Ephedrine Hydrochloride 30 mg per 1 ml Solution for Injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

Talk to your doctor before using Ephedrine Injection if:

• you suffer from diabetes
• you suffer from heart disease or any other heart conditions, including angina;
• you suffer from weakness in a blood vessel wall leading to a bulge developing (aneurysm);
• you have high blood pressure;
• you have a narrowing and/or blockage of blood vessels (occlusive vascular disorders)
• you have an overactive thyroid gland (hyperthyroidism);
• you know or suspect that you suffer from glaucoma (increased pressure in your eyes) or prostatic hypertrophy (enlarged prostate gland);
• you are about to have an operation which requires that you are given an anaesthetic;
• you are currently taking or have taken within the last 14 days any monoamine oxidase inhibitor medicine used to treat depression.

Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines.

Ephedrine Injection must not be used with drugs used to treat severe depression, such as phenelzine or moclobemide, or if you are within 2 weeks of discontinuing them. These drugs are known as monoamine oxidase inhibitors (MAOIs).

Other medicines which may interact with Ephedrine Injection are:

• methylphenidate, used to treat “attention deficit hyperactivity disorder (ADHD)”;
• indirect stimulators of the sympathetic nervous system such as phenylpropanolamine or pseudoephedrine (medicines used in nasal decongestant), phenylephrine (a medicine used to treat hypotension);
• direct stimulators of alpha receptors of the sympathetic nervous system (oral and/or nasal use) that are used to treat hypotension or nasal congestion, among others;
• anaesthetics that are inhaled, such as halothane;
• medicines used to treat depression;
• sibutramine, a medicine used as an appetite suppressant;
• linezolid, used to treat infections;
• medicines used to treat asthma such as theophylline
• corticosteroids, a type of medicine used to relieve swelling in a variety of different conditions;
• medicines for epilepsy;
• doxapram, medicines used to treat breathing problems;
• oxytocin, a medicine used during labour;
• reserpine and methyldopa and related medicines, used to treat high blood pressure;
• guanethidine and related medicines, used to treat high blood pressure;
• Ergot alkaloids, a type of medicines used as vasoconstrictors (narrowing blood vessels) or for their dopaminergic action (increasing the dopamine-related activity in the brain).

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

This medicinal product contains an active ingredient that can induce positive results in anti- doping controls.

Adults, elderly and children over 12 years:

The usual starting dose is 3-7.5mg given slowly into a vein.

Your dose may be repeated until the maximum amount of medicine (30mg) is given.

Use in children:

The paediatric dose will be given as a slow injection into the vein of either 0.5-0.75mg per kg of body weight or 17-25mg per square metre of body surface area.

Patients with kidney or liver disease:

There are no dose adjustments recommended for patients with kidney or liver disease.

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

This medicine is given to you by your doctor so it is unlikely you will receive too much. Your doctor has information on how to recognise and treat an overdose. If you are concerned about your treatment, please talk to your doctor.

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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

The active ingredient is Ephedrine Hydrochloride 3%w/v, equivalent to 30mg ephedrine hydrochloride in 1ml solution ampoule.

The other ingredient is water for injections.

Ephedrine Injection is a clear, colourless solution for injection supplied to your doctor or pharmacist in a pack of 10 clear glass ampoules, each containing 1ml of medicine.

Product Licence No.: PL 01883/6131