MEMANTINE KERN PHARMA 10 mg TABLETS

Introduction

Patient Information Leaflet

Memantina Kern Pharma 10 mg tablets EFG

Memantine hydrochloride

Read this leaflet carefully before starting to take this medicine because it contains important information for you.

• Keep this leaflet, as 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience 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 Kern Pharma is and what it is used for
2. What you need to know before taking Memantina Kern Pharma
3. How to take Memantina Kern Pharma
4. Possible side effects
5. Storage of Memantina Kern Pharma
6. Contents of the pack and further information

1. What Memantina Kern Pharma is and what it is used for

How Memantina Kern Pharma works

Memantina Kern Pharma 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. Memantine belongs to a group of medicines called NMDA receptor antagonists. Memantine acts on these receptors, improving the transmission of nerve signals and memory.

What Memantina Kern Pharma is used for

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

2. What you need to know before taking Memantina Kern Pharma

Do not take Memantina Kern Pharma

• if you are allergic to the active substance 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 Kern Pharma:

• 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 memantine.

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.

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

Taking Memantina Kern Pharma with other medicines

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

In particular, the administration of memantine may affect 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 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 Kern Pharma.

Taking Memantina Kern Pharma with food, drinks, and alcohol

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, breastfeeding, and fertility

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.

Memantine is not recommended during pregnancy.

Women taking memantine should stop breastfeeding.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and use machines safely.

Memantina Kern Pharma may also affect your ability to react, so driving or operating machinery may be inappropriate.

Memantina Kern Pharma contains lactose

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

3. How to take Memantina Kern Pharma

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Dosage

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

The normal starting dose is half a tablet once daily (5 mg) for the first week. It is increased to one tablet daily (10 mg) for the second week and to one and a half tablets once daily for the third week. From the fourth week onwards, the normal dose is 20 mg once daily (20 mg).

Dosage for patients with renal impairment

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

Administration

Memantine should be taken orally once daily. To get the most out of your medication, you should take it every day 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 memantine as long as it is beneficial for you. Your doctor should regularly assess the effects of your treatment.

If you take more Memantina Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

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

If you forget to take Memantina Kern Pharma

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

4. Possible side effects

Like all medicines, Memantina Kern Pharma 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, difficult breathing, 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 1,000 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, 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 Spanish Medicines Agency website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

If you think any of the side effects you are experiencing are serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

5. Storage of Memantina Kern Pharma

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 after "EXP". The expiry date refers to the last day of that month.

No special storage conditions are required.

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 Kern Pharma 10 mg tablets

• The active substance is memantine hydrochloride. Each tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
• The other ingredients are pregelatinized corn starch, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate (type A) (potato starch), colloidal anhydrous silica, and magnesium stearate.

Appearance and packaging of the product

Memantina Kern Pharma 10 mg tablets are white, round, flat tablets, 8 mm in diameter, with a score line on each face. The tablet can be divided into two equal halves.

Memantina Kern Pharma 10 mg tablets are available in packs of 112 tablets and in a clinical pack of 490 tablets.

Not all pack sizes may be marketed.

Other presentations

Memantina Kern Pharma 20 mg tablets EFG

Marketing authorisation holder and manufacturer

Kern Pharma, S.L.

Pol. Ind. Colón II, C/ Venus 72

08228 Terrassa (Barcelona)

Spain

Date of last revision of this leaflet: April 2013.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/