Glyceryl Trinitrate Spray

Document: leaflet MAH GENERIC_PL 18190-0013 change

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Glyceryl Trinitrate Spray

PACKAGE LEAFLET: INFORMATION FOR THE USER

Active substance: glyceryl trinitrate

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

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

• 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)

• take Viagra (sildenafil), Cialis (tadalafil) or Levitra (vardenafil)

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

Take special care with Glyceryl Trinitrate Spray

If you are predisposed to postural hypotension (low blood pressure),

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

If you suffer from liver disease, alcoholism, epilepsy, cerebral trauma and other CNS diseases (The preparation contains 79.2 % of ethanol. Each dose (2 sprays) contains up to 0.08 g of alcohol. Its use may cause harm in the above-mentioned conditions),

There is a large inter-individual variation of patient sensitivity to nitrates.

Increases of dose may lead to tolerance.

Glyceryl trinitrate increases the urinary excretion of catecholamines and VMA (vanillylmandelic acid).

Patients with a history of previous organic nitrate treatment (with e.g. isosorbide-dinitrate, isosorbide-mononitrate) may require higher glyceryl trinitrate doses.

Taking other medicines

Never use Glyceryl Trinitrate Spray with:

Sildenafil (Viagra), vardenafil (Levitra) or tadalafil (Cialis) containing erectile dysfunction preparations (blood-pressure lowering effect of Glyceryl Trinitrate Spray may be increased).

Carefully combine Glyceryl Trinitrate Spray with:

Other vasodilators (eg ACE inhibitors or Calcium channel blockers), antihypertensive agents (eg Beta blockers or Sympatholytics) antipsychotics and tricyclic antidepressants as all of these drugs types may augment the reduction of blood pressure;

Dihydroergotamine containing gynaecological preparations as the effect of this drug can be augmented by glyceryl trinitrate;

Heparin containing blood-thinner preparations (the efficacy of heparin may decrease).

Other products containing nitrates, which may be tablets that are swallowed, patches or ointment, may still be used.

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

Using Glyceryl Trinitrate Spray with food and drink

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

165 x 200 mm page 1

1 : 1 UK

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Zombor Cs. /2009.07.24.

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This medicinal product is authorised in the Member States of the EEA under the following names:

Country

Hungary

Poland

Romania

Lithuania

Slovakia

United Kingdom Czech Republic Latvia Ireland

United Kingdom

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 effect (blood pressure lowering) will be unknown. Later on, the extent of the restriction should be determined on a case-by-case basis.

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.

31 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.

41 POSSIBLE SIDE EFFECTS

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

Headache may occur at the beginning of the treatment. Occasionally, the first dose, or the first elevated 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, transient burning sensation in the mouth.

Rarely, nausea, vomiting, flush and allergic skin reactions or in some cases hypersensitivity reactions and exfoliative dermatitis may appear. Sporadically, in cases with extreme blood pressure reduction, the treatment may aggravate the symptoms of angina pectoris (paradoxical nitrate reaction). Sometimes collapse occurs with bradycardia (your heart may seem to slow down) and syncope.

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.

51 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.

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.

61 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 10 g 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

Name of the Product

Nitromint aerosol Nitromint aerosol Nitromint aerosol Nitromint aerosol Nitromint aerosol Nitromin spray Nitromint aerosol Nitromint aerosol Nitromin spray Glyceryl trinitrate spray

This leaflet was last approved in August 2007.

EGIS Doc. No.:

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