Metaraminol 10mg/ml Solution for Injection or Infusion

• Keep this leaflet. You may need to read it again.
• 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.

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

• if you are allergic to metaraminol tartrate or any of the other ingredients of this medicine (listed in section 6).
• if you are being given certain types of anaesthetics (halothane or cyclopropane), unless your doctor sees a clinical need to do so.
• if you have low blood pressure caused by low blood volume.

Talk to your doctor, nurse or pharmacist before using Metaraminol if you suffer from or have suffered in the past from any of the following conditions:

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

Do not use this medicine in children below the age of 12 years.

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.
• Anaesthetics such as cyclopropane or halothane.
• Oxytocin, a drug used to prevent or control bleeding after delivery of your baby.

Pregnancy

The effects of this medicine on the unborn baby are 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.

This medicine is not expected to affect your ability to drive or use machines.

This medicine contains less than 1 mmol sodium (23mg) per 10mg/ml ampoule, that is to say essentially ‘sodium free’.

The initial dose is 0.5 – 5mg metaraminol, followed by an infusion of 15 – 100mg metaraminol, in a diluent, made up to a total volume of 500ml.

15 – 100mg in 500ml Sodium Chloride Injection or Glucose 5% Injection. Higher concentrations of Metaraminol have been used when appropriate to the circumstances.

In the event you are given too much Metaraminol, you may experience high blood pressure accompanied by a headache, a tight feeling in the chest, nausea, vomiting, euphoria, sweating, fluid in the lungs, increased or decreased heart rate, irregular heartbeat, heart attack, heart failure, or convulsions (fits).

Tell your doctor immediately if you feel unwell. Treatment with this medicine may subsequently be stopped, and if needed, an antidote will be administered by medical staff.

Tell your doctor immediately if you experience:

Very Common

(may affect more than 1 in 10 people):

• Headache
• High blood pressure

Rare (may affect up to 1 in 1,000 people):

• Abscess or peeling skin at the site of injection, or an area where the tissue around the injection site dies

Not known

(Frequency cannot be estimated from available data):

• Fatal changes in heart rhythm in patients suffering from liver cirrhosis
• Changes in heartbeat including slower or faster heart rates or palpitations
• Reduced blood supply to the arms and legs (including hands and feet)
• Feeling sick

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 (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.

The active substance is Metaraminol Tartrate (1.9% w/v), which is equivalent to 1% w/v (10mg/ml) Metaraminol. The other ingredients are: Sodium Chloride, Citric acid monohydrate (pH adjuster), Glacial acetic acid, Sodium acetate trihydrate, Disodium edetate and Water for Injections

This medicine is a clear, colourless solution in a 1ml clear glass ampoule.

This medicine is packed into cartons containing 5 ampoules.