PACKAGE LEAFLET: INFORMATION FOR THE USER ADRENALINE (HCl) STEROP 0,4mg/1ml ADRENALINE (HCl) STEROP 0,8mg/1ml Solution for injection Adrenaline (Levorenine, Epinephrine) 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, pharmacist 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What ADRENALINE (HCl) STEROP is and what it is used for 2. What you need to know before you use ADRENALINE (HCl) STEROP 3. How to use ADRENALINE (HCl) STEROP 4. Possible side effects 5. How to store ADRENALINE (HCl) STEROP 6. Contents of the pack and other information 1. WHAT ADRENALINE (HCl) STEROP IS AND WHAT IT IS USED FOR This medicine contains epinephrine (adrenaline), an alpha and beta sympathomimetic agent. This medicine is used to treat hypotension. Epinephrine (Adrenaline) for injection is indicated: - in case of extreme emergency following cardiac arrest in order to restart the heart. - in the treatment of severe allergic reactions caused by insect stings or bites, medicines, food or other substances. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ADRENALINE (HCl) STEROP Do not use ADRENALINE (HCl) STEROP - If you are or you think you are allergic to epinephrine or any of the other ingredients of this medicine (listed in section 6). In any other emergency situation, the doctor must consider the potential beneficial effect/potential risk ratio when chosing the medicine to administer or prescribe. - If you are pregnant, except if the doctor prescribes this medicine for you. He will explain to you the risks and benefits of using epinephrine during pregnancy. - If you are giving birth: epinephrine can stop the contractions of the uterus during labour. - If you are breast-feeding: epinephrine is excreted in breast milk. - If the solution is pink or brown coloured or if it contains a precipitate. Page 1 of 5
Warnings and precautions Epinephrine must be used with extreme caution in case of: - If you are allergic to any of the ingredients of the medicine, especially sodium metabisulphite. - Cardiac or blood vessel disorders, - Angina pectoris or chest pain, - High blood pressure, - Rapid heartbeat, myocardial infarction, - Too high pressure in the eyes (glaucoma), - Diabetes, - Stroke, - Hyperactive thyroid, - Pulmonary diseases, - Chronic asthma, - Psychoneurotic disorders, - It is recommended to avoid any extravasation (= passage of the medicine outside of the vessels) during intravenous administration, since it could lead to the destruction of the surrounding tissue. Always tell your doctor if you have allergies to other medicines, to food, to preservatives or dyes. If you are already using other medicines, please also read the following section Other medicines and ADRENALINE (HCl) STEROP. Other medicines and ADRENALINE (HCl) STEROP Tell your doctor if you are using, have recently used or might use any other medicines. Some medicines can be affected by epinephrine or can affect its action: - Certain medicines to treat chills and cough, - Certain medicines treating high blood sugar, - General anaesthetics, - Medicines to treat depression such as monoamine oxidase inhibitor (MAOI), - Medicines that affect potassium levels such as diuretics and theophylline, - Medicines used to treat a too high tension and cardiac disorders (alpha and beta blockers), You may then need another dosage of your medicine or use another medicine. Your doctor and your pharmacist have more information about medicines for which the combination can be used with caution or cannot be used. Incompatibilities Since epinephrine is quickly destroyed in an alkaline medium or in the presence of oxidative agents, any mixture with other medicines for injection, and particularly with alkaline solutions (for example, bicarbonate solutions), is to be avoided. Epinephrine is compatible with 0.9% sodium chloride solutions (isotonic), but is incompatible with solutions at higher concentrations. ADRENALINE (HCl) STEROP with food, drink and alcohol Food and drinks have no influence on the use of ADRENALINE (HCl) STEROP. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Page 2 of 5
In case of use during pregnancy, epinephrine can lead to an insufficient concentration of oxygen for the foetus. Epinephrine is to be used during pregnancy only if, in the practitioner s opinion, the expected benefit justifies the possible risks for the foetus. Epinephrine is excreted in breast milk. Its use in women who are breast-feeding can lead to serious adverse reactions in the infant. In case of treatment with epinephrine, breast-feeding could be suspended. Your doctor can discuss with you the risks and benefits of use during breast-feeding. Driving and using machines No contraindication is known at this time. ADRENALINE (HCl) STEROP contains sodium metabisulphite, which can cause, in rare cases, hypersensitivity reactions (allergy) or a bronchospasm (difficulty in breathing). This medicinal product contains less than 1 mmol sodium (23mg) per ml, i.e. essentially sodiumfree. 3. HOW TO USE ADRENALINE (HCl) STEROP In terms of treatment of shock due to heightened sensitivity to a foreign substance or in intensive care, the administration of ADRENALINE (HCl) STEROP is not to be used alone but as a part of a highly specific treatment protocol. The administration of epinephrine is normally performed by a doctor or a trained nurse. If you must inject epinephrine, carefully follow your doctor s instructions. He will tell you which dose to use. This dose may differ from the information in this leaflet. The injection is to be administered just under the skin but can also be administered in the muscle or directly in a vein. Children receive a lower dose depending on their weight. For patients using epinephrine as emergency treatment for an allergic reaction: - If you have an allergic reaction as your doctor described it to you, use ADRENALINE (HCl) STEROP immediately. - Keep the medicine ready for use at all times. ADRENALINE (HCl) STEROP is solely intended for injection. If you administer the injections to yourself or to another person, be sure you know the correct technique. In case of doubt, ask your doctor or pharmacist for advice. If you must use ADRENALINE (HCl) STEROP as emergency treatment, talk to your doctor immediately or go immediately to the nearest hospital emergency room. You may need hospital assistance. If you use more ADRENALINE (HCl) STEROP than you should The doctor or nurse who administers ADRENALINE (HCl) STEROP to you will be experienced in the use of this product; it is therefore extremely rare that you would receive it too much. If you must inject ADRENALINE (HCl) STEROP, be sure to administer it exactly as your doctor has indicated to you. This will make an overdose unlikely. Page 3 of 5
If you think that you have administered too much ADRENALINE (HCl) STEROP, immediately contact your doctor, your pharmacist or the Anti-poison Centre (070/245.245). Call your doctor even if no sign of discomfort or poisoning appears. You may need emergency medical help. Symptoms Symptoms of overdose can be the following: discomfort, redness or pallor, chills, difficulty breathing, abnormal heartbeats and headache. Treatment Since epinephrine is quickly eliminated by the body, the treatment of an acute overdose should be mainly symptomatic. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. Do not be alarmed by the list of side effects provided herebelow. You may experience none of them. Epinephrine can cause the following adverse effects (which appear in an unknown number of users): - Acceleration of the pulse, arrhythmias, palpitations, angina pectoris, slowing down of the heart even in small doses. - High blood pressure, blood vessels constriction, local stop of the blood circulation, coldness of the extremities. - Trachea spasm, difficulty breathing, respiratory arrest. - Headache, dizziness, tremors (increase in patients with Parkinson s disease), syncope, numbness, restlessness, insomnia, irritability. - Muscular weakness, abundant sweating, general weakness, paleness. - High blood sugar levels, too low potassium level, high metabolic acid level. - Nausea, vomiting. - Anxiety, delirium, psychomotor agitation, confusion, memory disorders, aggressiveness, panic, tendency to suicide or to homicide, mental illnesses (psychose) and paranoia (induction or worsening in certain patients). Immediately tell your doctor or go to the closest hospital emergency room if you notice one of the following side effects: - difficulty breathing - palleness, abundant sweating, pain or loss of sensation at the injection site - seizures - abnormal heart beats or palpitations ADRENALINE (HCl) STEROP contains sodium metabisulphite, which can cause, in rare cases, severe allergic reactions or difficulty breathing. 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 Page 4 of 5
Federal Agency for Medicines and Health Products - Vigilance division - EUROSTATION II - place Victor Horta, 40/ 40 - B-1060 Brussels. Site internet: www.afmps.be e-mail: patientinfo@fagg-afmps.be By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE ADRENALINE (HCl) STEROP Keep out of the sight and reach of children. Store in the refrigerator (between 2 C and 8 C) protected from light. Store the solution at a temperature not exceeding 25 C for a period not exceeding 6 months. Do not store the solution in the freezer. Do not use the solution if it is pink or brownish, if it is not clear or if it contains a precipitate. Do not use this medicine after the expiry date which is stated on the labelling after EXP (month/year). The expiry date refers to the last day of that month. 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 ADRENALINE (HCl) STEROP contains The active substance is epinephrine in the form of epinephrine hydrochloride: ADRENALINE (HCl) STEROP 0,4mg/1ml: 0,4mg epinephrine basis equivalent to 0,5mg epinephrine hydrochloride. ADRENALINE (HCl) STEROP 0,8mg/1ml: 0,8mg epinephrine basis equivalent to 1mg epinephrine hydrochloride. The other ingredients are sodium chloride, sodium metabisulphite (E223), hydrochloric acid, water for injections. What ADRENALINE (HCl) STEROP looks like and contents of the pack Solutions for injection by subcutaneous, intramuscular and intravenous route. 1ml glass ampoules, packed by 1, 5 ampoules (public) and 10, 50, 100 ampoules (hospital use). Dispensing: On medical prescription. Registration numbers ADRENALINE (HCl) STEROP 0,4mg/1ml: BE325717 ADRENALINE (HCl) STEROP 0,8mg/1ml: BE325726 Marketing Authorisation Holder and Manufacturer Laboratoires STEROP S.A., Avenue de Scheut 46-50, 1070 Brussels This leaflet was last approved in 05/2015 Page 5 of 5