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NAUSETIL
_Prochlorperazine maleate_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Nausetil. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor or pharmacist
has weighed the risks of you taking
Nausetil against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NAUSETIL IS
USED FOR
Nausetil contains the active
ingredient prochlorperazine maleate
and is used to treat nausea associated
with migraine (severe headache).
Nausetil belongs to a group of
medicines called phenothiazines,
which help to correct chemical
imbalances in the brain allowing it to
function correctly. These chemicals
may also affect the parts of the brain
which control nausea.
There is no evidence that it is
addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE NAUSETIL IF YOU HAVE
EVER HAD AN ALLERGIC REACTION TO:
•
prochlorperazine maleate
•
the group of medicines called
phenothiazines
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction
may include asthma, wheezing,
shortness of breath, swelling of the
face, lips or tongue which may cause
difficulty in swallowing or breathing,
skin rash, itching or hives.
DO NOT TAKE NAUSETIL IF YOU HAVE
ANY OF THE FOLLOWING MEDICAL
CONDITIONS:
•
shock
•
disease of the blood with a low
number of blood cells
•
jaundice, yellowing of the skin
and/or eyes.
NAUSETIL MUST NOT BE GIVEN TO
ANYONE WHO IS UNCONSCIOUS OR IN A
COMA.
DO NOT TAKE ANY MEDICINES THAT
CAUSE DROWSINESS WHILE YOU ARE
TAKING NAUSETIL.
DO NOT GIVE NAUSETIL TO CHILDREN
UNDER THE AGE OF TWO (2) YEARS OR
UNDER 10 KG IN WEIGHT.
DO NOT TAKE IT AFTER THE EXPIRY DATE
(EXP) PRINTED ON THE PACK.
DO NOT TAKE IT IF THE PACKAGING IS
TORN OR SHOWS SI
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NAUSETIL PI –S3, marketed
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PRODUCT INFORMATION
NAUSETIL
(Schedule 3 - prochlorperazine maleate)
NAME OF THE MEDICINE
NAUSETIL (prochlorperazine maleate).
Chemical name:
2-chloro-10-[3-(4-methylpiperazin-1-yl)propyl]-10_H_-phenothiazine
bis[hydrogen (Z)-butenedioate].
Structural formula:
Chemical formula: C
20
H
24
ClN
3
S, 2C
4
H
4
O
4
Molecular weight: 606.2
CAS: 84-02-6
DESCRIPTION
Prochlorperazine maleate is an odourless, nonhygroscopic, white
or almost white, fine granular
powder, which becomes coloured on exposure to light. It is very
slightly soluble (about 0.1%) in
water, ethanol or methanol and is insoluble in ether or chloroform.
Prochlorperazine is a phenothiazine with a piperazine moiety in the
side chain. It possesses
strong antiemetic and antipsychotic activity with less
sedative action than chlorpromazine.
Each NAUSETIL tablet contains 5 mg of prochlorperazine maleate as the
active ingredient.
Excipients include starch–wheat, magnesium stearate, sodium lauryl
sulfate, calcium hydrogen
phosphate anhydrous and quinoline yellow.
PHARMACOLOGY
As with other phenothiazines, prochlorperazine has actions on several
neurotransmitter systems
as follows:
NAUSETIL PI –S3, marketed
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• Antidopamine action, which probably contributes to both the
therapeutic effect and
unwanted effects including extrapyramidal disorders and endocrine
disturbances.
• alpha-Adrenoreceptor antagonism, which contributes to
cardiovascular side effects, e.g.
orthostatic hypotension and reflex tachycardia.
• Potentiation of noradrenaline by blocking its reuptake into
nerve terminals.
• Weak anticholinergic action.
• Weak antihistamine action.
• Weak serotonin antagonism.
Prochlorperazine also has an effect on temperature control and blocks
conditioned avoidance
responses.
Pharmacokinetics
There are few publis
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