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MEMANTINE LEK 10 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - MEMANTINE LEK 10 MG FILM-COATED TABLETS

Read all of this 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 further questions, ask your doctor or pharmacist.

  • – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if

their signs of illness are the same as yours.

- if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects

not listed in this leaflet. See section 4.

What is in this leaflet

  • 1. What Memantine LEK is and what it is used for

  • 2. What you need to know before you take Memantine LEK

  • 3. How to take Memantine LEK

  • 4. Possible side effects

  • 5. How to store Memantine LEK

  • 6. Contents of the pack and other information

1. what memantine lek is and what it is used formemantine lek contains the active substance memantine hydrochloride.

Memantine LEK belongs to a group of medicines known as anti-dementia medicines.

Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory. Memantine LEK belongs to a group of medicines called NMDA-receptor antagonists. Memantine LEK acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Memantine LEK used for

Memantine LEK is used for the treatment of adult patients with moderate to severe Alzheimer’s di­sease.

2. what you need to know before you take memantine lek if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Memantine LEK

  • if you have a history of epileptic seizures.
  • if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).

In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine LEK reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

The use of medicinal products called amantadine (for the treatment of Parkinson’s di­sease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.

Children and adolescents

Memantine LEK is not recommended for children and adolescents under the age of 18 years.

Other medicines and Memantine LEK

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription.

In particular, Memantine LEK may change the effects of the following medicines and their dose may need to be adjusted by your doctor:

  • 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 cramps)
  • anticonvulsants (substances used to prevent and relieve seizures)
  • barbiturates (substances generally used to induce sleep)
  • dopaminergic agonists (substances such as L-dopa, bromocriptine)
  • neuroleptics (substances used in the treatment of mental disorders)
  • oral anticoagulants

If you go into hospital, let your doctor know that you are taking Memantine LEK.

Memantine LEK with food and drink

You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast-feeding

Women taking Memantine LEK should not breast-feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and to use machines safely.

Also, Memantine LEK may change your reactivity, making driving or operating machinery inappropriate.

Memantine LEK contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take memantine lek

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dose

The recommended dose of Memantine LEK for adults and elderly patients is 20 mg once a day. In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:

week 1

half 10 mg tablet

week 2

one 10 mg tablet

week 3

one and a half 10 mg tablets

week 4 and beyond

two 10 mg tablets or one 20 mg tablet once a day

The usual starting dose is half a tablet of 10 mg once a day (1× 5 mg) for the first week. This is increased to one tablet of 10 mg once a day (1× 10 mg) in the second week and to 1 and a half tablet of 10 mg once a day in the third week. From the fourth week on, the usual dose is 2 tablets once a day (1 × 20 mg).

Dose in patients with impaired kidney function

If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.

Administration

Memantine LEK should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day. The tablets should be swallowed with some water. The tablets can be taken with or without food.

Duration of treatment

Continue to take Memantine LEK as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Memantine LEK than you should

  • – In general, taking too much Memantine LEK should not result in any harm to you. You may experience increased symptoms as described in section 4 “Possible side effects”.

  • – If you take a large overdose of Memantine LEK, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Memantine LEK

  • – If you find you have forgotten to take your dose of Memantine LEK, wait and take your next dose at the usual time.

  • – Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

  • Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

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

  • Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/throm­boembolism)

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

  • Seizures

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 side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store memantine lek

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

Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information the active substance is memantine hydrochloride.

Each 10 mg tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.

Each 20 mg tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.

  • The other ingredients are:

10 mg:

Film-coating: polyvinyl alcohol, titanium dioxide (E-171), talc, macrogol 3350 and iron oxide yellow (E-

172)

20 mg:

Film-coating: polyvinyl alcohol, titanium dioxide (E-171), talc, macrogol 3350, iron oxide yellow (E-

172) and iron oxide red (E-172)

What Memantine LEK looks like and contents of the pack

Memantine LEK 10 mg film-coated tablets are presented as yellow, oval film-coated tablet scored in one side. The tablet can be divided into equal doses.

Memantine LEK 20 mg film-coated tablets are presented as pale red, oval film-coated tablet scored in one side. The score line is not intended for breaking the tablet.

Memantine LEK 10 mg film-coated tablets are available in PVC/PVDC-Aluminium blister packs of 28, 30, 42, 50, 56, 60, 98, 100 and 112 tablets.

Memantine LEK 20 mg film-coated tablets are available in PVC/PVDC-Aluminium blister packs of 28, 30, 42, 56, 98 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pharmathen S.A., 6, Dervenakion str., 15351 Pallini, Attiki, Greece

Manufacturers

Pharmathen S.A , 6, Dervenakion str., 15351 Pallini, Attiki, Greece

Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece

Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia

Distributor

Sandoz Limited

Park View, Riverside Way

Watchmoor Park

Camberley, Surrey

GU15 3YL

United Kingdom

This leaflet was last revised in

5

Sources: Original (products.mhra.gov.uk)