MEMANTINE NORMON 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Memantina Normon 10 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

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

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

What Memantina Normon is

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

What Memantina Normon is used for

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

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

Do not take Memantina Normon

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

Warnings and precautions

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

• 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 Normon.

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 as an anesthetic), dextromethorphan (a medicine for the treatment of cough) and other NMDA antagonists should be avoided.

Children and adolescents

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

Taking Memantina Normon 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 Memantina Normon 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 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 Normon.

Taking Memantina Normon 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy: Memantina Normon is not recommended for use in pregnant women.

Breastfeeding: Women taking Memantina Normon should not breastfeed.

Driving and using machines

Your illness may affect your ability to drive or use machines and you should not carry out these activities unless your doctor tells you it is safe to do so. Memantina Normon may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or use machines.

Memantina Normon contains lactose

This medicine 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 Normon

Follow exactly the administration instructions of Memantina Normon indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Posology

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

The normal starting dose is half a tablet once a day (1 x 5 mg) 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 in the third week. From the fourth week onwards, the normal dose is two tablets administered once a day (1 x 20 mg).

Posology for patients with renal impairment

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

Administration

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

If you take more Memantina Normon than you should

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

However, in case of overdose or accidental ingestion, go to a medical center or consult the Toxicological Information Service. Phone 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Memantina Normon

• If you realize that you have forgotten to take your dose of Memantina Normon, 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 other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Generally, side effects are classified as mild to moderate.

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

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorder, 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 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 (cannot be estimated from the available data):

• Pancreatitis and psychotic reactions.

Alzheimer's disease has been associated with depression, suicidal ideation, and suicide. These events have been reported in patients treated with Memantina Normon.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantina Normon

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 is the last day of the month shown.

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 other information

Composition of Memantina Normon

• The active substance is memantine hydrochloride. Each film-coated tablet of 10 mg contains 8.31 mg of memantine.

• The other ingredients are: Cores (lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, anhydrous colloidal silica, and magnesium stearate). Coating (titanium dioxide (E-171), hypromellose, macrogol 6000, and talc).

Appearance of the product and pack contents

Memantina Normon 10 mg film-coated tablets are white, elongated, biconvex tablets with a break line and marked with "M 10" on one face. They are available in packs of 56 and 112 tablets.

Marketing authorisation holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

Memantina Normon 20 mg film-coated tablets EFG.

Date of last revision of this leaflet: February 2015

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/79493/P_79493.html