XOLINE TABLET 500MCG [SIN17275P]
Active ingredients: XOLINE TABLET 500MCG
Product Info
XOLINE TABLET 500MCG
[SIN17275P]
Product information
Active Ingredient and Strength | COLCHICINE - 0.5 MG |
Dosage Form | TABLET |
Manufacturer and Country | RENATA PLC - BANGLADESH |
Registration Number | SIN17275P |
Licence Holder | SEA PHARMA CONSULTANCY PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | M04AC01 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
4.1 Therapeutic indications
Adults
Treatment of acute gout.
Dosing
4.2 Posology and method of administration
Posology
Adults
Treatment of acute gout attack:
1 mg (2 tablets of 500 micrograms) to be taken initially followed by 500 micrograms every two to three hours until pain subsides. A total dose of 6 mg should not be exceeded. After completion of a course, another course should not be started for at least three days.
Patients with renal impairment
Use with caution in patients with mild renal impairment. For patients with moderate renal impairment, reduce dose or increase interval between doses. Such patients should be carefully monitored for adverse effects of colchicine (see also section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
For patients with severe renal impairment, see section 4.3.
Patients with hepatic impairment
Use with caution in patients with mild/moderate hepatic impairment. Such patients should be carefully monitored for adverse effects of colchicine.
For patients with severe hepatic impairment, see section 4.3.
Elderly
Use with caution.
Method of administration
For oral administration
Tablets should be swallowed whole with a glass of water.
Contraindications
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Patients with blood dyscrasias
Pregnancy
Breastfeeding
Women of childbearing potential unless using effective contraceptive measures
Patients with severe renal impairment
Patients with severe hepatic impairment
Colchicine should not be used in patients undergoing haemodialysis since it cannot be removed by dialysis or exchange transfusion.
Colchicine is contraindicated in patients with renal or hepatic impairment who are taking a P-glycoprotein (P-gp) inhibitor or a strong CYP3A4 inhibitor (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
