Medicinal Products

EBIXA 20 mg

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

Coated tablet
Box of 1 Blister of 28
All forms

Indication

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

Dosage EBIXA 20 mg Film-coated tablet Box of 1 Blister of 28

Treatment should be initiated and supervised by a physician trained in the diagnosis and treatment of dementia Alzheimer's disease.


Dosage


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.


adults


Dosage progress


The maximum recommended dose is 20 mg daily. 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 indicated below. To increase the dose, other tablets are available.


Week 1 (Days 1-7)

The patient should take a 5 mg film-coated tablet daily for 7 days.


Week 2 (days 8-14)

The patient should take a 10 mg film-coated tablet daily for 7 days.

Week 3 (days 15-21)

The patient should take a 15 mg film-coated tablet daily for 7 days.


At the latest of the week 4

The patient should take a 20 mg film-coated tablet daily.


Maintenance dose


The recommended maintenance dose is 20 mg daily.


The elderly

Based on clinical studies, the recommended dose for patients over 65 years of age is 20 mg per day, as described above.


Renal failure

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 insufficiency

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.


Children and adolescents

No data available.


Administration mode


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

Against indications

Hypersensitivity to the active substance or to any of the excipients listed under Composition .

Ebixa side effects

Summary of the security profile

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%).


Tabulated list of adverse reactions

Adverse effects in the table below were collected during clinical trials with Ebixa and since marketing.


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). Within each frequency group, adverse effects are presented in descending order of severity.

ORGAN SYSTEM CLASS

FREQUENCY

UNDESIRABLE EFFECT

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

Balance disorders

Rare

Very rare

Walking disorders

convulsions

Heart conditions

Rare

Heart failure

Vascular disorders

Frequent

Rare

Hypertension
Vein thrombosis/
thromboembolism

Respiratory, thoracic and mediastinal disorders

Frequent

Dyspnea

Frequent

Constipation

Gastrointestinal disorders

Rare

Not known frequency

vomiting

Pancreatitis 2

Frequent

Elevation of liver function tests

Heparobiliary disorders

Not known frequency

Hepatitis

General disorders and administration site conditions

Frequent

Rare

cephalalgia

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 reactions have been reported in patients treated with Ebixa.


Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system - see Annex V.

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