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PANTOPRAZOLE 40mg Gastro-resistant tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Pantoprazole 40 mg gastro-resistant tablets.

Qualitative and quantitative composition

Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate). For the full list of excipients, see section 6.1.

Pharmaceutical form

Gastro-resistant tablet (tablet). Yellow, oval, biconvex film-coated tablet imprinted with P 40 in brown ink on one side.

Therapeutic indications

Pantoprazole is indicated for use in adults and adolescents 12 years of age and above for: Reflux oesophagitis. Pantoprazole is indicated in adults for: Eradication of Helicobacter pylori (H. pylori) ...

Posology and method of administration

Posology Adults and adolescents 12 years of age and above Reflux oesophagitis One tablet of Pantoprazole per day. In individual cases the dose may be doubled (increase to 2 tablets Pantoprazole daily) ...

Contraindications

Hypersensitivity to the active substance, substituted benzimidazoles, any of the other 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 ...

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 40 mg oral dose. On average at about 2.5 h p.a. the maximum serum concentrations of about ...

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

Core: Sodium carbonate, anhydrous Mannitol (E421) Crospovidone Povidone K90 Calcium stearate Coating: Hypromellose Povidone K25 Titanium dioxide (E171) Yellow iron oxide (E172) Propylene glycol Methacrylic ...

Incompatibilities

Not applicable.

Shelf life

Shelf life Blister packs: 3 years. Bottles: Unopened: 3 years. After first opening: 100 days.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

HDPE bottles with LDPE screw cap closure. 7 gastro-resistant tablets 10 gastro-resistant tablets 14 gastro-resistant tablets 15 gastro-resistant tablets 24 gastro-resistant tablets 28 gastro-resistant ...

Special precautions for disposal and other handling

No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Takeda UK Limited, Building 3, Glory Park, Glory Park Avenue, Wooburn Green, Bucks, HP10 0DF, UK

Marketing authorization number(s)

PL 16189/0035

Date of first authorization / renewal of the authorization

Date of first authorisation: 25<sup>th</sup> May 2009 Date of last renewal: 30<sup>th</sup> July 2014

Date of revision of the text

6<sup>th</sup> August 2019

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