Deseblok 0.5 mg/ml Oral solution

DESEBLOK 0.5 mg/ml is indicated for the relief of symptoms associated with allergic rhinitis (AR). DESEBLOK 0.5 mg/ml 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) DESEBLOK 0.5 mg/ml oral solution once a day.

Children 6 to 11 years of age: 5 ml (2,5 mg) DESEBLOK 0.5 mg/ml oral solution once a day.

Adults and adolescents (12 years of age and over): 10 ml (5 mg) DESEBLOK 0.5 mg/ml oral solution once a day.

Method of administration

Oral use. The dose can be taken with or without food.

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

DESEBLOK 0.5 mg/ml should be administered with caution in patients with a medical or family history of seizures, and mainly young children (see section 4.8), being more susceptible to develop new seizures with desloratadine treatment. Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment.

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 years old are phenotypic poor metabolisers of desloratadine and exhibit a higher exposure (see section 5.2). The safety of desloratadine, as in DESEBLOK 0.5 mg/ml in children 2 to 11 years of age who are poor metabolisers, is the same as in children who are normal metabolisers. The effects of desloratadine in poor metabolisers < 2 years of age have not been studied. In the case of severe renal insufficiency, DESEBLOK 0.5 mg/ml should be used with caution (see section 5.2). DESEBLOK 0.5 mg/ml contains 150 mg sorbitol per ml. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicines for oral use may affect the bioavailability of other medicines for oral use administered concomitantly. DESEBLOK 0.5 mg/ml contains propylene glycol 750 mg/5 ml.

No clinically relevant interactions were observed in clinical trials with desloratadine in which erythromycin or ketoconazole were co-administered (see section 5.1). There was no effect of food or grapefruit juice on the disposition of desloratadine. Co-administration of desloratadine with azithromycin resulted in an increase of both C max (31 %) and AUC (12 %) of azithromycin. Co-administration of fluoxetine with desloratadine 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-OH desloratadine respectively. The C max and AUC of fluoxetine were 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.

Paediatric population

Interaction studies have only been performed in adults. In a clinical pharmacology trial, desloratadine taken concomitantly with alcohol did not potentiate the performance-impairing effects of alcohol (see section 5.1). However, cases of alcohol intolerance and intoxication have been reported during post-marketing use. Therefore, caution is recommended if alcohol is taken concomitantly.

Pregnancy

The safe use of DESEBLOK 0.5 mg/ml oral solution during pregnancy has not been established. The use of DESEBLOK 0.5 mg/ml oral solution during pregnancy is therefore not recommended. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

Breastfeeding

Desloratadine is excreted into breast milk, therefore the use of DESEBLOK 0.5 mg/ml oral solution is not recommended in woman who are breastfeeding their infants. The effect of desloratadine on newborns/infants is unknown.

DESEBLOK 0.5 mg/ml oral solution has no or negligible influence on the ability to drive a vehicle or operate machines. However, a small number of individuals may experience dizziness or sedation (see section 4.8). Patients should be advised to take special care when performing tasks requiring their attention, until they are reasonably certain that their performance is not affected by DESEBLOK 0.5 mg/ml.

Paediatric population

The most frequently occurring adverse event reported was headache.

Adults and adolescents

The most frequently occurring adverse events reported were fatigue, dry mouth and headache.

System organ class

Frequency Adverse reactions

Metabolism and nutrition disorders

Frequency unknown Increased appetite

Psychiatric disorders

Less frequent Hallucinations

Frequency unknown Abnormal behaviour, aggression

Nervous system disorders

Frequent Headache

Frequent (children less than 2 years) Insomnia

Less frequent Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures

Cardiac disorders

Less Frequent Tachycardia, palpitations.

Frequency unknown: QT prolongation

Gastrointestinal disorders

Frequent Dry mouth

Frequent (children less than 2 years) Diarrhoea

Less frequent Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea

Hepatobiliary disorders

Less frequent Elevations of liver enzymes, increased bilirubin, hepatitis

Frequency unknown Jaundice

Skin and subcutaneous tissue disorders

Frequency unknown Photosensitivity

Musculoskeletal, connective tissue and bone disorders

Less frequent Myalgia

General disorders and administrative site conditions

Frequent Fatigue

Frequent (children less than 2 years) Fever

Less frequent Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria)

Frequency unknown Asthenia

Investigations

Frequency unknown Increase in body mass

Post-marketing studies

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

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after authorisation of DESEBLOK 0.5 mg/ml is important. It allows continued monitoring of the benefit/risk balance of DESEBLOK 0.5 mg/ml. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u201cAdverse 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 haemodialysis; it is not known if it is eliminated by peritoneal dialysis.