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SPC, UK: OMEPRAZOLE Gastro-resistant capsules (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Omeprazole 10mg Gastro-resistant Capsules.

Qualitative and quantitative composition

Each capsule contains 10mg omeprazole. Excipient with known effect: Contains sucrose, see section 4.4. Each 10mg omeprazole capsule contains 51 to 58mg of sucrose. For the full list of excipients, see ...

Pharmaceutical form

Gastro-resistant capsules, hard. Hard gelatine capsules of size 3, Opaque yellow cap and body containing white to off-white spherical pellets.

Therapeutic indications

Treatment of duodenal ulcers. Prevention of relapse of duodenal ulcers. Treatment of gastric ulcers. Prevention of relapse of gastric ulcers. In combination with appropriate antibiotics, Helicobacter pylori ...

Posology and method of administration

Posology Adults Treatment of duodenal ulcers The recommended dose in patients with an active duodenal ulcer is Omeprazole 20mg once daily. In most patients healing occurs within two weeks. For those patients ...

Contraindications

Hypersensitivity to omeprazole, substituted benzimidazoles or to any of the excipients listed in section 6.1. Omeprazole like other proton pump inhibitors (PPIs) must not be used concomitantly with nelfinavir ...

Special warnings and precautions for use

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

Interaction with other medicinal products and other forms of interaction

Effects of omeprazole on the pharmacokinetics of other active substances Active substances with pH dependent absorption The decreased intragastric acidity during treatment with omeprazole might increase ...

Pregnancy and lactation

Pregnancy Results from three prospective epidemiological studies (more than 1000 exposed outcomes) indicate no adverse effects of omeprazole on pregnancy or on the health of the foetus/newborn child. Omeprazole ...

Effects on ability to drive and use machines

Omeprazole is not likely to affect the ability to drive or use machines. Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4.8). If affected, patients should not drive ...

Undesirable effects

The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting. The following adverse drug reactions have been identified or suspected ...

Overdose

There is limited information available on the effects of overdoses of omeprazole in humans. In the literature, doses of up to 560 mg have been described, and occasional reports have been received when ...

Pharmacodynamic properties

Pharmacotherapeutic group: Selective proton plump inhibitor, substituted benzimidazole ATC-CODE: A02BC01 Mechanism of action Omeprazole, a racemic mixture of two enantiomers reduces gastric acid secretion ...

Pharmacokinetic properties

Absorption Omeprazole and omeprazole magnesium are acid labile and are therefore administered orally as enteric-coated granules in capsules or tablets. Absorption of omeprazole is rapid, with peak plasma ...

Preclinical safety data

Gastric ECL-cell hyperplasia and carcinoids, have been observed in life-long studies in rats treated with omeprazole. These changes are the result of sustained hypergastrinaemia secondary to acid inhibition. ...

List of excipients

Sugar spheres (consisting of corn starch and sucrose) Sodium lauryl sulfate Disodium phosphate Mannitol Hypromellose Polyethylene glycol 6000 Talc Polysorbate 80 Titanium dioxide Eudragit L30-D55 (poly(methacrylic ...

Incompatibilities

None known.

Shelf life

Shelf life Aluminium-aluminium blister: 3 years. HDPE tablet containers with a PP closure incorporating a LDPE capsule containing silica gel dessicant: 3 years. Use within 3 months of opening.

Special precautions for storage

Store below 25°C. Aluminium/Aluminium blister pack: Store in the original package to protect from moisture. HDPE tablet container: Keep the bottle tightly closed to protect from moisture.

Nature and contents of container

OPA/Aluminium/PVC: Aluminium blister; OPA/Aluminium/PVC: PET/Aluminium blister: Pack sizes: 7s, 10s, 14s, 15s, 20s, 21s, 28s, 30s, 50s, 56s, 60s, 84s, 90s, 98s, 100s HDPE tablet containers with a PP closure ...

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization number(s)

PL 00142/0516

Date of first authorization / renewal of the authorization

22.03.2002

Date of revision of the text

03.07.2018

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