Memantina Flas Stada 20 mg buccal tablets EFG

Hidrochlorideofmemantine

Read this 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 and should not be given to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctororpharmacist,evenif they are not listed in this leaflet.See section 4.

2. What you need to know before you start taking Memantina Flas Stada

3. How to take Memantina Flas Stada

4. Possible side effects

5. Storage of Memantina Flas Stada

6. Contents of the pack and additional information

How Memantina Flas Stada works

Memantina Flas Stada contains the active ingredient hydrochloride of memantine.

Memantina Flas Stada belongs to a group of medications called dementia medications.

The memory loss in Alzheimer's disease is due to an alteration in brain signals. The brain contains the so-called N-­metil­-D-aspartato (NMDA) receptors that participate in the transmission of important nervous signals in learning and memory. Memantine belongs to the group of medications called NMDA receptor antagonists. Memantine acts on these receptors by improving the transmission of nervous signals and memory.

What Memantina Flas Stada is used for

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

Do not take Memantina Flas Stada:

- if you are allergic to the active ingredient hydrochloride of memantine or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take memantine:
- 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.

In the above situations, treatment should be closely monitored and your doctor should reevaluate the clinical benefit of memantine regularly.

If you have renal tubular acidosis (RTA, excess of acid-producing substances in the blood due to renal dysfunction (kidney problem)) or severe urinary tract infections (urinary tract), your doctor may need to adjust the medication dose.

If you have renal insufficiency (kidney problems), 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 (anesthesia-inducing drug), dextromethorphan (cough medication) and other NMDA antagonists.

Children and adolescents

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

Other medications and Memantina Flas Stada

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

Specifically, the administration of memantine 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)

- neuroleptics (substances used in the treatment of mental illnesses)

- oral anticoagulants.

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

Taking Memantina Flas Stada with food and drinks

You should inform your doctor if you have recently changed or intend to change your diet significantly (e.g., from a normal diet to a strict vegetarian diet) as your doctor may need to adjust the medication dose.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend 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 discontinue breastfeeding.

Driving and operating machinery

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

Memantina Flas Stada contains aspartame, lactose and sodium

This medication contains 5 mg of aspartame in each 20 mg memantine buccal dispersible tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per buccal dispersible tablet; it is essentially "sodium-free".

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

Dosage

The recommended dose of memantine in adult patients and elderly patients is 20 mg administered once a day.

To reduce the risk of adverse effects, this dose is achieved gradually following the daily schedule:

For doses not available of memantine, you should use another medication containing memantine whose dose is available.

Maintenance dose

The recommended daily dose is 20 mg once a day.

Consult your doctor for continuation of treatment.

Dosage for patients with renal insufficiency

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

Administration form

Memantine 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 tablets should be swallowed with a little water. The tablets can be taken with or without food.

Treatment duration

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

Usage instructions

The Memantina Flas Stada buccodispersible tablets break apart, so they should be handled with care. Do not handle the tablets with wet hands because they may disintegrate.

1. Hold the blister pack by the ends and separate one compartment from the rest, breaking it gently around the perforations that surround it.

2. Remove the back part of the compartment gently.

Deposit the tablet on your tongue. It will dissolve directly in your mouth, so you can swallow it without water.

If you take more Memantina Flas Stada than you should

Generally, taking memantine in excess 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Memantina Flas Stada

-If you realize you have forgotten to take your memantine 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, memantine can produce adverse effects, although not all people will experience them.

Adverse effects are generally classified as mild to moderate.

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

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

Poorly frequent (may affect up to 1 in 100 people):

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

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

· Seizures.

Unknown frequency (frequency cannot be estimated from available data):

· Pancreatitis, hepatitis, and psychotic reactions.

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 an adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the carton packaging and on the blister after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Memantina FlasStada

The active ingredient is hydrochloride of memantine. Each buccal dispersible tablet contains 20 mg of hydrochloride of memantine, equivalent to 16.62 mg of memantine.

The other components are carboxymethylcellulose, sodium hydroxide (for pH adjustment), lactose monohydrate, microcrystalline cellulose, mannitol (E421), sodium croscarmellose, aspartame (E951), anhydrous colloidal silica, iron oxide red (E172), peppermint flavor (made up of cornstarch, modified cornstarch (maize starch) and peppermint oil [Mentha arvensis]) and magnesium stearate.

Appearance of the product and content of the container

Memantina Flas Stada 20 mg buccal dispersible tablets are pale pink, round, flat, speckled, with beveled edges, with a diameter of12 mm and engraved with a “20” on one of the faces.

They are presented in containers with blisters of 7, 28or56 buccal dispersible tablets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorizationand responsible for manufacturing

Holder of the marketing authorization

STADA Laboratorio, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)

Spain

Responsible for manufacturing

Genepharm, S.A.

18 km Marathon Avenue

15351 Pallini Attikis

Greece

or

Rontis Hellas S.A.
Industrial Area of Larissa, P.O. Box 3012,
GR41004 Larissa (Greece)

or

Adamed Pharma S.A.

Pienkow 149

Czosnow - 05-152

Poland

Last review date of this leaflet: December 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es