Dazit Tablets 5 mg FC tablet

• DAZIT u00ae TABLETS are indicated for the relief of symptoms associated with seasonal allergic rhinitis.
• DAZIT u00ae TABLETS are also indicated for the short-term relief of symptoms associated with chronic idiopathic urticaria.

Posology

Adults and adolescents (u2265 12 years of age): One DAZIT u00ae TABLET once daily regardless of mealtime for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and chronic idiopathic urticaria. Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patientu2019s disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance. Persistent allergic rhinitis: (presence of symptoms for more than 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during allergen exposure periods). Improvement of symptoms associated with seasonal allergic rhinitis usually becomes noticeable within 1 - 2 hours after administration of desloratadine.

Method of administration

Oral Use

DAZIT u00ae TABLETS should be taken orally once daily with or without food:

• Hypersensitivity to desloratadine or to any of the excipients listed in Section 6.1.
• Cross sensitivity to other antihistamines.

Liver impairment: DAZITu00ae TABLETS should be used with caution in patients with severe liver impairment as reduced clearance of desloratadine may occur. Dosage adjustment may be needed (see section 4.2).

Renal function impairment: A lower starting dose should be used. In patients with chronic renal impairment (creatinine clearance of 30 ml / minute or less), both oral bioavailability and peak plasma concentrations may be increased.

Epilepsy: DAZITu00ae TABLETS should be administered with caution in patients with medical or familial 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.

Weight gain: The use of DAZIT u00ae TABLETS has been associated with the risk of weight gain (see section 4.8).

Skin test: DAZITu00ae TABLETS should be discontinued prior to skin tests using allergen extracts as it may inhibit the cutaneous histamine response, thus producing false-negative results. Desloratadine should be discontinued at least 48 hours before skin test.

DAZITu00ae TABLETS should be used with caution when the following medical conditions exists (below) and/or patients using other medication metabolised by the cytochrome P-450 system (see section 4.5) such as:

• emphysema,
• prostatic hypertrophy,
• narrow angle glaucoma,
• cardiovascular disorder,
• epilepsy or
• during acute attacks of asthma.

Safety and efficacy of DAZITu00ae TABLETS have not been established for treatment periods in excess of 4 weeks.

Special populations:

Geriatric use: In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or with concomitant medicines.

Paediatric population: Safety and efficacy of DAZITu00ae Tablets have not been established in paediatric patients younger than 12 years of age.

Cytochrome P-450 Inhibitors

Concomitant use of DAZIT u00ae TABLETS with inhibitors of cytochrome P-450 enzyme system such as cimetidine, ketoconazole, clarithromycin, azithromycin and erythromycin may increase the plasma concentration (C max ) and area under the time concentration curve (AUC) of desloratadine as in DAZIT u00ae TABLETS (see section 4.4).

Ketoconazole or Cimetidine

Reported studies relating to interactions together with desloratadine as in DAZIT u00ae TABLETS, have shown, that there were no clinically relevant adverse changes in the desloratadine plasma concentrations, when ketoconazole, and/or cimetidine were used in multiple-dose interaction studies (see section 5.2).

Erythromycin or Ketoconazole

In reported studies of clinical trials, no clinically relevant interactions were observed in with desloratadine tablets in which erythromycin or ketoconazole were co-administered (see section 5.2).

Fluoxetine

• Reports have shown that co-administration of fluoxetine with desloratadine, as contained in DAZITu00ae TABLETS, cause an increase in the C max and the AUC of desloratadine and increases C max of 3-OH desloratadine respectively.
• The corresponding mean parameters of norfluoxetine may be increased, with co-administration of desloratadine and fluoxetine.
• Reports of studies conducted have indicated that the C max and AUC of fluoxetine may be decreased when administered with desloratadine as in DAZIT u00ae TABLETS.

Food / Grapejuice

There was no effect of food or grapefruit juice on the disposition of desloratadine (see section 5.2).

Alcohol

As reported, in a clinical pharmacology trial study, desloratadine tablets taken concomitantly with alcohol 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 (see section 4.8).

Paediatric population

Reports indicate that Interaction studies were only performed in adults.

Pregnancy

Safety and efficacy in pregnancy and lactation has not been established. The use of DAZITu00ae TABLETS during pregnancy is therefore not recommended.

Breast-feeding

It has been reported that desloratadine as in DAZITu00ae TABLETS is excreted in breast milk and is therefore not recommended in breast-feeding women.

Fertility

No data has been reported on male and female fertility.

DAZIT u00ae TABLETS lacks significant sedative effects (see section 4.8). Patients should, however be warned that a small number of individuals may experience sedation and blurred vision (see section 4.8). It is therefore advisable to determine individual response before driving or performing complicated tasks.

Summary of the safety profile

In reported studies in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with desloratadine as in DAZIT u00ae TABLETS have been reported in 3 % of patients in excess of those treated with placebo. The most frequent of adverse reactions reported in excess of placebo were fatigue (1,2 %), dry mouth (0,8 %) and headache (0,6 %).

Paediatric population

In a reported study with adolescent patients, 12 through 17 years of age, the most common adverse event was headache; this has been reported in 5,9 % of patients treated with desloratadine as in DAZITu00ae TABLETS and 6,9 % of patients receiving placebo.

Table 1: Tabulated List of Adverse Reactions

System organ class Frequent Less frequent Frequency Not known

Immune system disorders - Anaphylaxis, angioedema, dyspnoea, urticaria, pruritus, rash, oedema.

- Metabolism and nutrition disorders - - Increased appetite

Psychiatric disorders - Depression, hallucinations, confusion and nightmares Abnormal behaviour, aggression

Nervous system disorders Headache Fatigue, dizziness, somnolence, sedation, nervousness, insomnia, psychomotor hyperactivity, seizures.

- Eye disorders - Blurred vision

- Cardiac disorders - Tachycardia, palpitations, QT prolongation

Vascular disorders - - Hypotension

Blood and lymphatic system disorders - Blood disorders including agranulocytosis, leucopenia, haemolytic anaemia, thrombocytopenia

- Respiratory, thoracic and mediastinal disorders Pharyngitis. - Dyspnoea

Gastrointestinal disorders Dry mouth Abdominal pain; vomiting, dyspepsia, diarrhoea, gastritis, anorexia.

- Hepato - biliary disorders - Hepatitis, elevations in liver enzymes, increased bilirubin. Jaundice

Ear and labyrinth disorders - - Tinnitus

Skin and subcutaneous tissue disorders - Rash, alopecia Photosensitivity

Musculoskeletal and connective tissue disorders - Myalgia - Reproductive system and breast disorders - Dysmenorrhoea - General disorders and administration site conditions Fatigue Asthenia

Investigations - - Weight increase

Description of selected adverse reactions

A reported observational safety study indicated an increased incidence of new-onset seizure in patients 0 to 19 years of age when receiving desloratadine as in DAZIT u00ae TABLETS compared with periods not receiving desloratadine. There have been reports of other undesirable effects that were reported during the post-marketing period such as cases of alcohol intolerance and intoxication (see section 4.5). Reports of cases with an unknown frequency in paediatric patients, which included QT prolongation, arrhythmia, bradycardia, abnormal behaviour, and aggression.

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 u201c6.04 Adverse Drug Reactions Reporting Formu201d found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

In the event of overdose, consider standard measures to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended. Desloratadine is not eliminated by hemodialysis; it is not known if it is eliminated by peritoneal dialysis.