Product Information for the User

Memantina Normon 10 mg Film-Coated Tablets EFG

Memantine Hydrochloride

Read this entire 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3.How to take Memantina Normon

4.Possible side effects

5.Storage of Memantina Normon

6.Contents of the pack and additional information

What is Memantina Normon

Memantina Normon belongs to a group of medications known as dementia medications.

The loss of memory in Alzheimer's disease is due to an alteration in brain signals. The brain contains called N-methyl-D-aspartate (NMDA) receptors that participate in the transmission of important nervous signals in learning and memory. Memantina Normon belongs to the group of medications called NMDA receptor antagonists. Memantina Normon acts on these receptors by improving the transmission of nervous signals and memory.

What is Memantina Normon used for

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

Do not take Memantina Normon

-if you are allergic (hypersensitive) to memantine hydrochloride (the active ingredient of Memantina Normon) or to 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 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 high blood pressure.

In the above situations, treatment should be closely monitored and your doctor should reevaluate the clinical benefit of Memantina Normon regularly.

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

The use of memantine should be avoided with other medications such as amantadine (for the treatment of Parkinson's disease), ketamine (a medication generally used as an anesthetic), dextromethorphan (a medication for the treatment of cough), and other NMDA antagonists.

Children and adolescents

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

Taking Memantina Normon with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Specifically, the administration of Memantina Normon 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 generally used to treat movement disorders or intestinal spasms),

- anticonvulsants (substances used to prevent and eliminate seizures),

- barbiturates (substances generally used to induce sleep),

- dopamine agonists (substances such as L-dopa, bromocriptine),

- neuroleptics (substances used in the treatment of mental illnesses),

- oral anticoagulants.

If you are admitted to a 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 change your diet significantly (for example from a normal diet to a strict vegetarian diet) or if you have acidosis tubular renal (ATR, excess of acid-producing substances in the blood due to renal dysfunction) or severe urinary tract infections, as your doctor may need to adjust the medication dose.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

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

Breastfeeding: Women taking Memantina Normon should not breastfeed.

Driving and operating machinery

Your condition may affect your ability to drive or operate machinery and you should not perform 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 operate machinery.

Memantina Normon contains lactose

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.

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

Dosage

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

The normal starting dose is half a tablet once a day (1 x 5 mg) in the first week. It is increased to one tablet a day (1 x 10 mg) in the second week and to one and a half tablets 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).

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 monitor your renal function periodically.

Administration

Memantina Normon should be taken orally once a day. 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.

Treatment duration

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

If you take more Memantina Normon than you should

- In general, taking an excessive amount of Memantina Normon should not cause any harm. You may experience an increase in the symptoms described in section 4 “Possible adverse 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 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 compensate for the missed dose.

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

Like all medications, Memantina Normon may produce adverse effects, although not everyone will experience them.

Generally, adverse 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 medication.

Rare (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 (venous thromboembolism).

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

- Seizures.

Unknown frequency (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 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of MemantineNormon

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

- The other components 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 content of the packaging

Memantine Normon 10 mg film-coated tablets are white, elongated, biconvex tablets with a breaking bar and marked with “M 10” on one side. They are presented in packs of 112 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Memantine Normon 20 mg film-coated tablets EFG.

Last review date of this leaflet: February 2015

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/