CELEVAC Tablet (2016)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Celevac 500mg Tablets. Boots Appetite Control Aid 500 mg Tablets. Methylcellulose 500 mg Tablets.
Qualitative and quantitative composition
Each tablet contains 500 mg of methylcellulose. Excipients with known effect: Lactose fine (110.467 mg per tablet) For the full list of excipients, see section 6.1.
Pharmaceutical form
Pink, biconvex tablet marked with a breakline on one face and CELEVAC on the other. OR Pink, biconvex tablet marked with a breakline on one face and METHYLC on the other. The score line is only to facilitate ...
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. ...
Posology and method of administration
Posology 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 ...
Contraindications
Celevac Tablets are contraindicated in patients: hypersensitive to methylcellulose or to any of the excipients listed in section 6.1 with imminent or threatened intestinal obstruction with faecal impaction ...
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. Methylcellulose should be taken with sufficient fluid to prevent faecal impaction ...
Interaction with other medicinal products and other forms of interaction
Bulk laxatives such as oral methylcellulose lower the transit time through the gut and could affect the absorption of other drugs.
Pregnancy and lactation
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 ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
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 ...
Overdose
Symptoms Methylcellulose is not absorbed. The features to be expected would be abdominal distension which may be followed by intestinal obstruction. Management Gastric lavage should be employed where appropriate. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Bulk-forming laxative ATC Code: A06AC06 The active ingredient is a simple bulking agent.
Pharmacokinetic properties
The active ingredient is not absorbed and hence the product cannot be described in terms of pharmacokinetics.
Preclinical safety data
None listed.
List of excipients
Lactose monohydrate Saccharin sodium Povidone Erythrosine (E127) Strawberry flavour 52.318 AP Talc Magnesium stearate
Incompatibilities
None listed.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Polypropylene securitainer containing 112 or 250 tablets with polyethylene cap. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK
Marketing authorization number(s)
PL 20072/0045
Date of first authorization / renewal of the authorization
Date of first authorisation: 11 November 1992 Date of latest renewal: 21 September 2010
Date of revision of the text
30/03/2016
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