MEMANTINE MYLAN 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Memantina Mylan 20 mg Film-Coated Tablets EFG

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.

Contents of the Package Leaflet

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

1. What is Memantina Mylan and what is it used for

Memantina Mylan contains the active substance memantine. It belongs to a group of medicines called 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 the transmission of nerve signals important for learning and memory. Memantina Mylan belongs to a group of medicines called NMDA receptor antagonists. Memantina Mylan acts on these receptors improving the transmission of nerve signals and memory.

Memantina Mylan is used for the treatment of patients with moderate to severe Alzheimer's disease.

2. What you need to know before you take Memantina Mylan

Do not take Memantina Mylan:

• if you are allergic to memantine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking Memantina Mylan.

• if you have a history of epileptic seizures
• if you have recently suffered from myocardial infarction (heart attack), if you suffer from congestive heart failure or if you have uncontrolled hypertension (high blood pressure).

In these situations, treatment must be carefully supervised and your doctor must regularly re-evaluate the clinical benefit of Memantina Mylan.

If you have kidney problems, your doctor should closely monitor your kidney function and if necessary, adjust the dose of memantine.

The use of memantine should be avoided in combination with other medicines such as amantadine (for the treatment of Parkinson's disease), ketamine (a medicine generally used to produce anesthesia), dextromethorphan (a medicine for the treatment of cough) and other NMDA antagonists.

Children and adolescents:

Memantina Mylan is not recommended for use in children below 18 years of age.

Use of Memantina Mylan with other medicines

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

In particular, the administration of Memantina Mylan may cause changes in the effects of the following medicines, so your doctor may need to adjust the dose:

• 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 spasms)
• anticonvulsants (substances used to prevent and eliminate convulsions)
• barbiturates (substances generally used to induce sleep)
• dopaminergic agonists (substances such as L-dopa, bromocriptine)
• neuroleptics (substances used in the treatment of mental illnesses)
• oral anticoagulants

If you are admitted to hospital, inform your doctor that you are taking Memantina Mylan.

Taking Memantina Mylan with food and drinks

You should inform your doctor if you have recently changed or intend to change your diet considerably (e.g. from normal to strict vegetarian) or if you suffer from renal tubular acidosis (RTA, excess of acid-producing substances in the blood due to kidney dysfunction) or severe urinary tract infections, as your doctor may need to adjust the dose of the 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

Memantine is not recommended for use in pregnant women.

Breast-feeding

Memantina Mylan is contraindicated during breast-feeding.

Driving and using machines

Your illness may affect your ability to drive or use machines and you should not carry out these activities unless your doctor tells you it is safe to do so. Memantina Mylan may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you experience these effects, you should not drive or use machines.

Memantina Mylan contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Memantina Mylan

Follow exactly the administration instructions given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Posology

The recommended dose of Memantina Mylan for adults and elderly patients is 20 mg once a day.

To reduce the risk of side effects, this dose is achieved gradually by following the following daily therapeutic scheme. Other concentrations of the tablet are available for dose escalation.

The normal starting dose is half a 10 mg tablet once a day (5 mg) for the first week. It is increased to one 10 mg tablet once a day (10 mg) for the second week and to one and a half 10 mg tablets once a day for the third week. From the fourth week onwards, the normal dose is one 20 mg tablet administered once a day (20 mg).

Posology for patients with renal impairment

If you have kidney problems, your doctor will decide on the appropriate dose for your condition. In this case, your doctor should regularly monitor your kidney function.

Administration

Memantina Mylan should be administered orally once a day. To get the most out of your medication, you should take it every day and at the same time. The tablets should be swallowed with a little water. The tablets can be taken with or without food.

Duration of treatment

Continue taking Memantina Mylan as long as it is beneficial for you. Your doctor should evaluate the effects of your treatment periodically.

If you take more Memantina Mylan than you should

• Generally, taking too much Memantina Mylan should not harm you. You may experience an increase in the symptoms described in section 4 “Possible side effects”.
• If you take an overdose of Memantina Mylan, contact your doctor or seek medical advice, as you may need medical attention.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Memantina Mylan

• If you realize that you have forgotten to take your dose of Memantina Mylan, wait and take the next dose at the usual time.
• Do not take a double dose to make up for the forgotten dose.

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

4. Possible side effects

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

Generally, side effects are mild to moderate.

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

• Headache, somnolence, constipation, elevated liver function tests, dizziness, balance disorder, shortness of breath, high blood pressure and hypersensitivity to the medicine.

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

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure and formation of blood clots in the venous system (thrombosis/thromboembolism).

Rare (may affect up to 1 in 10,000 people):

• Seizures

Frequency not known (cannot be estimated from the available data):

• Pancreatitis, hepatitis (inflammation of the liver) 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 hydrochloride.

Reporting of side effects

If you experience 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. Storage of Memantina Mylan

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 carton, after EXP. The expiry date refers to the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Memantina Mylan

• The active substance is memantine. Each film-coated tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
• The other ingredients are microcrystalline cellulose, sodium croscarmellose (see section 2 “Memantina Mylan contains sodium”), magnesium stearate, talc and anhydrous colloidal silica, in the tablet core; polydextrose (E1200), hypromellose 3cP (E464), hypromellose 6cP (E464), hypromellose 50cP (E464), red iron oxide (E 172), macrogol 400 (E1521) and macrogol 8000, in the tablet coating.

Appearance of Memantina Mylan and contents of the pack

Memantina Mylan is presented in the form of film-coated tablets, red, oval, biconvex, with a bisected edge, engraved with “ME” on one face of the tablet and “20” on the other.

Memantina Mylan is presented in blister packs of 7, 10, 14, 28, 28 x 1, 30, 42, 50, 56, 56 x 1, 60, 70, 84, 98, 98 x 1, 100, 100 x 1 or 112 film-coated tablets.

Pack sizes of 28 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets are presented in unit-dose blisters.

Not all pack sizes may be marketed.

Marketing authorisation holder

Mylan Pharmaceuticals Limited

Damastown Industrial Park,

Mulhuddart, Dublin 15,

DUBLIN

Ireland

Manufacturer

McDermott Laboratories Ltd. T/A Gerard Laboratories

Unit 35 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Mylan Hungary Kft.

H-2900 Komárom, Mylan utca. 1, Hungary.

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet: {MM/AAAA}.

Other sources of information

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