LANSOPRAZOLE Gastro-resistant capsules (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Lansoprazole 15 mg Gastro-Resistant Capsules.
Qualitative and quantitative composition
Each capsule contains 15 mg lansoprazole. Excipient with known effect: Each 15 mg capsule contains 100.474 mg sucrose. For the full list of excipients, see section 6.1.
Pharmaceutical form
Lansoprazole 15 mg: opaque yellow cap and body capsules. Each capsule contains white or almost white spherical microgranules.
Therapeutic indications
Treatment of duodenal and gastric ulcer. Treatment of reflux oesophagitis. Prophylaxis of reflux oesophagitis. Eradication of Helicobacter pylori (H. pylori) concurrently given with appropriate antibiotic ...
Posology and method of administration
Posology Treatment of duodenal ulcer The recommended dose is 30 mg once daily for 2 weeks. In patients not fully healed within this time, the medication is continued at the same dose for another two weeks. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
In common with other anti-ulcer therapies, the possibility of malignant gastric tumour should be excluded when treating a gastric ulcer with lansoprazole because lansoprazole can mask the symptoms and ...
Interaction with other medicinal products and other forms of interaction
Effects of lansoprazole on other medicinal products Medicinal products with pH dependent absorption Lansoprazole may interfere with the absorption of other medicinal products where gastric pH is an important ...
Fertility, pregnancy and lactation
Pregnancy For lansoprazole no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, ...
Effects on ability to drive and use machines
Adverse drug reactions such as dizziness, vertigo, visual disturbances and somnolence may occur (see section 4.8). Under these conditions the ability to react may be decreased.
Undesirable effects
Frequencies are defined as common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Blood and ...
Overdose
The effects of overdose on lansoprazole in humans are not known (although the acute toxicity is likely to be low) and, consequently, instruction for treatment cannot be given. However, daily doses of up ...
Pharmacodynamic properties
Pharmacotherapeutic group: Proton pump inhibitors ATC code: A02BC03 Lansoprazole is a gastric proton pump inhibitor. It inhibits the final stage of gastric acid formation by inhibiting the activity of ...
Pharmacokinetic properties
Lansoprazole is a racemate of two active enantiomers that are biotransformed into the active form in the acidic environment of the parietal cells. As lansoprazole is rapidly inactivated by gastric acid, ...
Preclinical safety data
Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeated dose toxicity, toxicity to reproduction or genotoxicity. In two rat carcinogenicity ...
List of excipients
Sugar spheres (sucrose and maize starch) Sodium laurilsulphate Meglumine Mannitol (E421) Hypromellose Macrogol Talc Polysorbate 80 Titanium dioxide (E171) Methacrylic Acid-Ethyl Acrylate Copolymer, 1:1, ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 25°C Store in the original package in order to protect from moisture.
Nature and contents of container
Al/Al blister. Pack sizes: 7, 14, 28, 56 and 98 capsules. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland
Marketing authorization number(s)
PL 30306/0148
Date of first authorization / renewal of the authorization
08/10/2008 Renewal Approved: 26/06/2013
Date of revision of the text
21/05/2019
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