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SPC, UK: ZANTAC Tablets (2016)

Αναφορές

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).Adverse ...

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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