4.1. Therapeutic indications

Telfast 30 mg is indicated in children aged 6 to 11 years for the relief of symptoms associated with seasonal allergic rhinitis.

4.2. Posology and method of administration

Posology

Paediatric population

• Children 6 to 11 years of age

The recommended dose of Fexofenadine hydrochloride in children aged 6 to 11 years is 30 mg twice daily.

• Children under 6 years of age

The efficacy of Fexofenadine hydrochloride has not been established in children under 6 years of age.

Special population

The safety and efficacy of Fexofenadine hydrochloride in renally or hepatically impaired children have not been established (see section 4.4). Studies conducted in adults in special risk groups (renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of Fexofenadine hydrochloride in adults.

4.3. Contraindications

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

4.4. Special warnings and precautions for use

The safety and efficacy of fexofenadine hydrochloride in renally or hepatically impaired children have not been established (see section 4.2). Fexofenadine hydrochloride should be administered with caution in these patients.

Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a drug class have been associated with the adverse events, tachycardia and palpitations (see section 4.8).

Telfast contains sodium

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

Interaction studies have only been performed in adults.

Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other medicinal products through hepatic mechanisms.

Fexofenadine is a P-glycoprotein (P-gp) and organic-anion-transporting polypeptide (OATP) substrate. Concomitant use of fexofenadine with P-gp inhibitors or inducers can affect the exposure to fexofenadine.

Co administration of fexofenadine hydrochloride with P-gp inhibitors, erythromycin or ketoconazole has been found to result in a 2-3 times increase in the level of Fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval and were not associated with any increase in adverse reactions compared to the medicinal products given singly.

A clinical drug-drug interaction study showed that co-administration of apalutamide (a weak inducer of P-gp) and a single oral dose of 30 mg fexofenadine resulted in a 30 % decrease in AUC of fexofenadine.

No interaction between Fexofenadine hydrochloride and omeprazole was observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to Fexofenadine hydrochloride caused a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of Fexofenadine hydrochloride and aluminium and magnesium hydroxide containing antacids.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no adequate data from the use of Fexofenadine hydrochloride in pregnant women. Limited animal studies do not indicate direct or indirect harmful effects with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Fexofenadine hydrochloride should not be used during pregnancy unless clearly necessary.

Breast-feeding

There are no data on the content of human milk after administering Fexofenadine hydrochloride. However, when terfenadine was administered to nursing mothers Fexofenadine was found to cross into human breast milk. Therefore Fexofenadine hydrochloride is not recommended for mothers breast-feeding their babies.

Fertility

No human data on the effect of fexofenadine hydrochloride on fertility are available. In mice, there was no effect on fertility with fexofenadine hydrochloride treatment (see section 5.3).

4.7. Effects on ability to drive and use machines

On the basis of the pharmacodynamic profile and reported adverse reactions it is unlikely that Fexofenadine hydrochloride tablets will produce an effect on the ability to drive or use machines.

In objective tests, Telfast has been shown to have no significant effects on central nervous system function. This means that patients may drive or perform tasks that require concentration. However, in order to identify sensitive people who have an unusual reaction to medicinal products, it is advisable to check the individual response before driving or performing complicated tasks.

4.8. Undesirable effects

The following frequency rating has been used, when applicable: very common ≥1/10; common ≥1/100 and <1/10; uncommon ≥1/1,000 and <1/100; rare ≥1/10,000 and <1/1,000; very rare <1/10,000 and not known (frequency cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

In controlled clinical trials in children aged 6 to 11 years, the most commonly reported adverse reaction considered at least possibly related to fexofenadine hydrochloride by the investigator was headache. The incidence of headache in pooled data from clinical trials was 1.0% for patients taking fexofenadine hydrochloride 30 mg (673 children) and for patients taking placebo (700 children). There are no clinical safety data in children treated with fexofenadine hydrochloride for periods longer than two weeks

In controlled clinical trials in 845 children aged 6 months to 5 years with allergic rhinitis, 415 children were administered 15 mg or 30 mg of fexofenadine hydrochloride (capsule content sprinkled onto dosing vehicle) and 430 children were administered placebo. There were no unexpected adverse events in the children treated with fexofenadine and the adverse event profile was similar to that of older children and adults (see section 4.2).

In adults, the following undesirable effects have been reported in clinical trials, with an incidence similar to that observed with placebo:

Nervous system disorders

Common: headache, drowsiness, dizziness

Eye disorders

Not known: Vision blurred

Gastrointestinal disorders

Common: nausea

General disorders and administration site conditions

Uncommon: fatigue

In adults, the following undesirable effects have been reported in post-marketing surveillance. The frequency with which they occur is not known (cannot be estimated from available data):

Immune system disorders

hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis

Psychiatric disorders

insomnia, nervousness, sleep disorders or nightmares/excessive dreaming (paroniria)

Cardiac disorders

tachycardia, palpitations

Gastrointestinal disorders

diarrhoea

Skin and subcutaneous tissue disorders

rash, urticaria, pruritus

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

Dizziness, drowsiness, fatigue and dry mouth have been reported with overdose of Fexofenadine hydrochloride. Doses up to 60 mg twice daily for two weeks have been administered to children, and single doses up to 800 mg and doses up to 690 mg twice daily for 1 month or 240 mg once daily for 1 year have been administered to healthy adult subjects without the development of clinically significant adverse reactions as compared with placebo. The maximum tolerated dose of Fexofenadine hydrochloride has not been established.

Standard measures should be considered to remove any unabsorbed medicinal product. Symptomatic and supportive treatment is recommended. Haemodialysis does not effectively remove Fexofenadine hydrochloride from blood.