Patient Information Leaflet

Mylan Memantine 20 mg Film-Coated Tablets

memantine hydrochloride

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you are unsure about anything, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What you need to know before you take Memantine Mylan

1. How to take Memantine Mylan

1. Possible side effects

1. Storage of Memantine Mylan

1. Contents of the pack and additional information

Memantina Mylan contains the active ingredient memantine. It belongs to a group of medicines known as dementia medicines.

The loss of memory in Alzheimer's disease is due to an alteration in brain signals. The brain contains called N-methyl-D-aspartate (NMDA) receptors, which participate in the transmission of important nerve signals for learning and memory. Memantina Mylan belongs to a group of medicines called NMDA receptor antagonists. Memantina Mylan acts on these receptors by improving the transmission of nerve signals and memory.

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

Do not take Memantina Mylan:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Memantina Mylan.

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

In the above situations, treatment must be closely monitored and your doctor should regularly reevaluate the clinical benefit of Memantina Mylan.

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

Memantine should be avoided when used with other medications such as amantadine (for Parkinson's treatment), ketamine (a medication generally used to induce anesthesia), dextromethorphan (a medication for cough treatment) and other NMDA antagonists.

Children and adolescents:

Memantina Mylan is not recommended for individuals under 18 years.

Use of Memantina Mylan with other medications

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

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

• 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 seizures)
• barbiturates (substances generally used to induce sleep)
• dopamine agonists (substances such as L-dopa, bromocriptine)
• neuroleptics (substances used in the treatment of mental illnesses)
• oral anticoagulants

If you are admitted to a 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 significantly (for example, from normal to strict vegetarian) or if you have kidney tubular acidosis (ATR, excess acid-producing substances in the blood due to renal dysfunction) or severe urinary tract infections, as your doctor may need to adjust the medication dose.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The use of memantine is not recommended in pregnant women.

Breastfeeding

Memantina Mylan is contraindicated during breastfeeding.

Driving and operating machinery

Your condition may affect your ability to drive or operate machinery and you should not engage in these activities unless your doctor tells you it is safe to do so. Memantina Mylan may cause dizziness and somnolence, mainly at the beginning of treatment or when increasing the dose. If you experience these effects, do not drive or operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dosage

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

To reduce the risk of adverse effects, this dose is achieved gradually following the daily therapeutic schedule. For dose escalation, other concentrations of the tablet are available.

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

Dosage for patients with renal insufficiency

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

Administration

Memantina Mylan should be taken 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.

Treatment duration

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 an excessive amount of Memantina Mylan should not cause you any harm. You may experience an increase in the symptoms described in the section 4 “Possible adverse effects”.
• If you take a Memantina Mylan overdose, 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, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Memantina Mylan

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

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Generally, adverse effects are classified as mild to moderate.

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

Headache, drowsiness, constipation, elevated liver function tests,

vertigo, balance disorder, shortness of breath, high blood pressure, and hypersensitivity to the medication.

Poorly frequent (may affect up to 1 in 100 patients):

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

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

Seizures

Unknown frequency (cannot be estimated from available data):

Pancreatitis, hepatitis (liver inflammation), and psychotic reactions.

Alzheimer's disease has been associated with depression, suicidal ideation, and suicide. There have been reports of these events occurring in patients treated with hydrochloride memantine.

Reporting 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 prospectus. You can also report them directly through the national notification system included in theAppendix V.* By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Memantine Mylan Composition

• The active ingredient is memantine. Each film-coated tablet contains 20 mg of memantine hydrochloride, which is 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 (E172), macrogol 400 (E1521), and macrogol 8000, in the tablet coating.

Appearance of Memantine Mylan and packaging contents

Memantine Mylan is presented as a bisected, film-coated, oval-shaped, biconvex tablet with a red color, engraved with “ME” on one face and “20” on the other.

Memantine Mylan is presented in blisters 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.

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

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Mylan S.A.S.

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

Responsible Person for Manufacturing

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.

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last date of revision of this leaflet: {MM/AAAA}.

Other sources of information

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