Memantina Pharma Combix 10 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Memantina PharmaCombix 10 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you; do not give it to other people, even if they have the same symptoms as you, as it may 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.
Leaflet contents
- What Memantina PharmaCombix is and what it is used for
- Before you take Memantina PharmaCombix
- How to take Memantina PharmaCombix
- Possible side effects
- How to store Memantina PharmaCombix
- 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 receptors known as 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 in the treatment of patients with moderate to severe Alzheimer's disease.
2. Before taking 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
Talk to 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 have congestive heart disease, or if you have uncontrolled high blood pressure.
In these situations, treatment should be carefully monitored and your doctor should regularly reassess the clinical benefit of Memantina Pharma Combix.
If you have renal impairment (kidney problems), your doctor should closely monitor your kidney function and, if necessary, adjust the doses of memantine.
If you have renal tubular acidosis (RTA, excess acid-producing substances in the blood due to kidney dysfunction [kidney problem]) or severe urinary tract infections, your doctor may need to adjust the dose of the medicine.
The use of memantine should be avoided together with other medicines such as amantadine (for the treatment of Parkinson's disease), ketamine (a medicine generally used in anesthesia), dextromethorphan (generally used to treat cough), and other NMDA antagonists.
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
Tell 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 drink
You should inform your doctor if you have recently changed or intend to make significant changes to 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 breast-feeding
If you are pregnant or breast-feeding, think you may 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.
Breast-feeding: Women taking Memantina Pharma Combix must not breast-feed.
Driving and using machines
Your doctor will advise you whether your condition allows you to drive and use machines safely. In addition, 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 is reached gradually according to the following daily schedule:
Week 1 | half a 10 mg tablet |
Week 2 | one 10 mg tablet |
Week 3 | one and a half 10 mg tablets |
Week 4 and onwards | two 10 mg tablets or one 20 mg tablet once daily |
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 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 renal function.
Administration
Memantina Pharma Combix must be administered orally once daily. To obtain the maximum benefit from your medication, you should 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 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, consult 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 you any 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 can cause adverse effects, although not everyone will experience them.
In general, adverse effects are classified as mild to moderate.
Common (affects between 1 and 10 people in every 100):
- Headache, drowsiness, 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 in every 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 in every 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 Medicinal Products: 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 stated on the carton and blister pack after EXP. The expiry date refers to the last day of the month indicated.
This medicinal product does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to your local pharmacy's SIGRE collection point. If you are unsure, please consult your pharmacist on how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Additional Information
Composition of Memantina PharmaCombix
- The active substance is memantine hydrochloride.
Each film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 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 white 03F58991 (hypromellose 6 cps (E464), macrogol 6000 (E1521), titanium dioxide (E171) and talc (E553b)).
Appearance of the medicinal product and contents of the container
Memantina PharmaCombix film-coated tablets are white or almost white, capsule-shaped, biconvex, film-coated tablets, with a score line on one side and smooth on the other. The tablet can be divided into equal doses.
Memantina PharmaCombix film-coated tablets are available in blister packs in pack sizes of 28, 56, 98, 100 and 112 tablets.
Only some 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:
Spain: Memantina PharmaCombix 10 mg film-coated tablets EFG
France: Memantine Zydus France 10 mg scored 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/.