PANTOPRAZOLE 20mg Gastro-resistant tablets (2019)
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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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