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GLYCERYL TRINITRATE 300 MICROGRAMS TABLETS

Active substance(s): GLYCERYL TRINITRATE / GLYCERYL TRINITRATE

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D03891

Glyceryl Trinitrate 300 micrograms 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.

• have been told that you do not have enough oxygen in the blood
in your arteries (hypoxemia)
• have any of the following heart conditions: narrowing of heart
valves, inflammation of the heart, build up of fluid around the
heart or heart failure
• suffer from severe liver or kidney problems
• have an under-active thyroid gland
• have a history of heart attacks
• are suffering from malnutrition (poor nutrition due to an
unbalanced diet or digestion problems)
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
1. What Glyceryl Trinitrate tablets are, and what they are used for
2. What you need to know before you take Glyceryl Trinitrate tablets • n-acetylcysteine used in paracetamol overdose
• long acting nitrates (isosorbide dinitrate, isosorbide
3. How to take Glyceryl Trinitrate tablets
mononitrate)
4. Possible side effects
• medicines used to treat high blood pressure
5. How to store Glyceryl Trinitrate tablets
• medicines that can cause dry mouth (amitriptyline,
6. Contents of the pack and other information
disopyramide, atropine and propantheline, tricyclic
1. What Glyceryl Trinitrate tablets are, and what
antidepressants)
• apomorphine used to treat Parkinson’s disease
they are used for
Glyceryl Trinitrate belongs to a group of medicines known as nitrates. • medicines used to treat migraine (ergot alkaloids)
Nitrates temporarily relax most smooth muscle, including that found Glyceryl Trinitrate tablets with alcohol
You are advised not to drink alcohol with this medicine as it increases
in the walls of blood vessels in the heart. This reduces strain on the
some of the effects of Glyceryl Trinitrate.
heart by making it easier to pump blood.
Pregnancy, breast-feeding and fertility
Glyceryl Trinitrate tablets are used in the prevention and treatment
If you are pregnant, think you may be pregnant, planning to become
of the chest pain associated with angina. They work rapidly by
pregnant or are breastfeeding, ask your doctor or pharmacist for
dissolving under the tongue and being absorbed quickly into the
advice before taking this medicine.
blood stream.
Driving and using machines
2. What you need to know before you take Glyceryl This medicine may make you feel faint or dizzy. If affected, do not
Trinitrate tablets
drive or operate machines, especially if taken with alcohol..
Do not take Glyceryl Trinitrate tablets if you:
Glyceryl Trinitrate tablets contain lactose
If you have been told that you have an intolerance to some sugars,
• are allergic (hypersensitive) to glyceryl trinitrate or any of the
contact your doctor before taking this medicine.
ingredients of this medicine (listed in section 6 of this leaflet)
• are taking sildenafil (Viagra) or similar medicines (such as tadalafil
3. How to take Glyceryl Trinitrate tablets
or vardenafil) used for the treatment of erection problems.
• are suffereing from an inherited disease of the heart muscle where Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
the muscle wall becomes thickened ( hypertrophic obstructive
cardiomyopathy)
Adults, including older people
• have suffered any head injury or bleeding in the brain
One tablet should be placed under the tongue and allowed to
• suffer from anaemia
dissolve slowly.
• suffer from glaucoma (increased pressure within the eyeball)
Do not swallow.
Warnings and precautions
The dose may be repeated after 5 minutes if symptoms are not
Talk to your doctor or pharmacist before taking Glyceryl Trinitrate
relieved. If the chest pain persists for more than 15 minutes, you
tablets if you:
should seek medical advice immediately.
• have low body temperature (hypothermia), very low blood
pressure (hypotension) or low blood volume
If Glyceryl Trinitrate tablets are taken frequently and for long periods,
• have a disease of the blood vessels supplying the brain
Continued overleaf
(cerebrovascular disease).

What is in this leaflet

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

4. Possible side effects
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

100mm Measurement Verification Bar

If Glyceryl Trinitrate 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
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 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
label. 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 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 Pharma
Dales Pharmaceuticals Ltd.
Bampton Road,
Snaygill Industrial Estate
Harold Hill, Romford,
Keighley Road, Skipton
Essex RM3 8UG
North Yorkshire BD23 2RW
United Kingdom
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 August 2017
D03891

PACKAGE LEAFLET: INFORMATION FOR THE USER

3891-D

DEVELOPMENT ARTWORK
D03891
300 micrograms PIL Glyceryl
trinitrate (GTN) UK
170 x 180mm

02/08/17

NF

21/08/17

NF

25/08/17

NF

31/08/17

NF

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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