BOOTS DECONGESTANT Tablets (2018)
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Περιεχόμενα
Name of the medicinal product
Decongestant Tablets.
Qualitative and quantitative composition
Active ingredient: Pseudoephedrine hydrochloride 60mg/tablet.
Pharmaceutical form
Tablets.
Therapeutic indications
For the relief of nasal and sinus congestion without causing drowsiness. For oral administration.
Posology and method of administration
Adults and children over 12 years One tablet if necessary, up to four times daily at intervals of not less than 4 hours. Children under 12 years Not recommended. Elderly There is no need for dosage reduction ...
Contraindications
Hypersensitivity to any of the ingredients. Avoid in patients with cardiovascular disease, hypertension, severe renal impairment, diabetes mellitus, closed angle glaucoma, hyperthyroidism, prostatic enlargement ...
Special warnings and precautions for use
Severe Skin reactions Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products. This acute pustular eruption may occur within the ...
Interaction with other medicinal products and other forms of interaction
Should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment. May enhance the effects of anticholinergic drugs such as tricyclic antidepressants. ...
Pregnancy and lactation
The safety of decongestant tablets during pregnancy and lactation has not been established but in view of a possible association of foetal abnormalities with first trimester exposure to pseudoephedrine, ...
Effects on ability to drive and use machines
No adverse effects known.
Undesirable effects
Adverse effects may include dry mouth, anxiety, restlessness, tremor, insomnia, tachycardia, cardiac arrhythmias, palpitations, hypertension, nausea, vomiting, headache and occasionally urinary retention ...
Overdose
Symptoms of overdosage include irritability, restlessness, palpitations, hypertension, difficulty in micturition, nausea, vomiting, thirst and convulsions. In severe overdosage gastric lavage and aspiration ...
Pharmacodynamic properties
Pseudoephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. It has alpha and beta adrenergic activity and some stimulant effect on the central nervous system. The ...
Pharmacokinetic properties
Pseudoephedrine is readily and completely absorbed from the gastrointestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted in the urine unchanged. It has an elimination ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
List of excipients
Sodium starch glycolate Maize starch prd Microcrystalline cellulose Pregelled maize starch Purified water Stearic acid
Incompatibilities
None are known.
Shelf life
Shelf life: 36 months.
Special precautions for storage
None.
Nature and contents of container
Blister pack of white or clear 250 microns PVC coated with 40gsm PVdC and 20 micron aluminium foil. Pack sizes: 6, 7, 10, 12 tablets.
Special precautions for disposal and other handling
None.
Marketing authorization holder
The Boots Company PLC, 1 Thane Road West, Nottingham, NG2 3AA
Marketing authorization number(s)
PL 00014/0375
Date of first authorization / renewal of the authorization
28 January 1988 / 17 December 1997 / 17 December 2002
Date of revision of the text
8 June 2018
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