Normax 50mg/60mg Capsules
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NAME OF THE MEDICINAL PRODUCT
Co-danthrusate 50mg/60mg Capsules. Normax 50mg/60mg Capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Docusate Sodium 60mg Dantron 50mg
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Capsule for oral administration.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Constipation in terminally ill patients.
4.2 Posology and method of administration
Adults (including elderly): One to three capsules at bedtime.
Children (6-12 years): One capsule at bedtime.
4.3 Contraindications
In common with all laxatives, Co-danthrusate is contraindicated in cases of non-specific abdominal pain and when intestinal obstruction is suspected.
4.4 Special warnings and precautions for use
In experimental animals, dantron has been associated with adenocarcinomas in the bowel and tumours in the liver. A theoretical risk of similar effects in humans cannot be excluded.
Dantron is excreted in the urine and metabolised dantron in the faeces. There is evidence that these may cause perineal erythema in patients with urinary and/or faecal incontinence. It is recommended therefore that Co-danthrusate should be used with caution in all incontinent patients.
As with all laxatives, prolonged use is not recommended.
4.5 Interaction with other medicinal products and other forms of interaction
Docusate may enhance the gastrointestinal or hepatic cell uptake of mineral oil and quinidine potentiating their activity and possibly increasing their toxicity.
4.6 Pregnancy and lactation
Co-danthrusate should not be used in pregnancy or lactation.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Occasionally an orange tint in the urine may be observed due to the dantron component. Skin rash may occur and reports of skin irritation, skin discolouration and superficial sloughing of the perianal skin have been reported after prolonged use of Co-danthrusate.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9 Overdose
The patient should be encouraged to drink fluids. An anticholinergic preparation may be used to ease excessive intestinal motility if necessary.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Dantron is a mild peristaltic stimulant acting on the lower bowel to encourage normal bowel movement without causing irritation. Docusate sodium is a softening agent which prevents excessive colonic dehydration and hardening of stools.
5.2 Pharmacokinetic properties
None available.
5.3 Preclinical safety data
In experimental animals, dantron has been associated with adenocarcinomas in the bowel and tumours in the liver.
6.1 List of excipients
Lactose
Sodium benzoate (intra and extragranular)
Povidone
Colloidal silicon dioxide Magnesium stearate
Capsule Shell:
Gelatin
Black iron oxide (E172)
Red iron oxide (E172)
Titanium dioxide (E171)
Yellow iron oxide (E172)
Printing Ink:
Titanium dioxide (E171)
Shellac
Ammonium hydroxide Propylene glycol (E1520)
Simeticone
6.2 Incompatibilities
None known.
6.3 Shelf life
5 years for blister packs and aluminium canisters.
3 years for securitainers.
6.4 Special precautions for storage
Do not store above 25oC.
Store in a dry place.
6.5 Nature and contents of container
Blister pack containing 3 (professional sample pack), 21 or 63 capsules. Aluminium canisters containing 12, 30 or 250 capsules.
Securitainers containing 30 or 250 capsules.
Not all pack sizes may be marketed
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Galen Limited Seagoe Industrial Estate Craigavon BT63 5UA UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 27827/0008.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17/06/2010
10 DATE OF REVISION OF THE TEXT
21/11/2014