Last Updated on eMC 04-04-2016 View medicine  | Concordia International - formerly AMCo Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Date of revision of text on the SPC:30-03-2016

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 and 4.5 have been updated

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text
  • Change to section 7 - Marketing authorisation holder

Date of revision of text on the SPC:15-04-2014

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7: MAH address updated.

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:31-10-2013

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 1 of SPC:  Addition of Boots Appetite Control Aid 500mg Tablets and Methylcellulose 500mg tablets

Section 4.2, 4.3, 4.6, 4.8: Replace Celevac tablets with Methycellulose tablets

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-12-2007

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Verbiage added or removed as noted in bold:

 

 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.

 4.2 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.

 

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.

4.8 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.

5.1 Pharmacodynamic properties

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

ATC Code: A06AC 06

 

 

6.1 List of excipients

Lactose monohydrate

Saccharin sodium

Povidone

Erythrosine (E127)

Strawberry flavour 52.318 AP

{REMOVED Purified} Talc

Magnesium stearate

6.3 Shelf life

3 years.

 

6.5 Nature and contents of container

Polypropylene securitainer containing 112 or 250 tablets with polyethylene cap.

Not all pack sizes may be marketed.

 

10 DATE OF REVISION OF THE TEXT

December 2007

Reasons for adding or updating:

  • New SPC for new product