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SPC, UK: PANTOPRAZOLE 20mg Gastro-resistant tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Pantoprazole 20 mg gastro-resistant tablets.

Qualitative and quantitative composition

Each gastro-resistant tablet contains 20 mg pantoprazole (as pantoprazole sodium sesquihydrate). For the full list of excipients, see section 6.1.

Pharmaceutical form

Gastro-resistant tablet. Light Yellow colored, enteric coated oval biconvex tablets plain on both the sides.

Therapeutic indications

Pantoprazole is indicated for use in adults and adolescents 12 years of age and above for: Symptomatic gastro-oesophageal reflux disease. Long-term management and prevention of relapse in reflux oesophagitis. ...

Posology and method of administration

Posology Adults and adolescents 12 years of age and above Symptomatic gastro-oesophageal reflux disease The recommended oral dose is one gastro-resistant tablet Pantoprazole 20 mg per day. Symptom relief ...

Contraindications

Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Hepatic Impairment In patients with severe liver impairment the liver enzymes should be monitored regularly during treatment with pantoprazole, particularly on long-term use. In the case of a rise of the ...

Interaction with other medicinal products and other forms of interaction

Medicinal products with pH-Dependent Absorption Pharmacokinetics Because of profound and long lasting inhibition of gastric acid secretion, pantoprazole may interfere with the absorption of other medicinal ...

Fertility, pregnancy and lactation

Pregnancy A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of Pantoprazole. Animal studies have shown reproductive toxicity ...

Effects on ability to drive and use machines

Pantoprazole has no or negligible influence on the ability to drive and use machines. Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4.8). If affected, patients ...

Undesirable effects

Approximately 5% of patients can be expected to experience adverse drug reactions (ADRs). The most commonly reported ADRs are diarrhoea and headache, both occurring in approximately 1% of patients. The ...

Overdose

There are no known symptoms of overdose in man. Systemic exposure with up to 240 mg administered intravenously over 2 minutes were well tolerated. As pantoprazole is extensively protein bound, it is not ...

Pharmacodynamic properties

Pharmacotherapeutic group: Proton pump inhibitors ATC code: A02BC02 Mechanism of action Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific ...

Pharmacokinetic properties

Absorption Pantoprazole is rapidly absorbed and the maximal plasma concentration is achieved even after one single 20 mg oral dose. On average at about 2.0h-2.5h p.a. the maximum serum concentrations of ...

Preclinical safety data

Non-clinical data reveal no special hazard to humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. In the two-year carcinogenicity studies in rats neuroendocrine ...

List of excipients

Tablet core: Sodium carbonate (Anhydrous) Mannitol Crospovidone (Type B) Hydroxypropyl cellulose Calcium stearate Coating: Hypromellose Yellow iron oxide (E172) Methacrylic acid-ethyl acrylate copolymer ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Blisters of Polyamide/Aluminium/PVC-Aluminium in a blister carton, and white opaque round HDPE container with white opaque polypropylene closure. Pack sizes: Blister: 7, 14, 15, 28, 30, 56, 60, 98, 100 ...

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Marketing authorization number(s)

PL 16363/0403

Date of first authorization / renewal of the authorization

Date of first authorisation: 24/07/2014 Date of last renewal: 07/11/2018

Date of revision of the text

26/03/2019

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