amneal

PHARMACEUTICALS

Package leaflet: Information for the user

Memantine 10 mg film-coated tablets Memantine 20 mg film-coated tablets

Memantine hydrochloride

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, pharmacist or nurse.

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

What is in this leaflet:

1.    What Memantine is and what it is used for

2.    What you need to know before you take Memantine

3.    How to take Memantine

4.    Possible side effects

5.    How to store Memantine

6.    Contents of the pack and other information

1.    What Memantine is and what it is used for How does Memantine work

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.

What is Memantine used for

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

2.    What you need to know before you take Memantine Do not take Memantine

•    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, pharmacist or nurse before taking Memantine:

•    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.

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

Other medicines and Memantine

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

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 mental disorders).

•    oral anticoagulants.

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

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 dose of Memantine for adults and elderly patients is 20 mg once a day.

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

At the beginning of treatment you will start by using 5 mg once a day. This dose will be increased weekly by 5 mg until the recommended (maintenance) dose is reached. The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the 4^th week.

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

If you take more Memantine than you should

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

If you forget to take Memantine

•    If you find you have forgotten to take your dose of Memantine, 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, pharmacist or nurse.

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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

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

5.    How to store Memantine

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, label 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

The active substance is memantine hydrochloride. Each tablet contains 10 mg /20 mg of memantine hydrochloride equivalent to 8.31 mg /16.62 mg Memantine.

The other ingredients are:

Tablet core: Silica colloidal anhydrous, cellulose, microcrystalline, silicified microcrystalline cellulose, sodium starch glycolate, talc, sodium stearyl fumarate.

Tablet film-coat: Hypromellose, macrogol 6000, talc, titanium dioxide (E 171), iron oxide yellow (E 172) for 20 mg, iron oxide red (E 172) for 20 mg.

What Memantine looks like and contents of the pack

Film-coated tablet.

Memantine 10 mg film-coated tablets:

White to off-white, centrally tapered oblong, biconvex, film-coated tablets with a single break line on both sides and debossed with 'Z' and '03' on either side of break line on one side and plain on other side. The tablet can be divided in equal doses.

Memantine 20 mg film-coated tablets:

Pale-red to grey-red, oval oblong, film-coated tablets debossed with 'Z' on one side arid '06' on other side.

Memantine tablets are available in clear PVC/PE/PVDC/Aluminium lidding foil blisters.

Blister pack:

10 mg: 1, 10, 28, 30, 50, 56, 98, 100 and 112 tablets 20 mg: 10, 28, 30, 42, 56 and 98 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Amneal Pharma Europe Limited 70 Sir John Rogerson's Quay,

Dublin 2,

Ireland.

Manufacturer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate,

Hal Far, Birzebbugia, BBG 3000 Malta

This leaflet was last revised in 09/2014

M

5 mm