Memantina Tecnigen 20 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Memantina TecniGen 20 mg film-coated tablets EFG
Memantine hydrochloride
Read the entire leaflet carefully before you start taking this medicine, as 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, pharmacist or nurse.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if the effects are not listed in this leaflet.
Leaflet contents:
- What Memantina TecniGen is and what it is used for
- What you need to know before taking Memantina TecniGen
- How to take Memantina TecniGen
- Possible side effects
- Storage of Memantina TecniGen
- Package contents and other information
1. What Memantina TecniGen is and what it is used for
How Memantina TecniGen works
Memantina TecniGen 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 TecniGen belongs to a group of medicines called NMDA receptor antagonists. Memantina TecniGen acts on these receptors, improving nerve signal transmission and memory.
What Memantina TecniGen is used for
Memantina TecniGen is used in the treatment of patients with moderate to severe Alzheimer's disease.
2. Taking Memantina TecniGen
Do not take Memantina TecniGen
If you are allergic to memantine hydrochloride or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Memantina TecniGen:
- 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 hypertension (high blood pressure).
In the above situations, treatment must be carefully supervised and your doctor should regularly re-evaluate the clinical benefit of memantine.
If you have renal impairment (kidney problems), your doctor must closely monitor kidney function and, if necessary, adjust the dosage of memantine.
The use of memantine together with other medicines such as amantadine (used to treat Parkinson's disease), ketamine (a drug generally used as an anesthetic), dextromethorphan (a cough medicine), and other NMDA antagonists should be avoided.
The use of memantine is not recommended in children and adolescents under 18 years of age.
Taking Memantina TecniGen with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
Specifically, administration of memantine may cause changes in the effects of the following medicines, so your doctor may need to adjust the dosage:
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 TecniGen.
Taking Memantina TecniGen with food, drinks and alcohol
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), or 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 (urine passage infections), as your doctor may need to adjust the dose of the medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
The use of memantine is not recommended in pregnant women.
Women taking Memantina TecniGen should discontinue breastfeeding.
Driving and use of machines
Your doctor will advise you whether your condition allows you to drive and operate machinery safely.
Furthermore, Memantina TecniGen may affect your reaction ability, so driving or operating machinery may be inappropriate.
Memantina TecniGen contains Sunset Yellow FCF (E110)
This medicine may cause allergic reactions because it contains Sunset Yellow FCF (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.
Memantina TecniGen contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; hence, it is essentially "sodium-free".
3. How to take Memantina TecniGen
Follow exactly the administration instructions for this medicine as given by your doctor. Consult your doctor or pharmacist if you have any doubts.
Dosage
The recommended dose for adults and elderly patients is 20 mg administered 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 taking Memantina TecniGen 5 mg film-coated tablets 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 reached at the beginning of the fourth week.
Dosage for patients with renal impairment
If you have kidney problems, your doctor will decide the appropriate dose for your condition. In this case, your doctor should periodically monitor your kidney function.
Administration
Memantina TecniGen 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 TecniGen for as long as it is beneficial to you. Your doctor should periodically evaluate the effects of your treatment.
If you take more Memantina TecniGen than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.
In general, taking an excessive amount of Memantina TecniGen should not cause you any harm. You may experience an increase in symptoms described in section 4 “Possible side effects”.
If you take an overdose of Memantina TecniGen, contact your doctor or seek medical advice, as you may require medical attention.
If you forget to take Memantina TecniGen
If you realize you have forgotten to take your dose of memantine, wait and take the next dose at the usual time.
Do not take a double dose to make up for the missed dose.
If you have any other questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Memantina TecniGen may produce adverse effects, although not everyone experiences them.
In general, adverse effects are mild to moderate in severity.
Common (may affect between 1 and 10 out of 100 patients):
- Headache, somnolence, constipation, elevated liver function tests, dizziness, balance disorder, dyspnea, high blood pressure, and drug hypersensitivity.
Uncommon (may affect between 1 and 10 out of 1,000 patients):
- 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 (may affect less than 1 out of 10,000 patients):
- Seizures.
Frequency not known (frequency cannot be estimated from available data):
- Pancreatitis, 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 memantine.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not mentioned in this leaflet.
5. Storage of Memantine TecniGen
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Memantina TecniGen
Composition of Memantina TecniGen
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 microcrystalline cellulose, povidone K-25, sodium croscarmellose and magnesium stearate in the tablet core; and hydroxypropylcellulose, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and sunset yellow FCF (E110) in the tablet coating.
Appearance of the product and contents of the container
Memantina TecniGen is available as pink to orange, biconvex elliptical film-coated tablets.
Memantina TecniGen tablets are available in packs of 28 and 56 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Tecnimede España Industria Farmacéutica, S.A.
Avda. de Bruselas, 13, 3º D.
28108 Alcobendas (Madrid) SPAIN
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra, Portugal
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Portugal: Memantina TecniGen
Italy: Memantina Tecnimede
Spain: Memantina TecniGen 20 mg film-coated tablets EFG
Date of the most recent review of this leaflet: July 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/