Memantina Flas CINFA 10 mg orodispersible tablets EFG
Spain
Table of Contents
- Patient Information Leaflet
- Introduction
- 1. What memantina flas cinfa is and what it is used for
- 2. What you need to know before taking memantina flas cinfa
- 3. How to take memantina flas cinfa
- 4. Possible adverse effects
- 5. Storage of memantine flas cinfa
- 6. Contents of the container and other information
Patient Information Leaflet
Introduction
Patient Information Leaflet
memantina flas cinfa 10 mg orodispersible 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 or pharmacist.
- This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet Contents
- What memantina flas cinfa is and what it is used for
- What you need to know before taking memantina flas cinfa
- How to take memantina flas cinfa
- Possible side effects
- How to store memantina flas cinfa
- Contents of the pack and other information
1. What memantina flas cinfa is and what it is used for
Memantina flas cinfa 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 a disruption 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 flas cinfa belongs to the group of medicines called NMDA receptor antagonists. Memantina flas cinfa acts on these receptors, improving the transmission of nerve signals and memory.
Memantina flas cinfa is used in the treatment of patients with moderate to severe Alzheimer's disease.
2. What you need to know before taking memantina flas cinfa
Do not take memantina flas cinfa
If you are allergic to memantine 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 memantina flas cinfa.
- 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 high blood pressure.
In the above situations, treatment must be carefully supervised, and your doctor should regularly reevaluate 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 dosage 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 (urine passage), 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 as an anesthetic), dextromethorphan (a medicine for the treatment of cough), and other NMDA antagonists.
Children and adolescents
The use of memantine is not recommended in children and adolescents under 18 years of age.
Taking memantina flas cinfa with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Specifically, the administration of memantina flas 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 flas.
Taking memantina flas cinfa with food and drinks
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), as your doctor may need to adjust the dose of the medicine.
Pregnancy and breastfeeding
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 memantine must not breastfeed.
Driving and using machines
Your illness may affect your ability to drive or operate machinery, and you should not carry out these activities unless your doctor tells you it is safe to do so. Memantina flas may cause dizziness and somnolence, mainly at the beginning of treatment or when the dose is increased. If you experience these effects, you must not drive or operate machinery.
Memantina flas cinfa contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
Memantina flas cinfa contains aspartame (E-951)
This medicine contains 2.5 mg of aspartame per tablet. Aspartame is a source of phenylalanine, which may be harmful in patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
3. How to take memantina flas cinfa
Follow exactly the administration instructions for this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose of memantina flas in adult patients and elderly patients is 20 mg taken 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 |
Memantina Flas Cinfa tablets cannot be split. For memantina flas cinfa doses that are not available, you should use another medicine containing memantine with an available dosage strength.
Dosage in patients with renal impairment
If you have kidney problems, your doctor will decide the appropriate dose according to your condition. In this case, your doctor should periodically monitor your kidney function.
Administration
Memantina Flas Cinfa should be administered orally once daily. To get the maximum benefit from your medication, you must take it every day at the same time.
Take the orodispersible tablet as follows:
- Do not crush the orodispersible tablet
To avoid crushing the orodispersible tablet, do not press on the blister (Figure 1).
- Separate one blister
Each blister contains fourteen blisters separated by perforations. Separate one blister along the perforated lines, following the indication “fold here” (Figure 2).
- Remove the foil
Carefully remove the foil, starting at the corner marked with an arrow and indicated as “pull here” (Figures 3 and 4).
- Remove the orodispersible tablet
With dry hands, remove the orodispersible tablet and place it on the tongue (Figure 5).
The tablet will rapidly disintegrate, and once dissolved, it may be swallowed with or without water, according to your preference. The tablets may be taken with or without food.
Duration of treatment
Continue taking memantina flas as long as it is beneficial for you. Your doctor should periodically evaluate the effects of your treatment.
If you take more memantina flas cinfa than you should
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”.
In case of overdose or accidental ingestion, contact 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.
If you forget to take memantina flas cinfa
If you realize you have forgotten to take your dose of memantina flas, 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 may cause adverse effects, although not everyone experiences 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, impaired gait, heart failure, and formation of blood clots in the venous system (thrombosis/venous thromboembolism).
Very rare (may affect up to 1 in 10,000 people):
- Seizures.
Frequency not known (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. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of memantine flas cinfa
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.
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 packaging at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of memantina flas cinfa
- 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 (E-460), colloidal anhydrous silica, sodium croscarmellose, mannitol (E-421), aspartame (E-951), red iron oxide (E-172), magnesium stearate, sodium hydroxide (to adjust pH), and mint flavour: maltodextrin (corn), modified starch E-1450 (waxy corn), and peppermint oil (Mentha arvensis).
Appearance of the product and contents of the pack
memantina flas cinfa 10 mg is presented as a pale pink, round, flat, speckled tablet with bevelled edges, 9 mm in diameter, marked with the code "10" on one side.
memantina flas cinfa 10 mg is available in Al/Al blister packs containing 112 orodispersible tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Manufacturer
Genepharm S.A.
18 km Marathon Avenue
15351 Pallini Attikis, Greece.
or
Rontis Hellas S.A.
Industrial Area of Larissa, P.O. Box 3012, GR41004 Larissa
Greece.
or
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Date of the most recent revision of this leaflet: May 2020
Detailed 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
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83298/P_83298.html
QR code: https://cima.aemps.es/cima/dochtml/p/83298/P_83298.html