PIRITON Tablet (2021)
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Περιεχόμενα
Name of the medicinal product
Piriton Tablets.
Qualitative and quantitative composition
Each tablet contains 4 milligrams of chlorphenamine maleate. Round, circular, biconvex, yellow tablets engraved with a P to one side of the breakline; the reverse face has a breakline only.
Pharmaceutical form
Tablet. The tablet can be divided into equal doses.
Therapeutic indications
Piriton tablets are indicated for symptomatic control of all allergic conditions responsive to antihistamines, including hay fever, vasomotor rhinitis, urticaria, angioneurotic oedema, food allergy, drug ...
Posology and method of administration
Oral Administration only Do not exceed the stated dose or frequency of dosing Minimum dosing interval: 4 hours Do not use continuously for more than two weeks without consulting a doctor. Adults and children ...
Contraindications
Piriton tablets are contra-indicated in patients who are hypersensitive to antihistamines or to any of the tablet ingredients. The anticholinergic properties of chlorphenamine are intensified by monoamine ...
Special warnings and precautions for use
Chlorphenamine, in common with other drugs having anticholinergic effects, should be used with caution in epilepsy; raised intra-ocular pressure including glaucoma; prostatic hypertrophy; severe hypertension ...
Interaction with other medicinal products and other forms of interaction
Concurrent use of chlorphenamine and hypnotics or anxiolytics may cause an increase in sedative effects, concurrent use of alcohol may have a similar effect therefore medical advice should be sought before ...
Pregnancy and lactation
Pregnancy There are no adequate data from the use of chlorphenamine maleate in pregnant women. The potential risk for humans is unknown. Use during the third trimester may result in reactions in the newborn ...
Effects on ability to drive and use machines
The anticholinergic properties of chlorphenamine may cause drowsiness, dizziness, blurred vision and psychomotor impairment, which can seriously hamper the patients' ability to drive and use machinery. ...
Undesirable effects
The following convention has been utilised for the classification of the frequency of adverse reactions: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to ...
Overdose
Symptoms and signs The estimated lethal dose of chlorphenamine is 25 to 50mg/kg body weight. Symptoms and signs include sedation, paradoxical excitation of the CNS, toxic psychosis, convulsions, apnoea, ...
Pharmacodynamic properties
ATC Code: R06AB02 Chlorphenamine is a potent antihistamine (H<sub>1</sub>-antagonist). Antihistamines diminish or abolish the actions of histamine in the body by competitive reversible blockade of histamine ...
Pharmacokinetic properties
Chlorphenamine is well absorbed from the gastro-intestinal tract, following oral administration. The effects develop within 30 minutes, are maximal within 1 to 2 hours and last 4 to 6 hours. The plasma ...
Preclinical safety data
No additional data of relevance.
List of excipients
Lactose Maize starch Yellow iron oxide (E172) Magnesium stearate Purified water
Incompatibilities
None reported.
Shelf life
3 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
The tablets are supplied in securitainers containing 50 or 500 tablets or blister packs containing 30, 45, 60 or 100 tablets.
Special precautions for disposal and other handling
For detailed instructions for use refer to the Patient Information Leaflet in every pack.
Marketing authorization holder
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UNITED KINGDOM
Marketing authorization number(s)
PL 44673/0092
Date of first authorization / renewal of the authorization
14/02/1997 / 27/10/2005
Date of revision of the text
12<sup>th</sup> January 2021
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