STREPSILS INTENSIVE Lozenge Ref.[50291] Active ingredients: Flurbiprofen

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Reckitt Benckiser Ireland Ltd, 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

4.1. Therapeutic indications

For the symptomatic relief of sore throats.

Strepsils Intensive Lozenges are indicated in adults and adolescents over 12 years of age.

4.2. Posology and method of administration

Posology

Treatment should be administered for the shortest duration necessary to control symptoms. It is recommended that this product should be used for a maximum of three days.

Adults

One lozenge sucked/dissolved slowly in the mouth every 3-6 hours as required. Maximum 5 lozenges in any 24 hour period.

Paediatric population

Adolescents over the age of 12 years: As above for adults

Children: Not indicated for children under 12 years (see section 4.3).

Elderly

No dose modification is required.

The elderly are at increased risk of the serious consequences of adverse reactions to NSAIDs (see section 4.4).

Hepatic impairment: In patients with mild to moderate hepatic impairment, no dose reduction is required. In patients with severe hepatic insufficiency flurbiprofen is contraindicated (see section 4.3).

Renal impairment: In patients with mild to moderate renal impairment, no dose reduction is required. In patients with severe renal insufficiency flurbiprofen is contraindicated (see section 4.3).

Method of administration

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

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 If mouth irritation occurs, treatment should be withdrawn.

4.9. Overdose

Symptoms

Most patients who have ingested clinically important amounts of NSAIDs will develop symptoms of overdose that may include nausea, vomiting, epigastric pain, gastrointestinal irritation or more rarely diarrhoea, drowsiness, blurred vision and dizziness. Tinnitus, headache, and gastrointestinal bleeding are also possible.

In more serious poisoning with NSAIDs, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation, blurred vision and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning with NSAIDs metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Management

Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal and if necessary correction of serum electrolytes if the patient presents within one hour of ingestion or a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

There is no specific antidote to flurbiprofen.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

Lozenges are packed in blisters made up of white opaque 250micron Polyvinyl Chloride (PVC), coated with 40gsm or 90gsm Polyvinylidene Chloride (PVDC); heat sealed to 20 microns Aluminium lidding material coated with 7gsm of heat sealing lacquer containing 16 lozenges.

6.6. Special precautions for disposal and other handling

No special requirements.

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