Celevac Tablets 500mg.

1. Name Of The Medicinal Product

Celevac 500mg Tablets.

2. Qualitative And Quantitative Composition

Each tablet contains 500mg of methylcellulose.

For excipients, see 6.1.

3. Pharmaceutical Form

Tablet.

Pink, biconvex tablet marked with a breakline on one face and Celevac on the other.

4. Clinical Particulars

4.1 Therapeutic Indications

Methylcellulose is a hydrophilic colloid which absorbs water causing it to swell to a soft gel of uniform consistency.

Recommended clinical use

- In the control of colostomy, ileostomy and simple diarrhoea

- In the management of diverticular disease and ulcerative colitis

- In the management of simple constipation.

- As an aid to appetite control and the treatment of obesity.

Route of administration

Oral.

4.2 Posology And Method Of Administration

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.

Colostomy and ileostomy control and for simple diarrhoea: 3-6 tablets twice daily with the minimum of liquid. Liquids should be avoided for 30 minutes before and after each dose. Dosage should be adjusted to give stools of the required consistency.

Diverticular disease and ulcerative colitis: 3-6 tablets twice daily adjusted according to the degree of constipation (with 300ml of liquid), diarrhoea (with a little liquid) or spastic pain.

Simple constipation: 3-6 tablets twice daily to be taken with at least 300 ml of liquid. The dose may be reduced as normal bowel function is restored.

As an aid to appetite control and the treatment of obesity: 3 tablets with at least 300 ml of warm liquid, half an hour before each meal and between meals when hunger pangs are severe.

4.3 Contraindications

Celevac tablets are contraindicated in patients:

- hypersensitive to methylcellulose or to any of the excipients

- with imminent or threatened intestinal obstruction

- with faecal impaction

- who have difficulty in swallowing

- with colonic atony

- with infective bowel disease

- with severe dehydration

4.4 Special Warnings And Precautions For Use

Adequate fluid intake should be maintained to avoid intestinal obstruction. Guidance on fluid intake is stated in Section 4.2 Posology and method of administration.

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 Undesirable Effects).

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

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None listed.

4.6 Pregnancy And Lactation

Although Celevac has 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.

4.7 Effects On Ability To Drive And Use Machines

None listed.

4.8 Undesirable Effects

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

Flatulence and abdominal distention.

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

4.9 Overdose

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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Alimentary Tract and Metabolism; Laxatives; Bulk producers – Methylcellulose

ATC Code: A06AC 06

The active ingredient is a simple bulking agent.

5.2 Pharmacokinetic Properties

The active ingredient is not absorbed and hence the product cannot be described in terms of pharmacokinetics.

5.3 Preclinical Safety Data

None listed.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose monohydrate

Saccharin sodium

Povidone

Erythrosine (E127)

Strawberry flavour 52.318 AP

Talc

Magnesium stearate

6.2 Incompatibilities

None listed.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Polypropylene securitainer containing 112 or 250 tablets with polyethylene cap.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None given.

7. Marketing Authorisation Holder

Amdipharm PLC

Regency House

Miles Gray Road

Basildon

Essex

SS14 3AF

United Kingdom

8. Marketing Authorisation Number(S)

PL 20072/0045

9. Date Of First Authorisation/Renewal Of The Authorisation

11 November 1992

10. Date Of Revision Of The Text

December 2007

11 DOSIMETRY (IF APPLICABLE)

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)