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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 ^MSD

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 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. 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: www.mhra.gov.uk/yellowcard. 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.

^MSD

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.

PIL.NTR.15.UK.4604.UV46