Ebixa (Memantine hydrochloride 10mg) 30 Tablets/pack (Turkish)

General Information

What is Ebixa 10mg used for?

Ebixa tablet 10mg is used for the treatment of patients with moderate to severe Alzheimer’s disease and it 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. Ebixa tablet 10mg is called an NMDA receptor antagonist. Ebixa tablet 10mg acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

How does Ebixa 10mg work?

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. Ebixa tablet 10mg, belongs to a group of medicines called NMDA receptor antagonists. Ebixa acts on these NMDA-receptors improving the transmission of nerve signals and the memory. It is thought to work by protecting NMDA receptors in the brain against high levels of the chemical glutamate, which could be the cause of brain degeneration.

What does Ebixa 10mg contain?

Ebixa tablet 10mg contains the active substance memantine hydrochloride.

 The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E171) and iron oxide yellow (E172), all in the tablet coating.

Treating   with Ebixa 10mg

For moderate to severe Alzheimer’s Disease

Used to slow the progression of symptoms such as confusion, memory loss, performing daily activities and problems with thinking and reasoning.

What are the side effects of Ebixa 10mg

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 (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.

 Reporting of side effects If you get any side effects, talk to your doctor or pharmacist.

When should Ebixa 10mg not be used?

• Do not take Ebixa - if you are allergic to memantine or any of the other ingredients of this 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 Ebixa should not breast-feed.

 Warning and precautions

• Talk to your doctor or pharmacist before taking Ebixa: - 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 Ebixa 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.
• 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), your doctor may need to adjust the dose of your medicine.
• 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 Ebixa is not recommended for children and adolescents under the age of 18 years.
• Ebixa 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), as your doctor may need to adjust the dose of your medicine.
• Driving and using machines Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Ebixa may change your reactivity, making driving or operating machinery inappropriate

What medications interact with Ebixa 10mg?

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

 In particular, Ebixa 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 Ebixa.

How should Ebixa 10mg be taken?

Ebixa tablet 10mg 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.

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

Missed dose of Ebixa 10m

If you find you have forgotten to take your dose of Ebixa , wait and take your next dose at the usual time. - Do not take a double dose to make up for a forgotten dose.

How should Ebixa 10mg be stored?

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date. This medicinal product does not require any special storage condition