NEXAZOLE Hard gastro-resistant capsule (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Nexazole 20 mg hard gastro-resistant capsules.

2. Qualitative and quantitative composition

Each hard gastro-resistant capsule contains 20 mg esomeprazole (as magnesium dihydrate). Excipient (s) with known effect:   20 mg gastro-resistant capsules sucrose 28,464 – 32,556 mg For ...

3. Pharmaceutical form

Hard gastro-resistant capsule. The body and the cap of the capsule are slightly pink. The content of capsules are white to almost white pellets.

4.1. Therapeutic indications

Nexazole capsules are indicated in adults for: Gastroesophageal Reflux Disease (GERD)Treatment of erosive reflux esophagitis Long-term management of patients with healed esophagitis to prevent relapse ...

4.2. Posology and method of administration

Posology Adults Gastroesophageal Reflux Disease (GERD) Treatment of erosive reflux esophagitis 40 mg once daily for 4 weeks. An additional 4 weeks treatment is recommended for patients in whom esophagitis ...

4.3. Contraindications

Hypersensitivity to the active substance, substituted benzimidazoles or to any of the excipientslisted in section 6.1. Esomeprazole should 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 drugs Protease inhibitors Omeprazole has been reported to interact with some protease inhibitors. The clinical importance and the mechanisms behind ...

4.6. Fertility, pregnancy and lactation

Pregnancy Clinical data on exposed pregnancies with Nexazole are insufficient. With the racemic mixture, omeprazole, data on a 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) has 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

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 were ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for acid related disorders, proton pump inhibitors ATC code: A02BC05 Esomeprazole is the S-isomer of omeprazole and reduces gastric acid secretion through ...

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

Capsule core (pellets): Sucrose Maize starch Povidone K30 Sodium laurilsulfate Poly(vinyl alcohol) Titanium dioxide (E171) Macrogol 3000 Macrogol 6000 Talc Heavy magnesium carbonate Methacrylic ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Blister pack consisting of OPA/Alu/PE + DES film/Alu + PE foil: Store in the original package in order to protect from moisture. Blister pack consisting of OPA/Alu/PVC/Alu foil: Do not store ...

6.5. Nature and contents of container

Blister pack (OPA/Alu/PE + DES film/Alu + PE foil): 7, 14, 15, 28, 30, 50, 56, 60, 90, 98 and 100 hard gastro-resistant capsules, in a box. Blister pack (OPA/Alu/PVC/Alu foil): 7, 14, 15, ...

6.6. Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements. Administration through gastric tube: 1. Openthecapsuleand empty the pellets into an appropriate ...

7. Marketing authorization holder

Pinewood Laboratories Ltd, Ballymacarbry, Clonmel, Co. Tipperary, Ireland

8. Marketing authorization number(s)

PA0281/146/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 12th February 2010 Date of last renewal: 15th January 2015

10. Date of revision of the text

November 2020

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