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SPC, UK: RABEPRAZOLE ACCORD Gastro-resistant tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Rabeprazole 10mg Gastro-resistant Tablets.

Qualitative and quantitative composition

Rabeprazole 10mg gastro-resistant tablet contains rabeprazole sodium 10mg corresponding to 9.42mg rabeprazole. For the full list of excipients, see section 6.1.

Pharmaceutical form

Gastro-resistant tablet. 10mg: Pink, coated, elliptical, biconvex tablet.

Therapeutic indications

Rabeprazole 10mg Gastro-resistant Tablets are indicated for the treatment of: Active duodenal ulcer. Active benign gastric ulcer. Symptomatic erosive or ulcerative gastro-oesophageal reflux disease (GORD). ...

Posology and method of administration

Posology Adults/elderly Active Duodenal Ulcer and Active Benign Gastric Ulcer The recommended oral dose for both active duodenal ulcer and active benign gastric ulcer is 20 mg to be taken once daily in ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pregnancy. Breast feeding.

Special warnings and precautions for use

Symptomatic response to therapy with rabeprazole sodium does not preclude the presence of gastric or oesophageal malignancy, therefore the possibility of malignancy should be excluded prior to commencing ...

Interaction with other medicinal products and other forms of interaction

Rabeprazole sodium produces a profound and long lasting inhibition of gastric acid secretion. An interaction with compounds whose absorption is pH dependent may occur. Co-administration of rabeprazole ...

Pregnancy and lactation

Pregnancy There are no data on the safety of rabeprazole in human pregnancy. Reproduction studies performed in rats and rabbits have revealed no evidence of impaired fertility or harm to the foetus due ...

Effects on ability to drive and use machines

Based on the pharmacodynamic properties and the adverse events profile, it is unlikely that Rabeprazole 10mg Gastro- resistant Tablets would cause an impairment of driving performance or compromise the ...

Undesirable effects

The most commonly reported adverse drug reactions, during controlled clinical trials with rabeprazole were headache, diarrhoea, abdominal pain, asthenia, flatulence, rash and dry mouth. The majority of ...

Overdose

Experience to date with deliberate or accidental overdose is limited. The maximum established exposure has not exceeded 60 mg twice daily, or 160 mg once daily. Effects are generally minimal, representative ...

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD), proton pump inhibitors ATC code: A02BC04 Mechanism of action Rabeprazole sodium belongs to the class of anti-secretory ...

Pharmacokinetic properties

Absorption Rabeprazole 10mg Gastro-resistant Tablet is an enteric-coated (gastro-resistant) tablet formulation of rabeprazole sodium. This presentation is necessary because rabeprazole is acid-labile. ...

Preclinical safety data

Non-clinical effects were observed only at exposures sufficiently in excess of the maximum human exposure that make concerns for human safety negligible in respect of animal data. Studies on mutagenicity ...

List of excipients

Tablet core: Povidone Hydroxypropyl cellulose, low subst. Magnesium oxide, light Mannitol (E421) Magnesium stearate Undercoating: Ethyl cellulose Magnesium oxide, light Enteric coating: Methacrylic acid-ethyl ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Blister packs: Store below 25°C. Store in the original package in order to protect from moisture. Tablet containers: Store below 25°C. Keep the container tightly closed in order to protect from moisture. ...

Nature and contents of container

Blister packs (Al-OPA-PVC/Al). Tablet cotainers (HDPE) with plastic closure (LDPE) and a desiccant. Tablet containers (HDPE) with a plastic screw cap with an integrated desiccant. Pack sizes: Blister packs: ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Marketing authorization number(s)

20075/1235

Date of first authorization / renewal of the authorization

14/07/2010 / 01/06/2015

Date of revision of the text

27/04/2018

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