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Glyceryl Trinitrate Pump Spray 400 Micrograms Per Metered Dose


Glyceryl Trinitrate Pump Spray

400 micrograms per metered dose

Glyceryl Trinitrate 400 micrograms per metered dose

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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.


In this leaflet:

1.    What GTN Pump Spray is and what it is used for

2.    What you need to know before you use GTN Pump Spray

3.    How to use GTN Pump Spray

4.    Possible side effects

5.    How to store GTN Pump Spray

6.    Further information


1. WHAT GTN PUMP SPRAY IS & WHAT IT IS USED FOR

Your medicine is called Glyceryl Trintrate Pump Spray. It will be referred to throughout this leaflet as GTN Pump Spray.

It is a sublingual (under the tongue) pump spray that contains the active ingredient glyceryl trinitrate. Glyceryl trinitrate belongs to a group of medicines called nitrates that relax the muscle walls of the blood vessels and reduce the workload of the heart.

GTN Pump Spray is used to treat angina at the onset of an attack. It is also used for the prevention of angina, which can be brought on from physical effort, emotional stress, exposure to cold, etc.

WHAT YOU NEED TO KNOW BEFORE YOU USE GTN PUMP SPRAY

Do not use GTN Pump Spray:

•    If you are allergic to glyceryl trinitrate or any of the other ingredients of this medicine (listed in section 6).

•    If you have severe low blood pressure.

•    If you have shock caused by low blood pressure.

•    If you have severe anaemia.

•    If you have constrictive pericarditis (a heart condition).

•    If you have an extremely low heart rate.

•    If you have glucose-6-phosphate-dehydrogenase deficiency (an inherited enzyme deficiency, mainly affecting men).

•    If you have a brain trauma or cerebral haemorrhage (brain or head injury, including bleeding).

•    If you have narrowing of the heart valves or arteries or angina caused by a disease of the heart muscle.

•    If you have circulatory collapse (a failure of blood circulation).

•    If you have toxic pulmonary oedema (lung swelling/fluid).

•    If you have cardiogenic shock (a serious heart condition caused by very low blood pressure, which may result in the following symptoms dizziness and lightheadedness, fast pulse rate, white skin, sweating, restlessness or loss of consciousness).

Do not use if you are taking sildenafil, tildenafil, vardenafil or

similar phospho-diesterase inhibitors used to treat male erectile

dysfunction (impotence).

Warnings and precautions:

Talk to your doctor or pharmacist before using GTN Pump Spray if any of the following apply to you.

•    Fluid around the heart (pericardial tamponade).

•    Low filling pressures (e.g. acute myocardial infarction)

•    Problems controlling your blood pressure.

•    Any disease that increases pressure on the brain.

•    Glaucoma (a condition in which the pressure in the eye may be high.)

•    Liver or kidney problems.

•    An underactive thyroid gland.

Please consult your doctor, even if these statements were applicable to you at any time in the past. You may need to be more closely supervised during treatment.

Continuous use warning:

Continuous use of GTN Pump Spray and other nitrates may reduce effectiveness at relieving your symptoms, so high continuous doses should be avoided.

Other medicines and GTN Pump Spray:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Talk to your doctor before using GTN Pump Spray if you are

taking or have recently taken any of the following:

•    Medicines treating blood pressure or heart problems, such as vasodilators, antihypertensives, betablockers and calcium channel blockers.

•    Tricyclic anti-depressants or neuroleptics, used to treat mental health conditions.

•    Diuretics (water tablets to increase amount of urine produced).

•    Dihydroergotamine, used to treat migrane headaches.

•    Heparin, a blood thinner used to prevent blood clots. Your doctor will need to monitor you more closely.

•    Organic nitrates (other acute angina treatments).

GTN Pump Spray and alcohol:

Be careful about drinking alcohol as this spray may affect you more than usual. Both alcohol and GTN Pump Spray may lower your blood pressure and slow down your reactions.

Pregnancy and breast-feeding:

If you are, or think you might be pregnant, ask your doctor for advice before taking this medicine. GTN Pump Spray should not be used if you are breastfeeding.

Driving and using machines:

Your reactions may slow down. Therefore you should avoid driving and using machinery whilst taking GTN Pump Spray.

GTN Pump Spray contains ethanol:

This product contains small amounts of ethanol (alcohol), less than 100mg per spray.

Client:    AYRTON SAUNDERS

Product:    Glyceryl Trinitrate Pump Spray

Date:    15.09.2015

Color:    Black

Fonts and Size: Helvetica Neue LT Std    (Condensed, Bold Condensed) 8 pt

Leading:    9 pt


5. Do not use GTN Pump Spray if you are near a naked flame, e.g. a cigarette.


3. HOW TO USE GTN PUMP SPRAY

1.    GTN Pump Spray is not recommended for children.

2.    Always use GTN Pump Spray exactly as explained in this leaflet. You should check with your doctor or pharmacist if you are not sure.

3.    Learn how to use GTN Pump Spray before the onset of an angina attack, as you may need to use it in a hurry, or in the dark. Familiarise yourself with the spray button, which has a finger rest to help you direct the spray.

4.    Keep a spare handy at all times as it can be difficult to tell how many doses are left in the bottle.

6.    Before using the pump spray for the first time press the spray button three times to fill the pumping chamber. If you have not used the spray for a few days pump the spray 1 or 2 times before use.

7.    At the onset of an attack, or to prevent an imminent attack:

•    Sit down.

•    Hold the bottle upright and near your mouth.

   Hold your breath.

•    Aim the spray under your tongue.

•    Press down the button firmly, once only.

   Close your mouth immediately.

   Do not inhale the spray.

8.    The usual dose is one or two sprays. No more than three doses are recommended at any one time.

9.    After using GTN Pump Spray, rest for a while. When you stand up, rise slowly, as you may feel faint.

If you use more GTN Pump Spray than you should:

Special treatment is not normally required.

Overdose symptoms are usually the same as the stated side effects. Some people may experience a reaction similar to shock, with nausea, weakness and sweating. If you feel faint sit down and raise your legs. Contact your doctor if your symptoms do not improve. Rarely a bluish colour to lips/fingers may occur (cyanosis or methaemoglobinaemia). If this happens contact your doctor immediately

4. POSSIBLE SIDE EFFECTS

Like all medicines, as well as benefits, GTN Pump Spray can cause side effects, although not everybody gets them.

If you experience one of the following rare serious side effects (affecting less than 1 in 1000 patients unless specified), stop taking GTN Pump Spray immediately and consult your doctor:

•    An allergic skin reaction (with or without rash).

•    Tongue blistering (less than 1 in 100 patients).

•    Fainting due to a low heart rate and a severe fall in blood pressure. This may be accompanied by a worsening of the original angina symptoms.

•    Transient hypoxaemia (deprived oxygen supply).

•    Patients with coronory heart disease may experience a restriction in blood supply.

Continuous use may result in a tolerance to GTN Pump Spray,

reducing its effectiveness.

Other known side effects are:

Very common

(more than 1 in 10 patients)

headache

Common

(less than 1 in 10 patients)

vertigo (spinning sensation), dizziness, nausea, facial flushing, weakness

Uncommon

(less than 1 in 100 patients)

burning sensation, stinging sensation

Rare

(less than 1 in 1000 patients)

severe fall in blood pressure, heart rhythm change

Very rare

(less than 1 in 10000 patients)

flaking or peeling skin

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 GTN PUMP SPRAY

   Keep this medicine out of the sight and reach of children.

•    Do not use GTN Pump Spray after the expiry date which is stated on the carton and the bottle label after EXP. The expiry date refers to the last day of that month.

•    Do not store above 25°C. Do not refrigerate or freeze.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. FURTHER INFORMATION

What GTN Pump Spray contains:

•    The active ingredient is glyceryl trinitrate. Each spray of GTN Pump Spray contains 400 micrograms of glyceryl trinitrate.

•    The other ingredients are ethanol and medium chain triglyceride. What GTN Pump Spray looks like & contents of the pack:

•    GTN Pump Spray is a colourless spray presented in a labelled bottle fitted with a metered dose pump and spray nozzle, and a cap.

•    Each bottle contains enough product for either 160, 180 or 200 sprays.

Marketing Authorisation Holder and Manufacturer:

MA 16431/0024

Marketing Authorisation Holder: Ayrton Saunders Ltd., 9 Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire, WA7 1NU, UK. Manufacturer: Pharmasol Limited, North Way, Andover, SP10 5AZ, UK. For information in large print, audio CD or braille please contact the Marketing Authorisation Holder This leaflet was last approved in September 2015 ® Registered Trademark Ayrton Saunders Ltd.

Client:    AYRTON SAUNDERS

Product:    Glyceryl Trinitrate Pump Spray

Date:    15.09.2015

Color:    Black

Fonts and Size: Helvetica Neue LT Std    (Condensed, Bold Condensed) 8 pt

Leading:    9 pt