TRUSTAN Gastric resistant tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
Trustan 20 mg Gastric resistant tablets. Trustan 40 mg Gastric resistant tablets.
2. Qualitative and quantitative composition
Each tablet of TRUSTAN 20 mg contains 20 mg esomeprazole (as magnesium trihydrate) in the form of a multiple unit pellet system (MUPS). Each tablet of TRUSTAN 40 mg contains 40 mg esomeprazole (as magnesium ...
3. Pharmaceutical form
Gastric resistant tablets. TRUSTAN 20 mg is a light pink, oblong, biconvex, film-coated tablet engraved 20 mg on one side and on the other side. TRUSTAN 40 mg is a pink, oblong, biconvex, film-coated ...
4.1. Therapeutic indications
TRUSTAN tablets are indicated for: Gastro-oesophageal Reflux Disease (GORD):treatment of erosive reflux oesophagitis long-term management of patients with healed oesophagitis to prevent relapse symptomatic ...
4.2. Posology and method of administration
Adults <u>Gastro-oesophageal Reflux Disease (GORD):</u> Treatment of erosive reflux oesophagitis: 40 mg once daily for 4 weeks. An additional 4 weeks treatment is recommended for patients in whom oesophagitis ...
4.3. Contraindications
TRUSTAN is contraindicated in: Patients with hypersensitivity to esomeprazole, substituted benzimidazoles or to any excipients in TRUSTAN (see section 6.1). Concomitant administration of TRUSTAN with atazanavir ...
4.4. Special warnings and precautions for use
TRUSTAN is not indicated for mild gastrointestinal complaints such as nervous dyspepsia. Prior to treatment or in the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent ...
4.5. Interaction with other medicinal products and other forms of interaction
Effects of TRUSTAN on the pharmacokinetics of other medicines Medicines with pH dependent absorption The decreased intragastric acidity during treatment with TRUSTAN might increase or decrease the absorption ...
4.6. Fertility, pregnancy and lactation
The safety of TRUSTAN in pregnancy and lactation has not been established. Pregnancy Clinical data on exposed pregnancies with TRUSTAN are insufficient. With the racemic mixture omeprazole data on a larger ...
4.7. Effects on ability to drive and use machines
TRUSTAN has moderate influence on the ability to drive and use machines. Since adverse reactions such as dizziness and blurred vision have been reported in patients receiving TRUSTAN, patients should not ...
4.8. Undesirable effects
a) Summary of the safety profile Headache, abdominal pain, diarrhoea and nausea are among those adverse reactions that have been most commonly reported in clinical trials (and also from post-marketing ...
4.9. Overdose
Symptoms There is very limited experience to date with deliberate overdose. The symptoms described in connection with 280 mg were gastrointestinal symptoms and weakness. In overdose, side effects can be ...
5.1. Pharmacodynamic properties
<b>Category and Class:</b> A 11.4.3 Medicines acting on gastro-intestinal tract <b>Pharmacotherapeutic group:</b> Proton pump inhibitors <b>ATC code:</b> A02BC05 Mechanism of action Esomeprazole, the S-isomer ...
5.2. Pharmacokinetic properties
Absorption Esomeprazole is acid labile and is administered orally as enteric-coated granules. In vivo conversion to the R-isomer is negligible. Absorption of esomeprazole is rapid, with peak plasma levels ...
6.1. List of excipients
Crospovidone, glycerol monostearate, hypromellose, hydroxypropylcellulose, iron oxide, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, macrogol, polysorbate 80, ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store at or below 30°C. Store in a dry place. Keep the container tightly closed (bottle). The blisters are to be kept in the carton until required for use.
6.5. Nature and contents of container
White HDPE bottles (with desiccated, white, screw type caps, with or without child resistance and a tamper proof ring) of 2, 5, 7, 14, 15, 28, 30, 56, 60, 100 tablets. The bottles are packed in a cardboard ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead, 2191
8. Marketing authorization number(s)
TRUSTAN 20 mg: 45/11.4.3/0777 TRUSTAN 40 mg: 45/11.4.3/0778
9. Date of first authorization / renewal of the authorization
10 April 2014
10. Date of revision of the text
06 March 2021
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