4.1. Therapeutic indications

Neoclarityn is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with:

- allergic rhinitis (see section 5.1)

- urticaria (see section 5.1)

4.2. Posology and method of administration

Posology

Adults and adolescents (12 years of age and over)

The recommended dose of Neoclarityn is one tablet once a day.

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 patient's disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance. In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.

Paediatric population

There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12 through 17 years of age (see sections 4.8 and 5.1).

The safety and efficacy of Neoclarityn 5 mg film-coated tablets in children below the age of 12 years have not been established.

Method of administration

Oral use.

The dose can be taken with or without food.

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

Renal function impairment

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

Seizures

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.

Neoclarityn tablet contains lactose

Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

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, Neoclarityn 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 Neoclarityn 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 Neoclarityn 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

Neoclarityn 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 Neoclarityn 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 Neoclarityn

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

The adverse event profile associated with overdosage, as seen during post-marketing use, is similar to that seen 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 multiple dose clinical trial, in which up to 45 mg of desloratadine was administered (nine times the clinical dose), no clinically relevant effects were observed.

Paediatric population

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