In this leaflet:

1.    What Percutol Ointment is and what it is used for

2.    Before you use Percutol Ointment

3.    How you use Percutol Ointment

4.    Possible side effects

5.    How to store Percutol Ointment

6.    Further information

0 What Percutol Ointment is and what it is used for

Percutol Ointment contains the active ingredient glyceryl trinitrate 2%. Glyceryl trinitrate belongs to the group of medicines known as vasodilators (widens blood vessels). When Percutol Ointment is applied to the skin, glyceryl trinitrate is slowly absorbed. When in the bloodstream, glyceryl trinitrate widens blood vessels in the body, which allows blood to flow more easily. The heart gets more blood and also does not need to work so hard to keep the blood flowing. Percutol Ointment is used to prevent angina pectoris (the chest pain caused by not enough blood getting to the heart).

(2 Before you use Percutol Ointment

Do not use Percutol Ointment if you

•    are allergic (hypersensitive) to glyceryl trinitrate, other nitrates (similar drugs) or any of the other ingredients of Percutol Ointment (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

•    are taking medicines for failure to achieve an erection such as Viagra (sildenafil), Levitra (vardenafil), Cialis (tadalafil) or Caverject (alprostadil)

•    have severe anaemia (a low red blood cell count)

•    have ever had a serious head injury or have raised intra cranial pressure (an increased pressure in the skull)

•    if you have cerebrovascular disease (previous stroke or transient ischaemic attack - TIA)

•    if you have toxic pulmonary oedema (increased pressure in blood vessels supplying blood to the lungs)

•    have problems with any of your heart valves

•    suffer from inflammation of the heart lining

•    suffer from increased fluid around the heart

•    suffer from a heart condition called hypertrophic obstructive cardiomyopathy

•    have low blood pressure or low blood volume

•    have an acute angina attack.

Take special care with Percutol Ointment

•    if you have Glaucoma, check with your doctor that it is safe to use

•    if you have recently had alcohol (effect of Percutol Ointment may be increased)

•    when standing up suddenly, as you may get dizzy (especially if you are elderly)

•    if you suffer from hypoxaemia (insufficient oxygen in your blood)

•    if you have an underactive thyroid gland

•    if you suffer from malnutrition

•    if you have hypothermia (a very low body temperature)

•    if you have any diseases of the lungs, liver or kidneys

•    if you have recently had a heart attack or you suffer from heart failure.

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

Bellamy House, Winton Road, Petersfield,

Hampshire, GU32 3HA, United Kingdom

This leaflet was last revised in

01/2015

Aspire

1010015-P9.1    Pharma

Artwork for:	Aspire Pharma Limited
Product name:	Percutol Ointment
Size:
PL/PA no:	PL 35533/0020
Type:	Leaflet
Artwork dimensions:	148mm x 210mm
Profile supplied:	Yes
Date of first artwork:	12 May 2010
Reason for request:	Text edits
Version no:	9.1
Date of revision:	16 January 2015
Colours:	As swatch(es)
Font(s):	Text 8.25 FF Milo Headings 9.5pt FF Milo
Artwork software:	InDesign CS6
BAC ref:	S709 (formerly R650)