MEMANTINE AUROVITAS SPAIN 5 mg/dose ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Memantina Aurovitas Spain 5 mg/pump, oral solution 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 or pharmacist.
• 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 or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Memantina Aurovitas Spain and what is it used for
2. What you need to know before taking Memantina Aurovitas Spain
3. How to take Memantina Aurovitas Spain
4. Possible side effects
5. Storage of Memantina Aurovitas Spain

1. Contents of the pack and further information

1. What is Memantina Aurovitas Spain and what is it used for

Memantina Aurovitas Spain contains memantine hydrochloride as the active substance.

Itbelongs 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. Memantine belongs to the group of medications called NMDA receptor antagonists. Memantine acts on these receptors, improving the transmission of nerve signals and memory.

Memantine is used in the treatment of adult patients with moderate to severe Alzheimer's disease.

2. What you need to know before taking Memantina Aurovitas Spain

Do not take Memantina Aurovitas Spain

• 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 Memantina Aurovitas Spain:

• If you have a history of epileptic seizures.
• If you have recently suffered 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 Memantina Aurovitas Spain.

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 used to treat cough), and other NMDA antagonists should be avoided.

Children and adolescents

The use of Memantina Aurovitas Spain is not recommended in children and adolescents under 18 years of age.

Taking Memantina Aurovitas Spain with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

In particular, the administration of Memantina Aurovitas Spain 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 Memantina Aurovitas Spain.

Taking Memantina Aurovitas Spain with food, drinks, and alcohol

You should inform your doctor if you have recently changed or intend 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 (structure that carries urine), 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 using this medication.

The use of memantine is not recommended in pregnant women.

Women taking Memantina Aurovitas Spain should stop breastfeeding.

Driving and using machines

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

Additionally, Memantina Aurovitas Spain may alter your reaction ability, so driving or operating machines may be inappropriate.

Memantina Aurovitas Spain contains sorbitol

This medication contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Memantina Aurovitas Spain

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

Dosage

Please follow the instructions for using the doser. Pictograms with the necessary instructions for the correct use of the doser are attached.

One pump contains 5 mg of memantine hydrochloride.

The recommended dose of memantine in adult patients and elderly patients is four pumps of the doser, equivalent to 20 mg administered once a day. To reduce the risk of side effects, this dose is gradually achieved by following the treatment scheme:

The usual starting dose is one pump once a day (5 mg) for the first week. This dose is increased in the second week to two pumps once a day (10 mg) and in the third week to three pumps once a day (15 mg). From the fourth week, the recommended dose is four pumps once a day (20 mg).

Instructions for the correct use of the doser

The solution should not be poured or dispensed directly into the mouth from the bottle or doser. Measure the dose in a spoon or in a glass of water using the doser.

Remove the screw cap from the bottle:

The cap should be turned counterclockwise, completely unscrewed, and removed (fig.1).

Assemble the doser on the bottle:

Remove the doser from the plastic bag (fig.2) and place it on top of the bottle. Carefully insert the plastic tube into the bottle. Keep the doser on the neck of the bottle and turn it clockwise until it is firmly attached (fig.3). The doser should only be screwed on once when starting use and never unscrewed.

How the doser works:

The doser head has two positions and turns easily:

• counterclockwise to open
• clockwise to close

The doser head should not be pressed down while it is in the closed position. The solution can only be dispensed in the open position. To open, turn the doser head in the direction indicated by the arrow until it cannot be turned further (about one-eighth of a turn, fig.4). The doser is then ready for use.

Preparing the doser:

When used for the first time, the doser does not dispense the correct amount of oral solution. Therefore, it must be prepared (primed) by pressing the doser head down completely five times in a row (fig.5).

The dispensed solution should be discarded. The next time the doser head is pressed down completely (equivalent to one pump), it will dispense the correct dose (fig.6).

Correct use of the doser:

Place the bottle on a flat, horizontal surface, for example on a table, and it should only be used in a vertical position. Place a glass with a little water or a spoon under the spout. Press the doser head down firmly but calmly and steadily, not too slowly (fig.7, fig.8).

The doser head can then be released and is ready for the next pump.

The doser should only be used with Memantina Aurovitas Spain solution in the provided bottle, not for other products or containers. If the doser does not function correctly, consult your doctor or pharmacist. Close the doser after using Memantina Aurovitas Spain.

Dosage for patients with kidney problems

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

Memantina Aurovitas Spain 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 should be taken with a little water. The solution can be taken with or without food.

Duration of treatment

Continue taking Memantina Aurovitas Spain as long as it benefits you. Your doctor should periodically evaluate your treatment.

If you take more Memantina Aurovitas Spain than you should

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.

Generally, taking an excessive amount of Memantina Aurovitas Spain 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 Aurovitas Spain

If you realize you have forgotten to take your dose of Memantina Aurovitas Spain, wait and take the next dose at the usual time.

Do not take a double dose to make up for forgotten doses.

If you stop taking Memantina Aurovitas Spain

If you want to stop treatment before finishing the treatment course, talk to your doctor or pharmacist.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Side effects are generally classified as mild to moderate.

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

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

Infrequent (may affect up to 1 in 100 patients):

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

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

• Seizures.

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

• Pancreatitis, hepatitis, and psychotic reactions.

Alzheimer's disease has been associated with depression, suicidal ideation, and suicide. The occurrence of these events has been reported in patients treated with Memantina Aurovitas Spain.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Memantina Aurovitas Spain

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

Do not use this medication after the expiration date stated on the packaging and on the label of the bottle after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Once opened, the contents of the bottle should be used within 12 weeks.

The bottle with the doser attached should be stored and transported only in a vertical position.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Memantina Aurovitas Spain

• The active substance is memantine hydrochloride.

Each pump of the doser (one pump) releases 0.5 ml of solution containing 5 mg of memantine hydrochloride, equivalent to 4.16 mg of memantine.

Each ml of solution contains 10 mg of memantine hydrochloride.

• The other ingredients are potassium sorbate E202, non-crystallizing liquid sorbitol E420, and purified water.

Appearance of the product and contents of the pack

Memantina Aurovitas Spain, oral solution, is a clear, colorless to slightly yellowish solution.

Memantina Aurovitas Spain, oral solution, is presented in 100 ml bottles. A doser is included.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Chanelle Medical Unlimited Company

Dublin Road

Loughrea, Co. Galway

Ireland

Date of the last revision of this package leaflet: May 2018

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)