Public Assessment Report Omeprazole gastro-resistant capsules

نعليق: نشرة دواء اوميبراز من إنجلترا--احمد شوقي محمدين 21:22، 1 نوفمبر 2016 (ت ع م)

Waymade PLC PL 06464/2396/2400

UKPAR Waymade PLC, Omeprazol 10mg and 10mg gastro resistant capsules

Monitoring vision and hearing

Although not known for orally administered omeprazole, blindness and deafness have been reported in the use of the injection form of omeprazole; therefore, in severely ill patients the monitoring of visual and auditory senses is recommended.

Eye disorders Uncommon: visual disturbances including blurred vision, loss of visual acuity and/or reduced field of vision. Blindness (see Section 4.4).

وتحت خالص مكتوب: uncommon S/E = less than 1 in 100 & rare S/E= less than 1 in 1000 & very rare= less than 1 in 10,000. يلاحظ تصنيف: مشاكل البصر uncommon. كما أنه مكتوب جملة واضحة: although not known with oral omeprazole, blindness and deafness have been reported with the injectable form

Nervous system disorders

Common: somnolence, sleep disturbances (insomnia), vertigo, headaches and drowsiness. Rare: Paresthesia, light headedness. Mental confusion and hallucinations (predominantly in severely ill or elderly patients).

4.7. Effects on ability to Drive and use machines

Sleepiness/drowsiness are common reactions associated with omeprazole and visual disturbances (see Section 4.8) have also been reported: if patients are affected they should not drive, operate machinery or take part in activities where these symptoms could put themselves or others at risk.

Omeprazole may reduce the oral absorption of vitamin B12. This should be taken into account in those patients with low basal levels who undergo a longterm treatment with omeprazole.

Duration of therapy:

Because of limited safety data for patients on maintenance treatment for longer than 1 year, regular review of the treatment and thorough risk-benefit assessment should be performed in long-term use exceeding 1 year.

Potential interactions (monitoring of blood levels recommended)

During concomitant regimens with omeprazole and other medicinal products (for NSAID related ulcers or eradication therapy) caution should be exercised when administering additional medicinal products as interactions might occur (see section 4.5). This is particularly important with products with a narrow therapeutic index such as warfarin and phenytoin. Levels of these should be measured as a dose reduction may be needed. Levels of ciclosporin may be increased and therefore plasma levels should be monitored (see Section 4.5).

Monitoring vision and hearing

Although not known for orally administered omeprazole, blindness and deafness have been reported in the use of the injection form of omeprazole; therefore, in severely ill patients the monitoring of visual and auditory senses is recommended.

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

Cytochrome P450

Omeprazole is metabolised in the liver through cytochrome P450 isoforms (mainly CYP 2C19, S-mephenytoin hydroxylase) and inhibits enzymes of the CYP2C subfamily (CYP 2C19 and CYP 2C9) it and can delay the elimination of other active substances metabolised by these enzymes. This has been observed for diazepam (and also of other benzodiazepines as triazolam or flurazepam), phenytoin and warfarin. Periodic monitoring of patients receiving warfarin or phenytoin is recommended and a reduction of warfarin or phenytoin dose may be necessary. Other active substances that could be affected are hexabarbital, citalopram, imipramine, and clomipramine. Omeprazole may inhibit the hepatic metabolism of disulfiram. Some possibly related cases of muscular rigidity have been reported.

Increased plasma concentrations

There are contradictionary data on the interaction of omeprazole with ciclosporin. Therefore, the plasma levels of ciclosporin should be monitored in those patients treated with omeprazole, because an increase in ciclosporin levels is possible.

Decreased absorption

Due to the decreased intragastric acidity, the absorption of ketoconazole or itraconazole may be reduced during omeprazole treatment.

Increased absorption

Simultaneous treatment with omeprazole and digoxin in healthy subjects lead to a 10 % increase in the bioavailability of digoxin as a consequence of the increased gastric pH.

Omeprazole may reduce the oral absorption of vitamin B12. This should be taken into account in those patients with low basal levels who undergo a longterm treatment with omeprazole.

Concomitant use contra-indicated (see Section 4.3)

Because of potential clinically significant decrease in omeprazole plasma concentrations, St. John’s wort should not be used concomitantly with omeprazole.

Due to the reduction in atazanavir sulphate exposure levels, atazanavir should not be co-administered with omeprazole.

Due to the increase of plasma concentrations of omeprazole and clarithromycin during concomitant administration, the combination therapy with clarithromycin should not be used in patients with hepatic impairment. There is no evidence of an interaction of omeprazole with caffeine, propranolol, theophylline, metoprolol, lidocaine, quinidine, phenacetin, estradiol, amoxicillin, budesonide, diclofenac, metronidazole, naproxen, piroxicam, or antacids. The absorption of omeprazole is not affected by alcohol.

http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con025769.pdf