Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium dihydrogen phosphate anhydrous; Sodium bicarbonate
Forest Laboratories UK Ltd
A06AG20
Sodium dihydrogen phosphate anhydrous; Sodium bicarbonate
1.69gram ; 1.08gram
Suppository
Rectal
No Controlled Drug Status
Valid as a prescribable product
BNF: 01060400
103/L/e/2 1 PATIENT INFORMATION LEAFLET CARBALAX TM SUPPOSITORIES Carbalax Suppositories are used to treat constipation, including constipation caused by prolonged bedrest or the effect of medicines. They are also sued to evacuate the bowels before childbirth, operations or diagnostic procedures and to ease bowel movements after operations or in any condition where staining may be painful. Carbalax suppositories effervesce on contact with the rectal mucosa and this encourages evacuation. Carbalax are suitable for adults and children over 12 years of age. Do not administer to younger children. There are certain bowel conditions where treatment of constipation with Carbalax Suppositories may not be suitable. You should discuss this with your doctor or pharmacist if you are not sure. Administer one suppository 30 minutes before evacuation is required. Remove from packaging and moisten with water before insertion into the rectum. Do not lubricate with oil. There are not normally any problems following the use of Carbalax Suppositories. If you notice anything unusual tell your doctor or pharmacist. If anyone accidentally swallows Carbalax Suppositories contact a doctor or pharmacist. REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine. Each Suppository contains: Sodium Bicarbonate Ph.Eur. 1.08g And anhydrous Sodium Acid Phosphate 1.3g in an inert Polyethylene Glycol base. 12 suppositories. Keep out of reach of children. Do not remove from packaging until needed. Do not use after expiry date. Store below 25°C in a dry place. For rectal use only Manufactured by: Forest Laboratories UK Limited, Bourne Road, Bexley, Kent, DA5 1NX, United Kingdom Chemidex Pharma Limited Chemidex House Egham Business Village Crabtree Roa Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT CARBALAX SUPPOSITORIES 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains: Sodium acid phosphate anhydrous (equivalent to Sodium Acid Phosphate Ph.Eur. 1.69g) 1.30g Sodium Bicarbonate Ph.Eur. 1.08g 3 PHARMACEUTICAL FORM Suppository for rectal administration 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Chronic simple constipation. Constipation due to prolonged bed-rest or to drugs. Bowel evacuation before childbirth, surgery, sigmoidoscopy, radiological examination and post-operatively. To avoid discomfort associated with straining. To regularise bowel movement and keep stools to normal consistency in local anal conditions such as haemorrhoids, fissures and fistulae. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and the Elderly: Administer one suppository 30 minutes before evacuation is required. Children under 12: Not recommended. 4.3 CONTRAINDICATIONS Conditions where any bowel medication for the relief of constipation is contra- indicated. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The suppository should be moistened with water, not lubricated with oil before insertion. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 PREGNANCY AND LACTATION No restriction. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. 4.8 UNDESIRABLE EFFECTS Side effects are unlikely. 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 Overdose has not been reported. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Carbalax Suppositories function by a physical induction of reflex bowel evacuation caused when carbon dioxide is liberated when the suppository contacts m Lesen Sie das vollständige Dokument