MEMANTINE NORMON 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Memantina Normon 20 mg Film-Coated Tablets EFG

Memantine Hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult 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 side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

What is Memantina Normon

Memantina Normon 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 Normon belongs to the group of medications called NMDA receptor antagonists. Memantina Normon acts on these receptors, improving the transmission of nerve 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.

2. What you need to know before taking Memantina Normon

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 ingredients 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 suffered 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 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 should be avoided.

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 medications

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

In particular, 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),
• 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 plan 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.

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 use 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 use 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.

3. How to take Memantina Normon

Follow your doctor's instructions for taking Memantina Normon exactly. If you are unsure, 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 side effects, this dose is gradually achieved following a daily treatment schedule. To adjust the dose, use the 10 mg Memantina Normon tablets.

At the start of treatment, you will begin taking half a 10 mg Memantina Normon film-coated tablet once a day. This dose will be increased weekly by 5 mg until the recommended maintenance dose is reached (20 mg once a day), which is achieved at the beginning of the fourth week.

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 periodically monitor your kidney function.

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.

Duration of treatment

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

• 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 Toxicology 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 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 medications, Memantina Normon can cause side effects, although not everyone will experience them.

Generally, side effects are 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.

Uncommon (may affect up to 1 in 100 people):

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

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 side effects

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

5. Storage of Memantina Normon

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

Do not use this medication after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Memantina Normon

• The active ingredient is memantine hydrochloride. Each 20 mg film-coated tablet contains 16.62 mg of memantine.
• The other ingredients are: Core (lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, anhydrous colloidal silica, and magnesium stearate). Coating (titanium dioxide (E-171), hypromellose, macrogol 6000, talc, yellow iron oxide (E-172), and red iron oxide (E-172)).

Appearance of the product and packaging

Memantina Normon 20 mg film-coated tablets are pink to reddish-gray, elongated, and biconvex. They are available in packs of 56 tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Memantina Normon 10 mg film-coated tablets EFG.

Date of the last revision of this package leaflet: February 2015

Detailed and updated information on this medication 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 on this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/79494/P_79494.html