Allergex Non Drowsy Syrup

The relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhoea, and itching of nose and throat. ALLERGEX NON DROWSY SYRUP is also indicated for the relief of chronic idiopathic urticaria and other allergic dermatoses.

Children 2 to 5 years of age: 5 ml (1 medicine measure) once daily.
Children 6 to 12 years of age: 10 ml (2 medicine measures) once daily.
Adults and Children 12 years of age and over: 10 ml (2 medicine measures) once daily.
The use of ALLERGEX NON DROWSY SYRUP should be limited to 14 days.
ALLERGEX NON DROWSY SYRUP can be taken with or without a meal.

Method of administration
For oral administration. Shake the bottle before use.

Special Populations
Hepatic Impairment
Patients with hepatic impairment should be administered a reduced dose as they may have decreased clearance of loratadine; an initial dose of 5 ml once daily or 10 ml on alternate days is recommended.
Children
Efficacy of ALLERGEX NON DROWSY SYRUP has not been established in children younger than 2 years of age (see section 4.3).

• Hypersensitivity to loratadine or to any of the excipients listed in section 6.1.
• The safe use of ALLERGEX NON DROWSY SYRUP in children under 2 years of age and in the elderly has not been established.

• ALLERGEX NON DROWSY SYRUP lacks significant sedative properties. However, patients should be advised that a small number of individuals may experience sedation (see section 4.7).
• Use with caution in patients with epilepsy due to less frequent reports of convulsions. Cross sensitivity to related drugs may occur.
• H1 receptor antihistamines such as ALLERGEX NON DROWSY SYRUP may cause weight gain.

ALLERGEX NON DROWSY SYRUP contains sucrose. Patients with rare hereditary conditions of fructose intolerance e.g., glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take ALLERGEX NON DROWSY SYRUP. It may have an effect on the glycaemic control of patients with diabetes mellitus.

ALLERGEX NON DROWSY SYRUP contains sodium benzoate. This medicine contains 5 mg of sodium benzoate in each 5 ml which is equivalent to 0,1 % m/v. Increase in bilirubinaemia following its displacement from albumin may increase neonatal jaundice which may develop into kernicterus (non-conjugated bilirubin deposits in the brain tissue).

ALLERGEX NON DROWSY SYRUP contains sodium hydroxide. This medicine contains less than 1 mmol sodium (0,273 mg) per 5 ml, that it is to say essentially u201csodium-freeu201d.

ALLERGEX NON DROWSY SYRUP contains propylene glycol. This medicine contains 300 mg propylene glycol in each 5 ml dosage unit which is equivalent to 6 % w/v. Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates.

The use of ALLERGEX NON-DROWSY SYRUP should be stopped approximately 48 hours before skin testing as antihistamines may suppress the positive skin response to allergen extracts. Medicines known to inhibit the hepatic metabolism of loratadine include cimetidine, erythromycin, ketoconazole, quinidine, fluconazole and fluoxetine. These medicines should therefore not be administered concomitantly with loratadine as they may raise the plasma concentrations of loratadine. However, no clinically significant consequences have been observed when these medicines are administered concomitantly.

Pregnancy
Safety in pregnancy has not been established. The use of ALLERGEX NON DROWSY SYRUP during pregnancy is therefore not recommended.

Lactation
Loratadine and its metabolites are distributed into breastmilk, therefore its administration during lactation is not advised.

Fertility
No data has been reported on male and female fertility.

Patients should be advised that a small number of individuals may experience sedation (see section 4.4). Therefore, the effect of the medicine on a particular patient should be ascertained before they drive or generate machinery.

Tabulated list of adverse effects reactions presented in system organ class

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the Medsafety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org found on SAHPRA website. You may also report to Adcock Ingram Limited using the following email: [email protected]

See section 4.8. Cardiac effects such as tachycardia have been reported. Headache and somnolence have also been reported with overdoses. In the event of overdosage, treatment should be started immediately. Treatment is symptomatic and supportive. Haemodialysis is not an effective means of removing loratadine or its metabolite from the body.