STREPSILS MENTHOL LOZENGES

Posology Use the lowest dose for the shortest duration necessary to relieve symptoms.

Adults:

One lozenge to be dissolved slowly in the mouth every 2-3 hours up to a maximum of 12 lozenges in 24 hours.

Children over 12 years:

One lozenge to be dissolved slowly in the mouth every 2-3 hours up to a maximum of 8 lozenges in 24 hours.

Elderly:

There is no need for dosage reduction in the elderly.

Children under 12 years:

Not suitable for children under 12 years. Method of administration For oral administration. To be dissolved slowly in the mouth.

The list of the following adverse effects relates to those experienced with 2,4- dichlorobenzyl alcohol and amylmetacresol at OTC doses, in short term use. Adverse events which have been associated with 2,4-dichlorobenzyl alcohol and amylmetacresol are given below, tabulated by system organ class and frequency.

Frequencies are defined as:

Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

System Organ Class Frequency Adverse Events Immune System Disorders Not known Hypersensitivityab1 Gastrointestinal Disorders Not known Glossodyniaab, oral discomfortab a2,4-dichlorobenzyl alcohol bamylmetacresol 1 Hypersensitivity reactions may include rash, urticaria and angioedema, which may include swelling of the face, neck, throat or tongue that could affect breathing.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

If symptoms persist, have not improved, or have worsened after 3 days, consult a doctor or health care professional. 10 g per lozenge). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

• This medicine contains only very low levels of gluten (from wheat starch). It is regarded as ‘gluten-free’ and is very unlikely to cause problems if you have coeliac disease. 04 micrograms of gluten. If you have wheat allergy (different from coeliac disease) you should not take this medicine.

89 mg propylene glycol in each lozenge. • This medicine contains fragrance with Benzyl Alcohol, Cinnamyl Alcohol, Citral, Citranellol, d-Limonene, Eugenol and Linalool. Benzyl Alcohol, Cinnamyl Alcohol, Citral, Citranellol, d-Limonene, Eugenol and Linalool may cause allergic reactions.

• This medicine contains Sulphites – Sulphur Dioxide (E220) (present in liquid Glucose) which may rarely cause severe hypersensitivity reaction and bronchospasm.

Hypersensitivity to any of the ingredients.