VOCASEPT SUGAR FREE STRAWBERRY FLAVOUR

Posology Use the lowest dose for the shortest duration necessary to relieve symptoms. Adults: 1 lozenge every 2 or 3 hours, as needed, up to a maximum of 12 lozenges in 24 hours. Paediatric population Children over 6 years: as above for adults.

Vocasept sugar free strawberry flavour should not be used in children under 6 years of age. 4) Elderly: Adjustment of the dose is not required. The prolonged use of this medicine for more 3 days is not recommended. Method of administration For oromucosal use Allow the lozenge to dissolve slowly in the mouth.

Do not swallow, chew or bite. Lozenges should not be used just before or during meals.

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 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

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.

The use of Vocasept sugar free strawberry flavour is not recommended for children under 6 years of age. If symptoms persist, have not improved, or have worsened after 3 days, consult a doctor or health care professional.

Excipients with known effect:

Vocasept sugar free strawberry flavour may have a mild laxative effect. 3 kcal/g maltitol and isomalt. Patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicinal product contains less than 1 mmol sodium (23 mg) per lozenge, that is to say essentially "Sodium-free".

22 mg of propylene glycol per lozenge (present in strawberry flavour). This medicinal product contains Ponceau 4R and may cause allergic reactions.

1.