IMDUR isosorbide mononitrate 120 mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

isosorbide mononitrate, Quantity: 120 mg

Available from:

Clinect Pty Ltd

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: hypromellose; colloidal anhydrous silica; synthetic paraffin; hyprolose; magnesium stearate; titanium dioxide; macrogol 6000; aluminium sodium silicate

Administration route:

Oral

Units in package:

7 (sample pack), 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 08 MAY 2001 : IMDUR DURULES are indicated for prophylactic treatment of angina pectoris. IMDUR DURULES are not recommended for the management of acute attacks of angina pectoris (see PRECAUTIONS).

Product summary:

Visual Identification: a white to off-white, oval, biconvex, film-coated tablet with the engraving A/IF on one side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1998-02-23

Patient Information leaflet

IMDUR
®
I
M
D
U
R
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING IMDUR
®
?
IMDUR contains the active ingredient isosorbide mononitrate. Imdur is
used to prevent angina.
For more information, see Section 1. Why am I using IMDUR? in the full
CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE IMDUR
®
?
Do not use if you have ever had an allergic reaction to IMDUR or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
IMDUR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with IMDUR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE IMDUR
®
?
•
Take one IMDUR modified release tablet every day, at about the same
time.
•
If your doctor tells you to take two 60mg IMDUR modified release
tablets each day, take both tablets at the same time.
More instructions can be found in Section 4. How do I use IMDUR? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING IMDUR
®
?
THINGS YOU
SHOULD DO
•
Take IMDUR modified release tablets regularly once every day
•
Remind any doctor, dentist or pharmacist visit that you are using
IMDUR.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly
•
Do not use IMDUR modified release tablets to relieve acute attacks of
angina.
DRIVING
OR USING
MACHINES
•
Be careful driving or operating machinery until you know how IMDUR
affects you.
•
IMDUR may cause dizziness and fainting in some patients
DRINKING
ALCOHOL
•
Be careful when drinking alcohol while you are using IMDUR
•
If you drink alcohol while you are taking IMDUR, you may feel dizzy or
faint.
LOOKING AFTER
YOUR MEDICINE
•
Keep it

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – IMDUR
®
(ISOSORBIDE MONONITRATE)
1. NAME OF THE MEDICINE
Isosorbide mononitrate.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
IMDUR modified release tablets containing isosorbide mononitrate 60 mg
or 120 mg.
For the full list of excipients, see Section 6.1 List of Excipients.
3. PHARMACEUTICAL FORM
IMDUR (modified release tablets) 60 mg: Yellow, oval, biconvex
tablets, scored on both sides, engraved
A/ID.
IMDUR (modified release tablets) 120 mg: White to off-white, oval,
biconvex tablets, engraved A/IF.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
IMDUR are indicated for prophylactic treatment of angina pectoris.
IMDUR 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
One 60 mg IMDUR Durule once daily. The dose may be increased to 120 mg
once daily.
IMDUR should not be administered twice daily.
If headache occurs, the initial dose may be reduced to half a 60 mg
tablet daily until the headache
disappears. Patients with severe renal impairment may require dosage
reduction to half a tablet given once
daily.
IMDUR SHOULD NOT BE CHEWED OR CRUSHED, AND SHOULD BE SWALLOWED WHOLE
WITH HALF A GLASS OF FLUID. If
care is taken to avoid crushing or chewing the tablet, half doses of
the 60 mg tablet may be administered
without affecting the modified release properties of IMDUR. The 120 mg
tablet is not scored and should not
be administered in half doses.
4.3 CONTRAINDICATIONS
Known hypersensitivity to nitrates or to any of the components in
IMDUR.
Shock (including cardiogenic shock), hypotension, obstructive
hypertrophic cardiomyopathy and pericarditis.
Phosphodiesterase type 5 inhibitors (e.g. sildenafil, tadalafil and
vardenafil) must not be given concomitantly
with IMDUR.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
PLEASE NOTE:
There is a risk of developing tolerance to haemodynamic and
antianginal effects if higher doses (more than
120mg/day) and/or more fr