Amdipharm Limited

Celevac 500 mg Tablets.

Each tablet contains 500mg of methylcellulose.

For excipients, see section 6.1.

Tablet

Circular, biconvex pink tablets embossed “CELEVAC” on one face with a breakline on the other face.

For the treatment of constipation and in patients requiring a high fibre diet.

Route of administration

Oral.

Use should be under medical supervision. It is recommended that the tablets should be broken in the mouth before swallowing. Celevac Tablets swell in contact with water and should therefore be swallowed carefully.

It is not recommended that these tablets be taken before going to bed.

Adults and Children over 12 years:

The usual dose is 3-6 tablets twice daily, usually with 300ml of liquid.

Dosage of tablets and liquid should be adjusted within the above recommendations according to individual requirements.

Children 6 to 12 years

Half the adult dose.

Celevac Tablets are contraindicated in patients:

- hypersensitive to methylcellulose or to any of the excipients

- with intestinal obstruction or faecal impaction

- who have difficulty in swallowing

- with colonic atony

- with infective bowel disease.

Adequate fluid intake should be maintained to avoid intestinal obstruction.

Supervision may be necessary for patients who:

- are elderly

- are debilitated

- have intestinal narrowing

- have decreased intestinal motility.

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

No other medicines should be taken concomitantly with the product as medication absorption may be reduced. An appropriate interval should elapse.

Celevac Tablets should not be used during pregnancy except under medical supervision.

None listed.

The most commonly reported reactions with methylcellulose are of a gastrointestinal nature:

Flatulence and abdominal distension.

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

Methylcellulose is not absorbed. The features to be expected would be abdominal distension which may be followed by intestinal obstruction.

Gastric lavage should be employed where appropriate. The patient should be observed and fluid given. If obstruction develops, appropriate measures such as rectal washout must be taken.

Pharmacotherapeutic classification: Alimentary tract Metabolism; Laxatives;

Bulk producers - Methylcellulose

ATC group: A06AC06

The active ingredient is a simple bulking agent.

The active ingredient is not absorbed from the gut.

None listed.

Lactose monohydrate

Ssaccharin sodium

Povidone

Erythrosine (E127)

Strawberry flavour 52.318 AP

Purified talc

Magnesium stearate.

Not applicable.

3 years.

Do not store above 25ºC.

Polypropylene securitainers, containing 112 or 250 tablets with polyethylene cap.

Not all pack sizes may be marketed.

No special requirements.

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

PA

8 March 1993 / 8 March 2003