Summary of Product Characteristics
last updated on the eMC:
29/09/2009
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.
Updated on 29/09/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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Change to section 6. 3 - Shelf Life
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Dec-2007 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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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
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Updated on 10/03/2008 and displayed until 29/09/2009
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