Demiltix 5 ml Syrup

DEMILTIX is indicated for symptomatic relief of seasonal types of allergy that present with symptoms such as rhinitis.

Children 2 to 5 years of age: 2,5 ml (1,25 mg) once a day, with or without food.
Children 6 to 11 years of age: 5 ml (2,5 mg) once a day, with or without food.
Adults and adolescents (12 years of age and over): 10 ml (5 mg) once a day, with or without food.
Patients with hepatic or renal impairment should be given 10 ml (5 mg) DEMILTIX on alternate days initially.

Hypersensitivity to active substance or to any of the excipients.
Pregnancy and lactation (see section 4.6).
Cross sensitivity to other antihistamines.
Porphyria.

Patients with the rare hereditary condition of sorbitol or maltitol intolerance should not take DEMILTIX.
Patients with hepatic or renal impairment should be given 5 mg DEMILTIX on alternate days initially.
DEMILTIX lacks significant sedative effects.
Efficacy and safety of DEMILTIX in children under 2 years of age has not been established.
Safety and efficacy of DEMILTIX has not been established for treatment periods in excess of 4 weeks.
DEMILTIX should be discontinued prior to skin tests allergen extracts as it may inhibit the cutaneous histamine response, thus producing false-negative results. DEMILTIX should be discontinued at least 48 hours before test.
DEMILTIX should be used with caution when one or more of the following medical conditions exist and/or patient is using other medication metabolised by the cytochrome P450 system: -emphysema, prostatic hypertrophy, narrow angle glaucoma, cardiovascular disorder, epilepsy or during acute attack of asthma.
H1 receptor antihistamines such as DEMILTIX have been shown to cause weight gain.
DEMILTIX contains sodium benzoate which may increase jaundice in newborn babies (up to 4 weeks old).

Concomitant use of DEMILTIX with alcohol did not potentiate the performance impairing effects of alcohol.
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%. Co-administration of desloratadine with erythromycin increased the C max of desloratadine by 24% and the AUC by 14%. The increase in C max and AUC of desloratadine when co-administered with either ketoconazole or erythromycin did not cause any clinically relevant adverse events in the population studied.

DEMILTIX should not be used during pregnancy (see u2018CONTRAINDICATIONSu2019).
DEMILTIX is distributed into breast milk therefore is not recommended for use during lactation (see u2018CONTRAINDICATIONSu2019).

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

At the recommended dose of 5 mg daily, undesirable effects with DEMILTIX were reported in 4% of patients in excess of those treated with placebo.
System organ class Frequent Less Frequent Frequency Unknown
Metabolism and nutritional disorder Increased appetite.
Nervous system disorders No excess incidence of somnolence was reported. Headache was reported in 2% of patients receiving DEMILTIX. Dizziness, fatigue, sedation, nervousness, blurred vision, confusion and nightmares.
Cardiac disorders Tachycardia, palpitations
Respiratory, thoracic and mediastinal disorders: Pharyngitis. Dyspnoea
Gastrointestinal disorders Dyspepsia, nausea, dry mouth.
Skin and subcutaneous tissue disorders Pruritis, rash, urticaria, alopecia.
Musculoskeletal and connective tissue disorders Myalgia
Reproductive system and breast disorders: Dysmenorrhoea
General disorders and administrative site conditions Fatigue Anaphylaxis, oedema
Investigations Elevations of liver enzymes and bilirubin have been reported.
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. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. May also report to Adcock Ingram Limited using the following email: [email protected]

In the event of overdosage, symptomatic and supportive treatment is recommended. Desloratadine is not eliminated by haemodialysis and it is not known if it is eliminated by peritoneal dialysis.