Memantina Normon 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Memantina Normon 10 mg film-coated tablets EFG

Memantinum hydrochloridum

Read all of this leaflet carefully before you start taking this medicine because 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 medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Memantina Normon is and what it is used for
2. What you need to know before taking Memantina Normon
3. How to take Memantina Normon
4. Possible side effects
5. How to store 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 known as anti-dementia drugs.

Memory loss in Alzheimer's disease is due to a disruption in brain signaling. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors, which are involved in the transmission of nerve signals important for learning and memory. Memantina Normon belongs to the group of medicines called NMDA receptor antagonists. Memantina Normon acts on these receptors, improving nerve signal transmission 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 starting Memantina Normon

Do not take Memantina Normon

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Memantina Normon:

• if you have a history of epileptic seizures.
• if you have recently had a myocardial infarction (heart attack), if you have congestive heart disease, or if you have uncontrolled hypertension (high blood pressure).

In the above situations, treatment should be carefully supervised and your doctor should regularly re-evaluate the clinical benefit of Memantina Normon.

If you have renal impairment (kidney problems), your doctor should closely monitor kidney function and, if necessary, adjust the doses of memantine.

The use of memantine should be avoided together with other medicines such as amantadine (used to treat Parkinson’s disease), ketamine (a drug generally used as an anaesthetic), dextromethorphan (a cough medicine), and other NMDA antagonists.

Children and adolescents

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

Taking Memantina Normon with other medicines

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

Specifically, the administration of Memantina Normon may cause changes in the effects of the following medicines, so your doctor may need to adjust the dosage:

• amantadine, ketamine, dextromethorphan,
• dantrolene, baclofen,
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine,
• hydrochlorothiazide (or any combination containing hydrochlorothiazide),
• anticholinergics (substances generally used to treat movement disorders or intestinal spasms),
• anticonvulsants (substances used to prevent and stop 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 Normon.

Taking Memantina Normon with food and drinks

You should inform your doctor if you have recently changed or intend to substantially change your diet (for example, from a normal diet to a strict vegetarian diet), or if you have renal tubular acidosis (RTA, excess acid-producing substances in the blood due to renal dysfunction (kidney problem)) or severe urinary tract infections, 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 Memantina Normon is not recommended in pregnant women.

Breastfeeding: Women taking Memantina Normon should not breastfeed.

Driving and using machines

Your illness may affect your ability to drive or operate machinery, 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, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.

Memantina Normon contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Memantina Normon

Follow exactly the administration instructions for Memantina Normon as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose of Memantina Normon in adult and elderly patients is 20 mg taken once daily. To reduce the risk of adverse effects, this dose is reached gradually according to the following daily schedule:

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

Dosage 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 daily. To get the maximum benefit from your medication, you must take it every day at the same time. The tablets should be swallowed with some water. The tablets may be taken with or without food.

Duration of treatment

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

If you take more Memantina Normon than you should

• In general, taking an excessive amount of 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 require medical attention.

However, in case of overdose or accidental ingestion, go to a medical center or contact the Toxicology Information Service. Telephone 915 620 420, indicating the medication and the amount ingested.

If you forget to take Memantina Normon

• If you realize 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 missed dose.

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

4. Possible adverse effects

Like all medicines, Memantina Normon may cause adverse effects, although not everyone experiences them.

In general, adverse effects are classified as mild to moderate.

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

• Headache, somnolence, 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 blood clot formation in the venous system (venous thrombosis/venous thromboembolism).

Very rare (may affect up to 1 in 10,000 people):

• Seizures.

Frequency not known (cannot be estimated from 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantine Normon

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Memantina Normon

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

• The other components are: Core (monohydrate lactose, 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 contents of the pack

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

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

OTHER FORMULATIONS

Memantina Normon 20 mg film-coated tablets EFG.

Date of the most recent revision of this leaflet: February 2015

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

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

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