ZANTAC Tablets (2016)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Zantac Tablets 150 mg.
Qualitative and quantitative composition
Each tablet contains ranitidine 150 mg (as the hydrochloride). For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet.
Therapeutic indications
Adults Duodenal ulcer and benign gastric ulcer, including that associated with non-steroidal anti-inflammatory agents. Prevention of non-steroidal anti-inflammatory drug (NSAID) (including aspirin) associated ...
Posology and method of administration
Posology Adults (including the elderly) Usual dosage is 150 mg twice daily, taken in the morning and evening. Duodenal ulcer, gastric ulcer The standard dosage regimen is 150 mg twice daily or 300 mg at ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Malignancy The possibility of malignancy should be excluded before commencement of therapy in patients with gastric ulcer and in patients of middle age and over with new or recently changed dyspeptic symptoms) ...
Interaction with other medicinal products and other forms of interaction
Ranitidine has the potential to affect the absorption, metabolism or renal excretion of other drugs. The altered pharmacokinetics may necessitate dosage adjustment of the affected drug or discontinuation ...
Fertility, pregnancy and lactation
Pregnancy Ranitidine crosses the placenta but therapeutic doses administered to obstetric patients in labour or undergoing caesarean section have been without any adverse effect on labour, delivery or ...
Effects on ability to drive and use machines
None reported.
Undesirable effects
The following convention has been utilised for the classification of undesirable effects: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, ≤1/100), rare (≥1/10,000, ≤1/1000), very rare (≤1/10,000). ...
Overdose
Symptoms and signs Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage. Treatment Symptomatic and supportive therapy should be given as appropriate. ...
Pharmacodynamic properties
Pharmacotherapeutic group: H<sub>2</sub>-receptor antagonists ATC code: A02BA02 Mechanism of action Ranitidine is a specific rapidly acting histamine H<sub>2</sub>-antagonist. It inhibits basal and stimulated ...
Pharmacokinetic properties
Absorption Following oral administration of 150 mg ranitidine, maximum plasma concentrations (300 to 550 ng/mL) occurred after 1—3 hours. Two distinct peaks or plateau in the absorption phase result from ...
Preclinical safety data
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and ...
List of excipients
Tablet core: Microcrystalline cellulose NF Magnesium stearate EP Methylhydroxypropyl cellulose (E464) EP Film coat: Titanium Dioxide E171 EP Triacetin NF
Incompatibilities
Not applicable.
Shelf life
Shelf life: 36 months.
Special precautions for storage
Store below 25°C. Store in the original package in order to protect from moisture.
Nature and contents of container
Cartons of 30, 60 or 90 tablets, in aluminium foil strips or push through double foil blister packs.
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Glaxo Wellcome UK Limited, Trading as GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Marketing authorization number(s)
PL 10949/0042
Date of first authorization / renewal of the authorization
27 March 2002
Date of revision of the text
14<sup>th</sup> September 2016
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