Mantinex 20 mg film-coated tablets EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Mantinex 20 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, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, 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 such effects are not listed in this leaflet. See section 4.
Leaflet contents
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What Mantinex is and what it is used for
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What you need to know before taking Mantinex
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How to take Mantinex
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Possible side effects
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How to store Mantinex
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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 the transmission of nerve signals 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 monitored and your doctor should regularly re-evaluate the clinical benefit of memantine.
If you have renal insufficiency (kidney problems), your doctor must closely monitor kidney function and, if necessary, adjust the doses of memantine.
The use of memantine should be avoided together with other medicines such as amantadine (used to treat Parkinson's disease), ketamine (a drug generally used to produce anesthesia), dextromethorphan (a cough medicine), and other NMDA antagonists.
The use of Mantinex is not recommended in children and adolescents under 18 years of age.
Taking Mantinex 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 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 renal 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 might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using any medicine.
The use of memantine is not recommended in pregnant women.
Women taking Mantinex should stop breastfeeding.
Driving and using machines
Your doctor will advise you whether your condition allows you to drive or use machines safely.
Furthermore, Mantinex may affect your reaction capabilities, 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 administration instructions for this medicine provided by your doctor or pharmacist. If you have any doubts, 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 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 | One 20 mg tablet 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) in the second week, and to one and a half tablets once daily in the third week. From the fourth week onwards, the usual dose is one tablet 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 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 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: (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.
Common (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, 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 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 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 dispose of unused containers and medicines. 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 20 mg of memantine hydrochloride, equivalent to 16.62 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), macrogol 400 (E-1521), and red iron oxide (E-172).
Appearance of the product and contents of the pack
Mantinex 20 mg is presented as pink, oblong, biconvex, film-coated tablets.
Mantinex 20 mg film-coated tablets are available in monodose PVDC/Al blister packs containing 56 film-coated tablets.
Other presentations:
Mantinex 10 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)
Spain
Date of the most recent review 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 of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.