Colchicine Tiofarma 500 microgram Tablets

Држава: Малта

Језик: Енглески

Извор: Medicines Authority

Доступно од:

Tiofarma B.V. Benjamin Franklinstraat 5-10, 3261 LW Oud-Beijerland, Netherlands

АТЦ код:

M04AC01

INN (Међународно име):

COLCHICINE 0.5 mg

Фармацеутски облик:

TABLET

Састав:

COLCHICINE 0.5 mg

Тип рецептора:

POM

Терапеутска област:

ANTIGOUT PREPARATIONS

Резиме производа:

Licence number in the source country: NOT APPLICAPABLE

Статус ауторизације:

Authorised

Датум одобрења:

2022-04-25

Информативни летак

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PACKAGE LEAFLET: INFORMATION FOR THE USER
COLCHICINE TIOFARMA 500 MICROGRAM TABLETS
COLCHICINE TIOFARMA 1000 MICROGRAM TABLETS
colchicine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask you doctor or pharmacist.
•
This medicine has been described for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Colchicine Tiofarma is and what it is used for
2.
What you need to know before you use Colchicine Tiofarma
3.
How to use Colchicine Tiofarma
4.
Possible side effects
5.
How to store Colchicine Tiofarma
6.
Contents of the pack and other information
1.
WHAT COLCHICINE TIOFARMA IS AND WHAT IT IS USED FOR
Colchicine Tiofarma contains the active substance colchicine. It
belongs to the group of anti-gout
agents and is used to prevent or treat a gout attack.
_Gout attacks in Adults _
Colchicine Tiofarma is used, in adults, in the short term treatment of
acute gout, so called gout attacks,
and to prevent gout from recurring.
The concentration of uric acid in blood is increased in gout. This
might lead to precipitation of uric
acid crystals in the fluid of joints. Colchicine inhibits the
resulting inflammatory response.
_Familial Mediterranean Fever _
In addition, Colchicine Tiofarma is indicated in Familial
Mediterranean Fever (a hereditary disease
with recurring inflammation and fever attacks) to prevent fever
attacks and amyloidosis (abnormal
precipitation of proteins in tissues and organs).
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE COLCHICINE TIOFARMA
DO NOT USE COLCHICINE TIOFARMA:
•
If you are allergic to colchicine or any of

Карактеристике производа

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1.
NAME OF THE MEDICINAL PRODUCT
Colchicine Tiofarma 500 microgram Tablets
Colchicine Tiofarma 1000 microgram Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Colchicine Tiofarma 500 microgram Tablet contains 0.5 mg of
colchicine.
Each Colchicine Tiofarma 1000 microgram Tablets contains 1 mg of
colchicine.
Excipients with known effect
Each Colchicine Tiofarma 500 microgram Tablet contains 83 mg of the
excipient lactose
monohydrate, equivalent to 78.6 mg of lactose anhydrous.
Each Colchicine Tiofarma 1000 microgram Tablet contains 166 mg of the
excipient lactose
monohydrate, equivalent to 157.2 mg of lactose anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Colchicine Tiofarma 500 microgram Tablets are off-white, round, flat
tablets with facet, ca. 6
mm diameter, ca. 3 mm thickness and with the inscription “0,5” on
one side.
Colchicine Tiofarma 1000 microgram Tablets are off-white, oval
tablets, ca. 12 mm length, ca.
3 mm thickness and with the inscription “C1C” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Gout _
•
Colchicine is indicated in adults for the treatment of acute gout
•
Colchicine is indicated in adults for the prophylaxis of a gout attack
during initiation of
urate-lowering therapy
_Familial Mediterranean Fever _
•
Colchicine is indicated in adults and children with Familial
Mediterranean Fever for
prophylaxis of attacks and prevention of amyloidosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Important warning! _
_Because of the narrow therapeutic range of colchicine, the
recommended maximum dose must not be _
_exceeded. Overdosing, including by ignoring interactions, can lead to
a very painful and irreversible _
_poisoning with a fatal outcome. Please refer to sections 4.4, 4.5.,
4.8 and 4.9 of this SmPC. _
_The medicinal product must be kept out of reach of others before and
after use. _
Posology
_Adults_
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_Acute gout attack _
2 to 3 times daily 0.5 mg, possibly preceded by an initial dose