MEMANTINE RATIOPHARM 5 mg + 10 mg + 15 mg + 20 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Memantina ratiopharm 5mgfilm-coated tablets EFG

Memantina ratiopharm 10mgfilm-coated tablets EFG

Memantina ratiopharm 15mgfilm-coated tablets EFG

Memantina ratiopharm 20mg 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

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

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

How it worksMemantina ratiopharm

Memantina ratiopharm belongs to a group of medicines called 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 are involved in the transmission of important nerve signals in learning and memory. Memantina ratiopharm belongs to a group of medicines called NMDA receptor antagonists. Memantina ratiopharm acts on these receptors, improving the transmission of nerve signals and memory.

What it is used forMemantina ratiopharm

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

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

Do not takeMemantina ratiopharm:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Memantina ratiopharm:

• 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 these situations, treatment should be carefully supervised and your doctor should regularly reassess the clinical benefit of Memantina ratiopharm.

If you have renal insufficiency (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 with other medicines such as

• amantadine (for the treatment of Parkinson's disease),
• ketamine (a medicine usually used as an anesthetic),
• dextromethorphan (a medicine for the treatment of cough) and
• other NMDA antagonists.

Children and adolescents

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

Other medicines and Memantina ratiopharm

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

In particular, the administration of Memantina ratiopharm may produce 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 usually used to treat movement disorders or intestinal spasms)
• anticonvulsants (substances used to prevent and eliminate convulsions)
• barbiturates (substances usually 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 ratiopharm.

Taking Memantina ratiopharm 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 (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.

The use of memantine is not recommended in pregnant women.

Women taking Memantina ratiopharm should stop breastfeeding.

Driving and using machines

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

Memantina ratiopharm may also alter your reaction ability, so driving or operating machinery may be inappropriate.

Memantina ratiopharm contains lactose and soy lecithin

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

This medicine contains soy lecithin. If you are allergic to peanuts or soy, do not take this medicine.

3. How to take Memantina ratiopharm

The Memantina ratiopharm starter pack should only be used at the beginning of treatment with Memantina ratiopharm.

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

Dosage

The recommended dose is 20 mg per day, which is achieved by gradual dose increments of Memantina ratiopharm during the first 3 weeks of treatment. Take one tablet once a day.

Week 1 (day 1-7):

Take one 5 mg tablet once a day (white to off-white, biconvex, capsule-shaped, 9.6 x 4.54 mm, smooth on one side and with the number "5" embossed on the other) for 7 days.

Week 2 (day 8-14):

Take one 10 mg tablet once a day (white to off-white, biconvex, capsule-shaped, 12.5 x 5.6 mm, with a break line on one side and with the number "10" embossed on the other) for 7 days.

Week 3 (day 15-21):

Take one 15 mg tablet once a day (white to off-white, biconvex, capsule-shaped, 14.0 x 6.0 mm, smooth on one side and with the number "15" embossed on the other) for 7 days.

Week 4 (day 22-28):

Take one 20 mg tablet once a day (white to off-white, biconvex, capsule-shaped, 15.6 x 8.0 mm, with a break line on one side and with the number "20" embossed on the other) for 7 days.

Maintenance dose

The recommended daily dose is 20 mg once a day. For continued treatment, consult your doctor.

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.

Administration

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

If you take more Memantina ratiopharm than you should

• Generally, taking an excessive amount of Memantina ratiopharm 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 ratiopharm, contact your doctor or seek medical advice, as you may need medical attention.

If you forget to take Memantina ratiopharm

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

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

4. Possible side effects

Like all medicines, Memantina ratiopharm can cause side effects, although not everybody gets them.

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

Common (affects 1 to 10 of every 100 patients):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorder, difficult breathing, high blood pressure, and hypersensitivity to the medicine.

Uncommon (affects 1 to 10 of every 1,000 patients):

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

Rare (affects less than 1 in every 10,000 patients):

• 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, 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 ratiopharm

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 and blister pack after EXP. The expiry date refers to the last day of the month shown.

Do not store above 25°C.

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 ratiopharm

• The active substance is memantine hydrochloride.

Each film-coated tablet contains 5 mg of memantine hydrochloride, equivalent to 4.15 mg of memantine.

Each film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.

Each film-coated tablet contains 15 mg of memantine hydrochloride, equivalent to 12.46 mg of memantine.

Each film-coated tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.

• The other ingredients are:

Core of the tablet

Microcrystalline cellulose (E 460), pregelatinized starch (E 1404), anhydrous lactose, colloidal anhydrous silica (E 551), magnesium stearate (E 470b).

Coating

Polysorbate 80 (E 433), polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b), soy lecithin (E 322), xanthan gum (E 415).

Appearance of the product and pack contents

The 5 mg film-coated tablets are white to off-white, biconvex, capsule-shaped (9.6 x 4.54 mm), smooth on one side and with the number "5" embossed on the other.

The 10 mg film-coated tablets are white to off-white, biconvex, capsule-shaped (12.5 x 5.6 mm), with a break line on one side and with the number "10" embossed on the other.

The 15 mg film-coated tablets are white to off-white, biconvex, capsule-shaped (14.0 x 6.0 mm), smooth on one side and with the number "15" embossed on the other.

The 20 mg film-coated tablets are white to off-white, biconvex, capsule-shaped (15.6 x 8.0 mm), with a break line on one side and with the number "20" embossed on the other.

Memantina ratiopharm is available in packs of 28 (7 + 7 + 7 + 7) film-coated tablets.

Marketing authorisation holder

ratiopharm GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

HBM Pharma s.r.o.

Slabinská 30, 03680 Martin

Slovakia

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}><{month AAAA}>

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