Memantina Pharma Combix 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the PATIENT

Memantina Pharma Combix 20 mg film-coated tablets EFG

Memantine, hydrochloride

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it could harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Memantina Pharma Combix is and what it is used for
2. Before taking Memantina Pharma Combix
3. How to take Memantina Pharma Combix
4. Possible side effects
5. How to store Memantina Pharma Combix
6. Further information

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

Memantina Pharma Combix contains the active substance memantine hydrochloride. It belongs to a group of medicines known as anti-dementia drugs.

Memory loss in Alzheimer's disease is due to disturbances 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 Pharma Combix belongs to a group of medicines called NMDA receptor antagonists. Memantina Pharma Combix acts on these receptors, improving nerve signal transmission and memory.

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

2. What you need to know before starting to take Memantina Pharma Combix

Do not take Memantina Pharma Combix

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Memantina 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 disease, or if you have uncontrolled high blood pressure (hypertension).

In these situations, treatment must be carefully monitored, and your doctor should regularly re-evaluate the clinical benefit of Memantina Pharma Combix.

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

If you suffer from renal tubular acidosis (RTA, excess acid-producing substances in the blood due to kidney dysfunction [kidney problem]) or severe urinary tract infections (urine passage), your doctor may need to adjust the dose of the medicine.

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

Children and adolescents

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

Taking Memantina Pharma Combix 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 Pharma Combix may cause 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 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 Pharma Combix.

Taking Memantina Pharma Combix 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), as your doctor may need to adjust the dose of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Breastfeeding: Women taking Memantina Pharma Combix must not breastfeed.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive and use machines safely. Furthermore, Memantina Pharma Combix may affect your reaction ability, so driving or operating machinery may be inappropriate.

3. How to take Memantina Pharma Combix

Follow exactly the instructions for use of Memantina Pharma Combix provided by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose for adults and elderly patients is 20 mg of Memantina Pharma Combix once daily.

To reduce the risk of adverse effects, this dose should be reached gradually according to a daily treatment schedule. Different dosage strengths of tablets are available to adjust the dose.

At the beginning of treatment, you will start by taking half a tablet of Memantina Pharma Combix 10 mg once daily. This dose will be increased weekly by 5 mg until the recommended maintenance dose is reached. The recommended maintenance dose of 20 mg once daily is achieved at the beginning of the fourth week.

Dosage in patients with renal impairment

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

Administration

Memantina Pharma Combix 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 a little water.

The tablets may be taken with or without food.

Duration of treatment

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

If you take more Memantina Pharma Combix than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

• In general, taking an excessive amount of Memantina Pharma Combix should not cause harm. You may experience an increase in the symptoms described in section 4 “Possible side effects”.

If you forget to take Memantina Pharma Combix

• If you realize you have forgotten to take your dose of Memantina Pharma Combix, wait and take the next dose at the usual time.
• Do not take a double dose to make up for missed doses.

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 Pharma Combix may cause adverse effects, although not everyone experiences them.

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

Frequent (affects between 1 and 10 people out of 100):

• Headache, somnolence, constipation, elevated liver function tests, dizziness, balance disorders, difficulty breathing, high blood pressure, and hypersensitivity to the medicine.

Uncommon (affects between 1 and 10 people out of 1,000):

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

Very rare (affects less than 1 person out of 10,000):

• Seizures.

Frequency not known (frequency cannot be estimated from the available data):

• Inflammation of the pancreas, inflammation of the liver (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 Memantina Pharma Combix.

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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantina Pharma Combix

Keep out of the reach and sight of children.

Do not use Memantina Pharma Combix after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Additional information

Composition of Memantina Pharma Combix

• The active substance is memantine hydrochloride.

Each film-coated tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.

• The other components are:

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

Tablet coating: Opadry pink 03F540041 (hypromellose 6cps (E464), macrogol 4000 (E1521), titanium dioxide (E171), talc (E553b), red iron oxide (E172), and yellow iron oxide (E172)).

Appearance of the product and contents of the container

Memantina Pharma Combix is presented as pink or pale red, oval, biconvex, smooth-faced film-coated tablets.

Memantina Pharma Combix film-coated tablets are available in blisters in packs of 28, 56, and 98 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Combix, S.L.U.

C/Badajoz, 2. 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 medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Memantina Pharma Combix 20 mg film-coated tablets EFG

France: Memantine Zydus France 20 mg film-coated tablet

Date of the most recent review of this leaflet: June 2019.

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