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DEPONIT 5MG/24H PATCHES

Active substance(s): GLYCERYL TRINITRATE

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S608 LEAFLET Deponit 20160414



You suffer from hypoxaemia (insufficient oxygen in your blood)
due to lung disease, heart failure or severe anaemia (low
haemoglobin)



You have hypothermia (very low body temperature)



You are malnourished (severe lack of food).



You have a condition called Angina pectoris (chest pain).



You have had a heart attack.
You have a condition in which there is insufficient blood flow to
the brain (cerebral ischemia).

PACKAGE LEAFLET: INFORMATION FOR THE USER

DEPONIT 5mg / 24h PATCHES
(glyceryl trinitrate)
Read all of this leaflet carefully before you start using this
medicine.


Keep this leaflet. You may need to read it again





If you have further questions, please ask your doctor or
pharmacist

Taking other medicines



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



In this leaflet Deponit 5mg/24h Patches will be called Deponit.



Do not take Deponit with medicines for failure to achieve
an erection such as Viagra. Using Deponit with these
medicines could cause a severe drop in blood pressure
and could lead to collapse and unconsciousness, and may
be fatal

In this leaflet:

Tell your doctor if you are taking any of the following
medicines:

1. What Deponit is for



Medicines which are used to treat angina, heart failure, or an
irregular heartbeat. A blood condition (methaemoglobinaemia)
can occur when other nitrate treatments are given at the same
time. This can result in breathing problems, anxiety, loss of
consciousness and heart attack.



Medicines which reduce blood pressure (e.g. beta-blockers,
calcium channel blockers, vasodilators, ACE inhibitors)

2. Before you use Deponit
3. How to use Deponit
4. Possible side effects
5. How to store Deponit
6. Further information.


Diuretics (water tablets)

1. WHAT DEPONIT IS FOR



Tricyclic antidepressants (used to treat depression)

Deponit belongs to a group of medicines called ‘nitrates’. These are
used to widen your blood vessels and reduce the workload of your
heart.



Neuroleptics (used to treat anxiety)



Dihydroergotamine (used to treat migraine)



Amifostine (drug used along with anticancer drugs) and Aspirin
should not be taken together as they increase the blood
pressure lowering effect of Deponit 5.



Sapropterine (Tetrahydrobiopterine, BH4)



Any other medicine, including medicines obtained without a
prescription.

Deponit is used to prevent angina pectoris. Angina attacks feel like
a tight pain in your chest, neck or arm and are a sign that your heart
is not getting enough oxygen for the amount of work it is doing.
2. BEFORE YOU USE DEPONIT
Do not use Deponit if:


You are allergic to glyceryl trinitrate or to any of the other
ingredients in Deponit (See section 6)



You are taking medicines for failure to achieve an erection such
as Viagra. Using Deponit with these medicines could cause a
severe drop in blood pressure and could lead to collapse and
unconsciousness, and may be fatal



You have a condition in which your heart does not pump
enough blood around your body due to obstruction of the
arteries in the heart as in a condition called aortic or mitral
stenosis.

If any of the above applies to you, do not take Deponit. Talk to your
doctor.
Using Deponit with food and drink
Do not drink alcohol whilst using Deponit as it can cause your blood
pressure to drop. This may make you may feel dizzy or faint.
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or breast feeding,
ask your doctor for advice before using Deponit.
Driving and using machines
Deponit may make you feel dizzy, tired or have blurred vision. If this
happens to you, do not drive a vehicle or operate machinery.



You suffer from a heart condition which is associated with low
blood pressure leading to shock.



You suffer from low blood pressure

3. HOW TO USE DEPONIT



You suffer from low blood volume

Always use Deponit exactly as your doctor has advised.



You suffer from anaemia (low iron levels in your blood)

Important:



You have an eye disease called glaucoma



You have a heart valve disorder



You suffer from inflammation of the heart lining

Your doctor will choose the dose that is right for you. Your
dose will be shown clearly on the label that your pharmacist
puts on your medicine. If it does not, or you are not sure, ask
your doctor or pharmacist.



You suffer from increased fluid around the heart (cardiac
tamponade)

Deponit is not suitable for children.



You suffer from a heart condition called hypertrophic obstructive
cardiomyopathy



Normally one patch per day is enough



Your doctor may increase this to two patches depending on
how you respond to the medicine



At the start of your treatment, put on a patch in the morning



Remove the patch before you go to bed



You must have 8 to 12 hours each day without a patch on. This
will prevent you from becoming tolerant to the medicine. If you
do this it will ensure the treatment remains effective



You have ever had a serious head injury, cerebral haemorrhage
(bleeding in the brain) or a disease which is accompanied by
increased pressure on the brain



You have an acute angina attack. Your doctor will give you a
different medicine such as a GTN spray for this.



Adults and the Elderly

You are using riociguat, a medicine used in treating pulmonary
hypertension

Check with your doctor before using Deponit if:

 Each morning put on a new patch.
When applying the patch you should always:



You have an underactive thyroid gland



Place the new patch on a different area of skin



You have any diseases of the lungs, liver or kidneys





You have recently had a heart attack or you suffer from heart
failure

Allow several days to pass before applying a fresh patch to
the same area of skin.

If any of the above applies to you talk to your doctor.

Things to remember:

Common side effects (affects less than 1 in 10 people)



Do not stretch the skin when putting a patch on





Do not put the patch on a cut or reddened area of skin

 Do not pull the patch off the skin and then stick it back on again.
How and where to apply the patch


Choose a smooth area of skin to apply the patch. The area
should be hairless, to ensure good contact of the patch with the
skin. The chest, upper abdomen, upper arm, shoulder or thigh
is suitable.

Low blood pressure (hypotension) and light-headedness upon
standing which you may notice as dizziness, drowsiness, rapid
heart beat (reflex tachycardia) and a feeling of weakness at the
start of treatment or when the dosage is increased.

Uncommon side effects (affects less than 1 in 100 people)


Collapse sometimes with a slow heart beat and fainting



Very low blood pressure (severe hypotension) where you are
being sick, feeling sick, are restless, have a pale skin and sweat
a great deal. This may lead to a worsening of the chest pain
you often get with angina



Temporary low oxygen level in the blood (temporary
hypoxaemia). For people with heart disease this may lead to
low oxygen level in the tissue surrounding the heart (myocardial
hypoxia)



A slight reddening, slight itching or burning sensation on the
skin where you have applied the patch. This usually disappears
after the patch has been removed. Be sure to put your patch in
a different place each day.



Allergic skin rash, which may be severe



Flushing of the face

Fold the patch along the S-shaped cut so the sides of the
backing come apart.



Feeling sick





Being sick

Hold the patch on one side and peel off the backing on the
other side to expose the sticky patch. Place the sticky side of
the patch directly onto the skin.



Very red skin with scaling and thickened itchy skin (exfoliative
dermatitis)



Peel off the remainder of the backing and press down firmly
with the palm of your hand.



Your hands and the skin where you will apply the patch should
be clean and dry. Do not use powder or moisturiser.



Tear open the wrapper across the top, take out the patch and
hold it with the writing facing away from you.



If you use more Deponit than you should
If you accidentally use more Deponit than you should, remove the
patches straight away and immediately go to your doctor or the
nearest hospital casualty department.
If you use more Deponit than you should, you may have a fall in
blood pressure. This may make you feel dizzy, weak and lightheaded on standing. You may also be pale, sweat a lot, have a
weak pulse, rapid heart beats (tachycardia), flushed skin,
headache, feel sick or be sick, methaemoglobinaemia.



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 DEPONIT


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C. Store in the original package.



If you forget to change your patch: Take the old one off and put
a new one on as soon as you remember, then carry on as
before.

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



If you forget to apply a patch: Put a new one on as soon as
possible, then carry on as before.

Medicines should not be disposed of via wastewater or
household waste. Return all unused medicine to your
pharmacist.



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.

In severe cases of overdose you may get an increase of the
pressure of the fluid around the brain.
If you forget to use Deponit


 Heartburn.
Reporting of side effects

Do not take a double dose to make up for a missed dose.
If you stop using Deponit
Do not stop using Deponit even if you feel better. If you stop taking
your medicine your condition may get worse. Keep using Deponit
until your doctor tells you to stop.

6. FURTHER INFORMATION

If your doctor thinks you should stop taking Deponit your dose will
gradually be reduced.



Each patch contains 18.7mg of glyceryl trinitrate and is
designed to release 5mg of glyceryl trinitrate in 24 hours.

Also if you are being transferred to another treatment, your dose will
be gradually reduced or withdrawn and the overlapping treatment
will be started.



Deponit also contains the following inactive ingredients acrylate/
vinyl acetate copolymer, polypropylene, polyethylene.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Deponit can cause side effects, although not
everybody gets them.
Stop using Deponit and seek immediate medical help if you
have an allergic reaction. This includes any of the following
symptoms:


Sudden wheeziness



Difficulties in breathing



Swelling of your eyelids, face or lips



Rash or itching especially those covering your whole body.

Very common side effects (affects more than 1 in 10 people)


Headaches at the start of treatment. These usually disappear
after a few days of continuing to use the patches. If necessary
you can take mild painkillers e.g. paracetamol.

What Deponit contains

What Deponit looks like and contents of the pack
The patch is a self-adhesive transdermal patch.
Deponit is available as packs of 15 or 28 patches.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by


UCB Pharma GmbH, Monheim, Germany.



Aesica Pharmaceuticals GmbH, Monheim, Germany.

P

PL 19488/0608

Leaflet revision date: 14 April 2016
Deponit is a registered trade mark of Schwarz Pharma AG,
Germany.
S608 LEAFLET Deponit 20160414

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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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