What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 44374/0019.


Nitrocine 1mg/ml, solution for infusion

Package Leaflet: Information for the patient

Nitrocine® 1 mg/ml Solution for Infusion

Glyceryl trinitrate

Read all of this leaflet carefully before you start using 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 nurse
  • 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 nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Nitrocine is and what it is used for
2. What you need to know before you are given Nitrocine
3. How you will be given Nitrocine
4. Possible side effects
5. How to store Nitrocine
6. Contents of the pack and other information

1. What Nitrocine is and what it is used for

Nitrocine belongs to a group of medicines called ‘nitrates’. These are used to widen your blood vessels and reduce the workload of your heart.

Nitrocine is usually used in emergency situations to:

  • Rapidly control high blood pressure during surgery, especially heart surgery
  • Treat unstable angina. (Angina attacks feel like a tight pain in your chest, neck or arm and are a sign that your heart is not getting enough oxygen for the amount of work it is doing)
  • Treat heart failure following a heart attack. It is very important that your doctor treats these conditions as quickly and effectively as possible, as left untreated the consequences could be fatal.

2. What you need to know before you are given Nitrocine

Do not use Nitrocine:

  • If you are allergic to glyceryl trinitrate or any of the other ingredients of this medicine (listed in section 6)
  • If you are allergic to any other nitrates
  • If you are taking medicines for failure to achieve an erection such as Viagra. Using Nitrocine with these medicines could cause a severe drop in blood pressure and could lead to collapse and unconsciousness, and may be fatal
  • If you suffer from low blood pressure
  • If you suffer from low blood volume
  • If you suffer from severe anaemia (low iron levels in your blood)
  • If you have ever had a serious head injury, cerebral haemorrhage (bleeding in the brain) or a disease which is accompanied by increased pressure on the brain
  • If you have or had heart conditions
  • If you are using riociguat, a medicine used in treating pulmonary hypertension

Warnings and precautions

Talk to your doctor or nurse before using Nitrocine:

  • If you have an underactive thyroid gland
  • If you have any diseases of the liver or kidneys
  • If you have hypothermia (very low body temperature)
  • If you are malnourished (severe lack of food)
  • If you are pregnant or breastfeeding.

Other medicines and Nitrocine

  • Do not take Nitrocine with medicines for failure to achieve an erection such as Viagra. Using Nitrocine with these medicines could cause a severe drop in blood pressure and could lead to collapse and unconsciousness, and may be fatal.

Tell your doctor or nurse if you are taking, have recently taken or might take any of the following medicines:

  • Medicines which reduce blood pressure (e.g. beta-blockers, calcium channel blockers, vasodilators) ACE-inhibitors, monoamine oxidase inhibitors)
  • Tricyclic anti-depressants (used to treat depression)
  • Neuroleptics (used to treat anxiety)
  • Any other medicine, including medicines obtained without a prescription.
  • Non-steroidal anti-inflammatory drugs except acetyl salicylic acid.
  • Sapropterine containing medicines.

Nitrocine with alcohol

Do not drink alcohol whilst using Nitrocine as it can cause your blood pressure to drop. This may make you feel dizzy or faint.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before you are given Nitrocine.

Driving and using machines

Nitrocine may give you a headache, or make you feel dizzy or tired. If this happens to you, do not drive or operate machinery.

3. How you will be given Nitrocine

Important: Your doctor will choose the dose that is right for you. Your medicine will be administered by a doctor in hospital. It will be given via a drip into your bloodstream and may be diluted or undiluted.

Use in children

Nitrocine is not suitable for children.

Adults and Elderly

  • The usual dose is between 10 micrograms and 200 micrograms per minute, but sometimes as much as 400 micrograms per minute may be needed
  • The exact dose that the doctor will give you depends on the condition you are being treated for. As a guide:

To control high blood pressure during surgery:

  • 25 micrograms per minute will be given as a starting dose
  • This may be increased by 25 micrograms per minute at 5 minute intervals until your blood pressure is stabilised
  • Doses up to 400 micrograms per minute may occasionally be needed.

To control myocardial ischaemia during and after cardiovascular surgery:

  • 15-20 micrograms per minute will be given as a starting dose.
  • Depending on your response, the dose may be increased by increments of 10-15 micrograms per minute until the desired effect is obtained.

To treat unstable angina:

  • 10 micrograms per minute will be given as a starting dose
  • Depending on your response, the dose may be increased or decreased by 10 micrograms every 30 minutes until the desired effect is achieved.

Treat heart failure following a heart attack:

  • 20-25 micrograms per minute will be given as a starting dose
  • Depending on your needs, the doctor may decrease the dose by 10 micrograms per minute or give you a further 20-25 micrograms per minute until the required effect is obtained.

While you are being given Nitrocine, the doctor may monitor your heart rate and breathing to make sure that the medicine is working properly.

If you are given more Nitrocine than you should

This is unlikely as Nitrocine will be injected slowly by a doctor who will monitor your heart continuously during treatment. If any problem occurs, Nitrocine can be stopped and any symptoms of over dosage treated urgently.

If you have any further questions about this medicine, ask your doctor or nurse.

4. Possible side effects

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

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

  • Headaches

Common side effects (may affect up to 1 in 10 people)

  • Low blood pressure (hypotension) and light-headedness upon standing which you may notice as dizziness, drowsiness, rapid heartbeat (reflex tachycardia) and a feeling of weakness at the start of treatment or when the dosage is increased.

Uncommon side effects (may affect up to 1 in 100 people)

  • Collapse sometimes with a slow heartbeat and fainting
  • Very low blood pressure (severe hypotension) where you are being sick, feeling sick, are restless, have pale skin and sweat a great deal. This may lead to a worsening of the chest pain you often get with angina
  • Temporary low oxygen level in the blood (temporary hypoxaemia). For people with heart disease this may lead to low oxygen level in the tissue surrounding the heart (myocardial hypoxia)
  • Allergic skin rash, which may be severe
  • Feeling sick
  • Being sick

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

  • Heartburn

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

  • Palpitations
  • Flushing of the face
  • Low blood pressure
  • Very red skin with scaling and thickened itchy skin (exfoliative dermatitis)
  • Rash
  • Heart rate increase

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:

UK

The Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie

By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Nitrocine

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

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.

Nitrocine is for single use only. Unopened, this medicinal product does not require any special storage conditions. When opened, Nitrocine must be used immediately. If it has to be diluted, the mixed product should also be used immediately.

Your doctor or nurse will make sure your medicine is correctly stored and disposed of.

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 Nitrocine contains

  • The active substance is glyceryl trinitrate. Each 1 ml of solution contains 1 mg glyceryl trinitrate.
  • The other ingredients are glucose, propylene glycol, water for injection and hydrochloric acid for pH adjustment.

What Nitrocine looks like and contents of the pack

Nitrocine 1mg/ml solution for infusion is an isotonic sterile solution. It is supplied in packs of 10 ampoules, each containing 10 mg glyceryl trinitrate in 10 ml solution, or in a single glass vial containing 50 mg glyceryl trinitrate in 50 ml solution.

Marketing Authorisation Holder

In UK

Merus Labs Luxco II S.à r.l.
26-28, rue Edward Steichen
L-2540
Luxembourg

Manufacturer

Aesica Pharmaceuticals GmbH
Alfred-Nobel-Strasse 10
D-40789 Monheim
Germany

This leaflet was last revised in June 2018

If this leaflet is difficult to read and you would like it in a different format, please contact

Merus Labs Luxco II S.à r.l.
26-28, rue Edward Steichen
L-2540
Luxembourg