Memantina Alter 10 mg film-coated tablets EFG: detailed information

Brand name Memantina Alter 10 mg film-coated tablets EFG

Form tablets, film-coated

Active substance / Dosage

MEMANTINE HYDROCHLORIDE · 10 mg

Prescription type Hospital Diagnosis

ATC code

N06D N06DX N06DX01

Registration number 77746

Manufacturer Laboratorios Alter S.A.

Memantina Alter 10 mg film-coated tablets EFG tablets, film-coated

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Memantina Alter is and what it is used for
2. What you need to know before starting to take Memantina Alter
3. How to take Memantina Alter
4. Possible adverse effects
5. Storage of Memantina Alter
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Memantina Alter 10 mg film-coated 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

What Memantina Alter is and what it is used for.
What you need to know before taking Memantina Alter.
How to take Memantina Alter.
Possible side effects.
How to store Memantina Alter.
Contents of the pack and other information

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

Memantina Alter contains the active substance memantine hydrochloride. It 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. Memantine acts on these receptors, improving nerve signal transmission and memory.

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

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

Do not take Memantina Alter

if you are allergic to memantine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Memantina Alter:

if you have a history of epileptic seizures
if you have recently suffered 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 reassess the clinical benefit of memantine.

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

If you have renal tubular acidosis (RTA, excess acid-producing substances in the blood due to renal dysfunction [kidney problems]) or severe urinary tract infections (urine passage), 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 (for the treatment of Parkinson's disease), ketamine (a drug generally used as an anaesthetic), dextromethorphan (a drug for the treatment of cough), and other NMDA antagonists.

Children and adolescents

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

Taking Memantina Alter with other medicines

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

Specifically, the administration of Memantina Alter may cause changes in the effects of the following medicines, so your doctor may need to adjust the doses:

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 Memantina Alter.

Taking Memantina Alter 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 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 must not breastfeed.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive or use machines safely. In addition, memantine may affect your reaction ability, so driving or operating machinery may be inappropriate.

Memantina Alter contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, for practical purposes, it is "sodium-free".

3. How to take Memantina Alter

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

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

Week 1	half a 10 mg tablet
Week 2	one 10 mg tablet
Week 3	one and a half 10 mg tablets
Week 4 and onwards	two 10 mg tablets once daily

The usual starting dose is half a tablet once daily (1 x 5 mg) during the first week. This is increased to one tablet daily (1 x 10 mg) during the second week, and to one and a half tablets once daily during the third week. From the fourth week onwards, the usual dose is two tablets administered once daily (1 x 20 mg).

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.

Administration

Memantina Alter should be administered orally once daily. To obtain the maximum benefit from your medication, you must take it every day at the same time. The tablets should be swallowed with some water. The tablets may be taken with or without food.

Duration of treatment

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

If you take more Memantina Alter than you should

In case of overdose or accidental ingestion, consult 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.

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 take an overdose of memantine, contact your doctor or seek medical advice, as you may require medical attention.

If you forget to take Memantina Alter

If you realize you have forgotten to take your dose of Memantina Alter, wait and take the next dose at the usual time.
Do not take a double dose to make up for the missed dose.

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 (affects between 1 and 10 out of every 100 patients):

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

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

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 via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Memantina Alter

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Memantina Alter

The active substance is memantine hydrochloride. Each film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.

The other components are microcrystalline cellulose, povidone K-25, sodium croscarmellose, magnesium stearate, hydroxypropylcellulose and talc.

Appearance of the product and contents of the container

Memantina Alter 10 mg are white, oblong, biconvex, film-coated tablets with a break line.

The tablet can be divided into equal halves.

Blister made of PVC+PCTFE+ PVC and aluminium. Blister packs contain 56 and 112 tablets.