Package leaflet: Information for the user

Memantine hydrochloride 10mg film-coated tablets Memantine hydrochloride 20mg 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 symptoms 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 this medicine is and what it is used for

2.    What you need to know before you take this medicine

3.    How to take this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Contents of the pack and other information

1. What this medicine is and what it is used for

Memantine 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 belongs to a group of medicines called NMDA-receptor antagonists. Memantine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

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

2. What you need to know before you take this medicine

Do not take this medicine

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

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

•    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 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

This medicine is not recommended for children and adolescents under the age of 18 years.

Taking other medicines

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

In particular, memantine 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 mentaldisorders)

•    oral anticoagulants

If you go into hospital, let your doctor know that you are taking this medicine.

Taking this medicine 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 tubularyacidosis (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 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 may change your reactivity, making driving or operating machinery inappropriate.

3. How to take this medicine

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

Dosage

The recommended dose of memantine 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:

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

Other strengths and presentations of memantine are available.

Renal impairment

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.

Route and method of administration

Memantine tablets 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. The 10mg tablet can be divided into equal doses.

Duration of treatment

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

If you take more of this medicine than you should

•    In general, taking too much of this medicine 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 this medicine, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take this medicine

• If you find you have forgotten to take your dose of this medicine, 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 product, ask your doctor or pharmacist.

4. Possible side effects

report side effects directly via the Yellow Card Scheme at: http:// www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store this medicine

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also

•    Keep 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 medicinal product 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

What this medicine contains

•    The active substance is memantine hydrochloride. Each film- coated tablet contains 10 mg or 20mg of memantine hydrochloride equivalent to 8.31 mg or 16.62 mg of memantine respectively.

•    The other ingredients are Silicified microcrystalline cellulose, Croscarmellose Sodium, Talc and Magnesium stearate, all in the tablet core; and Hypromellose, Titanium dioxide (E171) and Macrogol 400, all in the tablet coating. Additionally 20mg tablets contain Iron oxide red (E172) and Iron oxide yellow (E172).

What this medicine looks like and contents of the pack

•    Memantine 10mg tablets are white to off white, capsule shape, film-coated tablets debossed with ‘BL 10’ on one side and breakline on both sides (approximate size 12.1 x 5.1mm).

•    Memantine 20mg tablets are peach colour, capsule shape, film-coated tablets, debossed with ‘BL 20’ on one side and plain on the other side (approximate size 14.6 x 7.1mm).

•    This medicine is available in blister packs of 28, 56 and 98 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road,

Berkhamsted, Hertfordshire, HP4 1EG,

United Kingdom

Telephone:    0044 (0)1442 200922

Fax :    0044 (0)1442 873717

E-mail:    info@bristol-labs.co.uk

Memantine hydrochloride 10mg film-coated tablets; PL 17907/0290 Memantine hydrochloride 20mg film-coated tablets; PL 17907/0291

This leaflet was last revised in August 2015.

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

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