Prospect: information for the user

NABILA 10 mg/ml oral solution EFG

Memantine hydrochloride

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

• Keep this prospect, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is Nabila and for what it is used

2. What you need to know before starting to take Nabila

3. How to take Nabila

4. Possible adverse effects

5. Storage of Nabila

6. Contents of the package and additional information

How Nabila works

Nabila contains memantine hydrochloride as the active ingredient, which belongs 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.

Nabila belongs to the group of medications called NMDA receptor antagonists.

This medication acts on these receptors by improving the transmission of nervous signals and memory.

What Nabila is used for

Nabila is used for the treatment of patients with moderate to severe Alzheimer's disease.

Do not take Nabila:

- if you are allergic to memantine hydrochloride or any of the other components 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 have congestive heart failure or if you have uncontrolled high blood pressure.

The treatment should be closely monitored in these situations and your doctor should regularly reevaluate the clinical benefit of Nabila.

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

If you have renal insufficiency, your doctor should closely monitor renal function and, if necessary, adapt memantine doses.

The use of memantine should be avoided with other medications such as amantadine (for Parkinson's treatment), ketamine (a medication generally used to induce anesthesia), dextromethorphan (a medication for cough treatment) and other NMDA antagonists.

Children and adolescents

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

Taking Nabila with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use another medication.

In particular, the administration of Nabila 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 such as L-dopa, bromocriptine),

- neurolleptics (substances used in the treatment of mental illnesses),

• oral anticoagulants.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy: Memantine is not recommended for use in pregnant women.

Breastfeeding: Women taking memantine should not breastfeed.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive and use machines safely. Additionally, Nabila may alter your reaction time, making driving or operating machinery inappropriate.

Nabila contains sorbitol

This medication contains 100 mg of sorbitol per ml of solution.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dose

Each milliliter (ml) of Nabila oral solution contains 10 milligrams (mg) of memantine hydrochloride.

The recommended dose of Nabila in adult and elderly patients is 2 ml, equivalent to 20 mg administered once a day. To reduce the risk of adverse effects, this dose is achieved gradually following the daily schedule below:

The initial starting dose is 0.5 ml once a day (5 mg) during the first week.

This dose is increased in the second week to 1 ml once a day (10 mg).

In the third week, it is increased to 1.5 ml once a day (15 mg).

From the fourth week, the recommended dose is 2 ml once a day (20 mg).

Dose for patients with reduced renal function

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

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 solution can be taken directly or with a small amount of water.

The solution can be taken with or without food.

Instructions for proper use

Open the bottle: press and turn the cap counterclockwise (Figure 1).

Insert the adapter for the syringe into the neck of the bottle (Figure 2).

Take the syringe and insert it into the orifice of the adapter (Figure 3).

Place the bottle upside down (Figure 4).

Fill the syringe with a small amount of solution by pulling the plunger down (Figure 4A). Then, press the plunger inward to remove any possible air bubbles (Figure 4B). Finally, fill the syringe by pulling the plunger to the corresponding milliliter (ml) graduation prescribed by your doctor. The flat part of the plunger should coincide with the graduation mark being measured (Figure 4C).

Place the bottle in a vertical position (Figure 5A).

Remove the syringe from the adapter (Figure 5B).

Insert the syringe into your mouth and press the plunger slowly to take the medicine. Alternatively, transfer the medicine to a spoon or a glass with a small amount of water and take it directly.

Clean the syringe with water and let it dry for the next use (Figure 6).

Close the bottle with the cap – leave the adapter in the bottle.

Treatment duration

Continue taking Nabila as long as it benefits you. Your doctor should evaluate your treatment periodically.

If you take more Nabila than you should

Generally, taking an excessive amount of Nabila should not cause any harm. You may experience an increase in the symptoms described in section 4 “Possible adverse effects.”In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take NABILA

If you realize you have forgotten to take your Nabila dose, wait and take the next dose at the usual time.

Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Adverse effects are generally classified as mild to moderate.

Frequent(may affect up to 1 in 10 patients):

?Headache

?Sleep

?Constipation

?Elevated liver function tests (according to blood analysis)

?Dizziness

?Balance alteration

?Difficulty breathing

?High blood pressure

?Medication hypersensitivity

Less frequent(may affect up to 1 in 100 patients):

?Fatigue

?Fungal infections

?Confusion

?Hallucinations

?Vomiting

?Gait alteration

?Heart failure

?Formation of blood clots in the venous system (venous thrombosis/thromboembolism)

Very rare(may affect up to 1 in 10,000 patients):

?Seizures

Unknown frequency(cannot be estimated from available data):

Alzheimer's disease has been linked to depression, suicidal ideation, and suicide. These events have been reported in patients treated with memantine.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es

Reporting adverse effects can help provide more information about the safety of this medication.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the bottle label after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Once opened, the contents of the bottle must be used within 3 months.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of NABILA

- The active ingredient is memantine hydrochloride. Each ml of solution contains 10 mg of memantine hydrochloride, equivalent to 8.32 mg of memantine.

- The other components (excipients) are: potassium sorbate (E202), non-crystallizable liquid sorbitol (E-420) and purified water.

Appearance of the product and contents of the packaging

Nabila oral solution is a transparent and colourless solution.

Nabila oral solution is presented in a 100 ml bottle with a dosing syringe and an adapter for the syringe.

Holder of the marketing authorization

Exeltis Healthcare, S.L

Avda. de Miralcampo, 7.

Polígono Industrial Miralcampo.

19200 Azuqueca de Henares (Guadalajara).

Spain

Responsible for manufacturing

Jenson R+ (Ireland) Ltd.

Unit 15, Daingean Hall,

N4 Axis Centre,

Longford,

N39 W6K0, Ireland

Last review date of this leaflet: April 2018

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/