MEMANTINE STADA 5 mg/dose ORAL SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Memantina Stada5mg/pump,oral solution EFG

Memantine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

1. What is Memantina Stada and what is it used for
2. What you need to know before you take Memantina Stada
3. How to take Memantina Stada
4. Possible side effects
5. Storage of Memantina Stada
6. Contents of the pack and other information

1. What is Memantina Stada and what is it used for

Memantina Stada contains memantine as the active substance.

What Memantina Stada is used for

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

How Memantina Stada works

Memantine belongs to a group of medicines called anti-dementia medicines.

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 are involved in the transmission of important nerve signals in learning and memory.

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

2. What you need to know before you take Memantina Stada

Do not take Memantina Stada

• if you are allergic (hypersensitive) to memantine hydrochloride or any of the other ingredients of this medicine (see section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Memantina Stada.

• 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 memantine.

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

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

Children and adolescents

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

Taking Memantina Stada with other medicines

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

In particular, the administration of memantine may produce changes in the effects of the following medicines, 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 usually used to treat movement disorders or intestinal spasms)
• anticonvulsants (substances used to prevent and eliminate convulsions)
• barbiturates (substances usually 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 Stada.

Taking Memantina Stada 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 (urine conduit), 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The use of memantine is not recommended during pregnancy.

Women who take memantine should stop breastfeeding.

Driving and using machines

Your doctor will inform you if your illness allows you to drive and use machines safely. Also, memantine may alter your reaction ability, so driving or operating machinery may be inappropriate.

Memantina Stada contains sorbitol

This medicine contains 100 mg of sorbitol in each ml of oral solution.

3. How to take Memantina Stada

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

Posology

Please follow the following instructions when 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, which is equivalent to 20 mg once a day. In order to reduce the risk of side effects, this dose is gradually reached by following the following daily treatment scheme:

The usual starting dose is one pump once a day (5 mg) 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).

Assembly of 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 should never be 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 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 memantine solution in the provided bottle, not for other products or containers. If the doser does not work correctly, consult your doctor or pharmacist. Close the doser after using memantine.

Dosage for patients with renal impairment

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

Administration

Memantina Stada 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 memantine as long as it is beneficial for you. Your doctor should periodically evaluate the effects of your treatment.

If you take more Memantina Stada 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 medicine and the amount ingested.

Generally, taking an excessive amount of memantine 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 Stada

If you realize that 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 stop treatment with Memantina Stada

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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Generally, the side effects observed are mild to moderate.

Frequent (affects 1 to 10 users in 100):

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

Uncommon (affects 1 to 10 users in 1,000):

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

Rare (affects less than 1 user in 10,000):

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. The occurrence of these events has been reported in patients treated with memantine.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantina Stada

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

Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP. The expiry date is the last day of the month stated.

This medicine does not require any 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.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicinal product in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicinal products. This will help protect the environment.

6. Contents of the pack and other information

Composition of Memantina Stada

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 Stada oral solution is a clear, colorless to yellowish solution.

Memantina Stada oral solution is available in bottles of 50 ml, 100 ml or 10 x 50 ml.

A doser is included.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturer

Chanelle Medical

Loughrea, Co. Galway

Ireland

or

STADA Arzneimittel AG

Stadastrasse 2 – 18, 61118 Bad Vilbel,

Germany

or

Clonmel Healthcare Ltd

Waterford Road, Clonmel, Co. Tipperary

Ireland

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names

Ireland: Memantine Clonmel 10 mg/ml Oral Solution

Netherlands: Memantine CF 10 mg/ml, drank

Portugal: Memantina Ciclum

Spain: Memantina Stada 5 mg/pump, oral solution EFG

Malta: Memantine Clonmel 10 mg/ml oral solution

Date of last revision of this leaflet: April 2021

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