CAFFOX TABLET

País: Malásia

Língua: inglês

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

Ingredientes ativos:

CAFFEINE; ERGOTAMINE TARTRATE

Disponível em:

IMEKS PHARMA SDN. BHD.

DCI (Denominação Comum Internacional):

CAFFEINE; ERGOTAMINE TARTRATE

Unidades em pacote:

10 Tablets

Fabricado por:

T.O. PHARMA CO LTD

Folheto informativo - Bula

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CAFFOX TABLET
Caffeine/Ergotamine Tartrate (100/1 mg)
_ _
1
WHAT IS IN THE LEAFLET
1.
What CAFFOX is used for
2.
How it works
3.
Before you take CAFFOX
4.
How to take CAFFOX
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of CAFFOX
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT CAFFOX
IS USED FOR
CAFFOX contains the active ingredient Er-
gotamine tartrate and Caffeine.
CAFFOX is used to treat migraine which has
not responded to painkillers. It is used at the
first sign of a migraine attack to relieve the
symptoms and to stop the attack getting worse.
HOW IT WORKS
CAFFOX belongs to the group of anti-
migraine drugs. Migraine is thought to be
caused by electrical and chemical imbalances
that affect the blood vessels in the brain and
increase sensitivity to pain and cause inflam-
mation and swelling. Anti-migraine drugs are
believed to work by correcting the imbalanc-
es and relieve the migraine pain.
BEFORE YOU TAKE CAFFOX
-
When you must not use it
Do not take CAFFOX if you
• Have had allergic reaction to Ergotamine
tartrate and Caffeine or to any other ingredients
in this product.
• Have Raynaud’s disease (rare blood vessels
disorder).
• Have other blood vessels disorder.
• Have peptic ulcer disease.
• Have kidney problem.
• Have liver problem.
• Are malnutrition.
• Have uncontrolled high blood pressure
• Have heart disease.
• Have severe blood infection (Sepsis)
• Have glaucoma.
• Have Porphyria (rare tumour at adrenal gland)
• Are pregnant, or think you are pregnant.
• Are breast feeding.
_If you are not sure whether you should start _
_taking this medicine, consult your doctor. _
-
Before you start to use it
Tell your doctor if you:
• Have allergies to any other medicines, foods,
preservatives, or dyes.
CAFFOX TABLET is not recommended for
children under 12 years old of aged.
-
Taking other medicines
Tell your doctor if you are taking any other
medicine, includin

Características técnicas

CAFFOX
CONTENT
Each tablet contains: Ergotamine tartrate 1 mg and caffeine 100 mg.
DESCRIPTION
A yellow round biplane scored-tablet.
INDICATIONS
Acute attacks of migraine and related types of vascular headache
unresponsive
to analgesics.
RECOMMENDED DOSE
CAFFOX should be given at the first symptoms of an attack.
Adults:
The first time CAFFOX is taken, an initial dose of 2 tablets orally is
recommended. If relief is not obtained within half an hour, a further
tablet
should be administered; this may be repeated at half-hourly intervals,
but the
maximum daily dose indicated below should not be exceeded. For
subsequent
attacks the initial dose may be increased to 3 tablets, depending on
the total
dose required in previous attacks. If pain persists, additional doses
of 1 tablet
may be taken at half-hourly intervals up to the maximum dose (see
below).
The following restriction must be observed: If supplementary
antimigraine
medication is required, the use of any ergotamine-containing
preparations,
intranasal or parenteral dihydroergotamine or sumatriptan or other
5HT1-
receptor agonists must be avoided (see _Contraindications_).
_Maximum dose per attack or per day:_ Adults: 6 mg ergotamine tartrate
= 6
tablets.
_Maximum weekly dose:_ Adults: 10 mg ergotamine tartrate = 10 tablets.
ROUTE OF ADMINISTRATION Oral
CONTRAINDICATIONS
•
Known hypersensitivity to ergot alkaloids, caffeine, or any other
components
of the formulations.
•
Pregnancy and breast-feeding (see _Pregnancy and Lactation_).
•
Impaired peripheral circulation, obliterative vascular disease,
coronary heart
disease, inadequately controlled hypertension, septic conditions,
shock.
•
Severe renal or hepatic impairment.
•
Temporal arteritis.
•
Hemiplegic or basilar migraine.
•
Concomitant treatment with macrolide antibiotics, HIV protease or
reverse
transcriptase inhibitors, azole antifungals (see _Drug Interactions_).
•
Concomitant treatment with vasoconstrictor agents (including ergot
alkaloids,
sumatriptan and other 5HT1 receptor agonists) (see