COLCHICINE 0.5 mg

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

COLCHICINE

Available from:

RAFA LABORATORIES LTD

ATC code:

M04AC01

Pharmaceutical form:

TABLETS

Composition:

COLCHICINE 500 MCG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

RAFA LABORATORIES LTD, JERUSALEM

Therapeutic group:

COLCHICINE

Therapeutic area:

COLCHICINE

Therapeutic indications:

Prevention and treatment of gout and FMF (familial mediterranean fever).

Authorization date:

2021-06-30

Patient Information leaflet

1
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold with a doctor's prescription only
COLCHICINE 0.5 MG
TABLETS
ACTIVE INGREDIENT:
Each tablet contains: Colchicine 0.5 mg (500 microgram).
For the list of the additional ingredients, see section 6. See also
'Important information about some
of the medicine's ingredients' in section 2.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further questions,
please refer to your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
IMPORTANT WARNING!
Do not exceed the recommended dose. Overdosing, including as a result
of possible drug
interactions, can lead to a life threatening, very painful and
irreversible poisoning with a fatal
outcome (see also sections 2-4 in this leaflet). Keep this medicine
out of reach of others (before and
after use).
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for treatment and prevention of gout and
Familial Mediterranean
Fever (FMF).
THERAPEUTIC GROUP: alkaloid, anti-gout
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
additional
ingredients the medicine contains (for the list of the additional
ingredients, see section
6).
•
You have a disorder in the blood composition (blood dyscrasias).
•
You have severe kidney impairment.
•
You have severe liver impairment.
•
Pregnancy: See section 2 - 'Pregnancy, breastfeeding and fertility'.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
There is only a slight difference between the dose necessary to obtain
the desired action of
Colchicine and the dose that may cause symptoms of medicine poisoning;
this means that even
taking a dose that is slightly higher can cause acute symptoms of
poisoning. If you have
sympto

Summary of Product characteristics

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