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 Strawberry Sugar Free Lozenges

1. NAME OF THE MEDICINAL PRODUCT

Strepsils Strawberry Sugar Free Lozenges

Amylmetacresol 600 micrograms

2,4-Dichlorobenzyl alcohol 1.2mg

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each Lozenge contains amylmetacresol 600 micrograms and 2,4-Dichlorobenzyl alcohol 1.2 mg.

Each lozenge also contains the excipients:

Maltitol syrup 457.6mg

Isomalt 1830.4mg

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Lozenge.

Pink, circular lozenge with a characteristic strawberry taste, embossed on both sides with Strepsils brand icon.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Strepsils Sugar Free are indicated for the symptomatic relief of mouth and throat infections including sore throat.

4.2 Posology and method of administration

Posology

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 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

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.

4.4 Special warnings and precautions for use

This product is not recommended for young children due to a risk of choking.

Contains maltitol syrup (E956). Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Consult your doctor if symptoms persist or if anything unusual happens.

4.5 Interaction with other medicinal products and other forms of interaction

Not applicable.

4.6 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

There is insufficient information on the excretion of amylmetacresol or 2,4-dichlorobenzyl alcohol metabolites in human milk. A risk to the newborns/infants cannot be excluded.

Fertility

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 Pharmacovigilance Section, Health Products Regulatory Authority, Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie

4.9 Overdose

In view of the nature and presentation of Strepsils Sugar Free Lozenges, accidental or deliberate overdosage is highly unlikely.

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 Strawberry Sugar Free lozenge base has a demulcent action providing throat soothing.

5.2 Pharmacokinetic properties

No data available.

5.3 Preclinical safety data

Not applicable.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Strawberry Flavour 052312B

Pink Antho (E163)

Sodium Saccharin (E954)

Tartaric Acid

Isomalt (E953)

Maltitol Syrup (E965)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

The lozenges are packed in blisters made up of white (opaque) 250 micron Polyvinyl Chloride (PVC), coated wth 90g/m2 Polyvinylidene Chloride (PVDC).

The blisters are heat sealed to 20 microns Aluminium lidding material coated with 7 g/m2 of heat sealing lacquer.

Each blister contains 6, 8, 10, 12, 16, 20 or 24 lozenges. Two trays are packed in a carton or for two lozenge sample two blisters are attached to a stencilled card.

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

7 Riverwalk

Citywest Business Campus

Dublin 24

8. MARKETING AUTHORISATION NUMBER(S)

PA 979/38/3

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 02 May 1997

Date of last renewal: 02 May 2007

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.