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PERCUTOL OINTMENT

Active substance(s): GLYCERYL TRINITRATE / GLYCERYL TRINITRATE / GLYCERYL TRINITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Percutol Ointment

Read all of this leaflet carefully before you start taking 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:
• have severe anaemia (a low red blood cell count)
1. What Percutol Ointment is and what it is used for
• have ever had a serious head injury or have raised
2. Before you use Percutol Ointment
intra cranial pressure (an increased pressure in
3. How you use Percutol Ointment
the skull)
4. Possible side effects
• if you have cerebrovascular disease (previous stroke
5. How to store Percutol Ointment
or transient ischaemic attack - TIA)
6. Further information
• if you have toxic pulmonary oedema (increased
pressure in blood vessels supplying blood to the
1 What Percutol Ointment is and
lungs)
what it is used for
• have problems with any of your heart valves
Percutol Ointment contains the active ingredient
• suffer from inflammation of the heart lining
glyceryl trinitrate 2%. Glyceryl trinitrate belongs to the
• suffer from increased fluid around the heart
group of medicines known as vasodilators (widens
• suffer from a heart condition called hypertrophic
blood vessels). When Percutol Ointment is applied to
obstructive cardiomyopathy
the skin, glyceryl trinitrate is slowly absorbed. When in • have low blood pressure or low blood volume
the bloodstream, glyceryl trinitrate widens blood
• have an acute angina attack.
vessels in the body, which allows blood to flow more Take special care with Percutol Ointment
easily. The heart gets more blood and also does not
• if you have Glaucoma, check with your doctor that
need to work so hard to keep the blood flowing.
it is safe to use
Percutol Ointment is used to prevent angina pectoris • if you have recently had alcohol (effect of Percutol
(the chest pain caused by not enough blood getting to
Ointment may be increased)
the heart).
• when standing up suddenly, as you may get dizzy
(especially if you are elderly)
2 Before you use Percutol Ointment
• if you suffer from hypoxaemia (insufficient oxygen in
Do not use Percutol Ointment if you
your blood)
• are allergic (hypersensitive) to glyceryl trinitrate,
• if you have an underactive thyroid gland
other nitrates (similar drugs) or any of the other
• if you suffer from malnutrition
ingredients of Percutol Ointment (see list of
• if you have hypothermia (a very low body
ingredients in Section 6). An allergic reaction may
temperature)
include rash, itching, difficulty breathing or swelling
• if you have any diseases of the lungs, liver
of the face, lips, throat or tongue.
or kidneys
• are taking medicines for failure to achieve an
• if you have recently had a heart attack or you suffer
erection such as Viagra (sildenafil), Levitra
from heart failure.
(vardenafil), Cialis (tadalafil) or Caverject (alprostadil)

Please tell your doctor if any of the above applies
to you.
Taking other medicines
Please tell your doctor or pharmacist if you are taking,
or have recently taken, any other medicines, including
medicines obtained without a prescription. This is
especially important of the following medicine (see
‘Do not use’ above):
• medicines used to treat erectile problems such as
Viagra (sildenafil), Levitra (vardenafil), Cialis
(tadalafil) or Caverject (alprostadil).
• medicines used to treat angina, heart failure or an
irregular heart beat
• alpha blockers (a type of medicine used to treat high
blood pressure and also to relieve the symptoms of
an enlarged prostate)
• other medicines used to treat high blood pressure
such as beta blockers, ACE inhibitors, calcium
channel blockers, angiotensin 2 receptor
antagonists, clonidine, or other vasodilators
(medicines that relax the blood vessels, e.g.
hydralazine, moxonidine, sodium nitroprusside,
diazoxide)
• muscle relaxants (baclofen, tizanidine)
• medicines used for diseases affecting the brain
and central nervous system including anxiety
and depression, migraine, epilepsy and
Parkinson’s disease
• aldesleukin (a medicine used for certain cancers)
• moxisylyte (a medicine used for Reynaud’s disease)
• diuretics (water tablets)
• medicines used to treat pain and inflammation (e.g.
aspirin, non-steroidal anti-inflammatory drugs,
corticosteroids)
• certain hormones used in hormone replacement
therapy and for contraception (‘The Pill’).
Pregnancy and breast-feeding
Do not use Percutol Ointment while pregnant or while
breast-feeding unless your doctor tells you to.
Ask your doctor or pharmacist for advice before taking
any medicine.

Driving and using machines
Percutol Ointment may cause dizziness. If this
happens you should not drive or use machines.
You should wait until the effects of the treatment are
known before driving or using any machines.
Important information about some of the
ingredients of Percutol Ointment
Percutol Ointment contains lanolin. Lanolin may cause
local skin reactions (e.g. contact dermatitis).

3 How you use Percutol Ointment

Dosage
Always take Percutol Ointment exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
Adults and the elderly
The usual dose is 1 to 2 inches squeezed from the
tube. This dose may be repeated every 3 to 4 hours
as needed.
Half an inch of ointment should be applied on the first
day, increasing by half an inch per day until headache
occurs. This dose is then reduced by half an inch. If
several applications per day are needed, the dose may
be reduced.
Children
Percutol is not recommended for children.
Method of administration
The ointment may be measured and applied using
the paper ‘Applirules’ enclosed in the carton.
After squeezing the required length of ointment onto
the ‘Applirule’ it should be pressed on to the chest,
thigh, or arm until the ointment is spread in a thin
layer under the paper. The ointment should not be
rubbed in. The ‘Applirule’ may be kept in place with
surgical tape.
If you use more Percutol Ointment than
you should
Wash the ointment off the skin then contact your
doctor or go to your nearest hospital immediately.
The symptoms of overdose include headache,
dizziness, and collapse.

If you forget to use Percutol Ointment
If you miss an application, use the application as soon
as possible. However, if it is nearly time for your next
application, skip the missed application and carry on
as before. Do not use a double application to make up
for a forgotten application.
If you stop using Percutol Ointment
You should not stop treatment suddenly. If your
doctor tells you to stop treatment, you will be told to
reduce the dose and number of doses gradually over
4-6 weeks.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4 Possible side effects

Like all medicines, Percutol Ointment can cause side
effects, although not everybody gets them.
All medicines can cause allergic reactions, although
serious allergic reactions are very rare. Tell your
doctor straight away if you get any sudden
wheeziness, difficulty in breathing, swelling of
the eyelids, face or lips, rash or itching (especially
affecting your whole body).
The following side effects have been reported:
Very Common (affects more than 1 user in 10):
Headache
Common (affects 1 to 10 users in 100):
Dizziness
Feeling sick (Nausea), Vomiting
Uncommon (affects 1 to 10 users in 1,000):
Fainting (Syncope)
Burning sensation
Low blood pressure (Hypotension)
Circulatory Collapse
Allergic skin disorders including eczema, inflammation
of the skin, itching, hives and non specific rashes
Rare (affects 1 to 10 users in 10,000):
Increased heart rate (Tachycardia)
Decreased heart rate (Bradycardia) in the presence
of fainting
Flushing
Very Rare (affects less than 1 user in 10,000):
Heartburn

Reporting of side effects
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
(website: 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 Percutol Ointment

Percutol Ointment should be kept out of reach and
sight of children.
Store below 25°C.
Do not use Percutol Ointment after the expiry date
which is stated on the carton. The expiry date refers to
the last day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.

6 Further information

What Percutol Ointment contains
The active substance is glyceryl trinitrate 2%.
The other ingredients are: lanolin, purified water,
white petroleum and lactose.
What Percutol Ointment looks like and
contents of the pack
Percutol Ointment is a light yellow coloured ointment
and is in an aluminium tube containing 60g.
Marketing Authorisation Holder and Manufacturer
Aspire Pharma Ltd
Unit 4, Rotherbrook Court, Bedford Road, Petersfield,
Hampshire, GU32 3QG, United Kingdom
This leaflet was last revised in
02/2017

1010015-P10.1

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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