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NITRONAL

Active substance: GLYCERYL TRINITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nitronal® 1 mg/ml solution for infusion
glyceryl trinitrate
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Nitronal ® is and what it is used for
2. Before you take Nitronal ®
3. How to take Nitronal ®
4. Possible side effects
5. How to store Nitronal ®
6. Further information
1. WHAT NITRONAL® IS AND WHAT IT IS USED FOR
Nitronal ® contains glyceryl trinitrate (GTN). GTN belongs to a group of medicines
called nitrates, which relax the muscle around blood vessels and make the heart’s
work easier.
Nitronal ® is a medicine which is only used in hospitals. It is used in three conditions:
- in heart failure
- in angina
- to lower the blood pressure during surgery.
All patients given Nitronal ® are monitored very carefully.
2. BEFORE YOU TAKE NITRONAL®
Do not take Nitronal ® if you
- are allergic (hypersensitive) to nitrates or any of the other ingredients of
Nitronal ® (see list of ingredients in Section 6). An allergic reaction may include
rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
- are taking Viagra (sildenafil) or similar products for the treatment of erectile
dysfunction or hypertension of arterial lung vessels. If you take these products
and Nitronal ®, a severe and possibly dangerous fall in blood pressure can occur.
This would result in collapse, unconsciousness and could be fatal.
- are suffering from:
- shock
- severe anaemia
- bleeding in the brain
- low blood oxygen
- severe blood loss
- a certain heart disease called hypertrophic obstructive cardiomyopathy
Nitronal ® is not intended for use in children.
Take special care with Nitronal ®
Before treatment with Nitronal ®, tell your doctor if you have any of these medical
conditions:
- severe liver disease
- kidney disease
- low body temperature
- underactive thyroid
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription. This is important as using more than one medicine at the same time can strengthen or weaken
the effect of the medicines. Your doctor may need to take special care or change
the dose. This is especially important for:
- drugs which lower blood pressure
- certain antidepressants (tricyclics).
- pain killers which are similar to morphine (Nitronal ® may also affect these)
- medicines for the treatment of erectile dysfunction or hypertension of arterial
lung vessels (see ‘Do not take Nitronal ® if you’)
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or breast-feeding. Nitronal ® should not be used
during pregnancy or breast-feeding unless the doctor considers it essential.
Driving and using machines
Do not drive or operate any tools or machines until you know how Nitronal ® affects
you.

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Important information about some of the ingredients of Nitronal ®
Nitronal ® contains 49 milligrams of glucose monohydrate per millilitre (ml). You
should take this into account if you have diabetes mellitus.
3. HOW TO TAKE NITRONAL®
Dosage
Nitronal ® will be given to you in hospital.
Nitronal ® is always given slowly into the blood stream (intravenous administration).
The usual dose for adults and the elderly depends on the condition:
Heart failure: 10 to 100 micrograms per minute
Angina: Initially 10 to 15 micrograms per minute, increasing until the angina is
relieved
Lowering blood pressure during surgery: 25 to 200 micrograms per minute
If you take more Nitronal ® than you should
Overdose is highly unlikely, as Nitronal ® will be given to you in hospital, but you
might experience vomiting, restlessness, low blood pressure, fainting, a bluish tinge
to the skin, coldness of the skin, difficulty breathing, slow heart rate, psychosis or
methaemoglobinaemia (a blood disorder).
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Nitronal ® can cause side effects, although not everybody gets
them.
You may get a headache or feel sick, dizzy or restless. You may sweat or flush, have
low blood pressure, faster (or sometimes slower) heart rate or a pain in the chest or
abdomen. If this happens, the doctor may give less Nitronal ® or stop the treatment.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE NITRONAL®
Keep out of the reach and sight of children.
Your doctor and hospital pharmacist are responsible for the correct storage, use and
disposal of Nitronal ®. Nitronal ® should be stored unopened: do not store Nitronal ®
above 25°C. Keep the ampoules and vial in the outer carton and use before the
expiry date printed on the ampoule or vial and carton. The expiry date refers to the
last day of that month. The diluted solution, which should be used as soon as
possible, is stable in the recommended infusion system for up to 24 hours. Nitronal ®
is for single dose use only. Discard any unused contents.
6. FURTHER INFORMATION
What Nitronal ® contains
The active substance is glyceryl trinitrate (GTN). Nitronal ® contains 1 milligram (mg)
per millilitre (ml) of GTN. Each 5 ml ampoule contains 5 mg of GTN, each 25 ml
ampoule contains 25 mg GTN and each 50 ml vial contains 50 mg of GTN. The
other ingredients are glucose monohydrate, water for injections, and dilute hydrochloric acid.
What Nitronal ® looks like and contents of the pack
Nitronal ® is a sterile, colourless solution for infusion.
Nitronal ® is available as cartons of 10 amber glass ampoules containing 5 ml or
25 ml of solution, or single clear glass vials containing 50 ml of solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Merck Serono Limited
Bedfont Cross, Stanwell Road,
Feltham, Middlesex
TW14 8NX. UK.
Manufacturer:
G. Pohl-Boskamp GmbH & Co. KG
Kieler Strasse 11
25551 Hohenlockstedt
Germany
G. Pohl-Boskamp GmbH & Co. KG
Kaddenbusch 11
25578 Dägeling
Germany
This leaflet was last approved in February 2010.
TW238320

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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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