ZOTON FASTAB Oro-dispersible tablet (2021)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Zoton FasTab* 15 mg oro-dispersible tablets.
2. Qualitative and quantitative composition
Each oro-dispersible tablet contains 15 mg of lansoprazole. <u>Excipient(s) with known effect:</u> Each Zoton 15 mg oro-dispersible tablet contains 15 mg lactose and 4.5 mg aspartame. For the full list ...
3. Pharmaceutical form
White to yellowish white, circular flat beveled-edge oro-dispersible tablet with 15 debossed on one side. Each oro-dispersible tablet contains orange to dark brown microgranules.
4.1. Therapeutic indications
Treatment of duodenal and gastric ulcer Treatment of reflux oesophagitis Prophylaxis of reflux oesophagitis Eradication of <em>Helicobacter pylori (H. pylori)</em> concurrently given with appropriate antibiotic ...
4.2. 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. ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. 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 ...
4.5. 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 ...
4.6. 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, ...
4.7. 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.
4.8. Undesirable effects
Frequencies are defined as common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000). Common Uncommon Rare Very rare Not Known Blood and lymphatic system ...
4.9. 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 ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Proton pump inhibitors <b>ATC code:</b> A02BC03 Lansoprazole is a gastric proton pump inhibitor. It inhibits the final stage of gastric acid formation by inhibiting the ...
5.2. 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, ...
5.3. 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 ...
6.1. List of excipients
<u>Gastro-resistant microgranules:</u> Lactose monohydrate, microcrystalline cellulose, heavy magnesium carbonate, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, hypromellose, titanium ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5. Nature and contents of container
Aluminium blister packs of 28 or 56 Tablets. Not all pack sizes may be marketed.
6.6. 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.
7. Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CN13 9NJ, United Kingdom
8. Marketing authorization number(s)
PL 00057/1296
9. Date of first authorization / renewal of the authorization
17 June 2011
10. Date of revision of the text
09/2021
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
