COLSYN (Colchicine Tablets USP 500 mcg)

Šalis: Malaizija

kalba: anglų

Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Veiklioji medžiaga:

COLCHICINE

Prieinama:

UNIMED SDN BHD

INN (Tarptautinis Pavadinimas):

COLCHICINE

Vienetai pakuotėje:

10 x 10 Tablets

Pagaminta:

XL Laboratories Pvt. Ltd.

Pakuotės lapelis

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_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
COLSYN (COLCHICINE TABLET USP 500 MCG)
Colchicine (0.5 mg)
WHAT IS IN THIS LEAFLET
1.
What COLSYN is used for
2.
How COLSYN works
3.
Before you use COLSYN
4.
How to use COLSYN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
COLSYN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT COLSYN IS USED FOR
COLSYN is used for the relief of acute
gout when the dramatic response can be
diagnostic. It is also used for the
prevention of recurrent gout and to
prevent acute attacks during the first
few months of treatment with
Allopurinol or gout suppressants.
HOW COLSYN WORKS
Colchicine produces a dramatic
response in acute gout probably by
reducing the inflammatory reaction to
urate crystals. Colchicine also inhibits
cell division.
BEFORE YOU USE COLSYN
-
_When you must not use it _
_Pregnancy and lactation_
_ _
Do not take COLSYN if you are
pregnant, trying to get pregnant or
think you may be pregnant.
Do not take COLSYN if you are
breast- feeding. Ask your doctor or
pharmacist for advice before taking
any medicine.
-
_Before you start use it_
_ _
Tell your doctor if you have:
•
Hypersensitivity to the active
substance or to any of the
excipients.
•
Blood dyscrasias.
•
Pregnancy.
•
Breastfeeding.
•
Childbearing potential unless using
effective contraceptive measures.
•
Severe renal impairment.
•
Severe hepatic impairment.
•
Undergoing haemodialysis.
•
Renal or hepatic impairment who
are taking a P-glycoprotein (P-gp)
inhibitor or a strong CYP3A4
inhibitor.
-
_Taking other medicines_
_ _
Tell your doctor if you are taking any
other medicines, including any that you
buy without a prescription from a
pharmacy, supermarket or health food
shop.
Potential risk of severe drug
interactions, including death, in certain
individual treated with:
-
Clarithromycin (Antibiotic)
-
Cyclosporin (prevent organ
rejection in people who have
received organ transplant)
-
Erythromycin (Antibiotic)

Prekės savybės

•
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.
•
Hypersensitivity to the active substance or to any of the excipients
WARNINGS & PRECAUTIONS:
Colchicine is potentially toxic so it is important not to exceed the
dose prescribed by a physician with
the necessary knowledge and experience. Colchicine has a narrow
therapeutic window. The administration should
be discontinued if toxic symptoms such as nausea, vomiting, abdominal
pain, diarrhoea occur. Colchicine may
cause severe bone marrow depression (agranulocytosis, aplastic
anaemia, thrombocytopenia). The change in blood
counts may be gradual or very sudden. Aplastic anaemia in particular
has a high mortality rate. Periodic checks of
the blood picture are essential. If patients develop signs or symptoms
that could indicate a blood cell dyscrasia, such
as fever, stomatitis, sore throat, prolonged bleeding, bruising or
skin disorders, treatment with colchicine should be
immediately discontinued and a full haematological investigation
should be conducted straight away. Caution is
advised in case of:
•
liver or renal impairment
•
cardiovascular disease
•
gastrointestinal disorders
•
elderly and debilitated patients
•
patients with abnormalities in blood counts
Patients with liver or renal impairment should be carefully monitored
for adverse effects of colchicine. Co-
administration with P-gp inhibitors and/or moderate or strong CYP3A4
inhibitors will increase the exposure to
colchicine, which may lead to colchicine induced toxicity including
fatalities. If treatment with a P-gp inhibitor or a
moderate or strong CYP3A4 inhibitor is required in patients with
normal renal and hepatic function, a reduction in
colchicine dosage or inte