Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Reckitt Benckiser Ireland Ltd, 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Strepsils Strawberry Sugar Free Lozenges are contraindicated in persons who have previously shown hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
This product is not recommended for young children due to a risk of choking.
Consult your doctor if symptoms persist or if anything unusual happens.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’.
This medicine contains 7.30 mg propylene glycol (present in strawberry flavour) in each lozenge.
This medicine also contains 1.83 g isomalt and 0.458 g maltitol liquid. Patients with rare hereditary problems of fructose intolerance should not take this medicine. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May have a mild laxative effect. Calorific value 2.3 kcal/g.
This medicine contains 0.0028 mg benzyl alcohol in each lozenge which may cause allergic reactions.
Not applicable.
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of amylmetacresol and 2,4-dichlorobenzyl alcohol in pregnant women. As a precautionary measure, it is preferable to avoid the use of Strepsils during pregnancy.
There is insufficient information on the excretion of amylmetacresol or 2,4-dichlorobenzyl alcoholmetabolites in human milk. A risk to the newborns/infants cannot be excluded.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
No adverse effects are known.
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. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.
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 | Hypersensitivity1 |
| Gastrointestinal Disorders | Not known | Abdominal pain, nausea, oral discomfort2 |
| Skin and Subcutaneous Tissue Disorders | Not known | Rash |
1 Hypersensitivity reactions may present in the form of rash, angioedema, urticaria, bronchospasms and hypotension with syncope.
2 Oral discomfort may present in the form of throat irritation, oral paraesthesia, oedema of the mouth and glossodynia.
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.
Not applicable.
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