APO-ISOSORBIDE MONONITRATE 60 mg modified release tablet blister pack

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

isosorbide mononitrate, Quantity: 60 mg

Pieejams no:

Arrotex Pharmaceuticals Pty Ltd

Zāļu forma:

Tablet, modified release

Kompozīcija:

Excipient Ingredients: purified talc; titanium dioxide; lactose monohydrate; hypromellose; stearic acid; magnesium stearate; iron oxide yellow; macrogol 4000; Carnauba Wax; colloidal anhydrous silica

Ievadīšanas:

Oral

Vienības iepakojumā:

30 tablets

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

Prophylactic treatment of angina pectoris. APO- ISOSORBIDE Mononitrate 60mg Sustained Release tablets are not recommended for the management of acute attacks of angina pectoris (see Precautions).

Produktu pārskats:

Visual Identification: Oval tablet with a cream coloured film coating and half scored on both sides.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorizācija statuss:

Licence status A

Autorizācija datums:

2000-09-20

Lietošanas instrukcija

APO-ISOSORBIDE MONONITRATE SUSTAINED-RELEASE TABLETS
1
APO-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

Produkta apraksts

AUSTRALIAN PRODUCT INFORMATION
APO- ISOSORBIDE MONONITRATE (ISOSORBIDE
MONONITRATE) SUSTAINED RELEASE TABLETS
1
NAME OF THE MEDICINE
Isosorbide mononitrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APO- 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
APO- 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. APO- 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.
APO- Isosorbide Mononitrate 60 mg Sustained Release Tablets should not
be administered twice
daily.
There is insufficient evidence to show that one halved tablet of APO-
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 APO- Isosorbide
Mononitrate Sustained Release Tablets than with whole tablets.
APO- 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 APO-
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. SILDENAFIL, TADALAFIL AND
VARDENAFIL) ARE