NABILA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Nabila10 mg film-coated tablets EFG

Memantine hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse, even if they are side effects not listed in this package leaflet.

Contents of the package leaflet:

1. What Nabila is and what it is used for.
2. What you need to know before taking Nabila.
3. How to take Nabila.
4. Possible side effects.
5. Storage of Nabila.
6. Package contents and additional information.

1. What Nabila is and what it is used for

How Nabila works

Nabila belongs to a group of medications called 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. Nabila belongs to the group of medications called NMDA receptor antagonists. Nabila acts on these receptors, improving the transmission of nerve signals 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 any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult 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 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.

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 commonly used as an anesthetic), dextromethorphan (a medication for the treatment of cough), and other NMDA antagonists should be avoided.

The use of memantine is not recommended in children and adolescents under 18 years of age.

Taking Nabila with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those obtained without a prescription.

In particular, the administration of memantine 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 commonly used to treat movement disorders or intestinal spasms),
• Anticonvulsants (substances used to prevent and eliminate seizures),
• Barbiturates (substances commonly 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 Nabila.

Taking Nabila with food, drinks, and alcohol

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, 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 taking this medication.

The use of memantine is not recommended in pregnant women.

Women taking Nabila should stop breastfeeding.

Driving and using machines

Your doctor will inform you if your illness allows you to drive and use machines safely.

Additionally, Nabila may alter your reaction ability, so driving or operating machines may be inappropriate.

Your doctor will inform you if your illness allows you to drive and use machines safely.

Additionally, Nabila may alter your reaction ability, so driving or operating machines may be inappropriate.

Nabila contains Orange Yellow S (E110)

This medication may cause allergic reactions because it contains Orange Yellow S (E110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Nabila

Follow the administration instructions of this medication exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Posology

The recommended dose for adults and elderly patients is 20 mg administered once a 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 Nabila 5 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

Nabila 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 Nabila as long as it is beneficial for 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 medication and the amount taken.

Generally, 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 need 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 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, Nabila can cause side effects, although not everyone will experience them.

Generally, side effects are classified as mild to moderate.

Frequent (may affect 1 to 10 in every 100 patients):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorder, difficult breathing, high blood pressure, and hypersensitivity to the medication.

Uncommon (may affect 1 to 10 in every 1,000 patients):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure, and venous thrombosis/thromboembolism.

Rare (may affect less than 1 in every 10,000 patients):

• Seizures.

Frequency not known (frequency cannot be estimated from the available data):

• Pancreatitis, 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.

If you consider any of the side effects you experience to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.

5. Storage of Nabila

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Deposit 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 Nabila

The active ingredient is memantine hydrochloride. Each film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.

The other ingredients are microcrystalline cellulose, povidone K-25, sodium croscarmellose, and magnesium stearate in the tablet core; and hydroxypropylcellulose and talc in the tablet coating.

Appearance of the product and package contents

Nabila is presented in the form of white, oblong, biconvex film-coated tablets, scored on one side. The tablet can be divided into two equal doses.

Nabila tablets are presented in packs of 56 and 112 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 last revision of this package leaflet:September 2014.

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/