Memantina Mylan 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Memantina Mylan 20 mg film-coated tablets EFG

memantine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Memantina Mylan

3. How to take Memantina Mylan

4. Possible side effects

5. How to store Memantina Mylan

6. Contents of the pack and other information

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

Memantina Mylan contains the active substance memantine. It belongs to a group of medicines known as antidementia drugs.

Memory loss in Alzheimer's disease is due to disturbances in brain signaling. The brain contains receptors known as N-methyl-D-aspartate (NMDA) receptors, which 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 nerve signal transmission 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 starting Memantina Mylan

Do not take Memantina Mylan:

• if you are allergic 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 starting Memantina Mylan.

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

In the above situations, treatment should be carefully monitored and your doctor should regularly re-evaluate the clinical benefit of Memantina Mylan.

If you have renal impairment (kidney problems), your doctor should closely monitor kidney function and, if necessary, adjust the doses of memantine.

The use of memantine should be avoided together with other medicines such as amantadine (used to treat Parkinson's disease), ketamine (a drug generally used to induce anesthesia), dextromethorphan (a cough medicine), and other NMDA antagonists.

Children and adolescents:

Memantina Mylan is not recommended for use in individuals under 18 years of age.

Use of Memantina Mylan with other medicines

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

Specifically, administration of Memantina Mylan may produce changes in the effects of the following medicines, so your doctor may need to adjust the doses:

• amantadine, ketamine, dextromethorphan
• dantrolene, baclofen
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
• hydrochlorothiazide (or any combination containing hydrochlorothiazide)
• anticholinergics (substances generally used to treat movement disorders or intestinal spasms)
• anticonvulsants (substances used to prevent and stop seizures)
• 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 substantially change your diet (for example, from a normal diet to a strict vegetarian diet), or if you have renal tubular acidosis (RTA, excess acid-producing substances in the blood due to renal dysfunction [kidney problem]) or severe urinary tract infections, as your doctor may need to adjust the dose of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The use of memantine is not recommended in pregnant women.

Breastfeeding

Memantina Mylan is contraindicated during breastfeeding.

Driving and using machines

Your illness may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor has advised you that it is safe to do so. Memantina Mylan may cause dizziness and somnolence, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you must not drive or operate machinery.

3. How to take Memantina Mylan

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

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

To reduce the risk of adverse effects, this dose should be reached gradually according to the following daily therapeutic regimen. Other tablet strengths are available for dose titration.

The usual starting dose is half a 10 mg tablet once daily (5 mg) during the first week. This is increased to one 10 mg tablet once daily (10 mg) during the second week, and to one and a half 10 mg tablets once daily during the third week. From the fourth week onwards, the usual dose is one 20 mg tablet taken once daily (20 mg).

Dosage for patients with renal impairment

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

Administration

Memantina Mylan should be administered orally once daily. To get the maximum benefit from your medication, you must take it every day at the same time. The tablets should be swallowed with some water. The tablets may be taken with or without food.

Duration of treatment

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

If you take more Memantina Mylan than you should

• In general, taking an excessive amount of Memantina Mylan should not cause you any harm. 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 require medical attention.

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

If you forget to take Memantina Mylan

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

In general, adverse effects are classified as mild to moderate.

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

Headache, somnolence, constipation, elevated liver function tests,

dizziness, loss of balance, shortness of breath, high blood pressure, and hypersensitivity to the medicine.

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

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

Very rare (may affect up to 1 in 10,000 patients):

Seizures.

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

Inflammation of the pancreas, 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V*. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantine Mylan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

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 and packaging that you no longer need. This 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 components are microcrystalline cellulose, sodium croscarmellose, magnesium stearate, talc and anhydrous colloidal silica, in the tablet core; polydextrose (E1200), hypromellose 3cP (E464), hypromellose 6cP (E464), hypromellose 50cP (E464), iron oxide red (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 as red, oval, biconvex, film-coated, bevel-edged tablets, marked with “ME” on one side and “20” on the other.

Memantina Mylan is available in blisters containing 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.

Some pack sizes may not be marketed.

Marketing Authorization Holder

Mylan S.A.S.

117 Allée des Parcs, 69800 Saint-Priest, France.

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.

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire EN6 1TL, United Kingdom.

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the latest review of this leaflet: {MM/YYYY}.

Other sources of information

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