Mantinex Flas 20 mg buccodispersible tablets EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Mantinex Flas 20 mg orodispersible tablets EFG
Memantine hydrochloride
Read all of this 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 other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of this leaflet:
- What Mantinex Flas is and what it is used for.
- What you need to know before taking Mantinex Flas.
- How to take Mantinex Flas.
- Possible side effects.
- How to store Mantinex Flas.
- Contents of the pack and other information.
1. What Mantinex Flas is and what it is used for
How Mantinex Flas works
Mantinex Flas 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 receptors known as N-methyl-D-aspartate (NMDA) receptors, which are involved in the transmission of nerve signals important for learning and memory. Mantinex Flas belongs to a group of medicines called NMDA receptor antagonists. This medicine acts on these receptors, improving nerve signal transmission and memory.
What Mantinex Flas is used for
Mantinex Flas is used in the treatment of patients with moderate to severe Alzheimer's disease.
2. What you need to know before taking Mantinex Flas
Do not take Mantinex Flas
- 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
Consult your doctor or pharmacist before starting to take Mantinex Flas.
- if you have a history of epileptic seizures.
- if you have recently suffered 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 insufficiency (kidney problems), your doctor must closely monitor your kidney function and, if necessary, adjust the memantine dosage.
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 induce anesthesia), dextromethorphan (a medication used to treat cough), and other NMDA antagonists.
The use of Mantinex Flas is not recommended in children and adolescents under 18 years of age.
Taking Mantinex Flas 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 this medicine 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 control 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 memantine.
Taking Mantinex Flas 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 may 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 Flas should discontinue breastfeeding.
Driving and using machines
Your medical condition may affect your ability to drive or operate machinery, and you should not engage in these activities unless your doctor tells you it is safe to do so. Mantinex Flas may cause dizziness and somnolence, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.
Mantinex Flas contains lactose, aspartame and sodium
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
This medicine contains 5 mg of aspartame (E-951) per tablet, equivalent to 0.07 mg/kg. Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially "sodium-free".
3. How to take Mantinex Flas
Follow exactly the administration instructions for this medicine provided by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist again.
Dosage:
The recommended dose of memantine 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 regimen:
Week 1 | Take 5 mg once daily for 7 days. |
Week 2 | Take 10 mg (one 10 mg tablet) daily for 7 days. |
Week 3 | Take 15 mg once daily for 7 days. |
Week 4 and onwards | Take 20 mg (one 20 mg tablet or two 10 mg tablets) once daily |
Mantinex Flas tablets cannot be split. For doses not available with Mantinex Flas, you should use another medication containing memantine with the available dose.
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 Flas:
Mantinex Flas 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 placed on the tongue and allowed to dissolve before swallowing, with or without water, according to patient preference. The tablets may be taken with or without food.
Duration of treatment:
Continue taking this medicine for as long as it is beneficial to you. Your doctor should periodically evaluate the effects of your treatment.
If you take more Mantinex Flas 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 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 Flas
- If you realize you have missed a dose of this medicine, 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, this medicine can cause adverse effects, although not everyone will experience them.
In general, adverse effects are classified as mild to moderate.
Common (may affect up to 1 in 10 people):
- Headache, drowsiness, constipation, elevated liver function tests, dizziness, loss of balance, difficulty breathing, high blood pressure, and hypersensitivity to the medicine.
Uncommon (may affect up to 1 in 100 people):
- 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 up to 1 in 10,000 people):
- 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.
5. Storage of Mantinex Flas
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 is 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 you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Mantinex Flas
- The active substance is memantine hydrochloride. (Each orodispersible tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine).
- The other components are: Polacriline, lactose monohydrate, microcrystalline cellulose (E460), colloidal anhydrous silica, sodium croscarmellose, mannitol (E421), aspartame (E951), red iron oxide (E172), magnesium stearate (E-572), sodium hydroxide (to adjust pH), and mint flavour (modified corn starch).
Appearance of the product and contents of the pack
Mantinex Flas 10 mg is presented as pink, round, flat orodispersible tablets with bevelled edges, marked with "10" on one side.
Mantinex Flas 10 mg is available in Al/Al blister packs containing 112 orodispersible tablets.
Other presentations:
Mantinex Flas 20 mg orodispersible tablets EFG.
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 revision of this package leaflet: September 2021