Memantina Tarbis 20 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Memantina Tarbis 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, 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.
Leaflet contents:
- What Memantina Tarbis is and what it is used for
- What you need to know before taking Memantina Tarbis
- How to take Memantina Tarbis
- Possible adverse effects
- How to store Memantina Tarbis
- Contents of the pack and other information
1. What Memantina Tarbis is and what it is used for
How Memantina Tarbis works
Memantina Tarbis belongs to a group of medicines known as anti-dementia drugs.
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. Memantina Tarbis belongs to the group of medicines called NMDA receptor antagonists. Memantina Tarbis acts on these receptors, improving the transmission of nerve signals and memory.
What Memantina Tarbis is used for
Memantina Tarbis is used in the treatment of patients with moderate to severe Alzheimer's disease.
2. What you need to know before taking Memantina Tarbis
Do not take Memantina Tarbis
- if you are allergic to 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 taking Memantina Tarbis.
- if you have a history of epileptic seizures (convulsions).
- 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 Memantina Tarbis.
If you have renal impairment (kidney problems), your doctor must closely monitor your kidney function and, if necessary, adjust the dose of memantine.
The use of memantine together 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 should be avoided.
The use of Memantina Tarbis is not recommended in children and adolescents under 18 years of age.
Taking Memantina Tarbis with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Specifically, taking Memantina Tarbis 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 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 admitted to hospital, inform your doctor that you are taking Memantina Tarbis.
Taking Memantina Tarbis with food and drink
You should inform your doctor if you have recently changed or plan 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 Memantina Tarbis should stop breastfeeding.
Driving and using machines
Your doctor will advise you whether your condition allows you to drive and use machines safely.
Also, Memantina Tarbis may affect your reaction ability, so driving or operating machinery may be inappropriate.
3. How to take Memantina Tarbis
Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Dosage
The recommended dose is 20 mg once daily.
To reduce the risk of adverse effects, this dose should be reached gradually according to a daily treatment schedule. Different dosage strength tablets are available to adjust the dose.
At the beginning of treatment, you will start by taking half a tablet of Memantina Tarbis 10 mg film-coated tablets once daily. The dose will then be increased weekly by 5 mg until the recommended maintenance dose is reached. The recommended maintenance dose of 20 mg once daily is reached at the beginning of the fourth week.
Dosage for patients with renal impairment
If you have kidney problems, your doctor will determine the appropriate dose for your condition. In this case, your doctor should periodically monitor your kidney function.
Administration
Memantina Tarbis 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 Memantina Tarbis for as long as it is beneficial for you. Your doctor should periodically evaluate the effects of your treatment.
If you take more Memantina Tarbis than you should
- In general, taking an excessive amount of Memantina 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 Memantina Tarbis, contact your doctor or seek medical advice, as you may require medical attention.
If you forget to take Memantina Tarbis
- If you realize you have forgotten to take your dose of Memantina Tarbis, wait and take the next dose at the usual time.
- Do not take a double dose to make up for the missed dose.
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 (affects between 1 and 10 in every 100 patients):
- Headache, drowsiness, constipation, elevated liver function tests, dizziness, loss of balance, shortness of breath, high blood pressure, and hypersensitivity to the medicine.
Uncommon (affects between 1 and 10 in every 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 (affects less than 1 in every 10,000 people):
- Seizures.
Frequency not known (frequency cannot be estimated from available data):
- Pancreatitis, hepatitis (liver inflammation), and psychotic reactions.
Alzheimer's disease has been associated with depression, suicidal ideation, and suicide. These events have been reported in patients treated with Memantina Tarbis.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products at www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Memantina Tarbis
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the blister after EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and any unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Memantina Tarbis
The active substance is memantine hydrochloride. Each tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
The other components are microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate in the core; polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171) and yellow iron oxide and red iron oxide (E172) in the tablet coating.
Appearance of the product and contents of the pack
Memantina Tarbis 20 mg film-coated tablets are pale red, oval-shaped, with a break line on one side. The score line is intended to facilitate breaking the tablet and swallowing, but not to divide it into equal doses.
Memantina Tarbis film-coated tablets are available in a pack 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 leaflet was approved in: November 2013
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/