Glyceryl Trinitrate Spray

Document: leaflet ACTAVIS_PL 18190-0013 change

Read all of this leaflet carefully because it

contains important information for you.

This medicine is available without prescription.

However, you still need to use Glyceryl Trinitrate

Spray carefully to get the best results from it.

• Keep this leaflet. You may need to read it again.

• Ask your pharmacist if you need more information or advice.

• You must contact a doctor if your symptoms worsen or do not improve after taking the product and resting for 10 to 15 minutes.

• 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:

1 What Glyceryl Trinitrate Spray is and what it is used for

2 Before you use Glyceryl Trinitrate Spray 3. How to use Glyceryl Trinitrate Spray

.4. Possible side effects

.5. How to store Glyceryl Trinitrate Spray

6 Further information

1 WHAT GLYCERYL TRINITRATE SPRAY IS AND WHAT IT IS USED FOR

Glyceryl Trinitrate Spray is a smooth muscle relaxant. The walls of many of the body's veins and arteries are made of smooth muscle, and so glyceryl trinitrate helps to widen these vessels. When you spray Glyceryl Trinitrate Spray under your tongue it is quickly absorbed in the bloodstream. The action of Glyceryl Trinitrate Spray allows blood to flow more quickly and more easily. This means that your heart does not need to work so hard. The greater blood flow through the heart also means that the heart works more efficiently. These actions of glyceryl trinitrate bring relief in an attack of angina and can prevent an attack coming on.

Glyceryl Trinitrate Spray is for the relief and prevention of angina attacks (chest pains).

2 BEFORE YOU USE GLYCERYL TRINITRATE SPRAY

Do not use Glyceryl Trinitrate Spray if you:

• Are allergic (hypersensitive) to glyceryl trinitrate or any of the other ingredients of the spray (see section 6)

• Have marked hypotension (low blood pressure with a systolic pressure below 90mmHg)

• Have too little circulating blood (due to blood loss or dehydration)

• Suffer from conditions where your heart is unable to supply enough oxygenated blood to the rest of your body (cardiac shock or left sided heart failure)

• Have angina pectoris caused by hypertrophic, obstructive cardiomyopathy (abnormal heart growth)

• Have constrictive pericarditis (an inflammation of the smooth membrane that surrounds the heart)

• Have pericardial tamponade (an accumulation of fluid in the sac that surrounds the heart)

• Have aortic and mitral stenosis (heart valve disease)

• Suffer from primary pulmonary hypertension (an increased resistance to blood flow through the lungs)

• Have had a heart attack with low blood supply to the heart

• Are very anaemic

• Take sildenafil, tadalafil or vardenafil (these drugs are used for the treatment of male impotence)

• Suffer from any condition with raised pressure within your head including that caused by an accident

Take special care with Glyceryl Trinitrate Spray and talk to your doctor

• If you are prone to postural hypotension (low blood pressure) which can lead to dizziness and/or fainting on sitting up or standing up

• If you suffer from narrow angle glaucoma (increased pressure in the eye), or migraine

• If you suffer from liver disease, alcoholism, epilepsy, cerebral trauma and other nervous system diseases (the spray contains small amounts of alcohol and may be harmful to patients with the above conditions)

If your dose is increased, you may become tolerant to this medicine (where you need to use higher doses to prevent or relieve the symptoms of an angina attack).

If this medicine does not work it may be an early sign of a myocardial infarction (heart attack).

Please tell your doctor or nurse that you are using this medicine if you are having blood or urine tests, as it may affect the results.

Taking other medicines

Never use Glyceryl Trinitrate Spray with:

• Sildenafil, vardenafil or tadalafil containing erectile dysfunction preparations. The blood-pressure lowering effect of Glyceryl Trinitrate Spray may be increased.

Take care when using Glyceryl Trinitrate Spray with:

• Other vasodilators (medicines used to treat hypertension, angina and heart failure, e.g. ACE inhibitors or Calcium channel blockers), antihypertensive agents (medicines which help to lower blood pressure, e.g. Beta blockers or Sympatholytics, Diuretics, Renin-inhibitors) antipsychotics, sedatives, sleeping pills, tricyclic and MAOI-type antidepressants, baclofen (for the relief

of spasticity of muscles e.g. in multiple sclerosis), levodopa (for Parkinsonism), aldesleukin (for the treatment of kidney cancer which has spread to other parts of the body, as all of these drugs types may cause a greater reduction of blood pressure

Continued over page

• Dihydroergotamine containing preparations for the treatment of abnormal bleeding from the female reproductive system as the effect of this drug can be increased by glyceryl trinitrate

• Heparin containing blood-thinning preparations (the effectiveness of heparin may decrease)

Patients who have previously taken nitrates for their condition (e.g. isosorbide mononitrate or isosorbide dinitrate) may require higher doses of this medicine (glyceryl trinitrate) to prevent or relieve their symptoms.

If your doctor has prescribed tablets to be placed under the tongue for your angina, you should not use your spray for the same attack.

Using Glyceryl Trinitrate Spray with food and drink

You should not drink alcohol while being treated with Glyceryl Trinitrate Spray as some of the side effects may be worse than usual (see section 4).

Pregnancy and breast-feeding

If you are pregnant, or think you may be pregnant, or breast feeding, you should tell your doctor before using this medicine. He/she can then decide if you should use it.

Driving and using machines

It is not recommended to drive or use machinery when you start using this product as the hypotensive (blood pressure lowering) effect may lead to dizziness and/or feeling faint or unwell. After you have got used to the spray, it may be that you have no problems and are able to drive safely.

Important information about some of the ingredients of Glyceryl Trinitrate Spray

This product contains 79.2 volume% of ethanol. Each dose (2 sprays) contains up to 0.08g of alcohol. This product may be harmful for patients suffering from liver disease, alcoholism, epilepsy, brain injury or disease.

3 HOW TO USE GLYCERYL TRINITRATE SPRAY

Before using the spray for the first time, check that the pump is working by pressing the pump button a few times until it produces a fine mist of liquid. Practice aiming the spray onto a tissue or similar item so that you will be able to aim it correctly under the tongue when you need to use it. If you do not need to use the spray very often, remember to check the pump regularly to see that it still works properly.

If possible, sit down before using your spray. Take off the plastic cap and hold the spray bottle upright. Hold your breath for a moment to avoid breathing in the spray, then open your mouth and spray a dose under your tongue by pressing down on the pump button then letting go.

Use one or two sprays (never more than three within 15 minutes) and then immediately close your mouth before breathing normally through your nose again. Put the cap back on the spray bottle.

If you are not sure how to use the spray, ask your pharmacist to show you.

If you use more Glyceryl Trinitrate Spray than you should

If you use too many sprays some of the side effects (see below) may be worse than usual.

In this case you should see your doctor immediately.

4 POSSIBLE SIDE EFFECTS

Like all medicines, Glyceryl Trinitrate Spray can cause side effects, although not everybody gets them.

Some people are more sensitive to the effects of glyceryl trinitrate than others.

• Rarely flushing and allergic skin reactions or in some cases hypersensitivity reactions and exfoliative dermatitis (itchy, scaling skin rash) may appear. If you experience any

of these, stop using the spray and consult your doctor immediately.

• Headache may occur at the beginning of the treatment. Occasionally, the first dose, or the first higher dose, may cause a blood pressure drop and/or postural hypotension (fainting or feeling faint when standing up or getting out of bed), tachycardia (your heart may seem to speed up), dizziness and weakness.

• Application may cause a mild, temporary burning sensation in the mouth.

• Rarely, nausea (feeling sick), vomiting (being sick), heartburn may occur.

• Very rarely, in cases where there is a large fall in blood pressure, this medicine may make the symptoms of angina worse.

Sometimes the heart rate may slow and even lead to feeling faint or actually fainting.

Usually these are mild and will stop after a few minutes.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5 HOW TO STORE GLYCERYL TRINITRATE SPRAY

Keep out of the reach and sight of children.

Do not use Glyceryl Trinitrate Spray after the expiry date which is stated on the carton and on the base of the canister.

Do not store above 25°C (normal room temperature).

Protect from sunlight.

Do not use it near to anyone that is smoking; or spray the product into a naked flame or onto a hot surface.

Do not pierce or burn the canister after use. 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 Glyceryl Trinitrate Spray contains

The active substance is glyceryl trinitrate 0.8% w/w (400 micrograms per spray)

The other ingredients are ethanol and propylene glycol.

What Glyceryl Trinitrate Spray looks like and contents of the pack

The aluminium canister is equipped with a metered dose valve and a protective cap. Each canister containing 10g of solution is designed to deliver at least 180 doses.

Marketing Authorisation Holder

EGIS Pharmaceuticals UK Ltd.

127 Shirland Road London W9 2EP

United Kingdom

Manufacturer

EGIS Pharmaceuticals PLC Matyas kiraly ut 65.

Kormend

H-9900

Hungary

Distributor

Actavis, Barnstaple, EX32 8NS, UK

This leaflet was last approved in [05/2011].