NITRO-DUR 0.2MG/H TRANSDERMAL PATCH

Active substance: GLYCERYL TRINITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nitro-Dur 0.2 mg/hr, 0.4 mg/hr, 0.6 mg/hr Transdermal Patch
Glyceryl trinitrate

In this leaflet:
1. What NITRO-DUR is and what it is used for
2. Before you use NITRO-DUR
3. How to use NITRO-DUR
4. Possible side effects
5. How to store NITRO-DUR
6. Further information
1. WHAT NITRO-DUR IS AND WHAT IT IS USED FOR
NITRO-DUR is an adhesive patch containing Glyceryl Trinitrate (GTN). This is one of a
group of medicines called nitrate vasodilators which are used to treat the symptoms of
angina (chest pain). Vasodilators are drugs that cause widening of the blood vessels
and therefore an increase in blood flow. The GTN is contained in the adhesive and when
the patch is in contact with the skin the GTN passes slowly and steadily from the patch
through the skin and into the bloodstream.
Angina usually occurs as a pain or tightness in the chest although it may be felt in the
neck or arm. The pain occurs when the heart muscle does not receive the oxygen it
needs to do the work it has to do. NITRO- DUR is used to prevent symptoms of angina;
it is not for treatment of an acute attack. You should use your usual tablets or spray
under the tongue for treatment of acute attacks.
2. BEFORE YOU USE NITRO-DUR
Do not use NITRO-DUR if you:
- are allergic (hypersensitive) to GTN or any of the other ingredients of NITRO-DUR.
- suffer a head injury
- are anaemic (have low levels of haemoglobin – a substance contained within the red
blood cells which is responsible for carrying oxygen around the body)
- have heart problems other than angina or have low blood volume or pressure
- are taking medicines for erectile dysfunction, for example sildenafil, tadalafil or vardenafil. If these medicines are used together a severe and possibly dangerous fall in
blood pressure can occur. This could result in collapse, unconsciousness and could
be fatal.

Pregnancy and breast feeding
You should not use NITRO-DUR if you are pregnant or breast feeding. Ask your doctor
for advice if you are pregnant, trying to become pregnant or are breast feeding.

LCNS:

Using NITRO-DUR with food and drink
Be careful when drinking alcohol as it may cause your blood pressure to fall.

FILE NAME/VERSION:

Taking other medicines while using NITRO-DUR
Taking beta blockers, ACE inhibitors, calcium channel blockers, diuretic medicines or
other medicines to lower your blood pressure or medicines for anxiety or depression at
the same time as NITRO-DUR may lower your blood pressure further.
Taking NITRO-DUR with dihydroergotamine, a medicine used to treat migraine, can
affect the blood vessels in the heart.
The effect of NITRO-DUR may be reduced if you take pain killers such as aspirin or
anti-inflammatory medicines at the same time as you use your patch. Please tell your
doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines bought without a prescription.

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Take special care with NITRO-DUR if you:
- have had recent heart failure or a heart attack
- have lung disease
- have or have previously suffered from closed-angle glaucoma (an increase in pressure
in the eye causing visual disturbances)

3. HOW TO USE NITRO-DUR
Always use NITRO-DUR exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure. The usual dose is one patch daily. Your
doctor may tell you to remove the patch after a period shorter than 24 hours. He may
also tell you to apply the patch in the morning or at night. You should usually apply a
new patch at the same time each day.
Put the new patch on a different area of clean, dry skin.
Children should not use NITRO-DUR
How to apply your patch
1. Place the patch on a reasonably hair-free area on the outer upper
arm or chest. Avoid areas below the waist or elbow, skin folds,
scars or burnt or irritated area. Do not use any greasy substances
(creams, ointments) on the skin before applying the patch.
2. Wash your hands before putting the patch on.
3. Tear open the sachet at the slit and take out the patch.

PROOFREADER:

Driving and using machines
The patches may make you dizzy. Do not drive or use machines if you are affected in
this way.

MASTER ARTWORK FILE

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Please read this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

4. Hold the patch with the brown lines facing you in an up and
down position.

5. Bend the sides of the patch away from you. Then bend the sides
towards you until the plastic backing “snaps” in the middle.

6. Peel off one side of the backing.

7. Holding the other half, apply the sticky side of the patch to the
upper arm or chest. Smooth down.

8. Fold back the remaining side of the patch, take off the plastic
backing and smooth down well. You can bathe, shower or swim
with the patch in place if it is properly applied.
9. Wash your hands.
How to remove your patch
1. Press down the centre of the patch to raise its outer edge away
from the skin.

2. Grasp the edge gently and slowly peel off the patch.
3. Wash the skin where the patch was applied with soap and
water and towel dry. Wash your hands.

If you use more NITRO-DUR patches than you should
If you or someone else applies too many patches at once, remove the patches carefully
and wash the skin thoroughly to prevent any more medicines being absorbed. Too
much GTN can cause your blood pressure to drop, make you feel light-headed or cause
you to faint.
If you forget to use your NITRO-DUR patch
If you forget to change your patch, do so as soon as you remember. Then go on as
before. Do not apply two patches to make up for the forgotten dose.
If you stop using NITRO-DUR
Do not stop using your patches without talking to your doctor. If you want to stop your
treatment this must be done gradually and your doctor will need to give you a different
medicine to control your angina.

4. POSSIBLE SIDE EFFECTS

Like all medicines NITRO-DUR can cause side effects, although not everyone gets them.
- Headache is the most common side-effect. You can take some mild pain killers (such
as paracetamol) for this (if they continue or are very severe, do consult your doctor).
- Faintness or dizziness
- A fast heart beat or pulse.
- Rarely in some patients the heartbeat may slow and angina may get worse.
- Redness or irritation of the site where you have placed the patch (some redness is
normal but this should disappear in a short time).
If any of the side effects gets serious or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE NITRO-DUR

Keep out of the reach and sight of children. Do not use after the expiry date, which is
printed on the carton.
Store your patches below 30°C and do not refrigerate them. Remember to return any
unused patches to your pharmacist and dispose of the used ones carefully as they may
still contain some active medication.

6. FURTHER INFORMATION

What NITRO-DUR transdermal patches contain

Each patch contains 37.4% of the active ingredient glyceryl trinitrate (GTN). Each patch
releases either, 0.2mg/hour, 0.4mg/hour or 0.6mg/hour of glyceryl trinitrate. The size
of the patches are, 10cm2, 20cm2 or 30cm2, respectively.
The other ingredients which make up the adhesive components are Butylacrylate polymer,
sodium polyacrylate, melamine formaldehyde resin and purified water coated onto
tan-coloured thermoplastic film. The adhesive layer is covered by PVC release liner. The
patches come in sealed pouches and 28 patches are packed in a cardboard carton.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Merck Sharp & Dohme Limited,
Hertford Road, Hoddesdon,
Hertfordshire, EN11 9BU, UK
The Manufacturer is:
Schering-Plough, SA, Madrid, Spain
This leaflet was last revised in January 2013.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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