Memantina Sandoz 10 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Memantina Sandoz 10 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 Sandoz is and what it is used for
- What you need to know before taking Memantina Sandoz
- How to take Memantina Sandoz
- Possible side effects
- How to store Memantina Sandoz
- Contents of the pack and other information
1. What Memantina Sandoz is and what it is used for
How Memantina Sandoz works
Memantina 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 belongs to the group of medicines called NMDA receptor antagonists. Memantina acts on these receptors, improving the transmission of nerve signals and memory.
What Memantina Sandoz is used for
Memantina is used in the treatment of patients with moderate to severe Alzheimer's disease.
2. What you need to know before taking Memantina Sandoz
Do not take Memantina Sandoz
- if you are allergic to 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 Memantina Sandoz:
- if you have a history of epileptic seizures,
- if you have recently had a myocardial infarction (heart attack), or if you have congestive heart disease or uncontrolled hypertension (high blood pressure).
In the above situations, treatment must be carefully monitored and your doctor should regularly reassess the clinical benefit of memantine.
If you have renal impairment (kidney problems), your doctor should closely monitor 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 medicine generally used to induce anesthesia), dextromethorphan (a medicine used to treat 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 Sandoz 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 Sandoz may cause changes in the effects of the following medicines, so your doctor may need to adjust the doses:
- 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 Memantina Sandoz.
Taking Memantina Sandoz with food and drinks
You should inform your doctor if you have recently changed or intend to substantially change your diet (e.g., 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 (urine passage infections), as your doctor may need to adjust the dose of the medicine.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
The use of memantine is not recommended in pregnant women.
Breast-feeding
Women taking memantine should discontinue breast-feeding.
Driving and using machines
Your doctor will advise you whether your condition allows you to drive or use machines safely.
Furthermore, memantine may affect your reaction ability, so driving or operating machinery may be inappropriate.
Memantina Sandoz contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before using this medicine.
3. How to take Memantina Sandoz
Follow exactly the instructions for use of this medicine as provided by your doctor or pharmacist. If you are 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 schedule:
Treatment period | Daily dose |
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 | Two 10 mg tablets |
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.
Administration
Memantine must be taken orally once daily. To get the maximum benefit from your medication, you should 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.
The tablets can be split into two equal doses, as shown in the illustration. If necessary, take the tablet and press with your thumbs against your index fingers.
Duration of treatment
Continue taking memantine for as long as it is beneficial for you. Your doctor should periodically evaluate the effects of your treatment.
If you take more Memantina Sandoz than you should
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.
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 forget to take Memantina Sandoz
- If you realize you have forgotten to take your dose of memantine, wait and take your next dose at the usual time.
- Do not take a double dose to make up for forgotten 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 will experience them.
In general, adverse effects are mild to moderate.
Common, may affect up to 1 in 10 people:
- headache, somnolence, constipation, elevated liver function tests, dizziness, loss of balance, shortness of breath, 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 (thrombosis/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 this medicine.
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 national reporting system: Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Memantina Sandoz
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister, label, or packaging, after EXP. The expiry date refers to the last day of the month indicated.
After first opening, use the contents of the bottle within 6 months.
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 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 Sandoz
- The active substance is memantine. Each tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
- The other components are monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica and magnesium stearate in the core; hypromellose (E 464), monohydrate lactose, macrogol, triacetin and titanium dioxide (E 171) in the coating.
Appearance of the product and contents of the pack
White, oval film-coated tablets (6.1 x 11.6 mm) with a score line on both sides.
The film-coated tablets can be divided into equal doses.
The film-coated tablets are packed in transparent PVC-Aclar/aluminum and/or transparent PVC-PVDC/aluminum blisters or in HPDE bottles with polypropylene screw caps with child-resistant closure and desiccant, all contained in a cardboard outer carton.
Pack sizes:
Blister: 7, 10, 14, 18, 20, 22, 28, 30, 40, 42, 45, 48, 49, 49x1, 50, 56, 56x1, 60, 70, 84, 90, 96, 98, 98x1, 100, 100x1, 112, 980 (10x98) or 1000 (20x50) film-coated tablets.
Bottle: 28, 30, 56, 98, 100 or 112 film-coated tablets.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57,
1526 Ljubljana
Slovenia
or
Lek S.A.
ul. Domaniewska 50 C,
02-672 Warszawa
Poland
or
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
39179
Barleben
Germany
This medicinal product is authorised in the European Economic Area member states under the following names:
Netherlands: Memantine Sandoz 10 mg, filmomhulde tabletten
Austria: Memantin Sando z 1 0 m g – Filmtabletten
Belgium: Memantine Sandoz 10 mg filmomhulde tabletten
Czech Republic: Memantin Sandoz 10 mg
Greece: Memantine/Sandoz
Finland: Memantine Sandoz 10 mg tabletti, kalvopäällysteinen
France: Memantine Sandoz 10 mg, comprimé pelliculé sécable
Portugal: Memantina Sandoz
Sweden: Memantine Sandoz
United Kingdom: Memantine 10 mg Film-coated Tablets
Date of the most recent review of this summary: May 2020
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/