Memantina Flas Stadafarma 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Memantina Flas Stadafarma 10 mg orodispersible tablets EFG

Memantina Flas Stadafarma 20 mg orodispersible tablets EFG

Memantine hydrochloride

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on 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 effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Memantina Flas Stadafarma is and what it is used for

How Memantina Flas Stadafarma works

Memantina Flas Stadafarma contains the active substance memantine hydrochloride.

Memantina belongs to a group of medicines known as antidementia drugs. 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 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.

What Memantina Flas Stadafarma is used for

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

2. What you need to know before taking Memantina Flas Stadafarma

Do not take Memantina Flas Stadafarma:

• 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 memantine:

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

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

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

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), your doctor may need to adjust the dose of the medicine.

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

Children and adolescents

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

Other medicines and Memantina Flas Stadafarma

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

Specifically, administration of 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 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 memantine.

Taking Memantina Flas Stadafarma with food and drinks

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

Pregnancy and breastfeeding

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.

Pregnancy:

The use of memantine is not recommended in pregnant women.

Breastfeeding:

Women taking memantine should not breastfeed.

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 Flas Stadafarma contains aspartame, lactose, and sodium

The 10 mg dose contains 2.5 mg of aspartame per tablet and the 20 mg dose contains 5 mg per tablet. Aspartame contains a source of phenylalanine which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

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

This medicine contains less than 23 mg of sodium (1 mmol) per dose unit; hence, it is essentially “sodium-free”.

3. How to take Memantina Flas Stadafarma

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

Dosage

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

Memantine tablets cannot be split. For doses that are not available, you should use another medicine containing memantine for which the required dose is available.

Maintenance dose

The recommended daily dose is 20 mg once daily.

Consult your doctor regarding continuation of treatment.

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 monitor your kidney function.

Method of administration

Memantine must be administered orally once daily. To get the maximum benefit from your medication, you must take it every day and at the same time each day. The tablets should be placed on the tongue and allowed to dissolve before swallowing, with or without water, according to patient preference. The tablets 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.

Instructions for use

Memantine orodispersible tablets break easily and therefore must be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

• Hold the blister pack by the edges and separate one blister from the rest by gently breaking along the perforations surrounding it.
• Gently peel back the backing of the blister.

Place the tablet on your tongue. It will dissolve directly in the mouth and can therefore be swallowed without water.

If you take more Memantina Flas Stadafarma than you should

In general, taking an excess of memantine should not cause you any harm. You may experience an increase in the symptoms described in section 4 "Possible side effects".

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 the amount ingested.

If you forget to take Memantina Flas Stadafarma

• If you realize 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 missed doses.

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.

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

• 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 people):

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

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

• Seizures.

Frequency not known (frequency 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 memantine.

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 through 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 Flas Stadafarma

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

Do not use this medicine after the expiry date stated on the cardboard packaging and blister pack, following “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Memantina Flas Stadafarma

• The active substance is memantine hydrochloride. Each 10 mg orodispersible tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine. Each 20 mg orodispersible tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.

• The other components are polacrilin potassium, sodium hydroxide (for pH adjustment), lactose monohydrate, microcrystalline cellulose, mannitol (E421), sodium croscarmellose, aspartame (E951), colloidal anhydrous silica, iron oxide red (E172), mint flavour [composed of maltodextrin (corn), modified starch E1450 (waxy corn), peppermint oil (Mentha arvensis)] and magnesium stearate.

Appearance of the product and contents of the pack

Memantina Flas Stadafarma 10 mg orodispersible tablets are pale pink, rounded, flat, mottled, bevelled-edged tablets with a diameter of 9 mm, marked with a "10" on one side.

Memantina Flas Stadafarma 20 mg orodispersible tablets are pale pink, rounded, flat, mottled, bevelled-edged tablets with a diameter of 12 mm, marked with a "20" on one side.

Pack sizes contain 112 tablets for the 10 mg strength and 56 tablets for the 20 mg strength.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Genepharm, S.A.

18 km Marathon Avenue

15351 Pallini Attikis

Greece

or

Rontis Hellas Medical And Pharmaceutical Products S.A.

Industrial Area of Larissa, P.O. Box 3012,

GR41004 Larissa

Greece

or

Adamed Pharma S.A.

ul. Marszalka Jozefa Pilsudskiego 5

95-200 Pabianice

Poland

or

Laboratori Fundació DAU

c/ C 12-14,

Polígono Industrial de la Zona Franca,

08040 Barcelona

Spain

Date of the most recent revision of this leaflet: March 2021

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/)