Glyceryl Trinitrate tablets

500micrograms and 600micrograms

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

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

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

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

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

Index

H What Glyceryl Trinitrate tablets are and what they are used for

12    What you need to know before you take

13    How to take Glyceryl Trinitrate Tablets

4| Possible side effects Tj How to store Glyceryl Trinitrate Tablets

"6| Contents of the pack and other information

J 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 BP may be used to:

•    prevent or stop chest pain caused by angina pectoris

•    stop spasms in the blood vessels of the heart.

What you need to know before you take

Do not take Glyceryl Trinitrate tablets if you:

•    are allergic (hypersensitive) 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 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.

•    have increased pressure in the eye (glaucoma).

•    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

•    an under active thyroid gland

•    had a recent heart attack

•    low body temperature (hypothermia)

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

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

•    very low blood pressure, low blood volume or conditions that lower blood volume in the heart

•    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, including medicines obtained without a prescription. 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 alcohol

You are advised not to drink alcohol with Glyceryl Trinitrate tablets, as some of the effects of this medicine are increased.

Pregnancy and breast feeding

If you are pregnant, planning to become pregnant or breast feeding, 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.

Continued top of next column

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50868502 AAAI2227

130x210 Leaflet Reel Fed Profile (BST)

Glyceryl Trinitrate Tablets 500 & 600mg x 100's (UK)

JDE No.:    50868502

Dimensions: 130x210 (Reel Fed) Component: Leaflet for Bottles

Pharmacode: 2769

Date Sent: 10/08/15 Technologist: R.Wrey Technically Approved

Actavis BST - Packing Technical BSTCutterGuideReq@actavis.com

* Please note that only Actavis Global Artwork Studios are permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

|3| How to take Glyceryl Trinitrate Tablets

Always take Glyceryl Trinitrate tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Do not swallow the tablets.

Doses:

Adult: 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.

Older people: 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, Glyceryl Trinitrate tablets 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, pharmacist or nurse. 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 safety of this medicine.

How to store Glyceryl Trinitrate Tablets

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

The active medicine quickly evaporates from the tablet and you should observe the following conditions to ensure continued potency of the tablets.

•    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. (Fresh tablets should produce a slight burning sensation when placed under the tongue; if this does not occur, obtain a fresh supply). In any event do not use the tablets after the expiry date shown.

•    Your Glyceryl Trinitrate tablets will be in a glass airtight container with a foil-lined cap. Keep them in this.

•    After each use close the bottle cap tightly.

•    Do not put cotton wool, other medicines, or anything else in the bottle with the tablets.

•    Store the tablets below 25^oC in a dry place, protected from light. If you need to carry them with you do not carry them close to your body, rather in a purse, wallet or handbag.

Do not use Glyceryl Trinitrate tablets after the expiry date stated on the bottle. The expiry date refers to the last day of that month.

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 Contents of the pack and other information

What Glyceryl Trinitrate tablets contain

•    The active substance (the ingredient that makes the tablets work) is glyceryl trinitrate BP. Each tablet contains either 0.525mg or 0.630mg of the active ingredient Glyceryl trinitrate 2% adsorbate which is equivalent to 500micrograms and 600micrograms of Glyceryl trinitate.

•    The other ingredients are lactose, stearic acid, magnesium stearate, colloidal silicon dioxide, mannitol and acacia.

What Glyceryl Trinitrate tablets look like and contents of the pack

Glyceryl Trinitrate are white, circular, uncoated tablets.

Pack size is 100.

Marketing Authorisation Holder and Manufacturer

Actavis, Barnstaple, EX32 8NS, UK

This leaflet was last revised in August 2015.

50868502 AAAI2227

Actavis, Barnstaple, EX32 8NS, UK

130x210 Leaflet Reel Fed Profile (BST)

Glyceryl Trinitrate Tablets 500 & 600mg x 100's (UK)

JDE No.:    50868502

Dimensions: 130x210 (Reel Fed) Component: Leaflet for Bottles

Pharmacode: 2769

Date Sent: 10/08/15 Technologist: R.Wrey Technically Approved

Actavis BST - Packing Technical BSTCutterGuideReq@actavis.com

* Please note that only Actavis Global Artwork Studios are permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes.