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NITRIDERM TTS 5MG/24H

Active substance(s): GLYCERYL TRINITRATE

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You should also ask yourself these questions before using the patch:

Transiderm Nitro® 5 /
Nitriderm TTS 5mg/24h
(glyceryl trinitrate)






PATIENT INFORMATION LEAFLET

If the answer to any of these questions is YES, tell your doctor or pharmacist because Transiderm Nitro
5 might not be the right medicine for you.

Your medicine is available using the names Transiderm Nitro 5 / Nitriderm TTS 5mg/24h, but will be
referred to as Transiderm Nitro 5 in this leaflet.
This product is available in other strengths (Transiderm Nitro 10).

Are you taking other medicines?

Transiderm Nitro 5 interacts with a large number of other medicines. Tell your doctor or pharmacist if
you are taking any of the following:

What you need to know about Transiderm Nitro 5

Your doctor has decided that you need this medicine to help treat your condition.









Please read this leaflet carefully before you start to use the patches. It contains important
information.



Keep the leaflet in a safe place because you may want to read it again.
If you have any other questions, or if there is something you don’t understand, please ask your
doctor or pharmacist.
This medicine has been prescribed for you. Never give it to someone else. It may not be the right
medicine for them even if their symptoms seem to be 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
1.
2.
3.
4.
5.
6.

this leaflet:
What Transiderm Nitro 5 is and what it is used for
Things to consider before you start to use Transiderm Nitro 5
How to use Transiderm Nitro 5
Possible side effects
How to store Transiderm Nitro 5
Further information

1.

WHAT TRANSIDERM NITRO 5 IS AND WHAT IT IS USED FOR

Medicines for depression
Ergotamine products which are usually given for migraine
Medicines for erectile dysfunction (male impotence)
Medicines for high blood pressure or heart problems
Aspirin or other painkillers called NSAIDs (non-steroidal anti-inflammatory drugs)
Diuretics (“water tablets”)
Tranquillisers (e.g. chlorpromazine, flupenthixol, haloperidol, clozapine).

Always tell the doctor or pharmacist about all of the medicines you are taking. This means
medicines you have bought yourself, as well as medicines on prescription from the doctor.

Will there be any problems with driving or using machinery?

Some people have reported feeling faint or dizzy when they have started to use the patches. You
should not drive or operate machinery if you are affected.

Other special warnings

Be careful when drinking alcohol as the patch may affect you more than usual and you might feel faint
or dizzy.
You might find that your GTN (glyceryl trinitrate) tablets or spray aren’t working as well as they used
to. Discuss this with your doctor.
You must tell the doctor or nurse if you are wearing a patch before an MRI scan (Magnetic Resonance
Imaging scan to visualise internal organs and tissues of the body) or diathermy treatment (treatment
using hot wires) and before electrical treatment on the heart.

Transiderm Nitro 5 is a patch which you stick on your skin. The patch contains a supply of glyceryl
trinitrate which is released from the patch and absorbed through the skin and into the blood vessels.
This is called a transdermal patch. See diagram of patch below.
WATERPROOF BACKING

Have you recently had a heart attack or do you have heart failure or other heart problems?
Do you suffer from anaemia or lung disease?
Are you pregnant or trying to become pregnant?
Are you breast feeding?

3.

HOW TO USE TRANSIDERM NITRO 5

It is important to follow what your doctor says about how and when to use your patches. The dose will
be on the pharmacist’s label. Check the label carefully. If you are not sure, ask your doctor or
pharmacist.

SPECIAL MEMBRANE WHICH CONTROLS
THE RATE OF RELEASE OF GTN

LAYER OF WATER-RESISTANT ADHESIVE

The doctor will tell you how often to change the patch. Discard the old patch carefully because it will
still contain a little of the active ingredient.

RESERVOIR OF GLYCERYL TRINITRATE (GTN)

The side of the chest is a suitable place to apply the patch. Choose a different area of skin each time
you apply a new patch. Leave several days before you use the same patch of skin again.

BLOOD VESSEL

How to apply the patch

SKIN

1.

Decide where you will put the patch. It is important that you put it
on a hairless area to ensure that it sticks well. The side of the
chest is recommended.

2.

Wash the skin and dry it thoroughly to make sure the patch sticks
well. Wait a minute until the skin feels quite dry. Do not use
powder.

3.

Remove one sachet from the box and tear open the sachet at the
notch. Use your fingers as cutting with scissors might damage the
patch inside. Remove the patch from the sachet.

4.

Peel off the white plastic backing and discard it. Do not touch the
sticky surface of the patch.

(Diagram A)
Glyceryl trinitrate, the active ingredient in the patches is one of a group of medicines called
vasodilators. These cause blood vessels to relax, increasing the supply of blood and oxygen to the
heart and reducing the amount of work the heart has to do.
Transiderm Nitro 5 and 10 are used


to prevent angina attacks. Angina means a painful tightness in the chest. This is a good description
of a typical attack, although the pain may also be felt in the arm or neck. The pain really comes
from the heart muscle and is a sign that part of the muscle is not getting enough blood supply for
the amount of work it has to do.

Transiderm Nitro 5 is also used in patients who are receiving food or drugs directly into a vein
(intravenously)


2.

to prevent irritation and the intravenous fluid leaking into the surrounding tissues.

THINGS TO CONSIDER BEFORE YOU START TO USE TRANSIDERM
NITRO 5

Some people MUST NOT use Transiderm Nitro 5. Talk to your doctor if:






you think you may be allergic to glyceryl trinitrate or other nitrates or to any of the other
ingredients of the patch. (These are listed at the end of the leaflet)
you have very low blood pressure.
you have headaches, vomiting or seizures as a result of raised pressure inside the skull.
you have any problems with your heart because of faulty valves or inflammation.
you are taking any medicines for erectile dysfunction (male impotence).

If you are hospitalised due to severe dehydration or loss of blood tell the doctor you are using a
Transiderm Nitro 5 patch.

Page 1 of 2

5.

Place the sticky side of the patch on the clean skin, press
firmly while you count slowly up to five.

6/7. Run your finger around the edge of the
patch to make sure no air or water can
get in. If you have applied the patch
correctly you can bathe, shower or swim
with little risk of the patch coming off.

5.

HOW TO STORE TRANSIDERM NITRO 5

6.

FURTHER INFORMATION

Do not store your patches above 25ºC.
Do not open the sealed sachet until you are going to use the patch.
Keep out of the sight and reach of children.
Do not use these patches after the expiry date which is printed on the carton.
If your doctor tells you to stop using Transiderm Nitro 5 patches, please take any which are left back
to your pharmacist to be destroyed. Only keep them if the doctor tells you to. Do not throw them away
with your normal household water or waste. This will help to protect the environment.
Return any unused patches to your pharmacist for safe disposal.
If your medicine appears to be discoloured or show any other signs of deterioration, please return to
your pharmacist who will advise you.

What Transiderm Nitro 5 contains

Each Transiderm Nitro 5 patch contains 25mg of glyceryl trinitrate as the active ingredient.
For each Transiderm Nitro 5, your body will absorb approximately 5mg over 24 hours.
This patch is designed to release the drug through your skin into your body at a slow rate.
The patches also contain the following inactive ingredients: lactose, silicone oil,
polyvinylchloride (PVC), Aerosil 200, Ethylene-vinyl Acetate co-polymer, polyethylene terephthalate,
aluminium, vinyl acetate co-polymer and silicon adhesive.

What Transiderm Nitro 5 looks like and contents of the pack

To prevent angina
The usual dosage for adults and the elderly is one or two patches applied daily. The doctor will have
decided which strength of patch you need.

Transiderm Nitro 5 are self adhesive pink coloured patches containing a drug reservoir.
Transiderm Nitro 5 comes in packs containing 30 patches.

You may be told to wear a patch all of the time or for only part of the day. Don’t forget to follow the
doctor’s instructions exactly.

Manufacturer

Manufactured by: Famar France, 1, Avenue du Champ de Mars, 45072 Orleans, Cedex, France.
Or
Novartis Pharma S.A.S., 26 rue de la Chapelle, 68330 Huningue, France.
Or
Novartis Pharma S.A.S., 2 et 4, rue Lionel Terray, 92500 Rueil-Malmaison, France.

Do not stop using the patches suddenly without consulting your doctor first.
Sometimes patches are not enough to prevent all of your angina attacks and you may be given tablets
as well. Make sure you know when you need to take the tablets.
To prevent skin irritation when you are receiving drugs intravenously (into a vein)
One Transiderm Nitro 5 patch will be applied when the treatment is started and the patch changed
every 3-4 days until the treatment is stopped.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Transiderm Nitro 5 is not suitable for children.

PL No: 08929/0157

What if you forget to change your patch?

If you forget to change your patch, do not worry. Put on a new one as soon as you remember. Then go
on as before.

What if you accidentally use too many patches?

Leaflet revision and issue date: 23.01.15
Transiderm-Nitro® is a registered trademark of Novartis AG.
To listen to or request a copy of this leaflet in Braille, large print or audio please call 01302 552940
and ask for the Regulatory Department.

If you accidentally apply too many Transiderm Nitro 5 patches, tell your doctor or nearest hospital
casualty department immediately. Take your medicine pack with you.

4.

POSSIBLE SIDE EFFECTS

Transiderm Nitro 5 patches are suitable for most people. However, like all medicines they can
sometimes cause side effects.

The side effects listed below have been reported:
More than 10% of people have experienced


Nausea (feeling sick) or vomiting (being sick).

Up to 1 in 10 people have experienced:


Headaches. These will probably wear off after a few days. If necessary you can take mild
painkillers e.g. paracetamol.

Up to 1 in 100 people have experienced:



Reddening, itching or burning of the skin at the site of the patch. Be sure to put your patch in a
different place each day.
Allergic skin reactions such as reddening or itching anywhere on the body.

Up to 1 in 1,000 people have experienced:




P

Increased heart rate or palpitations.
Feeling faint or light-headed on standing, or feeling dizzy.
Flushing of the face.

If any of the symptoms become troublesome, or if you notice anything else not mentioned
here, please go and see your doctor. He/she may want to reduce the dose or give you a
different medicine.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via: Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on the safety of this medicine.

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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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