Allerbas Allergy 10mg Tablets

Allerbas Allergy 10 mg is indicated for the symptomatic treatment of allergic rhinitis (seasonal and perennial) and idiopathic chronic urticaria.

Posology
Adults and children over 12 years old: The recommended dose is 10 mg of Allerbas Allergy once daily.
Special populations
Elderly patients
No dose adjustment is necessary.
Renal impairment
No dose adjustment is necessary.
Hepatic impairment
No dose adjustment is necessary.
Paediatric population
The safety and efficacy of Allerbas Allergy 10 mg in children under 12 years have not been established.

Method of administration:
Allerbas Allergy 10 mg is for oral administration with a glass of water and may be taken with or without food.

Hypersensitivity to ebastine or any of the excipients listed in section 6.1
The safety of Allerbas Allergy 10 mg during pregnancy and lactation has not been established (see section 4.6).
The safety and efficacy of Allerbas Allergy 10 mg in children under 12 years have not been established.

Allerbas Allergy 10 mg lacks significant sedative effects. Administer with caution in patients with known cardiac risk such as QT prolongation, hypokalaemia or concomitant treatment with medicines that increase the QT interval or inhibit the CYP3A4 enzyme, such as azole antifungals and macrolide antibiotics (see section 4.5).
Since Allerbas Allergy 10 mg achieves its therapeutic effect between 1 and 3 hours after administration, it should not be used in acute allergic emergencies.
In patients with severe hepatic impairment the daily dose should not exceed 10 mg.
Warning about excipients:
Allerbas Allergy 10 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption problems should not take this medicine.

The interaction of ebastine in combination with ketoconazole or erythromycin (both compounds produce an increase in the QTc interval) has been studied. With both combinations a pharmacokinetic and pharmacodynamic interaction has been observed, leading to an increase in plasma levels of ebastine; the increase in QTc was approximately 18 u2013 19 ms (4,7 u2013 5 %) higher than that observed with ketoconazole or erythromycin alone. Therefore, it is recommended that Allerbas Allergy 10 mg be administered with caution to patients undergoing concomitant treatment with ketoconazole and erythromycin.
When Allerbas Allergy 10 mg is given with food, both plasma levels and AUC of the main ebastine metabolite increase by 1,5 to 2 times. This increase does not change the Tmax. The administration of Allerbas Allergy 10 mg with food does not modify its clinical effect.
Ebastine, as contained in [PRODUCT NAME], can interfere with the results of allergic skin tests, so it is advisable not to perform these tests until 5-7 days after treatment has been discontinued.
Allerbas Allergy 10 mg can enhance the effects of other antihistamines.

Pregnancy
The safety of Allerbas Allergy 10 mg for use in pregnancy has not been established. Studies in animals do not indicate direct or indirect harmful effects with reference to foetal or embryonic development, the course of gestation or peri- and post-natal development. Nor have teratogenic effects in animals been identified. However, there have been no controlled studies in pregnant women. Therefore, Allerbas Allergy 10 mg should only be used during pregnancy when clearly necessary.
Breast-feeding
It is not known whether ebastine is excreted in breast milk, so Allerbas Allergy 10 mg should not be used during lactation.

Allerbas Allergy 10 mg lacks significant sedative effects. Patients should, however, be warned that a small number of individuals may experience sedation. This effect may be compounded by the simultaneous intake of alcohol or other central nervous system depressants. Patients should therefore be advised to determine individual response before driving or performing complicated tasks.

a. Summary of safety profile
Frequently reported adverse reactions during use of ebastine were headache, dry mouth, pharyngitis, rhinitis and asthenia.
b. Tabulated List of adverse reactions
System organ Class
Frequent
Less frequent
Frequency unknown
Infections and Infestations
Pharyngitis, rhinitis
Sinusitis
Nervous system disorder
Headache, drowsiness
Gastrointestinal disorders
Dry mouth
Dyspepsia, abdominal pain, nausea
Psychiatric disorders
Insomnia
Respiratory, thoracic and mediastinal disorders:
Epistaxis
Metabolism and nutrition disorders
Increased appetite
Investigations
Weight increased
General disorders and administration site conditions
Asthenia
Reporting of suspected adverse reaction
Reporting suspected adverse reactions after authorization of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/publication/index/8 May also report to Adcock Ingram Limited using the following email: [email protected]

In studies with high doses, no clinically significant signs or symptoms were observed at doses up to 100 mg once a day. There is no specific antidote for ebastine. Monitoring of vital signs, including ECG and symptomatic treatment are recommended.