Coro-Nitro Pump Spray

400 micrograms per metered dose

Glyceryl Trinitrate 400 micrograms per metered dose

1. WHAT CORO-NITRO IS AND WHAT IT IS USED FOR

Your medicine is called Coro-Nitro Pump Spray. It will be referred to throughout this leaflet as Coro-Nitro.

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.

Coro-Nitro 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, and exposure to cold, etc.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE CORO-NITRO

Do not use Coro-Nitro

•    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 Coro-Nitro 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 Coro-Nitro and other nitrates may reduce effectiveness at relieving your symptoms, so high continuous doses should be avoided.

Other medicines and Coro-Nitro

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

Talk to your doctor before using Coro-Nitro 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 migraine 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).

Coro-Nitro with alcohol

Be careful about drinking alcohol as this spray may affect you more than usual. Both alcohol and Coro-Nitro 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, Coro-Nitro 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 Coro-Nitro.

Coro-Nitro contains ethanol

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

3. HOW TO USE CORO-NITRO

1.    Coro-Nitro is not recommended for children.

2.    Always use Coro-Nitro exactly as explained in this leaflet. You should check with your doctor or pharmacist if you are not sure.

3.    Learn how to use Coro-Nitro 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 Coro-Nitro, rest for a while. When you stand up, rise slowly, as you may feel faint.

If you use more Coro-Nitro 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, Coro-Nitro 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 Coro-Nitro 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 coronary heart disease may experience a restriction in blood supply.

Continuous use may result in a tolerance to Coro-Nitro, reducing

its effectiveness. If symptoms are not relieved, medical advice

should be sought immediately.

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 CORO-NITRO

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

•    Do not use Coro-Nitro 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 Coro-Nitro contains:

•    The active ingredient is glyceryl trinitrate. Each spray of Coro-Nitro contains 400 micrograms of glyceryl trinitrate.

•    The other ingredients are ethanol and medium chain triglyceride.

What Coro-Nitro looks like & contents of the pack:

•    Coro-Nitro 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 200 sprays.

Marketing Authorisation Holder and Manufacturer:

MA 16431/0021

Marketing Authorisation Holder: Ayrton Saunders Ltd., 9 Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire, WA7 1NU. 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 revised in September 2015 ® Registered Trademark Ayrton Saunders Ltd.

Client:    AYRTON SAUNDERS

Product:    Coro-Nitro Pump Spray

Date:    15.09.2015

Color:    Black

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