STREFEN HONEY AND LEMON Lozenge (2021)
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Περιεχόμενα
Name of the medicinal product
Strefen Honey and Lemon.
Qualitative and quantitative composition
Active ingredient flurbiprofen 8.75mg. <u>Excipient(s) with known effect:</u> Glucose Sucrose Wheat Starch* Sulphites – sulphur Dioxide (E220)* d-Limonene** Linalool** Citral** Citronellol** Farnesol** ...
Pharmaceutical form
Lozenge. A round, pale yellow to brown lozenge with an icon intagliated on both sides of the lozenge.
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 ...
Contraindications
Hypersensitivity to flurbiprofen or any of the excipients in the product. Patients who have previously shown hypersensitivity reactions (e.g. asthma, bronchospasm, rhinitis, angioedema, or urticaria) in ...
Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. Elderly population The elderly have an increased frequency of adverse reactions ...
Interaction with other medicinal products and other forms of interaction
<b>Flurbiprofen should be avoided in combination with:</b> Other NSAIDS including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of ...
Fertility, pregnancy and lactation
Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use of machines have been performed.
Undesirable effects
Hypersensitivity reactions to NSAIDs have been reported and these may consist of: non-specific allergic reactions and anaphylaxis respiratory tract reactivity e.g. asthma, aggravated asthma, bronchospasm, ...
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 ...
Pharmacodynamic properties
Pharmacotherapeutic Group: Throat preparations, other throat preparations ATC Code: R02AX01 Flurbiprofen is a propionic acid derivative NSAID which acts through inhibition of prostaglandin synthesis. In ...
Pharmacokinetic properties
Absorption Flurbiprofen 8.75mg lozenges dissolve over 5–12 minutes and the flurbiprofen is readily absorbed, with detection in the blood at 5 minutes and plasma concentrations peaking at 40-45 minutes ...
Preclinical safety data
There are no preclinical data of relevance additional to information already included in other relevant sections.
List of excipients
Macrogol 300 Potassium hydroxide Lemon flavour (d-Limonene, Citral, Citronellol, Farnesol, Geraniol, Linalool and Butylated Hydroxyanisole (E320)) Levomenthol Liquid sucrose Liquid glucose (Wheat Starch, ...
Incompatibilities
Not applicable.
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 ...
Special precautions for disposal and other handling
None.
Marketing authorization holder
Reckitt Benckiser Healthcare (UK) Ltd, 103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom
Marketing authorization number(s)
PL 00063/0714
Date of first authorization / renewal of the authorization
19/09/2006
Date of revision of the text
15/03/2021
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