PANTOFLUX Gastro-resistant tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Pantoflux 40 mg gastro-resistant tablets.

2. Qualitative and quantitative composition

Each gastro-resistant tablet contains 40 mg of pantoprazole (as 45.16 mg pantoprazole sodium sesquihydrate). For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Gastro-resistant tablet. Elliptical, biconvex, dark yellow gastro-resistant tablet.

4.1. Therapeutic indications

Adults and adolescents 12 years of age and above Reflux oesophagitis. Adults Eradication of Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with H. pylori ...

4.2. Posology and method of administration

Posology Adults and adolescents 12 years of age and above Reflux oesophagitis One Pantoflux 40 mg gastro-resistant tablet per day. In individual cases the dose may be doubled (increase to 2 Pantoflux 40 ...

4.3. Contraindications

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

4.4. 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 ...

4.5. 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 ...

4.6. 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 ...

4.7. 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 ...

4.8. 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 ...

4.9. 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 ...

5.1. 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 ...

5.2. 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 2.0 h-2.5 h p.a. the maximum serum concentrations ...

5.3. 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 ...

6.1. List of excipients

Tablet core: Mannitol Sodium carbonate, anhydrous Sodium starch glycolate (type A) Basic butylated methacrylate copolymer (Eudragit E PO) Calcium stearate Sub coating: Opadry white OY-D-7233; ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

4 years.

6.4. Special precautions for storage

Blister: This medicinal product does not require any special storage conditions. Tablet container: Do not store above 30°C

6.5. Nature and contents of container

Aluminium/aluminium blister pack. Tablet container (HDPE) closed with PP cap with integrated desiccant. Pack sizes: Blister: 7, 14, 15, 20, 28, 30, 56, 60, 98, 100 tablets and 10 14 tablets (hospital ...

6.6. 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.

7. Marketing authorization holder

Accord Healthcare Ireland Ltd., Euro House, Euro Business Park, Little Island, Cork T45 K857, Ireland

8. Marketing authorization number(s)

PA2315/187/002

9. Date of first authorization / renewal of the authorization

Date of First Authorisation: 9th June 2008 Date of last renewal: 3rd May 2013

10. Date of revision of the text

April 2021

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