4.1. Therapeutic indications

Loratadine 10 mg Tablets are indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.

4.2. Posology and method of administration

Posology

Adults:

10 mg once daily (one tablet once daily).

Paediatric population

Children 6 years of age and older:

Bodyweight more than 30 kg: 10 mg once daily (one tablet once daily).

Bodyweight 30 kg or less: The 10 mg strength tablet is not appropriate in children with a body weight less than 30 kg.

Children under 6 years of age:

For appropriate dosing in children younger than 6 years or body weight of 30 kg or less, there are other formulations more suitable.

Children under 2 years of age:

Efficacy and safety of loratadine in children under 2 years of age has not been established. No data available.

Hepatic impairment

Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. An initial dose of 10 mg every other day is recommended for adults and children weighing more than 30 kg.

Renal impairment

No dosage adjustments are required in patients with renal insufficiency.

Elderly

No dosage adjustments are required in the elderly.

Method of administration

Oral use. The tablet may be taken without regard to mealtime.

4.3. Contraindications

Loratadine 10 mg Tablets are contraindicated in patients who are hypersensitive to the active substance or to any of the excipients in the formulation listed in section 6.1.

4.4. Special warnings and precautions for use

Loratadine 10 mg Tablets should be administered with caution in patients with severe liver impairment (see section 4.2).

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

The administration of Loratadine 10 mg Tablets should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.

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

When administered concomitantly with alcohol, Loratadine 10 mg Tablets have no potentiating effects as measured by psychomotor performance studies.

Potential interaction may occur with all known inhibitors of CYP3A4 or CYP2D6 resulting in elevated levels of loratadine (see Section 5.2), which may cause an increase in adverse events.

Increase in plasma concentrations of loratadine has been reported after concomitant use with ketoconazole, erythromycin, and cimetidine in controlled trials, but without clinically significant changes (including electrocardiographic).

Paediatric population

Interaction studies have only been performed in adults.

4.6. Fertility, pregnancy and lactation

Pregnancy

A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor feto/ neonatal toxicity of loratadine. 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 Loratadine 10 mg Tablets during pregnancy.

Breast-feeding

Loratadine is excreted in breast milk, therefore the use of loratadine is not recommended in breast-feeding women.

Fertility

There are no data available on male and female fertility.

4.7. Effects on ability to drive and use machines

In clinical trials that assessed driving ability, no impairment occurred in patients receiving loratadine. Loratadine 10 mg Tablets have no or negligible influence on the ability to drive and use machines. However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.

4.8. Undesirable effects

Summary of the safety profile

In clinical trials involving adults and adolescents in a range of indications including allergic rhinitis (AR) and chronic idiopathic urticaria (CIU), at the recommended dose of 10 mg daily, adverse reactions with loratadine were reported in 2% of patients in excess of those treated with placebo. The most frequent adverse reactions reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%).

Tabulated list of adverse reactions

The following adverse reactions reported during the post-marketing period are listed in the following table by System Organ Class. 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).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

System Organ Class

Frequency Adverse

Experience Term

Immune system disorders

Very rare

Hypersensitivity reactions (including angioedema and anaphylaxis)

Nervous system disorders

Very rare

Dizziness, convulsion

Cardiac disorders

Very rare

Tachycardia, palpitation

Gastrointestinal disorders

Very rare

Nausea, dry mouth, gastritis

Hepatobiliary disorders

Very rare

Abnormal hepatic function

Skin and subcutaneous

tissue disorders

Very rare

Rash, alopecia

General disorders and administration site conditions

Very rare

Fatigue

Investigations

Not known

Weight increase

Paediatric population

In clinical trials in a paediatric population, children aged 2 through 12 years, common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%).

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

4.9. Overdose

Overdosage with loratadine increased the occurrence of anticholinergic symptoms. Somnolence, tachycardia and headache have been reported with overdoses.

In the event of overdose, general symptomatic and supportive measures are to be instituted and maintained for as long as necessary. Administration of activated charcoal as a slurry with water may be attempted. Gastric lavage may be considered. Loratadine is not removed by haemodialysis and it is not known if loratadine is removed by peritoneal dialysis. Medical monitoring of the patient is to be continued after emergency treatment.