Memantina Teva 20 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Memantina Teva 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, 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 other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Memantina Teva contains the active substance memantina hydrochloride.

Memantina belongs to a group of medicines known as anti-dementia 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 are involved in the transmission of nerve signals important for learning and memory. Memantina belongs to a group of medicines called NMDA receptor antagonists. Memantina works on these receptors, improving nerve signal transmission and memory.

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

2. What you need to know before taking Memantina Teva

Do not take memantine:

• 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 this medicine:

• 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 monitored, and your doctor should regularly re-evaluate the clinical benefit of memantine.

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

If you have renal impairment (kidney problems), your doctor must closely monitor kidney function and, if necessary, adapt the doses 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 anaesthetic), dextromethorphan (a medicine for the treatment of 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 Teva

Inform 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 Teva with food and drinks

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), 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 plan 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 discontinue breastfeeding.

Driving and using machines

Your medical condition may affect your ability to drive or operate machinery, and you should not engage in these activities unless your doctor tells you it is safe. Memantine may cause dizziness and somnolence, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.

Memantina Teva contains aspartame, lactose, and sodium

Aspartame

This medicine contains 5 mg of aspartame in each 10 mg orodispersible tablet. Aspartame is 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.

Lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Sodium

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

3. How to take Memantina Teva

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

Dosage

The recommended dose of memantine in adult 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 schedule:

The usual starting dose is one 5 mg tablet once daily during the first week. This is increased to one 10 mg tablet once daily during the second week, and to 15 mg once daily during the third week. From the fourth week onwards, the usual dose is two 10 mg tablets or one 20 mg tablet administered once daily.

For doses not available with this medicine, you should use another medicine containing memantine that provides the required dose.

Dosage for patients with renal impairment

If you have kidney problems, your doctor will decide the appropriate dose for your condition. In such cases, your doctor should periodically monitor your kidney function.

Method of administration

Memantine must be taken orally once daily. To get the maximum benefit from your medication, you should take it every day at the same time. The tablets should be swallowed with a small amount of water. 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 are fragile and must therefore be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

1. Hold the blister pack at the edges and separate one blister from the rest by gently breaking along the perforations surrounding it.

2. Gently peel back the backing of the blister.

Place the tablet on your tongue. It will dissolve directly in the mouth, so it can be swallowed without water.

If you take more MemantinaTeva than you should

• In general, taking an excessive amount of memantine should not cause harm. However, you may experience an increase in the symptoms described in section 4, “Possible side effects”.
• If you take an overdose of memantine, contact your doctor or seek medical advice, as you may require medical attention.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the name of the medicine and the amount taken.

If you forget to take MemantinaTeva

• 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, memantine 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 people):

• Headache, somnolence, constipation, elevated liver function tests, dizziness, gait disturbance, dyspnoea, hypertension, and drug hypersensitivity.

Uncommon (may affect up to 1 in 100 people):

• 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 (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, pharmacist, or nurse, 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 Teva

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

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Memantina Teva

• The active substance is memantine hydrochloride. Each orodispersible tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
• The other components are polacrilin, sodium hydroxide (for pH adjustment), lactose monohydrate, microcrystalline cellulose, manitol (E421), sodium croscarmellose, aspartame (E951), colloidal anhydrous silica, iron oxide red (E172), mint flavour, and magnesium stearate.

Appearance of the medicine and contents of the pack

Memantina Teva 20 mg orodispersible tablets are pale pink, rounded, flat, speckled, with bevelled edges, 12 mm in diameter, and marked with a "20" on one side.

Memantina Teva is available in unit dose blisters containing 56 orodispersible tablets.

Marketing Authorization Holder

Teva B.V.

Swensweg 5, 2031 GA Haarlem

The Netherlands

Manufacturer

Genepharm, S.A.

18 km Marathon Avenue

15351 Pallini Attikis

Greece

Local representative:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Spain

Date of the most recent revision of this leaflet: May 2022

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