Consumer Medicine Information

MINITRAN™ 5 and 10

glyceryl trinitrate 5mg and 10mg
Transdermal Delivery System

What is in this leaflet

This leaflet answers some common questions about Minitran patches. However it does not contain all the available information. Your doctor or pharmacist have more detailed information about Minitran patches. So if you need more information about Minitran please ask your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risk of you using Minitran patches against the benefits it can have for you. If you have any concerns about using Minitran please ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may want to read it again.

What MINITRAN is used for

Minitran patches are used to help prevent attacks of angina (chest pain). The active ingredient, glyceryl trinitrate, belongs to a group of medicines called nitrates. When a Minitran patch is placed on the skin, glyceryl trinitrate passes slowly through the skin and into the blood stream. Glyceryl trinitrate works by widening blood vessels, letting more blood and oxygen reach the heart.

Your doctor may prescribe Minitran for another purpose. If you are not sure why you are using this medicine please ask your doctor.

Before using MINITRAN

When you must not use MINITRAN

Do not use Minitran if:

• you are allergic to any of the ingredients listed under "Product Description" or to any medicine or food containing nitrates or nitrites. If you have an allergic reaction you may get a skin rash, difficulty in breathing, hayfever or faintness.
• you are taking sildenafil, a medicine used to treat male impotence.
• you are pregnant or breastfeeding unless your doctor says it is safe.
• after the expiry date (EXP) on the pouch.

Minitran should not be used in children.

Minitran has been prescribed for you only. Do not give it to anyone else even if you think their condition is the same as yours.

Before you start to use MINITRAN

• Tell your doctor if you are taking:
• any medicines to treat depression, mental illness, heart conditions, male impotence or migraine
• any medicines that you buy without a prescription

Using MINITRAN

Dosage

The usual dose of Minitran is one patch applied every day. Your doctor will prescribe the correct dose for you. Apply a new patch at the same time every day. Each patch is usually worn for 12 to 16 hours each day, or for as long as your doctor tells you.

How to use MINITRAN

Minitran patches can be placed on the chest, shoulder, upper arm or back. Do not place Minitran patches on your forearm or lower leg.

Always put your patch on a different area of skin each day. If you use the same area too much you may get a rash. Minitran patches should not be placed on broken skin such as cuts or grazes. You should place the patch on a hairless area of skin. If the area of skin is hairy, clip or shave the hair off. The skin should be clean and dry before sticking a Minitran patch on. This will make the patch stick properly. Do not use dusting powder or any greasy substances, eg. ointments or creams, on the skin before applying the patch.

Please follow the instructions below:

1. Start at notched corner. Tear pouch along dotted line. Remove patch from pouch.
   
2. Bend patch so that the tab on the liner pops up. Hold tab to peel off the liner.
   
3. Apply sticky side of patch to upper arm or chest. Remove and discard the other piece of the liner.
   
4. Press patch firmly into place.
   

While you are using MINITRAN

• Minitran patches may lower your blood pressure and make you feel dizzy, particularly when changing position suddenly. You should be especially careful if you are driving or operating machinery.
• Minitran patches are intended to prevent angina attacks. If you do have an attack of chest pain when using Minitran, you should use under-the-tongue glyceryl trinitrate tablets or a similar medication as instructed by your doctor.
• Tell your doctor if you continue to have angina attacks or if they become more frequent while you are using Minitran.
• Ask your doctor if it is safe to drink alcohol while you are using Minitran.
• You can bathe, shower and swim as normal when wearing a Minitran patch.
• If a patch does not stick or falls off, simply use a new patch on a different area of skin. Do not re-use a patch once it has been removed from the skin.

If you forget to use MINITRAN

If you forget to use Minitran, apply the patch as soon as you remember. However, if it is almost time for your next patch, skip the patch that you missed. Apply the next patch at the normal time. Never apply extra patches to make up for the patch you have missed.

If you use too much MINITRAN

Glyceryl trinitrate overdose is unlikely when using Minitran patches. If accidental overdose does occur, remove the patch and contact your doctor or Poisons Information Centre (in Australia call 131126; in New Zealand call toll free 0800 POISON or 0800 764 766) or go to the Accident and Emergency department at the nearest hospital.

When you stop using MINITRAN

Do not stop using Minitran abruptly. If you are to stop using Minitran, your doctor will gradually reduce the dose over 4 to 6 weeks before you completely stop using it.

Side Effects

All medicines can have side effects and this may occur with the normal use of Minitran. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Minitran.

Side effects of Minitran include:

• Headaches. These may develop when you begin to use Minitran. They are usually mild and stop after the first few days of treatment.
• Red and itchy skin. This usually only lasts for a few hours after removing the patch. You can help to prevent this if you make sure your skin is dry before you apply a patch and if you use a different area of skin each day.
• Other common side effects include dizziness, light headedness, low blood pressure, hot flushes, nausea and vomiting

If you have any side effect whether it is listed above or not, please contact your doctor.

Storage Conditions

Keep Minitran patches in a cool, dry place where the temperature stays below 25°C. Do not keep Minitran patches in the fridge. Keep Minitran patches where children cannot reach them. Dispose of used Minitran patches where children or others cannot find them. There is still some of the active ingredient in the used patches and this may be dangerous to others.

Product Description

What MINITRAN patches look like

Minitran is a patch made of thin, clear plastic covered by a layer of adhesive and the active ingredient, glyceryl trinitrate.

Minitran patches are oval shaped and are available in Australia in three sizes:

MINITRAN 5 is a 6.7 cm² patch (AUST R 52028). It releases 5 mg of glyceryl trinitrate every 24 hours. The patch is marked "MINITRAN 5".

MINITRAN 10 is a 13.3 cm² patch (AUST R 52029). It releases 10 mg of glyceryl trinitrate every 24 hours. The patch is marked "MINITRAN 10".

MINITRAN 15 is a 20 cm² patch (AUST R 52030). It releases 15 mg of glyceryl trinitrate every 24 hours. The patch is marked "MINITRAN 15".

Minitran 5 and Minitran 10 are available in New Zealand.

Each box of Minitran contains 30 patches.

Ingredients

• MINITRAN 5 contains 18 mg of glyceryl trinitrate
• MINITRAN 10 contains 36 mg of glyceryl trinitrate
• MINITRAN 15 contains 54 mg of glyceryl trinitrate

Each Minitran patch also contains polymer 3273, ethyl oleate and glyceryl laurate

Sponsor

Minitran is supplied in Australia by:

iNova Pharmaceuticals (Australia) Pty Limited
(ACN 88 000 222 408)
9-15 Chilvers Road
Thornleigh
NSW 2120
Australia

Minitran is supplied in New Zealand by:

iNova Pharmaceuticals (New Zealand) Limited
c/o Simpson Grierson
Level 27
88 Shortland Street
AUCKLAND

This leaflet was prepared in January 2003