Dazit Syrup 2,5 mg Oral Solution

DAZIT u00ae SYRUP is indicated for the relief of symptoms associated with allergic rhinitis (AR).

DAZIT u00ae SYRUP is also indicated for the short-term relief of symptoms associated with chronic idiopathic urticaria (CIU).

Posology

• Children 2 to 5 years of age: 2,5 mL (1,25 mg) DAZIT u00ae SYRUP once a day, with or without a meal.
• Children 6 to 11 years of age: 5 ml (2,5 mg) DAZIT u00ae SYRUP once a day, with or without a meal.
• Adults and adolescents (12 years of age and over): 10 mL (5 mg) DAZIT u00ae SYRUP once a day, with or without a meal.

Method of administration

For Oral Use.

Hypersensitivity to the active substance desloratadine or to any of the excipients listed in section 6.1.

DAZIT u00ae SYRUP should be administered with caution in patients with a medical or family history of seizures. In particular, young children may be more susceptible to developing new seizures under desloratadine treatment. Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment.

Efficacy and safety of DAZIT u00ae SYRUP in children under 2 years of age have not been reported to be established. Safety and efficacy of DAZIT u00ae SYRUP have not been reported to be established for treatment periods in excess of 4 weeks for allergic rhinitis and 6 weeks for chronic idiopathic urticaria.

Renal impairment

In the case of severe renal insufficiency, DAZIT u00ae SYRUP should be used with caution.

Paediatric population

In children below 2 years of age, the diagnosis of allergic rhinitis is particularly difficult to distinguish from other forms of rhinitis. The absence of upper respiratory tract infection or structural abnormalities, as well as patient history, physical examinations, and appropriate laboratory and skin tests should be considered. Approximately 6 % of adults and children 2- to 11-year old are reported to be phenotypic poor metabolisers of desloratadine and exhibit a higher exposure. The safety of desloratadine in children 2- to 11-years of age who are poor metabolisers is reported to be same as in children who are normal metabolisers. The effects of desloratadine in poor metabolisers <2 years of age have not been reported.

Excipients

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take DAZIT u00ae SYRUP.

Desloratadine taken concomitantly with alcohol reportedly did not potentiate the performance impairing effects of alcohol. However, cases of alcohol intolerance and intoxication have been reported during post-marketing use. Therefore, caution is recommended if alcohol is taken concomitantly.

There was no effect of food or grapefruit juice reported on the disposition of desloratadine. It is reported that co-administration of desloratadine with ketoconazole increases the maximum desloratadine concentration (C max) by 45 % and the area under the time concentration curve (AUC) by 37 %. It is reported that co-administration of desloratadine with erythromycin increased the C max of desloratadine by 24 % and the AUC by 14 %. Co-administration of desloratadine with azithromycin reportedly resulted in an increase of both C max (31 %) and AUC (12 %) of azithromycin.

The increase in C max and AUC of desloratadine when co-administered with either ketoconazole or erythromycin reportedly did not cause any clinical relevant adverse events in the populations studied. Co-administration of cimetidine with desloratadine reportedly did not significantly affect the pharmacokinetics of desloratadine. Co-administration of fluoxetine with desloratadine reportedly caused an increase in the C max of desloratadine by 15 % and an increase of 13 % in AUC and 17 % in C max of 3-0H desloratadine respectively. The C max and AUC of fluoxetine were reportedly reduced by 9 % and 11 % respectively. The corresponding mean parameters of norfluoxetine increased by 23 % and 18 % respectively with co-administration of desloratadine and fluoxetine. No clinically relevant changes in desloratadine plasma concentrations were reported in multiple-dose ketoconazole, erythromycin, azithromycin, fluoxetine and cimetidine interaction trials.

Paediatric population

Interaction studies have only been reported in adults.

Pregnancy

The safe use of DAZIT u00ae SYRUP during pregnancy has not been established. A large amount of reported data on pregnant women indicate no malformative nor foeto/neonatal toxicity of desloratadine. Reported animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. The use of desloratadine during pregnancy is therefore not recommended.

Breastfeeding

The effect of DAZIT u00ae SYRUP on newborns/infants is unknown. Desloratadine is excreted into breast milk, therefore the use of desloratadine is not recommended in mothers who are breastfeeding their infants.

Fertility

There are no data reported on male and female fertility.

DAZIT u00ae SYRUP lacks significant sedative effects. Patients should however be warned that a small number of individuals may experience sedation and dizziness. It is therefore advisable to determine individual response before driving or performing complicated tasks.

Summary of the safety profile

Paediatric population

In reported clinical trials in a paediatric population, the desloratadine as in DAZITu00ae SYRUP formulation was administered to a total of children aged 6 months through 11 years. The overall incidence of adverse events in children 2 through 11 years of age was similar for the desloratadine and the placebo groups. In infants and toddlers aged 6 to 23 months, the most frequent adverse reactions reported in excess of placebo were diarrhoea (3,7 %), fever (2,3 %) and insomnia (2,3 %). In an additional reported study, no adverse events were seen in subjects between 6 and 11 years of age following a single 2,5 mg dose of desloratadine oral solution. In a reported clinical trial with adolescent patients, 12 through 17 years of age, the most common adverse event was headache; this occurred in 5,9 % of patients treated with desloratadine and 6,9 % of patients receiving placebo.

Adults and adolescents

At the recommended dose, in reported clinical trials involving adults and adolescents in a range of indications including allergic rhinitis and chronic idiopathic urticaria, undesirable effects with desloratadine were reported in 3 % of patients in excess of those treated with placebo. The most frequent of adverse events reported in excess of placebo were fatigue (1,2 %), dry mouth (0,8 %) and headache (0,6 %).

Tabulated summary of adverse reactions

System Organ Class Frequency Adverse reactions seen with Desloratadine

Metabolism and nutrition disorders Not known Increased appetite

Immune system disorders Less frequent Not known Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria) Asthenia

Psychiatric disorders Less frequent Not known Hallucinations Abnormal behaviour, aggression

Nervous system disorders Frequent Frequent (children less than 2 years) Less frequent Headache Insomnia Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures

Cardiac disorders Less frequent Not known Tachycardia, palpitations QT prolongation

Gastrointestinal disorders Frequent Frequent (children less than 2 years) Less frequent Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea

Hepatobiliary disorders Less frequent Not known Elevations of liver enzymes increased bilirubin, hepatitis Jaundice

Skin and subcutaneous tissue disorders Not known Photosensitivity

Musculoskeletal and connective tissue disorders Less frequent Myalgia

General disorders and administration site conditions Frequent Frequent (children less than 2 years) Fatigue Fever

Investigations Not known Weight increased

Paediatric population Other undesirable effects reported during the post-marketing period in paediatric patients with an unknown frequency included QT prolongation, arrhythmia, bradycardia, abnormal behaviour, and aggression.

A reported retrospective observational safety study indicated an increased incidence of new-onset seizure in patients 0 to 19 years of age when receiving desloratadine as in DAZITu00ae SYRUP compared with periods not receiving desloratadine. Among children 0-4 years old, the adjusted absolute increase was 37,5 (95 % Confidence Interval (CI) 10,5 - 64,5) per 100,000 person years (PY) with a background rate of new onset seizure of 80.3 per 100,000 PY. Among patients 5 - 19 years of age, the adjusted absolute increase was 11,3 (95 % CI 2,3 - 20,2) per 100,000 PY with a background rate of 3,4 per 100,000 PY.

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation 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 u20186.04 Adverse Drug Reaction Reporting formu2019, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/index/8.

The adverse event profile associated with overdosage, as reported during post-marketing use, is similar to that reported with therapeutic doses, but the magnitude of the effects can be higher.

Treatment

In the event of overdose, consider standard measures to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended.

Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal dialysis.

Symptoms

Based on a reported multiple dose clinical trial in adults and adolescents, in which up to 45 mg of desloratadine was administered (nine times the clinical dose), no clinically relevant effects were observed.