CHEM MART Isosorbide mononitrate 60mg modified release tablet blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

isosorbide mononitrate

Dostupné s:

Apotex Pty Ltd

Stav Autorizace:

Registered

Informace pro uživatele

CHEMMART ISOSORBIDE
MONONITRATE SUSTAINED-
RELEASE TABLETS
_Isosorbide mononitrate_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
isosorbide mononitrate. It does not
contain all the information that is
known about this medicine. It does
not take place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking isosorbide
mononitrate 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 THIS MEDICINE IS
USED FOR
Isosorbide mononitrate sustained-
release tablets are used to prevent
angina.
Angina is a pain or uncomfortable
feeling in the chest, often spreading
to the arms or the neck and
sometimes to the shoulders and back.
This is caused by too little blood and
oxygen getting to the heart.
The pain of angina is usually brought
on by exercise or stress.
_HOW IT WORKS_
Isosorbide mononitrate belongs to a
group of medicines called nitrates. It
works by relaxing the blood vessels,
letting more blood and oxygen reach
the heart.
It is not recommended that isosorbide
mononitrate be taken for the
treatment of acute attacks.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is only available with
a doctor's prescription.
There is not enough information to
recommend the use of this medicine
in children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE ANY ALLERGY TO:
•
isosorbide mononitrate
•
food containing nitrates
•
nitrites
•
any ingredients listed at the end
of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or

Charakteristika produktu

AUSTRALIAN PRODUCT INFORMATION
CHEMMART ISOSORBIDE MONONITRATE (ISOSORBIDE
MONONITRATE) SUSTAINED RELEASE TABLETS
1
NAME OF THE MEDICINE
Isosorbide mononitrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chemmart Isosorbide Mononitrate Sustained Release Tablets contain 60
mg isosorbide
mononitrate.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
Chemmart Isosorbide Mononitrate 60 mg Sustained Release Tablets:
A cream, film-coated oval tablet of 13mm length, half scored on both
sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylactic treatment of angina pectoris. Chemmart Isosorbide
Mononitrate 60 mg Sustained
Release Tablets are not recommended for the management of acute
attacks of angina pectoris
(see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
One (1) tablet once daily. That dose may be increased to two (2)
tablets daily, both tablets taken
at the same time.
Chemmart Isosorbide Mononitrate 60 mg Sustained Release Tablets should
not be administered
twice daily.
There is insufficient evidence to show that one halved tablet of
Chemmart Isosorbide Mononitrate
delivers exactly half the dose of one full tablet, or whether the rate
of release is the same. _In-vitro _
dissolution testing showed that dissolution was slightly faster with
halved Chemmart Isosorbide
Mononitrate Sustained Release Tablets than with whole tablets.
Chemmart Isosorbide Mononitrate 60 mg Sustained Release Tablets should
not be chewed or
crushed, and should be swallowed whole with half a glass of fluid.
4.3
CONTRAINDICATIONS
•
Known hypersensitivity to nitrates or to any of the components in
Chemmart Isosorbide
Mononitrate 60 mg Sustained Release Tablets.
•
Shock (including cardiogenic shock), hypotension, obstructive
hypertrophic cardiomyopathy
and pericarditis, aortic stenosis, cardiac tamponade, mitral stenosis
and severe anaemia.
•
PHOSPHODIESTERASE TYPE 5 INHIBITORS (E.G. SILDE