MEMANTINE ACCORD 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Memantina Accord 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 pack and other information:

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

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

How Memantina Accord works

Memantina Accord contains the active substance memantine hydrochloride.

Memantina Accord belongs to a group of medicines called anti-dementia medicines.

Memory loss in Alzheimer's disease is due to a disturbance in brain signals. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors that are involved in the transmission of important nerve signals in learning and memory. Memantina Accord belongs to a group of medicines called NMDA receptor antagonists. Memantina Accord acts on these receptors, improving the transmission of nerve signals and memory.

What Memantina Accord is used for

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

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

Do not take Memantina Accord

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Memantina Accord

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

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

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 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 should be avoided.

Children and adolescents

Memantina Accord is not recommended for use in children and adolescents under 18 years of age.

Using other medicines and Memantina Accord

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

In particular, the administration of Memantina Accord may affect the action 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 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 Accord.

Taking Memantina Accord with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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.

Breastfeeding

Women taking Memantina Accord should stop breastfeeding.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and use machines safely. Also, Memantina Accord may affect your reaction ability, so driving or operating machinery may be inappropriate.

Memantina Accord contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine. Your doctor will advise you.

3. How to take Memantina Accord

Follow exactly the administration instructions of this medicine given by your doctor.

Ask your doctor or pharmacist if you have any questions.

Dosage

The recommended dose of Memantina Accord for adults and elderly patients is 20 mg per day.

To reduce the risk of side effects, this dose should be achieved gradually, following a daily treatment scheme. To adjust the dose, there are tablets with different doses.

At the start of treatment, you will begin taking Memantina Accord 5 mg film-coated tablets once a day. This dose will be increased weekly by 5 mg until the recommended maintenance dose is reached (20 mg per day), which will be achieved at the beginning of the fourth week.

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 periodically check your kidney function at specific intervals.

Administration

Memantina Accord 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.

Duration of treatment

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

If you take more Memantina Accord than you should

• Generally, taking too much Memantina Accord 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 Accord, contact your doctor or seek medical advice, as you may need medical attention.

If you forget to take Memantina Accord

• If you realize you have forgotten to take your dose of Memantina Accord, 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Side effects are usually 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, high blood pressure, and hypersensitivity to the medicine.

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

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbances, heart failure, and venous thrombosis/thromboembolism.

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

• Seizures.

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

• Pancreatitis, 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 experience any of these side effects or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantina Accord

Keep out of the sight and reach of children.

Do not use Memantina Accord after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

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 further information

Composition of Memantina Accord

The active substance is memantine hydrochloride. Each tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.

The other ingredients are lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate in the core; and hypromellose, polysorbate 80, macrogol 400, titanium dioxide (E171) and red iron oxide (E172), yellow iron oxide (E172) in the film coating.

Appearance of the product and pack contents

Memantina Accord 20 mg film-coated tablets are pale red to grey-red, elongated, and scored, engraved with "MT" divided by the score on one face and "20" divided by the score on the other. The tablet can be divided into equal doses.

Memantina Accord film-coated tablets are available in blister packs (PVC/PE/PVDC-aluminum blister) of 14, 28, 42, 56, and 98 tablets. Memantina Accord film-coated tablets are also available in a blister calendar pack in sizes of 14x1, 28x1, 56x1, or 98x1 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturer

Delorbis Pharmaceuticals Ltd

17, Athinon Street

Ergates Industrial Area, 2643 Nicosia

Cyprus

Accord Healthcare Limited

Sage house, 319 Pinner road

North Harrow, Middlesex, HA1 4HF,

United Kingdom

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

This leaflet was last revised on

For more information on this product, you can consult the European Medicines Agency (EMA) website http://www.ema.europa.eu