This information is intended for use by health professionals

1. Name of the medicinal product

Strepsils

2. Qualitative and quantitative composition

Amylmetacresol

0.6mg

2,4-Dichlorobenzyl alcohol

1.2mg

For a full list of excipients, see section 6.1.

3. Pharmaceutical form

A red circular lozenge.

4. Clinical particulars
4.1 Therapeutic indications

For the symptomatic relief of mouth and throat infections.

4.2 Posology and method of administration

Posology

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

Adults

One lozenge every 2-3 hours up to a maximum of 12 lozenges in 24 hours.

Elderly:

There is no need for dosage reduction in the elderly.

Children over 6 years old:

As above for adults.

Children under 6 years old:

Not suitable for children under 6 years. (see section 4.4).

Method of Administration

For oral administration. To be dissolved slowly in the mouth.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

Not to be given to children under 6 years.

If symptoms persist, have not improved, or have worsened after 3 days, consult a doctor or health care professional.

Patients with rare hereditary problems of fructose intolerance, glucose-glalctose malabsorption or sucrose-isomaltose insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant interactions are known.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of amylmetacresol and 2,4-dichlorbenzyl alcohol.

As with all medicines care should be taken when using this product in pregnancy and medical advice sought if necessary.

Breast-feeding

It is unknown whether 2,4-dichlorobenzyl alcohol, amylmetacresol or metabolites are excreted in human milk. A risk to the newborns / infants cannot be excluded.

Fertility

No data are available regarding the effects on fertility.

4.7 Effects on ability to drive and use machines

No or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

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

Hypersensitivityab

Gastrointestinal Disorders

Not known

Glossodyniaab, oral discomfortab

a2,4-dichlorobenzyl alcohol bamylmetacresol

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.

4.9 Overdose

Overdosage should not present a problem other than gastrointestinal discomfort. Treatment should be symptomatic.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Throat Preparations; Antiseptics; ATC Code: R02AA03 Dichlorobenzyl alcohol.

2,4-Dichlorobenzyl alcohol and amylmetacresol have antiseptic properties.

5.2 Pharmacokinetic properties

None available.

5.3 Preclinical safety data

None available.

6. Pharmaceutical particulars
6.1 List of excipients

Star anise oil, peppermint oil, menthol natural or menthol synthetic, tartaric acid gran 571 GDE, ponceau 4R edicol E124, carmoisine edicol E122, solids from liquid sugar demin, (or from liquid sugar T & L T1001) and from liquid glucose, water (potable).

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

36 months for lozenges packed in blister strips within a carton.

24 months for blister packs attached to a stencilled card.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

A blister push-through pack consisting of 15 or 20μm hard temper aluminium foil heat-sealed to a 250μm PVC/40gms or 90gms PVDC blister. The tray contains an appropriate number of lozenges to give pack sizes of 6, 8, 10, 12, 16, 20, 24, 32 and 36 lozenges in a cardboard carton or a flow wrap composed of PET/aluminium foil/polyethylene.

A blister push-through pack consisting of 15 or 20μm hard-temper aluminium foil heat-sealed to a 250μm PVC/40gms or 90gms PVDC blister. Two, four or six blisters are attached to a stencilled card.

A blister push-through pack consisting of 15 or 20μm hard temper aluminium foil heat-sealed to a 250μm PVC/40gms or 90gms PVDC blister. The tray contains an appropriate number of lozenges to give a pack size of lozenges in a wrap around cardboard carton with tamper-evident seal.

6.6 Special precautions for disposal and other handling

Not applicable.

7. Marketing authorisation holder

Reckitt Benckiser Healthcare (UK) Ltd

Slough

SL1 3UH

8. Marketing authorisation number(s)

PL 00063/0396

9. Date of first authorisation/renewal of the authorisation

19/03/2010

10. Date of revision of the text

31/03/2017