Memantinine Stada 5 mg/dose oral solution EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Memantina Stada 5 mg/dose, 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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.

Contents of the leaflet

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

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

Memantina Stada contains memantina as the active substance.

What Memantina Stada is used for

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

How Memantina Stada works

Memantina belongs to a group of medicines called anti-dementia medications.

Memory loss in Alzheimer's disease is due to disturbances in brain signaling. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors, which are involved in the transmission of nerve signals important for learning and memory.

Memantina belongs to a group of medicines known as NMDA receptor antagonists. Memantina acts on these receptors, improving nerve signal transmission and memory.

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

Do not take Memantina Stada

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

Warnings and precautions

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

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

In the above situations, treatment must be carefully monitored, and your doctor should regularly re-evaluate the clinical benefit of memantine.

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

The use of memantine together with other medicines such as amantadine (used to treat Parkinson's disease), ketamine (a drug generally used as an anaesthetic), dextromethorphan (a cough medication), 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 need to take any other medicines.

Specifically, taking memantine 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 control 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 Stada.

Taking Memantina Stada 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 kidney dysfunction (kidney problem)) or severe urinary tract infections (urine passage infections), 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 during pregnancy is not recommended.

Women taking memantine should discontinue breastfeeding.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Furthermore, memantine may affect 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 for this medicine given by your doctor or pharmacist. 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 the 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 once daily. To reduce the risk of adverse effects, this dose should be reached gradually according to the following daily treatment schedule:

Week 1	one pump (equivalent to 0.5 ml)
Week 2	two pumps (equivalent to 1 ml)
Week 3	three pumps (equivalent to 1.5 ml)
Week 4 and onwards	four pumps (equivalent to 2 ml)

The usual starting dose is one press once daily (5 mg) during the first week. This dose is increased in the second week to two presses once daily (10 mg), and in the third week to three presses once daily (15 mg). From the fourth week onwards, the recommended dose is four presses 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 into a glass of water using the dispenser.

Remove the screw cap from the bottle:

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

Attaching the dispenser to the bottle:

Remove the dispenser from the plastic bag (fig.2) and place it on top of the bottle. Carefully insert the plastic tube downwards into the bottle. Hold the dispenser at the neck of the bottle and turn clockwise until securely 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, turn 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 primed by fully pressing down the dispenser head five times in succession (fig.5).

The solution dispensed during this process must be discarded. The next time the dispenser head is fully pressed down (equivalent to one press), it will dispense the correct dose (fig.6).

Correct use of the dispenser:

Place a glass containing some water or a spoon under the nozzle. Press the dispenser head down firmly, steadily, and smoothly—but not too slowly (fig.7, fig.8).

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

The dispenser must only be used with memantine 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 memantine.

Dosage for patients with renal impairment

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

Administration

Memantina Stada 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 memantine for as long as it is beneficial to 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medication and the amount ingested.

In general, 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 you have missed your dose of memantine, wait and take the next dose at your usual time.

Do not take a double dose to make up for the missed dose.

If you stop treatment with Memantina Stada

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 will experience them.

In general, the adverse effects observed are mild to moderate.

Common (affects between 1 and 10 in every 100 patients):

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

Uncommon (affects between 1 and 10 in every 1,000 patients):

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

Very rare (affects less than 1 in every 10,000 patients):

Seizures.

Frequency not known (frequency cannot be estimated from the 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 memantine.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. You may also report them directly through the national reporting system included in the Spanish System of Pharmacovigilance of 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 Stada

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

Do not use this medicine after the expiry date stated on the packaging and on 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 opening, the contents of the bottle should be used within a maximum of 12 weeks.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. 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 actuation (one pump stroke) 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 components are potassium sorbate (E202), liquid sorbitol (non-crystallising) (E420) and purified water.

Appearance of the medicinal product and contents of the pack

Memantina Stada oral solution is presented as a clear, colourless to slightly yellow solution.

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

A dosing dispenser is included.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area member states 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 the most recent revision of this leaflet: April 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/