When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Reasons for adding or updating:
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Fertility, pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.8 - Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 01-Jan-2013
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The following text in bold has been added. Text crossed out has been removed.
a the full list of excipients, see section 6.1.
Pink, oval film-coated tablet with a breaking notch on both sides. The tablet can be divided into equal halves (14.2 x 7.2 mm).
children paediatric population
Hypersensitivity to omeprazole, substituted benzimidazoles or to any of the excipients listed in section 6.1.
Some children with chronic illnesses may require long term treatment although it is not recommended.
Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections, such as Salmonella,
and Campylobacter and Clostridium difficile (see section 5.1).
Interactions with investigations of neuroendocrine tumors
Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. To avoid this effect, treatment with omeprazole should be temporarily discontinued at least five days before the CgA measurements.
Some children with chronic illnesses may require long-term treatment although it is not recommended.
Results from studies in healthy subjects have shown a pharmacokinetic (PK)/pharmacodynamic (PD) interaction between clopidogrel (300 mg loading dose/75 mg daily maintenance dose) and omeprazole (80 mg p.o. daily) resulting in a decreased exposure to the active metabolite of clopidogrel by an average of 46% and a decreased maximum inhibition of (ADP induced) platelet aggregation by an average of 16%.
Inconsistent data on the clinical implications of a PK/PD interaction of omeprazole in terms of major cardiovascular events have been reported from both observational and clinical studies. As a precaution, concomitant use of omeprazole and clopidogrel should be discouraged (see section 4.4).
In a crossover clinical study, clopidogrel (300 mg loading dose followed by 75 mg/day) alone and with omeprazole (80 mg at the same time as clopidogrel) were administered for 5 days. The exposure to the active metabolite of clopidogrel was decreased by 46% (Day 1) and 42% (Day 5) when clopidogrel and omeprazole were administered together. Mean inhibition of platelet aggregation (IPA) was diminished by 47% (24 hours) and 30% (Day 5) when clopidogrel and omeprazole were administered together. In another study it was shown that administering clopidogrel and omeprazole at different times did not prevent their interaction that is likely to be driven by the inhibitory effect of omeprazole on CYP2C19. Inconsistent data on the clinical implications of this PK/PD interaction in terms of major cardiovascular events have been reported from observational and clinical studies.
When methotrexate is given together with proton pump inhibitors, methotrexate levels have been reported to increase in some patients. In high-dose methotrexate administration a temporary withdrawal of omeprazole may need to be considered.
Pregnancy and lactation
Severe hypomagnesaemia may result in hypocalcaemia.
Very rare: Dyspepsia
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard).
Treatment with acid-reducing drugs may lead to slightly increased risk of gastrointestinal infections such as Salmonella,
and Campylobacter and Clostridium difficile.
During treatment with antisecretory medicinal products serum gastrin increases in response to the decreased acid secretion. Also CgA increases due to decreased gastric acidity. The increased CgA level may interfere with investigations for neuroendocrine tumours. Literature reports indicate that proton pump inhibitor treatment should be stopped at least 5 days before CgA measurement. If CgA and gastrine levels have not normalised after 5 days, measurements should be repeated 14 days after cessation of omeprazole treatment.
An increased number of ECL cells possibly related to the increased serum gastrin levels, have been observed in some patients (both children and adults) during long term treatment with omeprazole. The findings are considered to be of no clinical significance.
Date of first authorisation: 05 July
Date of latest renewal: 22 January 2013
Reasons for adding or updating:
- New SPC for new product
Black Triangle (CHM): NO
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