MEMANTINE RATIOPHARM 10 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Memantina ratiopharm 10mg film-coated tablets EFG

Memantine hydrochloride

Read the entire leaflet carefully before starting to take this medication, 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Memantina ratiopharm and what is it used for
2. What you need to know before taking Memantina ratiopharm
3. How to take Memantina ratiopharm
4. Possible side effects
5. Storage of Memantina ratiopharm
6. Package contents and additional information

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

How it worksMemantina ratiopharm

Memantina ratiopharm belongs to a group of medications known as anti-dementia medications.

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 ratiopharm belongs to the group of medications 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 taking Memantina ratiopharm

Do not takeMemantina ratiopharm:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Memantina ratiopharm:

• 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 ratiopharm.

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 medications such as

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

should be avoided.

Children and adolescents

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

Other medications and Memantina ratiopharm

Tell your doctor or pharmacist if you are taking or have recently taken any other medications.

In particular, the administration of Memantina ratiopharm may produce changes in the effects of the following medications, 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 commonly used to treat movement disorders or intestinal spasms)
• anticonvulsants (substances used to prevent and eliminate convulsions)
• barbiturates (substances commonly 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 medication.

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 medication.

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 condition allows you to drive and use machines safely.

Additionally, Memantina ratiopharm may alter your reaction ability, so driving or operating machines may be inappropriate.

Memantina ratiopharm contains lactose and soy lecithin

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

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

3. How to take Memantina ratiopharm

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

Dosage

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

The normal starting dose is half a tablet once a day (1x 5 mg) in the first week. It is increased to one tablet a day (1x 10 mg) in the second week and to one and a half tablets once a day in the third week. From the fourth week onwards, the normal dose is two tablets administered once a day (1x 20 mg).

The tablet can be divided into equal doses.

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 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 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 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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Memantina ratiopharm can cause side effects, although not everyone will experience them.

Generally, side effects are classified as mild to moderate.

Frequent (affecting 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 medication.

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

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

Rare (affecting less than 1 of every 10,000 patients):

• Seizures.

Frequency not known (frequency cannot be estimated from 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Memantina ratiopharm

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

Do not use this medication after the expiration date stated on the carton and blister pack after EXP. The expiration date is the last day of the month indicated.

Blister packs

Do not store above 25°C.

HDPE bottles

This medication does not require special storage conditions.

Validity period after first opening of the container: 6 months

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package contents and additional information

Composition of Memantina ratiopharm

• 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 components 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 package contents

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

Memantina ratiopharm is available in blister packs of 10, 14, 21, 28, 30, 42, 50, 56, 98, 100, and 112 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization 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 obtain further information on this medication by contacting the local representative of the marketing authorization holder:

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