MEMANTINE TARBIS 20 mg FILM-COATED TABLETS
Ask a doctor about a prescription for MEMANTINE TARBIS 20 mg FILM-COATED TABLETS
How to use MEMANTINE TARBIS 20 mg FILM-COATED TABLETS
Introduction
Package Leaflet: Information for the User
MemantineTarbis20 mg film-coated tablets EFG
Memantine, hydrochloride
Read the entire package leaflet carefully before starting to takethismedication, as it contains important information for you.
- Keep this package leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
- If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
Contents of the package leaflet:
- What is Memantine Tarbis and what is it used for
- What you need to know before taking Memantine Tarbis
- How to take Memantine Tarbis
- Possible side effects
- Storage of Memantine Tarbis
- Package contents and additional information
1. What is Memantine Tarbis and what is it used for
How Memantine Tarbis works
Memantine Tarbis belongs to a group of medications known as anti-dementia medications.
Memory loss in Alzheimer's disease is due to an alteration in brain signals. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors that participate in the transmission of important nerve signals in learning and memory. Memantine Tarbis belongs to the group of medications called NMDA receptor antagonists. Memantine Tarbis acts on these receptors, improving the transmission of nerve signals and memory.
What Memantine Tarbis is used for
Memantine Tarbis is used in the treatment of patients with moderate to severe Alzheimer's disease.
2. What you need to know before starting to take Memantine Tarbis
Do not take Memantine Tarbis
- if you are allergic to memantine hydrochloride or any of the other ingredients of this medication (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Memantine Tarbis.
- if you have a history of epileptic seizures (convulsions).
- if you have recently suffered a myocardial infarction (heart attack), if you have congestive heart failure, or if you have uncontrolled hypertension (high blood pressure).
In these situations, treatment should be carefully supervised, and your doctor should regularly reassess the clinical benefit of Memantine Tarbis.
If you have kidney problems, your doctor should closely monitor your kidney function and, if necessary, adjust the dose of memantine.
The use of memantine with other medications such as amantadine (for the treatment of Parkinson's disease), ketamine (a medication generally used to produce anesthesia), dextromethorphan (a medication for the treatment of cough), and other NMDA antagonists should be avoided.
The use of Memantine Tarbis is not recommended in children and adolescents under 18 years of age.
Using Memantine Tarbis with other medications
Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.
In particular, the administration of Memantine Tarbis may produce changes in the effects of the following medications, so your doctor may need to adjust the dose:
amantadine, ketamine, dextromethorphan.
dantrolene, baclofen.
cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine.
hydrochlorothiazide (or any combination with hydrochlorothiazide).
anticholinergics (substances generally used to treat movement disorders or intestinal spasms).
anticonvulsants (substances used to prevent and eliminate convulsions).
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 hospitalized, inform your doctor that you are taking Memantine Tarbis.
Taking Memantine Tarbis with food and drinks
You should inform your doctor if you have recently changed or plan to change your diet substantially (e.g., from a normal diet to a strict vegetarian diet) or if you have renal tubular acidosis (RTA, excess of acid-producing substances in the blood due to kidney dysfunction) or severe urinary tract infections, as your doctor may need to adjust the dose of the medication.
Pregnancy, breast-feeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.
The use of memantine is not recommended in pregnant women.
Women taking Memantine Tarbis should stop breast-feeding.
Driving and using machines
Your doctor will inform you if your illness allows you to drive and use machines safely.
Additionally, Memantine Tarbis may alter your reaction ability, so driving or operating machines may be inappropriate.
3. How to take Memantine Tarbis
Follow the administration instructions of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
Posology
The recommended dose is 20 mg per day.
To reduce the risk of side effects, this dose should be achieved gradually following a daily treatment scheme. To adjust the dose, there are tablets with different doses.
At the start of treatment, you will begin taking half a tablet of Memantine Tarbis 10 mg film-coated tablets once a day. This dose will be increased weekly by 5 mg until the recommended maintenance dose is reached (20 mg once a day), which is achieved at the beginning of the fourth week.
Posology for patients with renal impairment
If you have kidney problems, your doctor will decide on the appropriate dose for your condition. In this case, your doctor should periodically monitor your kidney function.
Administration
Memantine Tarbis should be administered orally once a day. To get the most out of your medication, you should take it every day and at the same time. The tablets should be swallowed with a little water. The tablets can be taken with or without food.
Duration of treatment
Continue taking Memantine Tarbis as long as it is beneficial for you. Your doctor should periodically evaluate the effects of your treatment.
If you take more Memantine Tarbis than you should
- Generally, taking an excessive amount of Memantine Tarbis 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 Tarbis, contact your doctor or seek medical advice, as you may need medical attention.
If you forget to take Memantine Tarbis
- If you realize you have forgotten to take your dose of Memantine Tarbis, wait and take the next dose at the usual time.
- Do not take a double dose to make up for the forgotten dose.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible side effects
Like all medications, this medication can cause side effects, although not everyone gets them.
Generally, side effects are classified as mild to moderate.
Frequent (affecting 1 to 10 in every 100 patients):
- Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorder, shortness of breath, high blood pressure, and hypersensitivity to the medication.
Uncommon (affecting 1 to 10 in every 1,000 patients):
- Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure, and venous thrombosis/thromboembolism.
Very rare (affecting less than 1 in every 10,000 people):
- Seizures.
Frequency not known (frequency cannot be estimated from the available data):
- Pancreatitis, hepatitis (inflammation of the liver), 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 Tarbis.
If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.
Reporting side effects
If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use, www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Storage of Memantine Tarbis
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date stated on the carton and blister after EXP. The expiration date is the last day of the month indicated.
No special storage conditions are required.
Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.
6. Package contents and additional information
Composition of Memantine Tarbis
The active ingredient is memantine hydrochloride. Each tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
The other ingredients are microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate in the core; polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), and yellow and red iron oxide (E172) in the tablet coating.
Appearance of the product and package contents
Memantine Tarbis 20 mg film-coated tablets are pale red, oval-shaped with a break line on one face. The score line is to facilitate breaking and swallowing but not to divide into equal doses.
Memantine Tarbis film-coated tablets are available in a package of 56 tablets.
Marketing authorization holder
Tarbis Farma, S.L.
Gran Vía Carlos III, 94
08028 Barcelona
Manufacturer
Noucor Health, S.A.
Av. Camí Reial 51-57
08184 Palau-solità i Plegamans (Spain)
This package leaflet was approved in:November 2013
Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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