MEMANTINE PHARMA COMBIX 10 mg FILM-COATED TABLETS

Introduction

Leaflet:information for the user

MemantinePharmaCombix 10 mg film-coated tablets EFG

Memantine, hydrochloride

Read the entire leaflet carefully before starting to take this medication.

• Keep this 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 and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What is Memantine Pharma Combix and what is it used for
2. Before taking Memantine Pharma Combix
3. How to take Memantine Pharma Combix
4. Possible side effects
5. Storage of Memantine Pharma Combix
6. Additional information

1. What is Memantine Pharma Combix and what is it used for

Memantine Pharma Combix contains the active ingredient memantine hydrochloride. It 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. Memantine Pharma Combix belongs to the group of medications called NMDA receptor antagonists. Memantine Pharma Combix acts on these receptors, improving the transmission of nerve signals and memory.

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

2. Before taking Memantine Pharma Combix

Do not take MemantinePharmaCombix

• if you are allergic to memantine or any of the other components of this medication (see section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Memantine Pharma Combix:

• 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 Pharma Combix.

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

If you have renal tubular acidosis (RTA, excess of acid-producing substances in the blood due to kidney dysfunction) or severe urinary tract infections, your doctor may need to adjust the dose of the medication.

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

Children and adolescents

The use of Memantine Pharma Combix is not recommended in children and adolescents under 18 years of age.

Taking Memantine Pharma Combix with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take other medications.

In particular, the administration of Memantine Pharma Combix 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 commonly used to treat movement disorders or intestinal spasms),
• anticonvulsants (substances used to prevent and eliminate seizures),
• barbiturates (substances commonly 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 Memantine Pharma Combix.

Taking MemantinePharmaCombix with food and beverages

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), 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 memantine is not recommended in pregnant women.

Breastfeeding:Women taking Memantine Pharma Combix should not breastfeed.

Driving and using machines

Your doctor will inform you if your illness allows you to drive and use machines safely. Additionally, Memantine Pharma Combix may alter your reaction ability, so driving or operating machines may be inappropriate.

3. How to take Memantine Pharma Combix

Follow the administration instructions of Memantine Pharma Combix indicated by your doctor exactly. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for adults and elderly patients is 20 mg of Memantine Pharma Combix once a day. To reduce the risk of side effects, this dose is gradually achieved by following the 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).

Dosage in 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

Memantine Pharma Combix 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 Memantine Pharma Combix as long as it is beneficial for you. Your doctor should periodically evaluate the effects of your treatment.

If you take more MemantinePharmaCombix 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 medication and the amount ingested.

• Generally, taking an excessive amount of Memantine Pharma Combix should not cause you any harm. You may experience an increase in the symptoms described in section 4 "Possible side effects".

If you forget to take MemantinePharmaCombix

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

4. Possible side effects

Like all medications, Memantine Pharma Combix can cause side effects, although not everyone will experience them.

Generally, side effects are classified as mild to moderate.

Frequent (affectingbetween1 and 10 people in 100):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorders, breathing difficulties, high blood pressure, and hypersensitivity to the medication.

Uncommon (affectingbetween1 and 10 people in 1,000):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbances, heart failure, and formation of blood clots in the venous system (thrombosis/venous thromboembolism).

Very rare (affecting less than 1 person in 10,000):

• Seizures.

Frequency not known (frequency cannot be estimated from 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 Pharma Combix.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Memantine Pharma Combix

Keep out of the reach and sight of children.

Do not use Memantine Pharma Combix after the expiration date shown on the box and blister pack after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of MemantinePharmaCombix

• The active ingredient is memantine hydrochloride.

Each film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.

• The other components are:

Core of the tablet:Calcium hydrogen phosphate dihydrate (E341i), microcrystalline cellulose (Avicel PH101) (E460i), croscarmellose sodium, povidone K-90, colloidal anhydrous silica (Aerosil 200, pharma) (E551), magnesium stearate (E470b), and talc (E553b).

Coating of the tablet:Opadry white 03F58991 (hypromellose 6 cps (E464), macrogol 6000 (E1521), titanium dioxide (E171), and talc (E553b)).

Appearance of the product and packaging content

Memantine Pharma Combix film-coated tablets are film-coated tablets, white or almost white, capsule-shaped, biconvex, scored on one side and smooth on the other. The tablet can be divided into equal doses.

Memantine Pharma Combix film-coated tablets are available in blister packs in packs of 28, 56, 98, 100, and 112 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Combix, S.L.U.

C/Badajoz. Edificio 2,

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d’activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

This medication is authorized in the Member States of the European Economic Area under the following names:

Spain Memantine Pharma Combix 10 mg film-coated tablets EFG

France Memantine Zydus France 10 mg scored film-coated tablet

Date of the last revision of this leaflet: June 2019.

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