Nabila 20 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Nabila 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, pharmacist or nurse.
- 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 reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet.
Leaflet contents:
- What Nabila is and what it is used for
- What you need to know before taking Nabila
- How to take Nabila
- Possible side effects
- Storage of Nabila
- Contents of the pack and other information
1. What Nabila is and what it is used for
How Nabila works
Nabila 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 so-called N-methyl-D-aspartate (NMDA) receptors, which are involved in the transmission of nerve signals important for learning and memory. Nabila belongs to a group of medicines called NMDA receptor antagonists. Nabila acts on these receptors, improving nerve signal transmission and memory.
What Nabila is used for
Nabila is used in the treatment of patients with moderate to severe Alzheimer's disease.
2. What you need to know before taking Nabila
Do not take Nabila
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 starting to take Nabila:
- 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 (hypertension).
In the above situations, treatment should be carefully monitored, and your doctor should regularly reassess the clinical benefit of memantine.
If you have renal impairment (kidney problems), your doctor must 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 drug generally used as an anesthetic), dextromethorphan (a medicine used to treat cough), and other NMDA antagonists.
Memantine is not recommended for use in children and adolescents under 18 years of age.
Taking Nabila with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
Specifically, administration of memantine 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 Nabila.
Taking Nabila 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 kidney dysfunction (kidney problem)) or severe urinary tract infections (urine passage 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 taking this medicine.
The use of memantine is not recommended in pregnant women.
Women taking Nabila should stop breastfeeding.
Driving and using machines
Your doctor will advise you whether your condition allows you to drive and use machines safely.
In addition, Nabila may affect your reaction time; therefore, driving or operating machinery may be inappropriate.
Your doctor will advise you whether your condition allows you to drive and use machines safely.
In addition, Nabila may affect your reaction time; therefore, driving or operating machinery may be inappropriate.
Nabila contains Sunset Yellow FCF (E110)
This medicine may cause allergic reactions because it contains Sunset Yellow FCF (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.
3. How to take Nabila
Follow exactly the administration instructions for this medicine as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.
Dosage
The recommended dose for adults and elderly patients is 20 mg taken once daily.
To reduce the risk of adverse effects, this dose should be reached gradually according to a daily treatment schedule. Different dosage strengths of tablets are available to adjust the dose.
At the beginning of treatment, you will start taking Nabila 5 mg film-coated tablets once daily. This dose will 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 decide the appropriate dose for your condition. In this case, your doctor should periodically monitor your kidney function.
Administration
Nabila should be administered orally once daily. To get the maximum benefit from your medication, you must take it every day and at the same time each day. The tablets should be swallowed with a little water. The tablets may be taken with or without food.
Duration of treatment
Continue taking Nabila for as long as it is beneficial to you. Your doctor should periodically evaluate the effects of your treatment.
If you take more Nabila than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.
In general, taking an excessive amount of Nabila 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 Nabila, contact your doctor or seek medical advice, as you may require medical attention.
If you forget to take Nabila
If you realize you have forgotten to take your dose of memantine, wait and take the next dose at your 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, Nabila may cause adverse effects, although not everybody gets them.
In general, adverse effects are classified as mild to moderate.
Common (may affect between 1 and 10 out of 100 patients):
- Headache, drowsiness, constipation, elevated liver function tests, dizziness, loss of balance, difficulty breathing, high blood pressure, and hypersensitivity to the medicine.
Uncommon (may affect between 1 and 10 out of 1,000 patients):
- Fatigue, fungal infections, confusion, hallucinations, vomiting, impaired gait, heart failure, and formation of blood clots in the venous system (venous thrombosis/venous thromboembolism).
Very rare (may affect less than 1 out of 10,000 patients):
- 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 thoughts, and suicide. These events have been reported in patients treated with memantine.
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.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
5. Storage of Nabila
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, 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 Nabila
The active substance is memantine hydrochloride. Each film-coated tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
The other components are microcrystalline cellulose pH 200, povidone K-25, sodium croscarmellose and magnesium stearate in the tablet core; and hydroxypropylcellulose, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and sunset yellow FCF (E110) in the tablet coating.
Appearance of the product and contents of the pack
Nabila is presented as pink to orange, biconvex, elliptical film-coated tablets.
Nabila tablets are available in packs containing 28 and 56 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
EXELTIS HEALTHCARE, S.L.
Avda de Miralcampo 7. Polígono Industrial Miralcampo.
19200 Azuqueca de Henares. Guadalajara. Spain
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra, Portugal
Date of the most recent review of this summary: September 2014.
Detailed and up-to-date 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/