EMAZOLE Gastro-resistant tablet (2017)

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Περιεχόμενα

1. Name of the medicinal product

Emazole 20 mg Gastro-Resistant Tablets.

2. Qualitative and quantitative composition

Each gastro-resistant tablet contains 20 mg esomeprazole (as magnesium dihydrate). Excipient(s) with known effect: Each 20 mg gastro-resistant tablet contains 12.90 mg – 14.76 mg sucrose and 0.81 ...

3. Pharmaceutical form

Gastro-resistant tablet. 20 mg: Light pink oval film-coated tablet.

4.1. Therapeutic indications

Emazole 20 mg gastro-resistant tablets are indicated for: Adults Gastro-Oesophageal Reflux Disease (GORD) treatment of erosive reflux oesophagitis long-term management of patients with healed oesophagitis ...

4.2. Posology and method of administration

Posology Adults Gastro-Oesophageal Reflux Disease (GORD) treatment of erosive reflux esophagitis 40 mg once daily for 4 weeks. An additional 4 weeks treatment is recommended for patients in whom oesophagitis ...

4.3. Contraindications

Hypersensitivity to the active substance, to substituted benzimidazoles or to any of the excipients listed in section 6.1. Esomeprazole must not be used concomitantly with nelfinavir (see section 4.5). ...

4.4. Special warnings and precautions for use

In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, malignancy should ...

4.5. Interaction with other medicinal products and other forms of interaction

Effects of esomeprazole on the pharmacokinetics of other medicinal products Medicinal products with pH dependent absorption Gastric acid suppression during treatment with esomeprazole and other PPIs might ...

4.6. Fertility, pregnancy and lactation

Pregnancy Clinical data on exposed pregnancies with esomeprazole are insufficient. With the racemic mixture, omeprazole, data on larger number of exposed pregnancies from epidemiological studies indicate ...

4.7. Effects on ability to drive and use machines

Esomeprazole has minor influence on the ability to drive or use machines. Adverse reactions such as dizziness (uncommon) and blurred vision (rare) have been reported (see section 4.8). If affected, patients ...

4.8. Undesirable effects

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 use). ...

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. Single doses of 80 mg esomeprazole ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD), proton pump inhibitor ATC code: A02BC05 Esomeprazole is the S-isomer of omeprazole and reduces ...

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 ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. ...

6.1. List of excipients

Tablet core: Sucrose Maize starch Liquid glucose Hydroxypropylcellulose Povidone Talc Titanium dioxide (E171) Methacrylic acid-ethyl acrylate copolymer (1:1) Glycerol monostearate Propylene glycol ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

Aclar/aluminium blisters: 18 months. Aluminium/aluminium blister: 24 months. HDPE bottles: 24 months. Shelf life after first opening: 6 months. Do not store above 30°C. Keep ...

6.4. Special precautions for storage

Aluminium/aluminium blisters and aclar/aluminium blisters: Do not store above 25°C. HDPE bottles: Storage conditions before opening of the HDPE bottle: Do not store above 30°C. For storage ...

6.5. Nature and contents of container

Aluminium/aluminium blisters and aclar/aluminium blisters with 7, 14, 15, 28, 30, 56, 60, 90, 98, 100 and 100 1 gastro-resistant tablets. HDPE bottles with PP cap and desiccant with 7, 14, 15, 28, 30, ...

6.6. Special precautions for disposal and other handling

Administration via a stomach tube: 1. Put the tablet into an appropriate syringe and fill the syringe with approximately 25 ml water and approximately 5 ml air. For some tubes, dispersion in 50 ml water ...

7. Marketing authorization holder

Rowex Ltd, Bantry, Co. Cork

8. Marketing authorization number(s)

PA0711/158/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 8th April 2009 Date of last renewal: 2nd April 2014

10. Date of revision of the text

May 2017

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