It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.

Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

Summary of Product Characteristics last updated on medicines.ie: 22/5/2017

Strepsils Honey and Lemon

1. NAME OF THE MEDICINAL PRODUCT

Strepsils Honey and Lemon Lozenges

Amylmetacresol 0.6mg

2,4-Dichlorobenzyl Alcohol 1.2mg

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each lozenge contains Amylmetacresol 600 micrograms and 2,4-Dichlorobenzyl alcohol 1.2mg

Excipients: Contains 1.441g sucrose, 976mg glucose

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Lozenge

A yellow circular lozenge with a taste of honey and lemon, embossed on both sides with Strepsils brand icon.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

For the symptomatic relief of mouth and throat infections.

4.2 Posology and method of administration

Posolgy

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. It is recommended that the product should be used for a maximum of 3 days.

Adults:

One lozenge to be dissolved slowly in the mouth every 2 – 3 hours. Do not take more than 12 lozenges in 24 hours.

Paediatric population:

Children over 6 years of age: As above for adults.

Children under 6 years of age: Not suitable for children under 6 years (see section 4.4.

Elderly: There is no need for dosage reduction in the elderly.

Method of administration

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

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

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

4.4 Special warnings and precautions for use

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.

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 (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.

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.

However, animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

4.7 Effects on ability to drive and use machines

No adverse effects are known.

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. 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

Hypersensitivity

Gastrointestinal Disorders

Not known

Abdominal pain, nausea, oral discomfort

Skin and Subcutaneous Tissue Disorders

Not known

rash

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie

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.

Mechanism of action

2,4-Dichlorobenzyl alcohol and amylmetacresol are antiseptics and possess antibacterial, antifungal and antiviral properties. Both AMC and DCBA also reversibly block depolarisation-induced ion channels in a similar way to local anaesthetics. When the two active agents are combined, a synergistic antibacterial action is observed leading to the reduced combined dose used in Strepsils lozenges.

Clinical efficacy and safety

Evidence of an analgesic effect for Strepsils in reducing throat soreness, providing pain relief and relief from difficulty in swallowing has been demonstrated to clinical studies with an onset in 5 minutes which lasts for up to 2 hours. Significantly more relief than nonmedical lozenge was also demonstrated for up to 3 days treatment.

Strepsils lozenge have also been shown to significantly decrease postoperative throat soreness and hoarseness 20 minutes and 24 hours after intubation.

A study in children (6-16 years) with acute and recurring chronic sore throat demonstrates a reduction in subjective and objective signs of sore throat over 3 days.

Strepsils Honey and Lemon lozenge base has a demulcent action providing throat soothing.

5.2 Pharmacokinetic properties

None available.

5.3 Preclinical safety data

None available.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Honey

Tartaric Acid

Peppermint Oil

Terpeneless Lemon Oil

Quinoline yellow (E104)

Sucrose

Glucose Syrup

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years for 24 lozenge pack and 8 lozenge pack.

18 months for 2 lozenge pack.

3 years for lozenges packed in polypropylene tube, with an in use shelf-life of 'use within 3 months of opening.

6.4 Special precautions for storage

Blister pack: Do not store above 25°C.

Polypropylene tube - do not store above 25°C. Keep the tube tightly closed in order to protect from moisture.

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.

24 lozenge pack: Each blister contains 12 lozenges. Two trays are packed in a carton.

36 lozenge pack: Each blister contains 12 lozenges. Three trays are packed in a carton.

8 lozenge pack: One tray contains 8 lozenges in a wrap around cardboard carton with tamper-evident seal.

2 lozenge sample pack: Two blisters are attached to a stencilled card.

10 lozenge tube: An injection moulded white pigmented polypropylene tube fitted with a plastic spring with an injection moulded white polyethylene cap (containing white silica gel that is sealed with a white cardboard disc).

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Ireland Ltd

7 Riverwalk

Citywest Business Campus

Dublin 24

8. MARKETING AUTHORISATION NUMBER(S)

PA 979/38/2

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 16 October 1986

Date of last renewal: 16 October 2006

10. DATE OF REVISION OF THE TEXT

April 2017

It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.