CELEVAC Tablet Ref.[9189] Active ingredients: Methylcellulose

Adequate fluid intake should be maintained to avoid intestinal obstruction. Guidance on fluid intake is stated in section 4.2.

Methylcellulose should be taken with sufficient fluid to prevent faecal impaction or oesophageal obstruction (see section 4.2).

Supervision may be necessary for patients who:

• are elderly
• are debilitated
• have intestinal narrowing
• have decreased intestinal motility

Bowel obstruction is a rare complication of treatment with any bulk-forming hydrophilic colloid (refer also to section 4.8).

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Bulk laxatives such as oral methylcellulose lower the transit time through the gut and could affect the absorption of other drugs.

Pregnancy

Although Celevac Tablets have been in wide general use for many years there is no evidence of ill consequence during human pregnancy. Medicines should not be used in pregnancy, especially the first trimester, unless the expected benefit is thought to outweigh any possible risk to the foetus.

Not relevant.

The most commonly reported reactions with methylcellulose are of a gastrointestinal nature and include flatulence and abdominal distention.

Reactions not already stated, which are attributable to bulk-forming laxatives include gastrointestinal obstruction, faecal impaction and hypersensitivity.

Reporting of suspected adverse reactions

Reporting of 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, website: www.mhra.gov.uk/yellowcard.

None listed.