MEMANTINE ACCORD 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Memantina Accord 10 mg film-coated tablets EFG

Memantine hydrochloride

Read the entire package leaflet carefully before starting to take this medication because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you only. Do not give it to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any of the side effects, inform your doctor or pharmacist. See section 4.

Contents of the package leaflet:

1. What is Memantina Accord and what is it used for
2. What you need to know before taking Memantina Accord
3. How to take Memantina Accord
4. Possible side effects
5. Storage of Memantina Accord
6. Package contents 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 known as anti-dementia medicines.

Memory loss in Alzheimer's disease is due to an alteration in brain signals. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors that participate in the transmission of important nerve signals in learning and memory. Memantina Accord belongs to the 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 taking 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 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 these situations, treatment should be carefully supervised and your doctor should regularly reassess 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

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

Use of other medicines and Memantina Accord

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

In particular, the administration of Memantina Accord 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 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 hospitalized, inform your doctor that you are taking Memantina Accord.

Taking Memantina Accord with food and drinks

You should inform 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 (urine conduit), 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 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

Women taking Memantina Accord should stop breastfeeding.

Driving and using machines

Your doctor will inform you if your illness allows you to drive and use machines safely.

Also, Memantina Accord may alter your reaction ability, so driving or operating machines 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 the administration instructions of this medicine exactly as indicated by your doctor.

Consult your doctor or pharmacist if you are unsure.

Dosage

The recommended dose of Memantina Accord in adult patients and in elderly patients is 20 mg administered once a day. To reduce the risk of side effects, this dose is gradually achieved following the daily scheme:

The normal starting dose is half a tablet once a day (1 x 5mg) the first week. It is increased to one tablet a day (1 x 10 mg) the second week and to one and a half tablets once a day (1 x 15 mg) in the third week. From the fourth week onwards, the normal dose is two tablets administered once a day (1 x 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 periodically monitor your kidney function at specific intervals.

Administration

Memantina Accord 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 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 an excessive amount of 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 that 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 about 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.

In general, side effects are classified from mild to moderate.

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

• Headache, drowsiness, 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/venous thromboembolism)

Very 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 side effects, consult your doctor or pharmacist. You can also report them directly through the national reporting system included 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 sight and reach of children.

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

This medicine does not require 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. This will help protect the environment.

6. Package contents and further information

Composition of Memantina Accord

• The active substance is memantine hydrochloride. Each film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, crospovidone, and magnesium stearate in the tablet core; and hypromellose, polysorbate 80, macrogol 400, and titanium dioxide (E 171) in the tablet coating.

Appearance of the product and package contents

Memantina Accord is presented in the form of white, elongated film-coated tablets with a break line and engraved "MT" divided by the break line on one side and "10" divided by the break line on the other side. 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 tablets, 28 tablets, 30 tablets, 42 tablets, 50 tablets, 56 tablets, 98 tablets, 100 tablets, and 112 tablets. Memantina Accord film-coated tablets are also available in calendar blister packs in sizes of 14x1, 28x1, 56x1, or 98x1 tablets.

Not all pack sizes may be marketed.

Marketing authorization 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 package leaflet was last revised on

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