PACKAGE LEAFLET: INFORMATION FOR THE USER • you are currently taking or have taken within the last 14 days Pregnancy, breast-feeding and fertility any monoamine oxidase inhibitor medicine used to treat If you are pregnant or breast-feeding, think you may be pregnant depression. or are planning to have a baby, ask your doctor, pharmacist or Ephedrine Hydrochloride 30mg per 1ml Solution for Injection Other medicines and Ephedrine Injection nurse for advice before being given this medicine. Tell your doctor, pharmacist or nurse if you are taking, have Laboratory Testing Ephedrine Hydrochloride recently taken, or might take any other medicines. (Referred to as “Ephedrine Injection” in this leaflet) This medicinal product contains an active ingredient that can Ephedrine Injection must not be used with drugs used to treat induce positive results in anti- doping controls. severe depression, such as phenelzine or moclobemide, or if Read all of this leaflet carefully before you are given this 2. What you need to know before you are given you are within 2 weeks of discontinuing them. These drugs are 3. How Ephedrine Injection is given medicine because it contains important information for Ephedrine Injection known as monoamine oxidase inhibitors (MAOIs). This medicine is an injection and will be given to you by your D04585 you. You should not be given Ephedrine Injection if: doctor. Your doctor will determine the dose you require. • Keep this leaflet. You may need to read it again. Other medicines which may interact with Ephedrine • you are allergic to ephedrine hydrochloride or to any of the Injection are: • If you have any further questions, please ask your doctor, The recommended doses are: other ingredients in this medicine, (listed in section 6). • methylphenidate, used to treat “attention deficit hyperactivity pharmacist or nurse. • you are taking another indirect sympathomimetic agent such • If you get any side effects, talk to your doctor, pharmacist or disorder (ADHD)”; Adults, elderly and children over 12 years: as phenylpropanolamine, phenylephrine, pseudoephedrine • indirect stimulators of the sympathetic nervous system such as nurse. This includes any possible side effects not listed in this (medicines used to relieve blocked nose) or methylphenidate The usual starting dose is 3-7.5mg given slowly into a vein. leaflet. See section 4. phenylpropanolamine or pseudoephedrine (medicines used in (medicine used to treat “attention deficit hyperactivity nasal decongestant), phenylephrine (a medicine used to treat Your dose may be repeated until the maximum amount of disorder (ADHD)”) hypotension); medicine (30mg) is given. What is in this leaflet: • you are taking an alpha sympathomimetic agent (medicines • direct stimulators of alpha receptors of the sympathetic used to treat low blood pressure) nervous system (oral and/or nasal use) that are used to treat Use in children: 1. What Ephedrine Injection is and what it is used for • you are taking or have taken in the last 14 days a non-selective The paediatric dose will be given as a slow injection into the 2. What you need to know before you are given Ephedrine hypotension or nasal congestion, among others; monoamine oxidase inhibitor (medicines used to • anaesthetics that are inhaled, such as halothane; vein of either 0.5-0.75mg per kg of body weight or 17-25mg per Injection treat depression) square metre of body surface area. 3. How Ephedrine Injection is given • medicines used to treat depression; 4. Possible side effects Warnings and precautions • sibutramine, a medicine used as an appetite suppressant; Patients with kidney or liver disease: 5. How to store Ephedrine Injection Talk to your doctor before using Ephedrine Injection if: • linezolid, used to treat infections; There are no dose adjustments recommended for patients with 6. Contents of the pack and other information • you suffer from diabetes • medicines used to treat asthma such as theophylline kidney or liver disease. • you suffer from heart disease or any other heart conditions, • corticosteroids, a type of medicine used to relieve swelling in a 1. What Ephedrine Injection is and what it is used variety of different conditions; If you have any further questions on the use of this medicine, ask including angina; your doctor, pharmacist or nurse. for • you suffer from weakness in a blood vessel wall leading to a •medicines for epilepsy; • doxapram, medicines used to treat breathing problems; If you think you have been given too much Ephedrine Ephedrine belongs to a group of medicines called bulge developing (aneurysm); • you have high blood pressure; • oxytocin, a medicine used during labour; Injection sympathomimetics. Sympathomimetic drugs affect the part of • reserpine and methyldopa and related medicines, used to treat This medicine is given to you by your doctor so it is unlikely you your nervous system that works automatically. • you have a narrowing and/or blockage of blood vessels (occlusive vascular disorders) high blood pressure; will receive too much. Your doctor has information on how to Ephedrine Injection is used to relieve low blood pressure during • you have an overactive thyroid gland (hyperthyroidism); • guanethidine and related medicines, used to treat high blood recognise and treat an overdose. If you are concerned about your spinal or epidural anaesthesia. It raises blood pressure by • you know or suspect that you suffer from glaucoma (increased pressure; treatment, please talk to your doctor. • Ergot alkaloids, a type of medicines used as vasoconstrictors temporarily reducing the blood supply to small blood vessels. pressure in your eyes) or prostatic hypertrophy (enlarged If you have any further questions on the use of this product, ask prostate gland); (narrowing blood vessels) or for their dopaminergic action (increasing the dopamine-related activity in the brain). your doctor or nurse. • you are about to have an operation which requires that you are Continued overleaf given an anaesthetic; THE FOLLOWING INFORMATION IS INTENDED FOR Warnings: Hypokalaemia associated with high doses of beta2 agonists Noradrenergic-serotoninergic antidepressants (minalcipran, HEALTHCARE PROFESSIONALS ONLY Ephedrine should be used with caution in patients who may may result in increased susceptibility to digitalis-induced venlafaxine) be particularly susceptible to their effects, particularly those cardiac arrhythmias. Hypokalaemia may be enhanced by Paroxysmal hypertension with possibility of arrhythmias Ephedrine Hydrochloride 30mg per 1ml with hyperthyroidism. Great care is also needed in patients concomitant administration of aminophylline or other xanthines, (inhibition of adrenaline or noradrenaline entry in Solution for Injection with cardiovascular disease such as ischaemic heart disease, corticosteroids, or by diuretic therapy. sympathetic fibres). arrhythmia or tachycardia, occlusive vascular disorders including Guanethidine and related products Ephedrine Hydrochloride arteriosclerosis, hypertension, or aneurysms. Angina pain may be Interactions: Substantial increase in blood pressure (hyper reactivity linked precipitated in patients with angina pectoris. Indirect sympathomimetic agents (phenylpropanolamine, pseudoephedrine, phenylephrine, methylphenidate) to the reduction in sympathetic tone and/or to the inhibition of Indications: C C Care is also required when Ephedrine is given to patients Risk of vasoconstriction and/or of acute episodes of adrenaline or noradrenaline entry in sympathetic fibres). Reversal of hypotension from spinal or epidural anaesthesia. with diabetes mellitus, closed-angle glaucoma or prostatic Black hypertension. If Black the combination cannot be avoided, use with caution lower hypertrophy. Dose Alpha sympathomimetics (oral and/or nasal route of doses of sympathomimetic agents. Ephedrine should be avoided or used with caution in patients administration) Adults and the elderly Sibutramine undergoing anaesthesia with cyclopropane, halothane, or Risk of vasoconstriction and/or episodes of hypertension. Up to 30 mg in increments of 3 - 7.5 mg. other halogenated anaesthetics, as they may induce ventricular Paroxysmal hypertension with possibility of arrhythmia By slow intravenous administration, after development fibrillation. An increased risk of arrhythmias may also occur Non-selective MAO inhibitors (inhibition of adrenaline or noradrenaline entry in sympathetic of hypotension. if Ephedrine is given to patients receiving cardiac glycosides, Paroxysmal hypertension, hyperthermia possibly fatal. fibres). Children quinidine, or tricyclic antidepressants. Combinations not recommended: Halogenated volatile anaesthetics 0.5-0.75mg per kg of body weight or 17-25mg per square metre Ergot alkaloids (dopaminergic action) Many sympathomimetics interact with monoamine oxidase Risk of perioperative hypertensive crisis and serious ventricular of body surface area. By slow intravenous administration, after inhibitors, and should not be given to patients receiving such Risk of vasoconstriction and/or episodes of hypertension. development of hypotension. arrhythmias. treatment or within 14 days of its termination. It is advisable to Ergot alkaloids (vasoconstrictors) Contra-indications: avoid sympathomimetics when taking selective MAO inhibitors. Risk of vasoconstriction and/or episodes of hypertension. Combinations requiring precautions for use: This medicinal product must never be used in case of Ephedrine increases blood pressure and therefore special care Theophylline hypersensitivity