Nitro-Dur 0.4 Mg/H Transdermal Patch
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4. Hold the patch with the brown lines facing you in an up and down position.
7. Holding the other half, apply the sticky side of the patch to the upper arm or chest. Smooth down.
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PATIENT INFORMATION LEAFLET 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. 1
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)
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.
Using Nitro-Dur with food and drink
Be careful when drinking alcohol as it may cause your blood pressure to fall.
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.
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.
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 trinitrate delivered at the rate of 0.4 mg/hr from a 20 cm1 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.
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