Medicinal Products

EBIXA 10 mg

Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Memantine
laboratory: H. Lundbeck A / S

Divisible coated tablet
Box of 100 film-coated tablets
All forms

Indication

Treatment of patients with a moderate to severe form of Alzheimer's disease.

Dosage EBIXA 10 mg Film-coated tablet scored Box of 100 film-coated tablets

Treatment should be initiated and supervised by a physician trained in the diagnosis and treatment of dementia Alzheimer's disease. Treatment should begin only with the assurance of the availability of a care worker who will regularly monitor the patient's intake of the drug. The diagnosis must be established according to the criteria in force. The safety and posology of memantine should be re-evaluated at regular intervals, preferably within 3 months of starting treatment. Then, the clinical benefit of memantine and its tolerance should be re-evaluated at regular intervals according to clinical criteria. Maintenance treatment can be continued as long as the therapeutic benefit is favorable and the patient tolerates memantine treatment. Stopping treatment with memantine should be considered when it becomes clear that there is no longer any therapeutic benefit or if the patient does not tolerate treatment.


Ebixa should be given once a day, at the same time each day. The film-coated tablets can be taken during or after meals.


Adults:

Dosage progress

The maximum dose is 20 mg per day. To reduce the risk of adverse effects, this dose is achieved by a 5 mg weekly increase in dosage during the first three weeks, as follows:


Week 1 (Days 1-7):

The patient should take one half of a 10 mg (5 mg) film-coated tablet daily for 7 days.


Week 2 (days 8-14):

The patient should take a 10 mg (10 mg) film-coated tablet daily for 7 days.
Week 3 (days 15-21):

The patient should take one 10 mg (15 mg) film-coated tablet per day for 7 days.
From week 4:

The patient should take two 10 mg (20 mg) film-coated tablets daily.
Maintenance dose

The recommended maintenance dose is 20 mg daily.


Elderly: Based on clinical studies, the recommended dose for patients over 65 is 20 mg daily (two 10 mg film-coated tablets once daily) as described above.


Children and adolescents: Ebixa should not be used in children under 18 years of age due to a lack of data regarding safety and effectiveness.


Renal impairment: In patients with mild renal impairment (creatinine clearance 50-80 ml / min), no dose adjustment is required. In patients with moderate renal impairment (creatinine clearance 30-49 ml / min), the daily dose should be 10 mg. If tolerance is good after at least 7 days of treatment, the dose may be increased up to 20 mg daily following the usual dosing schedule. In patients with severe renal impairment (creatinine clearance between 5 and 29 ml / min), the daily dose should be 10 mg.


Hepatic impairment: In patients with mild to moderate hepatic impairment (Child-Pugh A and Child-Pugh B), no dose adjustment is required. No data on the use of memantine in patients with severe hepatic impairment are available. Administration of Ebixa is not recommended for this type of patients.

Against indications

Hypersensitivity to the active substance or to any of the excipients.

Ebixa side effects

In clinical trials in mild-to-severe dementia involving 1784 Ebixa-treated patients and 1595 placebo-treated patients, the overall frequency of adverse events for Ebixa did not differ from that of placebo; adverse events were generally of mild to moderate intensity. The most common adverse events with a higher incidence in the Ebixa group compared to the placebo group were: dizziness (6.3% vs 5.6%, respectively), headache (5.2% vs 3.9%) constipation (4.6% vs. 2.6%), somnolence (3.4% vs. 2.2%) and hypertension (4.1% vs. 2.8%).

Adverse effects in the table below were collected during clinical trials with Ebixa and since marketing. Within each frequency group, adverse effects are presented in descending order of severity.

Adverse reactions are classified by system organ class using the following conventions: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100) ), rare (≥ 1/10 000, <1/1000), very rare (<1 / 10, 000), not known (can not be estimated from the available data).

Infections and infestations

Rare

Fungal infections

Immune system disorders

Frequent

Hypersensitivity to the drug

Psychiatric disorders

Frequent

Drowsiness

Rare

Confusion

Rare

Hallucinations 1

Not known frequency

Psychotic reactions 2

Nervous system disorders

Frequent

Dizzying sensations

Frequent

Rare

Balance disorders

Walking disorders

Very rare

convulsions

Heart conditions

Rare

Heart failure

Vascular disorders

Frequent

Hypertension

Rare

Venous thrombosis / thromboembolism

Respiratory, thoracic and mediastinal disorders

Frequent

Dyspnea

Gastrointestinal disorders

Frequent

Constipation

Rare

vomiting

Not known frequency

Pancreatitis 2

Hepatobiliary disorders

Frequent

Not known frequency

Elevation of liver function tests

Hepatitis

General disorders and administration site conditions

Frequent

cephalalgia

Rare

Tired


1 Hallucinations have been observed mainly in patients with severe Alzheimer's disease.

2 Isolated cases reported during pharmacovigilance follow-up.

Alzheimer's has been associated with cases of depression, suicidal thoughts and suicide. In post-marketing surveillance, these events have been reported in patients treated with Ebixa.

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