Strepsils Extra Blackcurrant Lozenges

As an antiseptic and local anaesthetic for the relief of sore throat and its associated pain.

Posology

Adults: One lozenge every three hours or as required. Do not take more than 12 lozenges in 24 hours. Duration of therapy should be limited to a maximum of 3 days.

Paediatric Population:

Children of 6 years and over: Same as for adults.

Not to be given to children under 6 years.

Elderly Population:

No dosage adjustment is considered necessary in the elderly.

Method of administration

For oral administration. Allow the lozenge to dissolve slowly in the mouth.

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

If symptoms do not improve or worsen within 3 days, consult a healthcare professional.

The label will convey:

Keep out of the sight and reach of children.

If symptoms persist consult your doctor.

Not to be given to children under 6 years.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This product may cause allergic reactions.

None known.

There is a lack of evidence of safety of the product in human pregnancy and in animals, but hexylresorcinols has been widely used in lozenges for many years without apparent ill consequence.

Pregnancy

The product should be used with caution during pregnancy. There are no or limited amount of data from the use of hexylresorcinol in pregnant women. No effects during pregnancy are anticipated.

Breast-feeding

The product should be used with caution during breast-feeding. It is unknown whether hexylresorcinol/metabolites are excreted in human milk. No effects on the breastfed newborn/infant are anticipated.

Fertility

There are no data available regarding the use of hexylresorcinol on male or female fertility. No effects on fertility are anticipated.

The product has no or negligible influence on the ability to drive and use machines.

None known.

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

Symptoms

Hexylresorcinol over-dosage may cause minor gastrointestinal irritation.

Management

Treatment would be withdrawal of the product and symptomatic measures as appropriate.

Pharmacotherapeutic group: Throat preparations, antiseptics; ATC Code: R02AA12

Hexylresorcinol is a phenol derivative and local anaesthetic for topical use on the mucous membranes of the mouth and throat. The local anaesthetic-like properties of hexylresorcinol are due, at least in part, to sodium channel-blocking effects. Mild antiseptic activity has also been demonstrated. The product base has a demulcent action.

Pharmacokinetic considerations do not arise since the pharmacological action is local to the oro-pharangeal cavity.

There is no pre-clinical data of relevance additional to those already included in other section of the SPC.

Liquid Glucose

Liquid Sucrose

Blackcurrant flavour (containing propylene glycol)

Levomenthol

Carmoisine edicol (E122)

Patent Blue V (E131)

Not applicable.

3 years

Do not store above 30°C. Store in the original packaging.

Blister packs of 250 micron PVC coated 40 gsm PVdC with 20 micron hard temper aluminium foil, heat sealed to the PVC/PVDC blister.

24 lozenges in two blister strips in a carton.

No special requirements