Not all pack sizes may be marketed. Marketing Authorisation Holder KRKA, d.d., Novo mesto, marje ka cesta 6, 8501 Novo mesto, Slovenia Manufacturer KRKA, d.d., Novo mesto, marje ka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Stra e 5, 27472 Cuxhaven, Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien KRKA Belgium, SA. T l/Tel: + 32 (0) 487 50 73 Lietuva UAB KRKA Lietuva Tel: + 370 5 236 27

Te .: + 359 (02) 962 34 Luxembourg/Luxemburg KRKA Belgium, SA. T l/Tel: + 32 (0) 487 50 73 62 (BE) esk republika KRKA R, s.r.o. Tel: + 420 (0) 221 115 Magyarorsz g KRKA Magyarorsz g Kereskedelmi Kft. Tel.: + 36 (1) 355 8Danmark KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) Malta E. J. Busuttil Ltd. Tel: + 356 21 445 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 Norge KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE)

KRKA
: + 30 2100101 sterreich KRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 Espa a KRKA Farmac utica, S.L. Tel: + 34 911 61 03 Polska KRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7France KRKA France Eurl T l: + 33 (0)1 57 40 82 Portugal KRKA Farmac utica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 Hrvatska KRKA - FARMA d.o.o. Tel: + 385 1 6312 Rom nia KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 Ireland KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3Slovenija KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 sland LYFIS ehf. S mi: + 354 534 3Slovensk republika KRKA Slovensko, s.r.o. Tel: + 421 (0) 2 571 04 Italia KRKA Farmaceutici Milano S.r.l. Tel: + 39 02 3300 8Suomi/Finland KRKA Finland Oy Puh/Tel: + 358 20 754 5 KI.PA. (PHARMACAL) LIMITED : + 357 24 651 Sverige KRKA Sverige AB Tel: + 46 (0)8 643 67 66 (SE) Latvija United Kingdom (Northern Ireland) KRKA Latvija SIA Tel: + 371 6 733 86 Consilient Health Limited Tel: + 353 (0)1 2057This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site: