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TRANSIDERM NITRO 10 PATCHES

Active substance(s): GLYCERYL TRINITRATE

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you have very low blood pressure.

PACKAGE LEAFLET: INFORMATION FOR THE USER



TRANSIDERM NITRO 10 PATCHES
(glyceryl trinitrate)

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.

Your medicine is known as Transiderm Nitro 10 Patches but will be
referred to as Transiderm Nitro Patches throughout the following
patient information leaflet.



you are taking any medicines for erectile dysfunction (male
impotence).

Please note that information regarding other strength, Transiderm
Nitro 5 Patches, is also present in the below leaflet.
What you need to know about Transiderm Nitro Patches

If you are hospitalised due to severe dehydration or loss of blood
tell the doctor you are using a Transiderm Nitro patch.
You should also ask yourself these questions before using the
Transiderm Nitro Patches:

S765 LEAFLET Transiderm 20130219

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.



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?

If the answer to any of these questions is YES, tell your doctor or
pharmacist because Transiderm Nitro Patches might not be the
right medicine for you.
Are you taking other medicines?

In this leaflet

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

1. What Transiderm Nitro Patches are and what they are used for



Medicines for depression

2. Things to consider before you start to use Transiderm Nitro
Patches



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 antiinflammatory drugs)



Diuretics ("water tablets")



Tranquillisers (e.g. chlorpromazine, flupenthixol, haloperidol,
clozapine).

3. How to use Transiderm Nitro Patches
4. Possible side effects
5. How to store Transiderm Nitro Patches
6. Further information1. WHAT IS TOPAMAX AND WHAT IT IS
USED FOR?
1. WHAT TRANSIDERM NITRO PATCHES ARE AND WHAT THEY
ARE USED FOR
Transiderm Nitro Patches are patches 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.

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.

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


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

You must tell the doctor or nurse if you are wearing a patch before
an MRI scan (Magnetic Resonance Imaging scan to visualize
internal organs and tissues of the body) or diathermy treatment
(treatment using hot wires) and before electrical treatment on the
heart.
3. HOW TO USE TRANSIDERM NITRO PATCHES
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.
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.
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.
How to apply the patch

2. THINGS TO CONSIDER BEFORE YOU START TO USE
TRANSIDERM NITRO PATCHES
Some people MUST NOT use Transiderm Nitro Patches. 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.

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.

4. POSSIBLE SIDE EFFECTS
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.

Transiderm Nitro 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:


4

5

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

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

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:


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.
5. HOW TO STORE TRANSIDERM NITRO PATCHES


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Transiderm Nitro Patches should not be stored above 25°C



Do not use after the expiry date printed on the carton label or
sachet.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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.

6. FURTHER INFORMATION
To prevent angina

What Transiderm Nitro Patches contains

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.



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.
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)

Each Transiderm Nitro Patches contains 50mg of the active
ingredient, glyceryl trinitrate.



Transiderm Nitro Patches also contains the following inactive
ingredients: lactose, silicone oil 360, colloidal silica (Aerosil200), polyethylene terephthalate, aluminium, vinylacetate
copolymer, ethylene-vinyl-acetate copolymer, silicone adhesive
and polyvinyl chloride (PVC).
What Transiderm Nitro Patches looks like and contents of the
pack
The oblong patch has a greyish-orange backing film on one side
which is printed ‘Nitriderm TTS 10mg/24h’ and ‘CG DPD’. The other
side has an off-white protective release liner.
Transiderm Nitro Patches is available as packs of 28 or 30 patches.

One Transiderm Nitro Patches 5 will be applied when the treatment
is started and the patch changed every 3-4 days until the treatment
is stopped.

Product Licence holder

Transiderm Nitro Patches is not suitable for children.

Manufacturer

What if you forget to change your patch?

These products are manufactured by Novartis Pharma S.A.S., 2 et
4, rue Lionel Terray, 92500 Rueil-Malmaison, France.

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.

Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

P

PL No. 19488/0765

Leaflet revision date: 19 February 2013
What if you accidentally use too many patches?
If you accidentally apply too many Transiderm Nitro Patches, tell
your doctor or nearest hospital casualty department immediately.
Take your medicine pack with you.

Transiderm Nitro is a registered trade mark of Novartis AG,
Switzerland.
S765 LEAFLET Transiderm 20130219

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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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