This information is intended for use by health professionals

1. Name of the medicinal product

Strepsils Sore Throat and Blocked Nose Lozenges

Strepsils Sore Throat and Cough Lozenges

2. Qualitative and quantitative composition

Amylmetacresol BP

0.6mg

2,4-Dichlorobenzyl alcohol HSE

1.2mg

Levomenthol natural or synthetic EP

8.0mg

Excipient(s) with known effect:

• Liquid Glucose (containing Wheat Starch (containing Gluten) and Sulphites – Sulphur Dioxide (E220))

• Liquid Sucrose

• D-Limonene (present in Eucalyptus oil)

For a full list of excipients, see section 6.1.

3. Pharmaceutical form

A blue circular lozenge with a characteristic taste.

4. Clinical particulars
4.1 Therapeutic indications

For the symptomatic relief of mouth and throat infections, dry, irritating cough associated with the common cold and nasal congestion.

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.

Children over 6 years old:

As above for adults.

Elderly:

There is no need for dosage reduction in the elderly.

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.

Important information about some of the ingredients of this medicine

• This medicine contains sucrose (1.496g per lozenge) and glucose (1.013g 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. One lozenge contains no more than 20.26 micrograms of gluten. If you have wheat allergy (different from coeliac disease) you should not take this medicine.

• This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.

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

• This medicine contains fragrance with d-Limonene (Eucalyptus oil), d-limonene may cause allergic reactions.

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, 2,4-dichlorbenzyl alcohol and levomenthol.

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, levomenthol 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

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

Menthol has a mild local anaesthetic action on the throat and also relieves the symptoms of cough and nasal congestion.

5.2 Pharmacokinetic properties

None available.

5.3 Preclinical safety data

None available.

6. Pharmaceutical particulars
6.1 List of excipients

Liquid sucrose, liquid glucose (containing Wheat Starch (containing Gluten) and Sulphites – Sulphur Dioxide (E220)), tartaric acid gran 572 GDE, eucalyptus oil (containing d-Limonene), indigo carmine BP '73 (E132), water.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

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

18 months for blister pack 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 hard temper aluminium foil heat sealed to a PVC/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.

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

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 00063/0398

9. Date of first authorisation/renewal of the authorisation

06/04/2010

10. Date of revision of the text

04/05/2021