TEVA UK LIMITED

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Information for the patient

Memantine hydrochloride 5 mg + 10 mg + 15 mg + 20 mg Film-coated Tablets Starter Pack

1

What Memantine hydrochloride is and what it is used for

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.

How does Memantine hydrochloride work

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

What is Memantine hydrochloride used for

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

2.

What you need to know before you take Memantine hydrochloride

What is in this leaflet

1. What Memantine hydrochloride is and what it is used for

2. What you need to know before you take Memantine hydrochloride

3. How to take Memantine hydrochloride

4. Possible side effects

5. How to store Memantine hydrochloride

Do NOT take Memantine hydrochloride:

•    if you are allergic to memantine hydrochloride, peanut or soya 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 hydrochloride:

•    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 hydrochloride reassessed by your doctor on a regular basis.

6. Contents of the pack and other information

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

Other medicines and Memantine hydrochloride

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

In particular, Memantine hydrochloride 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 hydrochloride.

Memantine hydrochloride 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.

The use of memantine in pregnant women is not recommended.

Women taking Memantine hydrochloride 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 hydrochloride may change your reactivity, making driving or operating machinery inappropriate.

Memantine hydrochloride contains lactose and soya lecithin

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains soya lecithin. If you are allergic to peanut or soya, do not take this medicinal product.

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3.

How to take Memantine hydrochloride

The Memantine hydrochloride starter pack is only to be used for the beginning of the treatment with Memantine hydrochloride.

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

Dosage

The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Memantine hydrochloride dose during the first 3 weeks of treatment. Take one tablet once a day.

Week 1 (day 1-7):

Take one 5 mg tablet once a day (white, capsule shaped, biconvex, plain on one side and embossed with "5" on the other side) for 7 days.

Week 2 (day 8-14):

Take one 10 mg tablet once a day (white, capsule shaped, biconvex, with a break score on one side and embossed with "10" on the other side) for 7 days.

Week 3 (day 15-21):

Take one 15 mg tablet once a day (white, capsule shaped, biconvex, plain on one side and embossed with "15" on the other side) for 7 days.

Week 4 (day 22-28):

Take one 20 mg tablet once a day (white, capsule shaped, biconvex, with a break score on one side and embossed with "20" on the other side) for 7 days.

Maintenance dose

The recommended daily dose is 20 mg once a day. For continuation of the treatment please consult your doctor.

Dosage 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 hydrochloride 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 hydrochloride as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Memantine hydrochloride than you should

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

If you forget to take Memantine hydrochloride

•    If you find you have forgotten to take your dose of Memantine hydrochloride, 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.

Common (affects 1 to 10 users in 100):

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

Uncommon (affects 1 to 10 users in 1,000):

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

Very Rare (affects less than 1 user in 10,000):

•    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.

If you get any side effects, talk to your doctor or pharmacist. This includes

any side effects not listed in this leaflet.

6.

Contents of the pack and other information

5.

How to store Memantine hydrochloride

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.

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 pack after EXP. The expiry date refers to the last day of that month.

HDPE bottles

Shelf life after first opening of the container: 6 months.

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.

What Memantine hydrochloride contains

The active substance is memantine hydrochloride.

Each film-coated tablet contains 5 mg or 10 mg or 15 mg or 20 mg of memantine hydrochloride equivalent to 4.15 mg or 8.31 mg or 12.46 mg or 16.62 mg memantine.

The other ingredients are:

Tablet core

Cellulose microcrystalline, starch pregelatinised, lactose anhydrous, colloidal anhydrous silica, magnesium stearate.

Coating

Polysorbate 80, polyvinyl alcohol, titanium dioxide, talc, soya lecithin, xanthan gum. What Memantine hydrochloride looks like and contents of the pack

The 5 mg film-coated tablets are white, capsule shaped (9.6 x 4.54 mm), biconvex tablets plain on one side and embossed with "5" on the other side.

The 10 mg film-coated tablets are white, capsule shaped (12.5 x 5.6 mm), biconvex tablets with a break score on one side and embossed with "10" on the other side. The 15 mg film-coated tablets are white, capsule shaped (14.0 x 6.0 mm), biconvex tablets plain on one side and embossed with "15" on the other side.

The 20 mg film-coated tablets are white, capsule shaped (15.6 x 8.0 mm), biconvex tablets with a break score on one side and embossed with "20" on the other side. Memantine hydrochloride 5 mg + 10 mg + 15 mg + 20 mg Film-coated Tablets Starter Pack is available in packs with 28 (7 +7 +7 +7) film-coated tablets.

Marketing Authorisation Holder

Archie Samuel s.r.o., Slunna 16, 617 00 Brno, Czech Republic

Manufacturers

TEVA Pharmaceutical Works Private Limited Company Pallagi ut 13, 4042 Debrecen, Hungary

This leaflet was last revised in 04/2013    10141-B

PL 35737/0010    460x160

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