Memantina Aurovitas Spain 5 mg/puff oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Memantina Aurovitas Spain 5 mg/spray, oral solution 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, consult your doctor or pharmacist.
• 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Memantina Aurovitas Spain is and what it is 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. How to store Memantina Aurovitas Spain

6. Contents of the pack and other information

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

Memantina Aurovitas Spain contains memantine hydrochloride as the active substance.

It belongs to a group of medicines known as anti-dementia medications.

Memory loss in Alzheimer's disease is due to impaired signaling in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors, which play a role in the transmission of nerve signals important for learning and memory. Memantina belongs to a group of medicines called NMDA receptor antagonists. Memantina acts on these receptors, improving nerve signal transmission and memory.

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

2. What you need to know before starting to take Memantina Aurovitas Spain

Do not take Memantina Aurovitas Spain

• 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 Memantina Aurovitas Spain:

• 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 the above situations, treatment should be carefully monitored, and your doctor should regularly re-evaluate the clinical benefit of Memantina Aurovitas Spain.

If you have renal impairment (kidney problems), your doctor should closely monitor your kidney function and, if necessary, adjust the dosage of memantine.

The use of memantine should be avoided together with other medicines such as amantadine (for the treatment of Parkinson's disease), ketamine (a drug generally used as an anesthetic), dextromethorphan (a drug used to treat cough), and other NMDA antagonists.

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 medicines

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

Specifically, the administration of Memantina Aurovitas Spain 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 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 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 renal dysfunction (kidney problem)) or severe urinary tract infections (the structure that carries urine), 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 using this medicine.

The use of memantine is not recommended in pregnant women.

Women taking Memantina Aurovitas Spain should discontinue breastfeeding.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive and operate machinery safely.

Furthermore, Memantina Aurovitas Spain may affect your reaction ability, so driving or operating machinery may be inappropriate.

Memantina Aurovitas Spain contains sorbitol

This medicine contains sorbitol. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Memantina Aurovitas Spain

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

Please follow the instructions below when using the dispenser. Pictograms are attached with the necessary instructions for correct use of the dispenser.

One press delivers 5 mg of memantine hydrochloride.

The recommended dose of memantine in adult and elderly patients is four presses of the dispenser, equivalent to 20 mg administered once daily. In order to reduce the risk of adverse effects, this dose should be gradually reached according to the following daily treatment regimen:

The usual starting dose is one spray once daily (5 mg) during the first week. This dose is increased in the second week to two sprays once daily (10 mg), and in the third week to three sprays once daily (15 mg). From the fourth week onwards, the recommended dose is four sprays once daily (20 mg).

Instructions for correct use of the dispenser

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

Remove the screw cap from the bottle:

The cap must be turned counterclockwise, completely unscrewed, and removed (Fig. 1).

Assembling the dispenser onto the bottle:

Remove the dispenser from the plastic bag (Fig. 2) and place it on top of the bottle. Carefully insert the plastic tube down into the bottle. Hold the dispenser in place on the neck of the bottle and turn clockwise until firmly attached (Fig. 3). The dispenser should only be screwed on once at the beginning of use and must never be unscrewed.

How the dispenser works:

The dispenser head has two positions and rotates easily:

• counterclockwise direction to open
• clockwise direction to close

The dispenser head must not be pressed down while in the closed position. The solution can only be dispensed in the open position. To open, rotate the dispenser head in the direction indicated by the arrow until it stops (approximately one-eighth of a turn, Fig. 4). The dispenser is then ready for use.

Preparing the dispenser:

When used for the first time, the dispenser does not dispense the correct amount of oral solution. Therefore, it must be prepared (primed) by pressing the dispenser head fully down five consecutive times (Fig. 5).

The solution dispensed in this way must be discarded. The next time the dispenser head is pressed fully down (equivalent to one spray), it will dispense the correct dose (Fig. 6).

Correct use of the dispenser:

Place the bottle on a flat, horizontal surface, for example on a table, and use only in an upright position. Place a glass with a little water or a spoon under the nozzle. Press the dispenser head down firmly but gently and steadily, not too slowly (Fig. 7, Fig. 8).

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

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

Dosage for patients with kidney problems

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

Memantina Aurovitas Spain must be administered orally once daily. To get the maximum benefit from your medication, you should take it every day at the same time. The solution should be taken with a small amount of water. The solution may be taken with or without food.

Duration of treatment

Continue taking Memantina Aurovitas Spain for 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and amount ingested.

In general, taking an excessive amount of Memantina Aurovitas Spain should not cause 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 missed doses.

If you stop treatment with Memantina Aurovitas Spain

If you wish to stop treatment before completing the prescribed course, speak with your doctor or pharmacist.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

In general, adverse effects are classified as mild to moderate.

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

• Fatigue, fungal infections, confusion, hallucinations, vomiting, impaired gait, heart failure, and blood clot formation in the venous system (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):

• Inflammation of the pancreas, inflammation of the liver (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 Memantina Aurovitas Spain.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantine Aurovitas Spain

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

Do not use this medicine after the expiry date stated on the pack and on the label of the bottle after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

After first opening, the contents of the bottle should be used within 12 weeks.

The bottle with the attached dispenser must be stored and transported in an upright position only.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Memantina Aurovitas Spain

• The active substance is memantine hydrochloride.

Each pump actuation (one actuation) delivers 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 components are potassium sorbate E202, liquid sorbitol (non-crystallising) E420 and purified water.

Appearance of the product and contents of the container

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

Memantina Aurovitas Spain, oral solution, is supplied in 100 ml bottles. A dosing dispenser is included.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this leaflet: May 2018

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