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TRANSIDERM NITRO 10 PATCHES

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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:
• 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 the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects you can provide more
information on the safety of this medicine.

5. HOW TO STORE TRANSIDERM-NITRO









Do not store above 25°C.
Store in the original packaging
Keep out of the sight and reach of children
Do not use this medicine after the expiry date
which is stated on the carton and sachet label.
The expiry date refers to the last day of the
month.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer
required. These measures will help to protect
the environment.
If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
doctor or pharmacist (chemist) who will tell you
what to do.

6. FURTHER INFORMATION
What Transiderm-Nitro contains
Each patch contains 50mg glyceryl trinitrate.
Average absorption rate: 10mg glyceryl trinitrate
in 24 hours. Also contains lactose monohydrate,
dimeticone, colloidal anhydrous silica, ethylene
vinyl acetate copolymer, medical adhesive CH15,
polyethylene terephthalate, aluminium and printing
Ink.
What Transiderm-Nitro looks like and contents
of the pack
Oblong shaped skin-coloured patch with CG DPD
printed in brown and a tab for peeling in a sealed
sachet. The Sticky side of the patch contains a
white creamy substance. They come in packs of
28.
Manufacturer and Licence Holder
Transiderm-Nitro is manufactured by Novartis
Pharmaceuticals UK Limited, Frimley Business
Park, Frimley, Camberley, Surrey, GU16 7SR UK
and is procured from within the EU. Product
Licence Holder: LTT Pharma Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE and repackaged by
Lexon (UK) Limited, B98 0RE
Transiderm-Nitro is a registered trademark of
Novartis AG.

P

PATIENT INFORMATION LEAFLET

TRANSIDERM-NITRO 10 PATCHES
(glyceryl trinitrate)
What you need to know about Transiderm-Nitro
10
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.
Your medicine is called Transiderm-Nitro 10
Patches, throughout this remainder of this leaflet it
will be referred to as Transiderm-Nitro.

PL 33723/0158
Please note that the leaflet also contains
information about other strengths of the medicine,
Transiderm-Nitro 5 Patches.

Leaflet revision date: 12/09/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: LTT158/120916/1/F

®

In this leaflet:
1. What Transiderm-Nitro patches are and what
they are used for
2. Things to consider before you start to use
Transiderm-Nitro patches
3. How to use Transiderm-Nitro
4. Possible side effects
5. How to store Transiderm-Nitro
6. Further information

1. WHAT TRANSIDERM-NITRO PATCHES ARE
AND WHAT THEY ARE USED FOR
Transiderm-Nitro 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

SPECIAL MEMBRANE WHICH CONTROLS
THE RATE OF RELEASE OF GTN

LAYER OF WATER RESISTANT ADHESIVE
RESERVOIR OF GLYCERYL TRINITRATE
(GTN)
BLOOD VESSEL

SKIN

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

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.)
• 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 patch.
You should also ask yourself these questions
before using the patch:
• 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 TransidermNitro might not be the right medicine for you.
Are you taking other medicines?
Transiderm-Nitro interacts with a large number of
other medicines. Tell your doctor or pharmacist if
you are taking any of the following:
• 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 (nonsteroidal anti-inflammatory drugs)
• Diuretics ("water tablets")
• Tranquillisers (e.g. chlorpromazine, flupenthixol,
haloperidol, clozapine).

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.
3. HOW TO USE TRANSIDERM-NITRO

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.

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. 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.

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

Do not stop using the patches suddenly without
consulting your doctor first.

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

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.
Transiderm-Nitro is not suitable for children.

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.

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

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.

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.

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.

4. POSSIBLE SIDE EFFECTS

How to apply the patch
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.

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.

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.

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).

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.
Ref: LTT158/120916/1/B

Expand Transcript

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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