Losec Control

Present	Changes
4.8 Undesirable effects   The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting.	4.8 Undesirable effects   The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting and fundic gland polyps (benign).
Common:  Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting	Common: Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, fundic gland polyps (benign)

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4.4. Special warnings and precautions for use

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Interference with laboratory tests

Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Losec Control treatment should be stopped for at least 5 days before CgA measurements (see section 5.1). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.

5.1 Pharmacodynamic properties

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Pharmacodynamic effects

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Other effects related to acid inhibition

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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.

Available published evidence suggests that proton pump inhibitors should be discontinued between 5 days and 2 weeks prior to CgA measurements. This is to allow CgA levels that might be spuriously elevated following PPI treatment to return to reference range.

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10. DATE OF REVISION OF THE TEXT

February September 2016

 

4.5 Interaction with other medicinal products and other forms of interaction

 

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Other active substances

The absorption of posaconazole, erlotinib, ketoconazole and itraconazole is significantly reduced and thus clinical efficacy may be impaired. For posaconazol and erlotinib concomitant use should be avoided.

 

 

5.2 Pharmacokinetic properties

 

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Distribution

The mean apparent volume of distribution in healthy subjects given 20 mg orally, was reported to be approximately 0.3 l/kg body weight.

Omeprazole is more than 97% plasma protein bound, principally albumin and α1-acid glycoprotein. It subsequently becomes preferentially concentrated within parietal cells of stomach mucosa.

 

 

10. DATE OF REVISION OF THE TEXT

 

October 2015February 2016

 

 

 

4.4 Special warnings and precautions for use

 

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Subacute cutaneous lupus erythematosus (SCLE)

Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Losec Control. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

 

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4.8 Undesirable effects

 

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10. DATE OF REVISION OF THE TEXT

 

July October 2015

 

 

 

4.8 Undesirable effects

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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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

 

10 DATE OF REVISION OF THE TEXT

 

March 2014July 2015

None provided