STREFEN HONEY AND LEMON Lozenge Ref.[8117] Active ingredients: Flurbiprofen

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Reckitt Benckiser Healthcare (UK) Ltd, 103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom

Therapeutic indications

Strefen Honey and Lemon are indicated for the short term symptomatic relief of sore throat in adults and children over the age of 12 years.

Posology and method of administration

Posology

Adults, the elderly 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 a 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

A general dose recommendation cannot be given, since to date clinical experience is limited. The elderly are at increased risk of the serious consequences of adverse reactions.

Impaired hepatic

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

Impaired renal

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

Method of administration

For oromucosal administration and short-term use only.

As with all lozenges, to avoid local irritation, Strefen Honey and Lemon should be moved around the mouth whilst sucking.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4).

Overdose

Symptoms

Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. 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 or gastric lavage and if necessary correction of serum electrolytes and if the patient presents within 1 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.

Shelf life

36 months.

Special precautions for storage

Store in the original package.

Nature and contents of container

A push through strip consisting of 250 microns opaque PVC/PVdC (polyvinyl chloride/polyvinyl di-chloride) blister, heat sealed to hard tempered 20 micron aluminium foil. Blisters are enclosed in a cardboard carton in pack sizes of 2, 4, 6, 8, 10, 12, or 16 lozenges.

Special precautions for disposal and other handling

None.

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