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NITRO-DUR 0.4 MG/H TRANSDERMAL PATCH

Active substance: GLYCERYL TRINITRATE

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PATIENT INFORMATION LEAFLET

2255
08.05.12[3]

Nitro-Dur 0.4 mg/h Transdermal Patch
(glyceryl trinitrate)
This medicine is available as the above name but will be referred to as
Nitro-Dur throughout the following leaflet.
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.
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.

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)

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

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.

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

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

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.

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.
Driving and using machines
The patches may make you dizzy. 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 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.

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 Niro-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.
Do not store your patches above 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 Nitro-Dur 0.4 mg/h Transdermal patch contains 80 mg of glyceryl
2
trinitrate delivered at the rate of 0.4 mg/hr from a 20 cm releasing
surface.
Nitro-Dur also contains:
melamine formaldehyde resin, sodium polyacrylate, butylacrylate polymer
C, butylacrylate polymer D and purified water
What Niro-Dur looks like and contents of the pack
Nitro-dur Transdermal patches are round and beige colour backed with
clear plastic split into two halves.
Each patch are printed with Nitro-Dur 0.4 mg/hr
Each single patch come in sealed sachet and pack size is 30 patches in a
carton.
Manufacturer and Product Licence Holder
Manufactured by Schering-Plough, S.A., Km 36, Ctra Nacional.,san
Augustic de Guadalix, Madrid, Spain and procured from within the EU by
Product License holder Star Pharmaceuticals Ltd., 5 Sandridge Close,
Harrow, Middlesex. HA1 1XD. Repackaged by Servipharma Ltd.
P

PL 20636/2255- Nitro-Dur 0.4 mg/h Transdermal Patch

Leaflet issue and revision date (Ref) 08.05.12[3]
Nitro-Dur is trademark of Key Pharmaceuticals Inc. USA

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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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