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package leaflet: INFORMATION FOR THE USER    D02539|

Glyceryl Trinitrate 300 microgram Tablets

Glyceryl Trinitrate

Read all of 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

5. 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 known as nitrates. Nitrates temporarily relax most smooth muscle, including that found n the walls of blood vessels in the heart. This reduces strain on the heart by making it easier to pump blood.

Glyceryl Trinitrate tablets are used in the prevention and treatment bf the chest pain associated with angina. They work rapidly by dissolving under the tongue and being absorbed quickly into the blood stream.

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

Do not take Glyceryl Trinitrate tablets if you:

•    are allergic (hypersensitive) to glyceryl trinitrate or any of the ingredients of this medicine (listed in section 6 of this leaflet)

•    suffer from anaemia

•    suffer from glaucoma (increased pressure within the eyeball)

•    have low blood pressure or low blood volume

•    suffer from any form of heart disease

•    have suffered any head injury or bleeding in the brain

•    are taking Viagra, Cialis or Levitra (medicines used to treat erectile dysfunction). A potentially dangerous fall in blood pressure can occur if Glyceryl Trinitrate tablets are taken with these drugs

•    are being given heparin (a medicine used to prevent blood clots) Warnings and precautions

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

•    have suffered a recent head injury or have had a recent bleed into the brain

•    are suffering from malnutrition_

•    have an under-active thyroid gland

•    are suffering from hypothermia

•    suffer from severe liver or kidney problems

•    are pregnant, think you may be pregnant, planning to become pregnant or are breast-feeding

•    have a history of heart attacks

•    have been told that you do not have enough oxygen in the blood in your arteries (hypoxemia)

Other medicines and Glyceryl Trinitrate tablets

Tell your doctor or pharmacist if you are taking, have recently taken br might take any other medicines, including medicines obtained without a prescription

Tell your doctor if you are taking:

•    medicines which cause you to have a dry mouth. These include:

•    medicines for the treatment of depression

•    medicines used to treat an irregular heartbeat

•    medicines used to treat Parkinson's disease, bladder problems or travel sickness (antimuscarinic drugs).

The effect of Glyceryl Trinitrate may be lost as the tablet will not dissolve under the tongue if the mouth is dry.

•    medicines used to treat high blood pressure. These include:

•    angiotensin II receptor agonists

•    beta-blockers

•    clonidine

•    calcium channel blockers

•    diazoxide

•    hydralazine

•    methyldopa

•    minoxidil

•    moxonidine

•    nitroprusside

•    oestrogens (used for birth control)

•    medicines used to stop inflammation (corticosteroids)

•    non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac

•    carbenoxalone (a medicine used to treat ulcers)

•    baclofen and tizanadine (medicines used to relax the muscles)

•    levodopa (a medicine used to treat Parkinson's disease)

•    moxisylyte (thymoxamine) (a medicine used to treat Raynaud's syndrome)

•    monoamine oxidase inhibitors (known as MAOIs) (medicines used to treat severe depression)

•    diuretics (medicines used to remove excess water from the body)

•    anxiolytics (medicines used to treat anxiety)

•    hypnotics (medicines used to treat insomnia)

•    phenothiazines (medicines used to treat severe mental disorders)

•    any other medicines that are placed under the tongue e.g. apomorphine

Tell the anaesthetist if you have just taken Glyceryl Trinitrate and are about to have surgery.

Slyceryl Trinitrate tablets with alcohol

You are advised not to drink alcohol with this medicine as it increases ;ome of the effects of Glyceryl Trinitrate.

_Continued overleaf

Pregnancy and breast-feeding

f you are pregnant, think you may be pregnant, planning to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine may make you feel faint or dizzy. If affected, do not drive or operate machines.

Glyceryl Trinitrate tablets contain lactose

f you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.    How to take Glyceryl Trinitrate tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults, including older people

One tablet should be placed under the tongue and allowed to dissolve slowly.

Do not swallow.

The dose may be repeated if symptoms are not relieved. If the chest pain persists for more than 15 minutes, you should seek medical advice immediately.

f Glyceryl Trinitrate tablets are taken frequently and for long periods, the effectiveness of the drug may decrease. If you notice that your tablets are not working as well at relieving the pain as they have done, consult your doctor.

If you take more Glyceryl Trinitrate tablets than you should

f you take too many tablets, remove any tablets from your mouth and contact your doctor, or go to your nearest hospital casualty department immediately.

Please take this leaflet, any remaining tablets and the container with you so that they know what you have taken.

An overdose may make you vomit, feel restless or faint, develop bluish lips and fingers , or methaemoglobin in the blood. Severe poisoning may result in a slow heartbeat, difficulty in breathing and changes in your mental state.

f you have any further questions on the use of this product, please ask your doctor or pharmacist.

4.    Possible side effects

_ike all medicines, Glyceryl Trinitrate tablets can cause side effects, although not everybody gets them.

Possible side effects include:

•    throbbing headaches

•    facial flushing

•    dizziness

•    rapid heartbeat

•    faintness, especially when getting up from a seated or bent position

•    a slowing of the heartbeat

•    feeling or being sick Rarely, you may experience:

•    localised feeling of discomfort in the mouth or tongue, blistering

or ulcers._


f Glyceryl Irinitrate is taken frequently and for long periods, the effectiveness of the drug may decrease. Consult your doctor if you think this is occurring.

Reporting of side effects

f you get any side effects, talk to your doctor or pharmacist. This ncludes 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.

5.    How to store Glyceryl Trinitrate tablets

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

The active ingredient can evaporate from the tablets thereby making them less effective. You should therefore observe the following conditions to ensure continued potency of the tablets.

•    Close the cap tightly after removing a tablet

•    Do not transfer the tablets to another container

•    Do not put any packing material into the bottle with 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 the pharmacist for disposal

•    Store in a dry place below 25°C and protected from light

Do not use this medicine after the expiry date which is stated on the abel. 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 equired. These measures will help to 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 300 micrograms Glyceryl Trinitrate equivalent to 0.3mg glyceryl trinitrate.

•    The other ingredients are mannitol, acacia, lactose, magnesium stearate, talc and stearic acid.

What Glyceryl Trinitrate tablets look like and contents of the pack

Glyceryl Trinitrate tablets are plain white biconvex tablets and are supplied in amber glass bottles. Each bottle contains 100 tablets.

Marketing Authorisation Holder Manufacturer

Martindale Pharmaceuticals    Dales Pharmaceuticals Ltd.

3ampton Road, Harold Hill    Snaygill Industrial Estate

Romford, RM3 8UG    Keighley Road, Skipton

United Kingdom    North Yorkshire, bD23 2RW

United Kingdom

If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address.

Product Licence Number: PL 01883/5958R This leaflet was last revised in July 2013


MARTiNDALE PHARMA

Bampton Road, Harold Hill, Romford, RM3 8UG, UK


100mm Measurement Verification Bar

2539-C