Mantinex 10 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Mantinex 10 mg film-coated tablets EFG
Memantine hydrochloride
Read the entire leaflet carefully before you start taking this medicine, because 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 or pharmacist.
- 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 or pharmacist, even if the effects are not listed in this leaflet. See section 4.
Leaflet Contents
-
What Mantinex is and what it is used for
-
What you need to know before taking Mantinex
-
How to take Mantinex
-
Possible side effects
-
How to store Mantinex
-
Contents of the pack and other information
1. What Mantinex is and what it is used for
How Mantinex works
Mantinex belongs to a group of medicines known as anti-dementia medications.
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. Mantinex belongs to a group of medicines called NMDA receptor antagonists. Mantinex acts on these receptors, improving nerve signal transmission and memory.
What Mantinex is used for
Mantinex is used in the treatment of patients with moderate to severe Alzheimer's disease.
2. What you need to know before taking Mantinex
Do not take Mantinex
- if you are allergic to the active substance memantine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Mantinex.
- 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 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 dose of memantine.
The use of memantine should be avoided concomitantly with other medicines such as amantadine (used to treat Parkinson's disease), ketamine (a drug generally used to induce anesthesia), dextromethorphan (a cough medicine), and other NMDA antagonists.
Mantinex is not recommended for use in children and adolescents under 18 years of age.
Taking Mantinex with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Specifically, administration of Mantinex 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 Mantinex.
Taking Mantinex 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, 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.
The use of memantine is not recommended in pregnant women.
Women taking Mantinex should discontinue breastfeeding.
Driving and use of machines
Your doctor will advise you whether your condition allows you to drive or operate machinery safely.
In addition, Mantinex may affect your reaction ability, so driving or operating machinery may be inappropriate.
Mantinex contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Mantinex
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Dosage:
The recommended dose of Mantinex in adult and elderly patients is 20 mg administered once daily. To reduce the risk of adverse effects, this dose should be 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 once daily |
The usual starting dose is half a tablet once daily (5 mg) during the first week. This is increased to one tablet daily (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 (20 mg).
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.
How to administer Mantinex:
Mantinex should be taken 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 some water. The tablets may be taken with or without food.
Duration of treatment:
Continue taking Mantinex for as long as it is beneficial for you. Your doctor should periodically evaluate the effects of your treatment.
If you take more Mantinex than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at (91) 5620420, indicating the medication and the amount ingested.
- In general, taking an excessive amount of memantine 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 memantine, contact your doctor or seek medical advice, as you may require medical attention.
If you forget to take Mantinex
- If you realize you have forgotten to take your dose of Mantinex, 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 medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Mantinex may cause adverse effects, although not everyone experiences them.
In general, adverse effects are classified as mild to moderate.
Frequent (may affect between 1 and 10 out of 100 patients):
- Headache, drowsiness, constipation, elevated liver function tests, dizziness, loss of balance, difficulty breathing, high blood pressure, and hypersensitivity to the medicine.
Uncommon (may affect between 1 and 10 out of 1,000 patients):
- Fatigue, fungal infections, confusion, hallucinations, vomiting, impaired gait, heart failure, and formation of blood clots in the venous system (venous thrombosis/venous thromboembolism).
Very rare (may affect fewer than 1 out of 10,000 patients):
- Seizures.
Frequency not known (frequency cannot be estimated from 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 memantine.
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. They can also be reported directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.
5. Storage of Mantinex
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Mantinex
- 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: lactose monohydrate, microcrystalline cellulose (E-460i), colloidal anhydrous silica, talc and magnesium stearate (E-572).
Coating: hypromellose (E-464), titanium dioxide (E-171) and macrogol 400 (E-1521).
Appearance of the product and contents of the pack
Mantinex 10 mg is presented as white, oblong, biconvex, film-coated tablets with a score line.
Mantinex 10 mg film-coated tablets are available in monodose PVDC/Al blister packs containing 112 film-coated tablets.
Other presentations:
Mantinex 20 mg film-coated tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Neuraxpharm Spain, S.L.U.
Avda. Barcelona, 69
08970 Sant Joan Despí
Barcelona – Spain
Manufacturer:
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona, 69
08970 – Sant Joan Despí
(Barcelona)
Date of the most recent revision of this leaflet: July 2021.
Other sources of information:
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/.