STEMETIL prochlorperazine maleate 25mg suppositories blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

prochlorperazine maleate

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Registered

Authorization status:

Registered

Patient Information leaflet

Isordil Sublingual Tablets
1
ISORDIL® SUBLINGUAL TABLETS
_ _
_Isosorbide Dinitrate_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet answers some
common questions about Isordil
Sublingual tablets. It does not
contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist or asking questions.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Isordil Sublingual tablets against
the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING ISORDIL, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
ISORDIL TABLETS.
You may need to read it again.
WHAT ISORDIL IS USED
FOR
Isordil Sublingual tablets are for
the prevention and treatment of
attacks of angina. It will not
reduce the pain of an angina
attack, but when taken regularly
may prevent an attack from
occurring
Angina is a pain or
uncomfortable feeling in the
chest, often spreading to the
arms, neck and sometimes to the
shoulders and back. The pain
may be caused by too little blood
and oxygen getting to the heart.
Isordil belongs to a group of
medicines called nitrates. Isordil
works by opening up blood
vessels which allows more blood
and oxygen to reach the heart.
Isordil may also be helpful in the
treatment of some types of heart
failure.
Your doctor may have prescribed
Isordil for another purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS WHY ISORDIL HAS
BEEN PRESCRIBED FOR YOU.
There is no evidence that Isordil
is addictive.
BEFORE YOU USE IT
_ _
_WHEN YOU MUST NOT USE IT _
_ _
1. IF YOU HAVE ALLERGIES TO:
•
Isordil
•
any medication or food
containing nitrates or nitrites
•
any ingredients listed at the
end of this leaflet
Symptoms of an allergic reaction
may include skin rash, itching or
hives on the skin, swelling of the
face, lips, tongue or other parts
of the body, shortness of breath,
wheezing or troubled breathing,
hay fever, and feeling faint.
2. IF YOU HAVE ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
you suffer from certain types
of hea

Patient Information leaflet

STEMETIL
®
_(S-TEM-E-TIL)_
_Prochlorperazine (pro-klor-per-a-zeen)_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Stemetil.
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 has weighed
the risks of you taking Stemetil
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 STEMETIL IS USED
FOR
Stemetil belongs to a group of
medicines called phenothiazines. It
helps 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 (feeling sick) and
vomiting.
Stemetil is used to treat nausea,
vomiting and dizziness due to
various causes, including migraine
(severe headache).
Your doctor may have prescribed
Stemetil for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY STEMETIL HAS
BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
Stemetil is not recommended for use
in children (under the age of 2 years
or children under 10kg in weight)
because children may develop
unusual face and body movements.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE STEMETIL IF YOU HAVE AN
ALLERGY TO:
•
Stemetil
•
the group of medicines called
phenothiazines
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction to
Stemetil may include:
•
shortness of breath, wheezing or
difficulty in breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
YOU SHOULD NOT TAKE STEMETIL IF YOU
HAVE ANY OF THE FOLLOWING MEDICAL
CONDITIONS:
•
shock
•
disease of the blood with a low
number of blood cells
•
yellowing of the skin and/or eye,
also called jaundice
S

Summary of Product characteristics

ISORDIL- Product Information
Page 1 of 6
PRODUCT INFORMATION
ISORDIL ORAL AND SUBLINGUAL TABLETS
NAME OF THE MEDICINE
Isosorbide dinitrate; also known as sorbide nitrate. The chemical name
for isosorbide dinitrate is 1,4:3,6-
dianhydro-2,5-di-O-nitro-D-glucitol. Its structural formula is:
C
6
H
8
N
2
O
8
Molecular weight: 236.1
CAS: 87-33-2
DESCRIPTION
Isosorbide dinitrate is fine, white or almost white, crystalline
powder. It is very slightly soluble in water,
very soluble in acetone, sparingly soluble in ethanol (96 per cent).
Isordil sublingual tablets contain 5 mg of isosorbide dinitrate. The
tablets also contain the following
excipients:
cellulose-microcrystalline,
erythrosine,
lactose
monohydrate,
magnesium
stearate,
starch-
maize.
Isordil oral tablets come in three strengths and contain 10mg, 30mg or
40mg of isosorbide dinitrate. The
tablets
also
contain
the
following
excipients:
ammonium
phosphate-monobasic,
cellulose-
microcrystalline, lactose monohydrate, magnesium stearate, brilliant
blue FCF (30mg & 40mg only),
quinoline yellow (40mg only), sunset yellow FCF (40mg only).
PHARMACOLOGY
Antianginal, vasodilator.
Isosorbide dinitrate is an organic nitrate ester. It has a slower time
to onset of action but longer duration
of action than glyceryl trinitrate. The longer duration of action is
due, in part, to the drug having a longer
elimination
half
life
than
glyceryl
trinitrate
and
to
the
fact
that
its
mononitrated
metabolites
are
pharmacologically active and have long elimination half lives (See
also Pharmacokinetics).
Like other organic nitrate ester drugs, the principal action of
isosorbide dinitrate is to relax vascular
smooth muscle. Venodilation causes venous pooling which reduces venous
return, left ventricular filling
pressure and pulmonary artery and capillary pressures. Myocardial
oxygen requirements are also reduced.
Arteriolar
dilatation
can
result
in
a
reduction
in
after-load.
The
clinical
implication
of
these
haemodynamic changes in patients with congestive heart failure can be
an increase in

Summary of Product characteristics

stemetil-ccsiv4-piv17-08feb19
Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION– STEMETIL
®
(PROCHLORPERAZINE)
1
NAME OF THE MEDICINE
Stemetil Tablets – prochlorperazine maleate
Stemetil Solution for injection – prochlorperazine mesilate
Stemetil Suppositories – prochlorperazine base
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Stemetil tablets: each tablet contains 5mg prochlorperazine maleate.
Excipients of known effect: wheat starch (gluten).
Stemetil injection ampoules: each 1mL ampoule contains 12.5mL
prochlorperazine mesilate.
Excipients of known effect: sodium metabisulfite, sodium sulfite
(sulfites).
Stemetil suppositories: The suppositories come in two strengths, 5mg
or 25mg. Each
suppository contains 5mg or 25mg prochlorperazine maleate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Stemetil 5 mg tablets are off-white to pale cream coloured circular
tablets, not more than
slightly mottled or specked, one side impressed with 'S' and reverse
face plain.
Stemetil 12.5 mg/mL solution for injection is clean, bright and not
more than very pale
yellow.
Stemetil suppositories contain prochlorperazine base equivalent to 5
mg and 25 mg
prochlorperazine maleate. Stemetil suppositories are cream, smooth,
torpedo-shaped
suppositories.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nausea and vomiting due to various causes including migraine; vertigo
due to Meniere's
syndrome, labyrinthitis and other causes.
stemetil-ccsiv4-piv17-08feb19
Page 2 of 18
4.2
DOSE AND METHOD OF ADMINISTRATION
NAUSEA AND VOMITING
_ADULTS _
If oral administration is not practical, a deep intramuscular
injection of 1 mL (12.5 mg) or a
25 mg suppository should be used, followed if required, by normal oral
medication six hours
later.
Do not use a darkened solution for injection (more than pale yellow).
Dosage should be adjusted to suit the response of the individual,
beginning with lowest
recommended dosage.
Oral:
5 or 10 mg two or three times daily.
Acute:
20 mg at once, followed, if necessary