Package leaflet: Information for the user_

Glyceryl Trinitrate Tablets 500 micrograms Glyceryl Trinitrate Tablets 600 micrograms

(Glyceryl Trinitrate)

Read all this leaflet carefully before you start taking this medicine because it contains important information for you.

•    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.

What is in this leaflet

1.    What Glyceryl Trinitrate tablets are and what they are used for

2.    What you need to know before you take Glyceryl Trinitrate tablets

3.    How to take Glyceryl Trinitrate tablets

4.    Possible side effects

5.    How to store Glyceryl Trinitrate tablets

6.    Contents of the pack and other information.

1. What Glyceryl Trinitrate tablets are and what they are used for

Glyceryl Trinitrate belongs to a group of medicines called nitrate vasodilators. These medicines work by relaxing the blood vessels of the heart. This reduces the strain on the heart by making it easier to pump blood.

Glyceryl Trinitrate tablets may be used to:

•    prevent or stop chest pain caused by angina pectoris

•    stop spasms in the blood vessels of the heart.

|    2. What you need to know before you take Glyceryl Trinitrate tablets    |

Do not take Glyceryl Trinitrate Tablets if you:

•    are allergic to glyceryl trinitrate, nitrates or any of the ingredients in the tablet. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue (see section 6).

•    have anaemia

•    have glaucoma (increased pressure in the eye),

•    have raised pressure in your head including that caused by an accident to your head or bleeding on the brain, causing painful eyes, changes in vision and a bad headache especially behind the eyes.

•    are taking sildenafil (Viagra) or similar medicines (such as tadalafil or vardenafil) used for the treatment of erection problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Glyceryl Trinitrate tablets if you have:

•    severe liver or kidney problems

•    had an under active thyroid gland or a recent heart attack

•    low body temperature (hypothermia), very low blood pressure or low blood volume

•    poor nutrition due to an unbalanced diet or digestion problems (malnutrition)

•    abnormally low levels of oxygen in the blood (hypoxaemia)

•    any of the following heart conditions: narrowing of heart valves, inflammation of the heart, build up of fluid around the heart or heart failure

•    disease of the blood vessels supplying the brain (cerebrovascular disease).

Other medicines and Glyceryl Trinitrate Tablets

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

•    sildenafil (Viagra), tadalafil (Cialis) or vardenafil (Levitra) used to treat erection problems

•    heparin used to thin the blood

•    n-acetylcysteine used in paracetamol overdose

•    long acting nitrates (isosorbide dinitrate, isosorbide mononitrate)

•    medicines used to treat high blood pressure

•    medicines that can cause dry mouth (amitriptyline, disopyramide, atropine and propantheline, tricyclic antidepressants)

•    apomorphine used to treat Parkinson's disease

•    medicines used to treat migraine (ergot alkaloids)

Glyceryl Trinitrate tablets with food, drink and alcohol

You should not drink alcohol while using Glyceryl trinitrate tablets, as it may increase the effects of the tablets. Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

As glyceryl trinitrate can cause dizziness you should make sure you are not affected before driving or operating machinery, especially if taken with alcohol.

Glyceryl Trinitrate Tablets contain lactose

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains lactose.

Always this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you

are not sure.

120mm

SAME SIZE ARTWORK 120 x 265 mm Front

Do not swallow the tablets The recommended dose is:

Adults: Take the tablets sat down when taking to stop angina pectoris.

1 tablet should be placed under the tongue and allowed to dissolve slowly; this dose should be repeated after 5 minutes if symptoms are not relieved. If pain persists after a total of 3 doses in 15 minutes, you should seek medical advice immediately.

Elderly: When taking to prevent or stop angina pectoris take the tablets sat down to reduce possible fainting or low blood pressure.

Your doctor will change the dose to suit your condition. If you notice that your tablets are not working as well at relieving pain as they have done, contact your pharmacist or doctor. If you need more tablets than before to help, tell the doctor who will advise what to do.

If you take more Glyceryl Trinitrate Tablets than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include being sick, restlessness, low blood pressure, fainting, blueness of the skin, methaemoglobin in the blood, breathing difficulties, lack of oxygen in tissues, slow heart beat and mental illness.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following serious side effects happen, stop taking the medicine and tell your doctor immediately or go to your nearest hospital:

Worsening of angina symptoms, chest pains, hypoxaemia (difficulty breathing, increased rate of breathing), methaemoglobinaemia (breathing problems, headache, tiredness), difficulty breathing, blue colouring of the lips, fingers or toes (cyanosis), rapid (tachycardia) or slowed (bradycardia) heartbeat, blindness in one eye, cerebral ischaemia which may cause weakness in one arm or leg, or weakness in one entire side of the body, difficulty speaking, slurred speech, loss of coordination, loss of consciousness.

Other side effects:

Very common (may affect more than 1 in 10 people)

•    throbbing headache

Common (may affect up to 1 in 10 people)

•    spinning sensation, fall in blood pressure when seated or standing up, dizziness, drowsiness

•    weakness

Uncommon (may affect up to 1 in 100 people)

•    fainting

•    facial flushing

•    feeling or being sick

•    localised burning sensation

•    tongue blistering

Rare (may affect up to 1 in 1,000 people)

•    allergic skin reactions

Very rare (may affect up to 1 in 10,000 people)

•    restlessness

•    heartburn

•    bad breath, itchy, flaky or red skin, skin rash

Not known (frequency cannot be estimated from the available data)

•    pain around the eye, changes in vision 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safely of this medicine.

|    5. How to store Glyceryl Trinitrate Tablets    |

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

•    Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

•    Keep in the bottle with cap tight closed, in a dark place and protect from sunlight. Do not store above 25⁰C.

•    If you do not use the tablets within 8 weeks of first opening the bottle, obtain a fresh supply and return the old tablets to your pharmacist.

•    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. Contents of the pack and other information What Glyceryl Trinitrate Tablets contain

•    The active ingredient is Glyceryl Trinitrate. Each tablet contains either 500 micrograms or 600 micrograms of the active ingredient. The other ingredients are lactose, mannitol, acacia, stearic acid and magnesium stearate.

What Glyceryl Trinitrate Tablets look like and contents of pack

•    Glyceryl trinitrate 500mcg tablets are white, round, biconvex and unscored.

•    Glyceryl trinitrate 600mcg tablets are white, round, flat and unscored.

•    Glyceryl trinitrate tablets are available in packs of 100 tablets.

Marketing Authorisation Holder and Manufacturer

Bristol Laboratories Ltd., Unit 3, Canalside, Northbridge Road, Berkhamsted, HP4 1EG, United Kingdom Telephone:    0044(0)1442 200922,

Fax:    0044(0)1442 873717,

Email:    info@bristol-labs.co.uk

Glyceryl Trinitrate Tablets 500 micrograms; PL 17907/0171 Glyceryl Trinitrate Tablets 600 micrograms; PL 17907/0172 This leaflet was last revised in October 2016

To request a copy of this leaflet in Braille, large print or audio, please contact the licence holder at the address above (or telephone, fax, email).

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