Memantine STADA 5 mg + 10 mg + 15 mg + 20 mg filmomhulde tabletten

How does Memantine STADA work

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

What is Memantine STADA used for

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

Do not take Memantine STADA

• 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 STADA.

• 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).

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In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine STADA 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 adolescent

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

Other medicines and Memantine STADA

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

In particular, Memantine STADA 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 STADA.

Memantine STADA 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

Ask your doctor or pharmacist for advice before taking any 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 STADA 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 STADA may change your reactivity, making driving or operating machinery inappropriate.

The Memantine STADA treatment initiation pack is only to be used for the beginning of the treatment with

Memantine STADA.

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Always take this medicine exactly as your doctor or pharmacist has told you. You should 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 STADA dose during the first 3 weeks of treatment. The treatment scheme is also indicated on the treatment initiation pack. Take one tablet once a day.

Week 1 (day 1-7):

Take one 5 mg tablet once a day (white, oval biconvex) for 7 days.

Week 2 (day 8-14):

Take one 10 mg tablet once a day (white, biconvex, two-side scored) for 7 days.

Week 3 (day 15-21):

Take one 15 mg tablet once a day (light brown, oval biconvex) for 7 days.

Week 4 (day 22-28):

Take one 20 mg tablet per day (pink, oval biconvex) for 7 days.

Week 1	5 mg tablet (red blister)
Week 2	10 mg tablet (black blister)
Week 3	15 mg tablets (green blister)
Week 4 and beyond	20 mg tablets once a day (blue
blister)

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

If you take more Memantine STADA than you should

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

If you forget to take Memantine STADA

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

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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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 medicinal product does not require any special storage conditions.

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

What Memantine STADA contains

The active substance is memantine hydrochloride. Each film-coated tablet contains 5/10/15/20 mg memantine hydrochloride equivalent to 4.15/8.31/12.46/16.62 mg memantine.

The other ingredients for Memantine STADA 5/10/15 and 20 mg filmomhulde tabletten are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate, all in the tablet core; and polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc and additional for Memantine STADA 15 mg filmomhulde tabletten are iron oxide yellow, red and black (E172) and for Memantine STADA 20 mg filmomhulde tabletten are iron oxide yellow and red (E172), all in the tablet coating.

What Memantine STADA looks like and contents of the pack

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Memantine STADA 5 mg filmomhulde tabletten are presented as white, oval, biconvex, 8,1mm – 4,1mm, film-coated tablets embossed on one side with ‘5’.

Memantine STADA 10 mg filmomhulde tabletten are presented as white, slim through the middle, biconvex, 10mm – 5,6mm, film-coated tablet with breaking lines on both sides and engraving ‘1 0’ on one side.

The 10 mg tablet can be divided into equal doses.

Memantine STADA 15 mg filmomhulde tabletten are presented as light brown, oval, biconvex, 12,3mm – 6,6mm, film-coated tablets.

Memantine STADA 20 mg filmomhulde tabletten are presented as pink, oval, biconvex, 13,5mm – 7,3mm, film-coated tablets.

One treatment initiation pack contains 28 tablets with 7 tablets of Memantine 5 mg, 7 tablets of Memantine 10 mg, 7 tablets of Memantine 15 mg and 7 tablets of Memantine 20 mg.

Blister packs containing 7 tablets per blister (PVC/PE/PVDC and Aluminium).

Houder van de vergunning voor het in de handel brengen en fabrikant

STADA Arzneimittel AG Stadastr. 2-18,

61118 Bad Vilbel Germany

Fabrikant

Cemelog-BRS Ltd.

Vasút u. 13 (Pharma Park) 2040 Budaörs

Hongarije

In het register ingeschreven onder:

RVG 112207

Deze bijsluiter is voor het laatst goedgekeurd in november 2013.

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