Package leaflet: Information for the user Memantine Dawa 10 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 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 Dawa is and what it is used for

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

3.    How to take Memantine Dawa

4.    Possible side effects

5.    How to store Memantine Dawa

6.    Contents of the pack and other information

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

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

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

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

Do not take Memantine Dawa:

•    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 Dawa:

•    if you have a history of epileptic seizures

•    if you have recently experienced amyocardial 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 Dawa reassessed by your doctor on a regular basis.

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

The use of medicinal products called amantadine (used in 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.

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), as your doctor may need to monitor you.

Children and adolescents

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

Other medicines and Memantine Dawa

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

In particular, Memantine Dawa may change the effects of the 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 Dawa.

Memantine Dawa 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.

Tell your doctor if you are pregnant or planning to become pregnant. The use of memantine in pregnant women is not recommended.

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

3. How to take Memantine Dawa

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 Dawa 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:

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 tablets once a day (1x 15 mg) in the third week. From the fourth week on, the usual dose is 2 tablets once a day (1x 20 mg).

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

If you take more Memantine Dawa than you should

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

If you forget to take Memantine Dawa

If you have forgotten to take your dose of Memantine Dawa, 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

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 more than 1 in 10people):

-    headache

-    sleepiness

-    constipation

-    elevated liver function tests

-    dizziness

-    balance disorders

-    shortness of breath

-    high blood pressure

-    drug hypersensitivity

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

-    tiredness

-    fungal infections

-    confusion

-    hallucinations

-    vomiting

-    abnormal gait

-    heart failure

-    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)

-    psychotic reactions

Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events have been reported in patients treated with Memantine Dawa.

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; website: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 Memantine Dawa

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

This medicinal product does not require any special storage conditions.

HDPE bottle: Do not use for more than 75 days after you first open it.

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 Memantine Dawa contains

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

The other ingredients are:

Tablet core: Cellulose microcrystalline, silica, colloidal anhydrous, croscarmellose sodium, hydromellose, talc and magnesium stearate. Tablet coat: Hypromellose, Macrogol 400, Titanium dioxide (E171).

What Memantine Dawa looks like and contents of the pack

Memantine Dawa are presented as white to off-white, caplet shaped, biconvex film-coated tablets with break line on both sides. The tablet can be divided into equal halves.

Memantine Dawa is available in blisters pack sizes of 28, 42, 56 and 98 tablets.

Bottles are available in pack sizes of 30, 100 and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Dawa Ltd 5 Sandridge Close Harrow, Middlesex HA1 1XD

Manufacturer Drugsrus Ltd 5 Sandridge Close Harrow, Middlesex HA1 1XD

This medicinal product is authorised in the Member States of the EEA under the following names:

Bulgaria: Memantine Sopharma 10 mg

^rnMHpaHa Ta6neTKa

France: Memantine Pharmascope 10 mg

Comprime pellicule secable

Germany: Memantin Pharmascope 10 mg

Filmtabletten

Netherlands: Memantine Pharmascope 10 mg Filmomhulde tablet

Romania: Memantine Pharmascope 10 mg Comprimat filmat

Sweden: Memantine Pharmascope 10 mg Filmdragerad tablett

United Kingdom: Memantine DAWA 10 mg Film-coated Tablets

This leaflet was last revised in 12/2014