Cafergot Tablet

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

ERGOTAMINE TARTRATE; CAFFEINE

Verfügbar ab:

A. MENARINI SINGAPORE PTE. LTD.

INN (Internationale Bezeichnung):

ERGOTAMINE TARTRATE; CAFFEINE

Einheiten im Paket:

20tablet Tablets

Hergestellt von:

CENEXI SAS

Gebrauchsinformation

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CAFERGOT TABLET
_ _
Ergotamine Tartarate / Caffeine (1mg/100mg)
WHAT IS IN THIS LEAFLET
1.
What cafergot is used for
2.
How cafergot works
3.
Before you use cafergot
4.
How to use cafergot
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
cafergot
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT CAFERGOT IS USED FOR
Cafergot is used to treat acute
attacks of migraine and related
types of headache (vascular
headache)
HOW CAFERGOT WORKS
Cafergot contains 2 active
ingredients which are ergotamine
tartrate and caffeine. Headaches
are thought to be caused by
temporary changes in the
size of small blood vessels in the
brain. These blood vessels swell,
causing the pain and visual
disturbances that often happen
during an attack. Cafergot stops
the attack by causing the blood
vessels to constrict (shrink) back
to normal size.
BEFORE YOU USE CAFERGOT
Tell your doctor if you
smoke.
Nicotine in cigarettes may
increase the chance of you
having an unwanted side
effect called enhanced
vasoconstriction (excessive
constriction of blood vessels).
_- When you must not use it _
Please do not use Cafergot if you
have
ever had an allergic reaction to
any of the following
:
a) ergotamine or caffeine, the
active ingredients in Cafergot
tablets
b) any of the other ingredients
listed at the end of this leaflet
-any other ergot alkaloids
Do not use Cafergot if you have
any of the following health
problems/medical conditions
:
a) problems with your heart,
especially if you have chest pain
that is not controlled or you have
had a heart attack.
b) high blood pressure that is not
controlled liver or kidney disease
c) poor blood circulation or other
blood vessel disorders.
d) a serious infection
e) temporal arteritis
(inflammatory disease of the
blood vessel)
f) Rare and serious type of
migraine
g) you are being treated for
HIV/AIDS with medicine called
HIV protease or reverse
transcriptase inhibitors
i) you are being treated for

Fachinformation

102386/LF/1
CAFERGOT®
Controlled Medicine
Treatment of migraine attacks and related types of vascular headache.
COMPOSITION
Cafergot tablets contain 1 mg ergotamine tartrate and 100 mg caffeine.
Pharmaceutical form
Tablets
Description
Circular, flat, s peckled yellowish- white tablets with isolated dots of pigment and beveled edges.
One side bears the imprint ‘XL’ and a score line, plain on the other side.
Pharmacodynamics/ Pharmacokinetics
PHARMACOKINETICS
Ergotamine
Absorption
Ergotamine is rapidly a bsorbed following oral administration. Maximum plasma concentrations are
reached 1.5 to 2 hours after administration.
Studies with tritium- labelled ergotamine have shown that approximately 62% of the oral dose is
absorbed via the gastrointestinal route. Ma ximum plasma concentrations are reached approximately
2 hours after ingestion.
Any potential increase in plasma caffeine concentrations due to an interaction with one or more
other medicinal products may lead to a rise in ergotamine absorption. Caffeine is significantly
metabolised by CYP1A2 and medicinal products that increase or reduce enzyme activity may affect
the metabolic clearance of caffeine.
Distribution
Oral bioavailability is 62 ± 3%.
The medicinal product has a high level of tissue affinity.
P rotein binding of ergotamine is 98%. The absolute bioavailability of the parent drug is
approximately 2% following oral administration and approximately 5% following rectal
administration.
Biotransformation
Ergotamine is significantly metabolised in the liver and is a substrate of the CYP3A4 enzyme
system. It has been suggested that the therapeutic effects of the medicinal product are partially
linked to the active metabolites.
Elimination
The parent drug and metabolites are excreted mainly in the bile. Plasma elimination takes place in
two stages, with alpha and beta half -lives of 2.7 and 21 hours, respectively.
Elimination in the urine is low (4.3 ± 0.4%). The drug is primarily eliminated via the biliary and
faecal routes.
The addition of caffeine spe