Medicinal Products

EBIXA 10 mg film-coated tablet box of 56

Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Memantine
laboratory: BB Farma Srl

Divisible coated tablet
All forms

Indication

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

Dosage EBIXA 10 mg film-coated tablet box of 56

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

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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