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: PL13079/0012 .


Metaraminol 0.5mg/mL Solution for Injection

Package Leaflet: Information for the user

Metaraminol 0.5mg/mL Solution for Injection

Metaraminol Tartrate

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.
  • A nurse or doctor will give you the injection.
  • If you have any further questions, ask your doctor, nurse or pharmacist.
  • If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Metaraminol 0.5mg/mL Solution for Injection is and what it is used for
2. What you need to know before you use Metaraminol 0.5mg/mL Solution for Injection
3. How to use Metaraminol 0.5mg/mL Solution for Injection
4. Possible Side Effects
5. How to store Metaraminol 0.5mg/mL Solution for Injection
6. Contents of the pack and other information

1. What Metaraminol 0.5mg/mL Solution for Injection is and what it is used for

Metaraminol 0.5mg/mL Solution for Injection contains the active substance Metaraminol Tartrate and belongs to a group of medicines called vasopressors which work by narrowing the blood vessels causing blood pressure to rise.

It is used to:

  • Raise low blood pressure to normal levels in an emergency situation.

2. What you need to know before you use Metaraminol 0.5mg/mL Solution for Injection

You will be given this medicine in hospital by a doctor or nurse.

Do not use this medicine:

  • If you are allergic to metaraminol tartrate or any of the other ingredients in this medicine (listed in section 6).
  • With cyclopropane or halothane (anaesthetics) unless your doctor sees a clinical need to do so.

Warnings and Precautions

Talk to your doctor, nurse or pharmacist before using Metaraminol 0.5mg/mL Solution for Injection if you have:

  • Liver disease
  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes mellitus
  • A history of malaria

Children

This medicine is not recommended for use in children below the age of 12 years.

Other medicines and Metaraminol 0.5mg/mL Solution for Injection

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important if you are taking:

  • Digitalis medicines (such as digoxin) which may cause an irregular heartbeat.
  • Monoamine oxidase inhibitors which may increase the action of metaraminol.

Pregnancy, breast-feeding and fertility

The effects of this medicine on the unborn baby is unknown. It is not known whether this medicine is present in breast milk. You will only be given this medicine if your doctor sees the clinical need to do so in an emergency situation.

Metaraminol 0.5mg/mL Solution for Injection contains sodium metabisulfite and sodium chloride

This medicine contains

  • Sodium metabisulfite – a preservative which may rarely cause severe hypersensitivity reactions and bronchospasm. It may also cause skin reactions if spilt on the skin.
  • Sodium – there is less than 1mmol sodium (23mg) per 0.5mg/mL, that is to say essentially ‘sodium - free’.

3. How to use Metaraminol 0.5mg/mL Solution for Injection

A nurse or doctor will give you this medicine.

The recommended dose is:

In the case of an emergency, this medicine is given by direct injection into a vein, which may be followed by an infusion into a vein. The dose will be adjusted by your doctor, but the usual dose is between 0.5 – 5mg (1 – 10mL) injected into the vein, followed by an infusion of 15 – 100mg (30 – 200mL of metaraminol 0.5mg/mL solution for injection).

Metaraminol 0.5mg/mL Solution for Injection is already diluted and ready to use. It should be used without prior dilution.

If you are given more Metaraminol 0.5mg/mL Solution for Injection than you should

It is unlikely that you will receive too much because this medicine will be given to you in hospital. You will be carefully monitored by your doctor for symptoms or severely high blood pressure (see symptoms in Section 4 Possible Side Effects).

4. Possible side effects

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

Tell your doctor immediately if you experience:

  • Sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), feeling that you are going to faint (symptoms of a severe hypersensitivity reaction).
  • Pain and/or swelling at the injection site.

The following symptoms may be due to severely high blood pressure. Tell your doctor immediately if you experience:

  • Headaches
  • High blood pressure (hypertension)
  • Slow, or irregular heartbeat
  • Shortness of breath
  • Feeling sick
  • Chest pain
  • Abscesses

Tell your doctor as soon as possible if you experience:

  • Cold extremities
  • Pain in the extremities

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: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metaraminol 0.5mg/mL Solution for Injection

  • 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 and carton.

The expiry date refers to the last day of the month. Before use, the doctor or nurse will check the medicine has not passed this date and that the medicine does not show any sign of deterioration.

  • After the expiry date return any unused medicine to a pharmacy.
  • Do not throw away any medicines via waste water. These measures will help to protect the environment.
  • This medicinal product does not require any special storage condition.

6. Contents of the pack and other information

What Metaraminol 0.5mg/mL Solution for Injection contains

  • The active substance is metaraminol tartrate (0.095%w/v), which is equivalent to 0.05%w/v (0.5mg/mL) metaraminol.
  • The other ingredients are: sodium chloride, sodium metabisulfite (E223) and Water for Injections.

What Metaraminol 0.5mg/mL Solution for Injection looks like and contents of the pack:

This medicine is a clear, colourless solution in a 5 mL or 10 mL glass ampoule. This medicine is packed into cartons containing 10 ampoules.

Marketing Authorisation Holder and Manufacturer:

Torbay and South Devon NHS Foundation Trust
Torbay Pharmaceuticals
Wilkins Drive
Paignton
Devon
TQ4 7FG
UK
Tel: +44 (1803) 664707

Medical enquiries:

[email protected]

This leaflet was last revised in: April 2019

PL 13079/0012