Package Insert: Information for the Patient

Nabila10 mg Film-Coated Tablets

Memantine Hydrochloride

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert.

How Nabila works

Nabilabelongs to a group of medications known as dementia medications.

Memory loss in Alzheimer's disease is due to an alteration in brain signals. The brain contains called N-methyl-D-aspartate (NMDA) receptors that participate in the transmission of important nervous signals in learning and memory.Nabilabelongs to the group of medications called NMDA receptor antagonists.Nabilaacts on these receptors by improving the transmission of nervous signals and memory.

What Nabila is used forNabila

Nabilais used in the treatment of patients with moderate to severe Alzheimer's disease.

Do not takeNabila

If you are allergic to hydrochloride memantine or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to takeNabila:

• If you have a history of epileptic seizures.
• If you have recently had a myocardial infarction (heart attack), if you have congestive heart failure or if you have uncontrolled high blood pressure.

In the above situations, treatment should be closely monitored and your doctor should regularly reevaluate the clinical benefit of memantine.

If you have kidney problems, your doctor should closely monitor your renal function and, if necessary, adjust the memantine dose.

Memantine should be avoided when used with other medications such as amantadine (for Parkinson's treatment), ketamine (a medication generally used as an anesthetic), dextromethorphan (a medication for cough treatment) and other NMDA antagonists.

Memantine is not recommended for use in children and adolescents under 18 years old.

TakingNabilawith other medications

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

Specifically, 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 generally used to treat movement disorders or intestinal spasms),
• Anticonvulsants (substances used to prevent and eliminate seizures),
• Barbiturates (substances generally used to induce sleep),
• Dopamine agonists (substances like L-dopa, bromocriptine),
• Neuroleptics (substances used in the treatment of mental illnesses),
• Oral anticoagulants.

If you are admitted to a hospital, inform your doctor that you are takingNabila.

TakingNabilawith food, drinks and alcohol

You should inform your doctor if you have recently changed or plan to change your diet significantly (for example from a normal diet to a strict vegetarian diet) or if you have kidney tubular acidosis (ATR, excess of acid-producing substances in the blood due to a renal dysfunction) or severe urinary tract infections, as your doctor may need to adjust the medication dose.

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.

Memantine is not recommended for use in pregnant women.

Women takingNabilashould discontinue breastfeeding.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive and use machinery safely.

Similarly,Nabilamay alter your reaction time, making driving or operating machinery unsuitable.

Your doctor will inform you if your condition allows you to drive and use machinery safely.

Similarly,Nabilamay alter your reaction time, making driving or operating machinery unsuitable.

Nabilacontains Yellow orange S (E110)

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

Follow exactly the administration instructions of this medication 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 administered once a day.

To reduce the risk of adverse effects, this dose should be achieved gradually following a daily treatment schedule. There are tablets with different doses available to adjust the dose.

At the beginning of treatment, you will start takingNabila5 mg film-coated tablets once a day. This dose will be increased weekly by 5 mg until the recommended maintenance dose is reached. The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the fourth week.

Dosage for patients with renal insufficiency

If you have kidney problems, your doctor will decide on the appropriate dose for your condition. In this case, your doctor should monitor your renal function periodically.

Administration

Nabilashould be taken 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.

Treatment duration

Continue takingNabilaas long as it is beneficial for you. Your doctor should evaluate the effects of your treatment periodically.

If you take moreNabilathan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount taken.

Generally, taking an excessive amount ofNabilashould not cause you any harm. You may experience an increase in the symptoms described in section 4 “Possible adverse effects”.

If you take an overdose ofNabila, contact your doctor or seek medical advice, as you may need medical attention.

If you forgot to takeNabila

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 compensate for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Nabilamay cause adverse effects, although not all people will experience them.

Generally, adverse effects are classified as mild to moderate.

Frequent (may affect between 1 and 10 of every 100 patients):

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

Rare (may affect between 1 and 10 of every 1,000 patients):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disorder, heart failure, and formation of blood clots in the venous system (venous thrombosis/thromboembolism).

Very rare (may affect fewer than 1 of every 10,000 patients):

• Seizures.

Unknown frequency (frequency cannot be estimated from 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.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effects not mentioned in this prospectus, inform your doctor or pharmacist.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

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

Do not use this medication after the expiration date that appears on the blister pack and on the box after CAD. 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 through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Nabila

The active principle is hydrochloride of memantine. Each coated tablet contains 10 mg of hydrochloride of memantine, which are equivalent to 8.31 mg of memantine.

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

Appearance of the product and content of the container

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

Nabila tablets are presented in containers of 56 and 112 tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization

EXELTIS HEALTHCARE, S.L.

Avenida de Miralcampo 7. Miralcampo Industrial Estate.

19200 Azuqueca de Henares. Guadalajara.Spain

Responsible for manufacturing

Atlantic Pharma – Pharmaceutical Productions, S.A.

Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra, Portugal

Date of the last review of this leaflet:September2014.

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http: //www.aemps.gob.es/