DASERGIN Film-coated tablet Ref.[50435] Active ingredients: Desloratadine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: HCS bvba, H.Kennisstraat 53, Edegem 2650, Belgium

4.3. Contraindications

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

4.4. Special warnings and precautions for use

In the case of severe renal insufficiency, Dasergin should be used with caution (see section 5.2).

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

Dasergin contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

4.5. Interaction with other medicinal products and other forms of interaction

No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).

Paediatric population

Interaction studies have only been performed in adults.

In a clinical pharmacology trial desloratadine tablets 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.

4.6. Fertility, pregnancy and lactation

Pregnancy

A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformative nor foeto/ neonatal toxicity of desloratadine. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of desloratadine during pregnancy.

Breast-feeding

Desloratadine has been identified in breastfed newborns/infants of treated women. The effect of desloratadine on newborns/infants is unknown. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from desloratadine therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

There are no data available on male and female fertility.

4.7. Effects on ability to drive and use machines

Desloratadine has no or negligible influence on the ability to drive and use machines based on clinical trials. Patients should be informed that most people do not experience drowsiness. Nevertheless, as there is individual variation in response to all medicinal products, it is recommended that patients are advised not to engage in activities requiring mental alertness, such as driving a car or using machines, until they have established their own response to the medicinal product.

4.8. Undesirable effects

Summary of the safety profile

In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with desloratadine were 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 clinical trial with 578 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.

Tabulated list of adverse reactions

The frequency of the clinical trial adverse reactions reported in excess of placebo and other undesirable effects reported during the post-marketing period are listed in the following table. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

System Organ Class Frequency Adverse reactions seen with desloratadine
Metabolism and nutrition disorders Not known Increased appetite
Psychiatric disorders Very rare

Not known
Hallucinations

Abnormal behaviour, aggression
Nervous system disorders Common

Very rare
Headache

Dizziness, somnolence, insomnia, psychomotor
hyperactivity, seizures
Cardiac disorders Very rare

Not known
Tachycardia, palpitations

QT prolongation
Gastrointestinal disorders Common

Very rare
Dry mouth

Abdominal pain, nausea, vomiting, dyspepsia,
diarrhoea
Hepatobiliary disorders Very rare


Not known
Elevations of liver enzymes, increased bilirubin,
hepatitis

Jaundice
Skin and subcutaneous tissue disorders Not known Photosensitivity
Musculoskeletal and connective tissue disorders Very rare Myalgia
General disorders and administration site conditions Common

Very rare


Not known
Fatigue

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

Asthenia
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 retrospective observational safety study indicated an increased incidence of new-onset seizure in patients 0 to 19 years of age when receiving desloratadine 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 36.4 per 100,000 PY. (See section 4.4.)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie.

6.2. Incompatibilities

Not applicable.

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