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Active substance(s): GLYCERYL TRINITRATE

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Technical Info




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Package leaflet: Information for the user

Nitro-Dur 0.2 mg/h, 0.4 mg/h, 0.6 mg/h Transdermal Patch

Glyceryl trinitrate

Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
- 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 only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.

What is in this leaflet:
1. What Nitro-Dur is and what it is used for
2. What you need to know before you use Nitro-Dur
3. How to use Nitro-Dur
4. Possible side effects
5. How to store Nitro-Dur
6. Contents of this pack and other 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. What you need to know before you use Nitro-Dur
Do not use Nitro-Dur if you:
- are allergic to GTN or any of the other ingredients of Nitro-Dur.
- have had a head injury or a condition which could cause an increase in pressure within your head.
- have a low blood pressure or have a decrease in your blood pressure.
- have recently suffered from blood loss
- have heart problems other than angina
- are taking medicines for erectile dysfunction, for example Viagra (sildenafil), Cialis (tadalafil) or
Levitra (vardenafil). If these medicines are used together a severe and possibly dangerous fall in
blood pressure can occur.
- are taking Adempas (riociguat) for increased blood pressure of the pulmonary arteries or veins. If
these medicines are used together it can lead to low blood pressure.
- closed angle glaucoma (an increase in pressure in the eye)
Take special care with Nitro-Dur if you:
- have had recent heart failure or a heart attack. Please ask your doctor for further advice
- have low levels of oxygen in their blood due to lung disease
- experience angina whilst using Nitro-Dur
- develop low blood pressure – removal of the patch maybe considered.
- have a low blood volume for example after taking “water tablets” which may cause a low
blood pressure
- have or develop low blood pressure
- have a low thyroid level, are malnourished, have liver or kidney problems, have an enlarged
heart or have recently suffered a heart attack.
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 or anti-inflammatory medicines
at the same time as you use your patch, with the exception of aspirin. However Aspirin when
taken with Nitro-Dur and other medicines may cause your blood pressure to fall. Please tell
your doctor or pharmacist if you are taking or have recently taken these or any other medicines,
including medicines bought without a prescription.
Do not use phosphodiesterase inhibitors in any form or with products that are soluble guanylate
cyclase stimulators.
Using Nitro-Dur with food and drink
Be careful when drinking alcohol with this medicine, as it may cause your blood pressure to fall.
Pregnancy, breast feeding and fertility
You should not usually use Nitro-Dur if you are pregnant or breast feeding. If you are pregnant
or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor for
advice before taking this medicine.
Driving and using machines
The patches may impair reactions or rarely cause dizziness. Do not drive or use machines if you
are affected in this way.
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 areas. 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.

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4. Hold the patch with the brown lines facing you in an up and down
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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. The effects
of Nitro-Dur can be stopped by removing the patch.
If you forget to use your Nitro-Dur patch
If you forget to change your patch, do so as soon as you remember. Then change your patches
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 may 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).
- A lowered blood pressure which may cause faintness, dizziness or flushing
- Nausea and/or vomiting
- A fast heart beat (tachycardia) or irregular pulse (Palpitations)
- Redness or irritation (itching or burning) of the site where you have placed the patch (some
redness is normal but this should disappear in a short time).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme at: By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Nitro-Dur

Keep out of the sight and reach 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 medicine.

6. Contents of the pack and other 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
Saranex® 2014 extruded 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, Labo NV, Heist, Belgium
This leaflet was last revised in December 2015.
© Merck Sharp & Dohme Limited 2015. All rights reserved.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.