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 Intensive Orange Sugar Free Lozenges

1. NAME OF THE MEDICINAL PRODUCT

Strepsils Intensive Orange Sugar Free 8.75mg Lozenges

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One lozenge contains 8.75 mg of flurbiprofen.

Also contains liquid maltitol (508.5mg/lozenge) and Isomalt (2034mg/lozenge), please refer to 4.4.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lozenge

A round pale lozenge with a characteristic orange taste with an icon intagilated on both sides.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

For the symptomatic relief of sore throats.

4.2 Posology and method of administration

Adults and children over the age of 12 years:

One lozenge sucked/dissolved slowly in the mouth every 3 – 6 hours as required. Maximum 5 lozenges in any 24 hour period. It is recommended that this product should be used for a maximum of three days.

Children: Not indicated for children under 12 years.

Elderly: No dose modification is required.

As with all lozenges, to avoid local irritation, Strepsils Intensive Lozenges should be moved around the mouth whilst sucking.

4.3 Contraindications

Hypersensitivity to flurbiprofen, aspirin, other NSAIDs or other lozenge ingredients. History of gastrointestinal bleeding or perforation related to previous NSAIDs therapy. Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of bronchospasm, rhinitis, or urticaria associated with aspirin or other NSAIDs.

Severe heart failure.

4.4 Special warnings and precautions for use

The use of Strepsils Intensive Lozenges with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.

Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms (See section 4.2, and GI and cardiovascular risks below).

Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2)

Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without any warning symptoms or a previous history of serious GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and 4.5).

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, aspirin and clopidrogrel, selective serotonin reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving Strepsils Intensive Lozenges, the treatment should be withdrawn.

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's Disease) as their condition may be exacerbated (see section 4.8 – undesirable effects).

Cardiovascular and cerebrovascular effects: Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for flurbiprofen when given at a daily dose of 8.75mg to 43.75mg per day.

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

Caution is required in patients with renal or hepatic impairment. Strepsils Intensive should not be taken with other NSAIDs.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see 4.8). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Strepsils Intensive Lozenges should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Bronchospasm maybe precipitated in patients suffering from, or with a previous history of, bronchial asthma or allergic reactions.

Flurbiprofen can prolong bleeding time and caution is required in patients with potential for abnormal bleeding.

The use of flurbiprofen may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of flurbiprofen should be considered.

This product contains liquid maltitol (508.5mg/lozenge) and Isomalt (2034mg/lozenge), patients with rare hereditary problems of fructose intolerance should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4).

Anti-coagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4).

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section4.4).

Studies have shown that the diuretic response to frusemide can occasionally be reduced by Flurbiprofen. Other studies have failed to show any interaction between Flurbiprofen and digoxin, tolbutamide or antacids.

4.6 Fertility, pregnancy and lactation

Whilst no teratogenic effects have been demonstrated in animal experiments, the use of Strepsils Intensive during pregnancy should, if possible, be avoided. The onset of labour may be delayed and duration of labour increased. In limited studies, Flurbiprofen appears in the breast milk in very low concentrations and is unlikely to affect the breast-fed infant adversely.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4 –Special warnings and precautions for use) have been reported following administration. Less frequently, gastritis has been observed.

Cardiovascular: Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Cardiovascular and cerebrovascular effects: Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

Skin reactions: Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare).

Bronchospasm may be precipitated in patients with a history of aspirin-sensitive asthma.

A sensation of warmth or tingling in the mouth on sucking the lozenge have been reported in clinical trials with Strepsils Intensive.

4.9 Overdose

Symptoms of overdose may include nausea, vomiting, gastrointestinal irritation and drowsiness, blurred vision and dizziness. Treatment should consist of gastric lavage and if necessary correction of serum electrolytes.

There is no specific antidote to flurbiprofen.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Respiratory System; Throat preparations; Other throat preparations. ATC Code: R02AX01

Flurbiprofen is a propionic acid derivative NSAID which acts through inhibition of prostaglandin synthesis. In humans flurbiprofen has potent analgesic, antipyretic and anti-inflammatory properties and the 8.75mg dose dissolved in artificial saliva has been shown to reduce prostaglandin synthesis in cultured human respiratory cells.

According to studies using the whole body assay, flurbiprofen is a mixed COX-1/COX-2 inhibitor with some selectivity towards COX-1. Pre-clinical studies suggest that the R (-) enantiomer of flurbiprofen and related NSAIDs may relieve pain by acting on the central nervous system.

Reduction in throat soreness was observed after 15 minutes while onset of pain relief and reduction of throat swelling was observed 30 minutes after taking a lozenge. Duration of action extended up to 3 hours.

A single dose of flurbiprofen 8.75mg delivered locally to the throat in a lozenge has been demonstrated to relieve sore throat, including swollen and inflamed sore throats through a significant reduction (LS Mean Difference) in sore throat pain intensity from 22 minutes (-5.5mm), reaching a maximum at 70 minutes (-13.7mm) and remaining significant for up to 240 minutes (-3.5mm) including patients with streptococcal and non-streptococcal infections, reduction in difficulty swallowing from 20 minutes (-6.7mm), reaching a maximum at 110 minutes (-13.9mm) and for up to 240 minutes (-3.5mm) and reduction in the feeling of a swollen throat at 60 minutes (-9.9mm), reaching a maximum at 120 minutes (-11.4mm) and for up to 210 minutes (-5.1mm).

Multiple dose efficacy measured using Sum of Pain Intensity Differences (SPID) over 24 hours has demonstrated significant reduction in sore throat pain intensity (-473.7mm*h to -529.1mm*h), difficulty swallowing (-458.4mm*h to -575.0mm*h) and swollen throat (-482.4mm*h to -549.9mm*h) with statistically significant greater summed reduction in pain at each hourly interval over 23 hours for all three measures and statistically significantly greater sore throat relief each hour over the 6 hour assessment time. Efficacy of multiple doses after 24 hours and over 3 days has also been demonstrated.

For those patients taking antibiotics for streptococcal infection, there was statistically significant greater relief of sore throat pain intensity for flurbiprofen 8.75mg from 7 hours and onwards after antibiotics were taken. The analgesic effect of flurbiprofen 8.75 mg was not reduced by the administration of antibiotics to treat patients with streptococcal sore throat.

At 2 hours post first dose, flurbiprofen 8.75mg lozenges provided significant resolution of some of the associated symptoms of sore throat present at baseline including coughing (50% vs 4%), loss of appetite (84% vs 57%) and feverishness (68% vs 29%). The lozenge format dissolves in the mouth over 5 - 12 minutes and provides a measurable soothing and coating effect at 2 minutes.

Paediatric population

No specific studies in children have been undertaken. Efficacy and safety studies on flurbiprofen 8.75mg lozenges have included children aged 12-17 years, although small sample size means that no statistical conclusions can be drawn.

5.2 Pharmacokinetic properties

Flurbiprofen is rapidly absorbed following the use of Flurbiprofen Lozenges with plasma concentrations peaking at 30 – 40 minutes. Peak concentrations are achieved more rapidly than, but are of similar magnitude to, those achieved after an equivalent swallowed dose.

Flurbiprofen is rapidly distributed throughout the body. It is mainly metabolised by hydroxylation and excreted via the kidneys.

It is extensively bound to plasma proteins and has an elimination half-life of 3 to 6 hours.

The duration of effect for the flurbiprofen lozenge is over 6 hours with reduction in throat soreness maintained up to 4 hours.

Flurbiprofen is excreted in very small amounts in human milk (less than 0.05 μg/ml).

5.3 Preclinical safety data

In rats exposed to 0.4 mg/Kg/day and above during pregnancy an increased incidence of stillborn pregnancy has been observed. However, the relevance of this fact to humans is doubtful and not reflected in human experience with flurbiprofen so far.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Macrogol 300

Potassium Hydroxide

Orange Flavour

Levomenthol

Acesulfame Potassium

FD & C Yellow No 6

Liquid Maltitol

Isomalt

6.2 Incompatibilities

Not applicable

6.3 Shelf life

2 years

6.4 Special precautions for storage

Do not store above 25°C. Store in the Original package in order to protect from moisture.

6.5 Nature and contents of container

A push through strip consisting of 250 microns opaque PVC/PVdC (polyvinylchloride/polyvinyl di-chloride) blister, heat sealed to hard tempered 20 micron aluminium foil, containing 16 lozenges.

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)

979/41/4

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

04th July 2014

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.