Esmolol Hydrochloride 10 Mg/Ml Solution for Injection Esmolol Hydrochloride
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Package leaflet: Information for the patient Esmolol hydrochloride 10 mg/ml solution for injection Esmolol hydrochloride 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 or nurse. – This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. – If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Esmolol hydrochloride 10 mg/ml solution for injection is and what it is used for 2. What you need to know before you use Esmolol hydrochloride 10 mg/ml solution for injection 3. How to use Esmolol hydrochloride 10 mg/ml solution for injection 4. Possible side effects 5. How to store Esmolol hydrochloride 10 mg/ml solution for injection 6. Contents of the pack and other information 1. What Esmolol hydrochloride 10 mg/ml chlor promazine, used to treat mental dis - solution for injection is and what it is orders) used for – Clozapine which is used to treat mental Esmolol hydrochloride 10 mg/ml belongs to the disorders group of beta-blockers. These medicines slow – Epinephrine, which is used to treat allergic down the heartbeat and reduce blood pressure. reactions – Medicines used to treat asthma Esmolol hydrochloride 10 mg/ml is used for – Medicines used to treat colds or a blocked short-term treatment if your heart beats too nose, called nasal “decongestants” fast. – Reserpine, which is used to treat high blood Esmolol hydrochloride 10 mg/ml is also used pressure during or straight after surgery if your blood – Clonidine, which is used to treat high blood pressure gets too high and/or your heart beats pressure and migraine too fast. – Moxonidine, which is used to treat high blood pressure 2. What you need to know before you use – Ergot derivates, medicines mainly used to Esmolol hydrochloride 10 mg/ml treat Parkinson’s disease solution for injection – Warfarin, which is used to thin your blood Your doctor will not give you – Morphine, which is a strong pain killer Esmolol hydrochloride 10 mg/ml solution – Suxamethonium chloride (also known as for injection if: succinyl choline or scoline) or mivacurium, – You are allergic to esmolol hydrochloride. The which is used to relax your muscles, usually signs of an allergic reaction include shortness during an operation. Your doctor will also take of breath, wheezing, rash, itching or swelling special care when using Esmolol hydrochloride of your face and lips. 10 mg/ml solution for injection during – You have a very slow heart beat (less than operations, when you will be having 50 beats per minute). anaesthetics and other treatments. – You have a fast or alternating fast and slow If you are not sure if any of the above applies to heart beat. you, talk to your doctor or pharmacist before – You have something called “severe heart having Esmolol hydrochloride 10 mg/ml. block”. Heart block is a problem with the electrical messages that control your heart- Tests you may have while beat. Esmolol hydrochloride 10 mg/ml solution – You have low blood pressure. for injection is used – You have a problem with the blood supply to The use of medicines such as Esmolol hydro- your heart. chloride 10 mg/ml over a long period of time can – You have serious heart failure symptoms. cause a reduction in the force of your heartbeat. – You are receiving or have recently received Since Esmolol hydrochloride 10 mg/ml is only verapamil. You must not be given Esmolol used for a limited time, this is unlikely to happen hydrochloride 10 mg/ml within 48 hours of to you. During treatment you will be carefully when you stop receiving verapamil. monitored and Esmolol hydrochloride 10 mg/ml – You have a gland disease called phaeo- treatment will be reduced or stopped if the force chromocytoma which has not been treated. of your heartbeat is reduced. Phaeo chromocytoma arises from the adrenal Your doctor will also check your blood pressure gland and may cause a sudden increase in while you are being treated with Esmolol hydro- blood pressure, severe headache, sweating chloride 10 mg/ml. and increased heart beat. Pregnancy and breast-feeding – You have increased blood pressure in the lung If you are pregnant or breast-feeding, think you (pulmonary hypertension). may be pregnant or are planning to have a baby, – You have asthma symptoms that are ask your doctor for advice before taking this worsening rapidly. medicine. – You have increased level of acids in your body Insufficient data are available about the use of (a problem called metabolic acidosis). esmolol during pregnancy in humans to prove You will not be given Esmolol hydrochloride safety. However, there are no indicators of 10 mg/ml if any of the above applies to you. increased risk of birth defects in humans. If you are not sure if you have any of these Because of the lack of experience the use + conditions, talk to your doctor or nurse before of Esmolol hydrochloride 10 mg/ml during # having Esmolol hydrochloride 10 mg/ml. pregnancy is not recommended. + Warning and Precautions Tell your doctor if you are breast-feeding. Talk to your doctor or nurse before being given Esmolol hydrochloride 10 mg/ml may pass into ##### Esmolol hydrochloride 10 mg/ml. Your doctor will breast milk, so you should not be given Esmolol ++ take special care with this medicine if: hydrochloride 10 mg/ml if you are breast- – You are being treated for certain heart feeding. rhythm disorders called supraventricular Ask your doctor for advice before taking any arrhythmias and you: medicine. – Have other heart problems or Esmolol hydrochloride 10 mg/ml solution – Are taking other heart medicines. for injection contains sodium Use of Esmolol hydrochloride 10 mg/ml in this This medicine contains less than 1 mmol sodium way can lead to severe reactions which may (23 mg) per vial, that is to say essentially be fatal including: “sodium-free”. – Loss of consciousness – Shock (when your heart does not pump 3. How to use Esmolol hydrochloride enough blood) 10 mg/ml solution for injection – Heart attack (cardiac arrest) The dosage must be individually adapted. – You develop low blood pressure (hypotension). A starting dosage followed by a maintenance The signs of this may be feeling dizzy or light dosage should be administered. Your doctor will headed, especially when standing up. This is determine the dosage scheme and adapt the rapidly reversible with dosage reduction or dosage as needed based on the side effects. discontinuation. Usually, your blood pressure and ECG will be continously monitored if you Esmolol hydrochloride 10 mg/ml is administered are treated with Esmolol hydrochloride as an injection. It is administered into a vein by 10 mg/ml solution for injection. Low blood a doctor or a nurse. pressure usually gets better within The duration of use depends on the effect and 30 minutes of the end of your Esmolol possibly occurring side effects. Your doctor will hydrochloride 10 mg/ml treatment. determine the duration of treatment. – You have a low heart rate before treatment. – Your heart rate decreases to less than 50 to Changing the dose of Esmolol hydrochloride 55 beats per minute. If this happens your 10 mg/ml is not usually necessary if you: doctor may give you a lower dose or stop – Have liver problems. treatment with Esmolol hydrochloride 10 mg/ml. If you have kidney problems then your doctor – You have heart failure. will take appropriate caution. – You have problems with the electrical The Elderly messages that control your heartbeat (heart Your doctor will start your treatment with a lower block). dose. – You have a gland disease called phaeo- chromocytoma which has been treated with Use in children and adolescents medicines called alpha-receptor blockers. The safety and efficacy of Esmolol hydrochloride – You are being treated for high blood pressure 10 mg/ml have not been established in children (hypertension) which has been caused by low and adolescents. Children up to the age of body temperature (hypothermia). 18 years should not receive Esmolol hydrochloride ++ – You have narrowing of your airways or 10 mg/ml. ##### wheezing, such as with asthma. If you have received more – You have diabetes or low blood sugar (hypo- Esmolol hydrochloride 10 mg/ml solution glycaemia). You require special monitoring for injection than you should + because esmolol can mask the symptoms of As you are being given Esmolol hydrochloride # + a low blood sugar. Esmolol hydrochloride 10 mg/ml by a trained and qualified person, it is 10 mg/ml can increase the effects of your unlikely that you will have too much. However, if diabetes medicines. this happens the doctor will stop Esmolol – You develop skin problems. These can be hydrochloride 10 mg/ml and give you additional caused by the solution leaking around the site treatment, if necessary. of the injection. If this happens your doctor will use a different vein for your injection. If you think that a dose of – You have a particular type of angina (chest Esmolol hydrochloride 10 mg/ml solution pain) called “Prinzmetal’s angina”. for injection has been forgotten – You have low blood volume (with low blood As you are being given Esmolol hydrochloride pressure). You could develop circulatory 10 mg/ml by a trained and qualified person, it is collapse more easily. unlikely that you will miss a dose. However, if you – You have circulatory problems, such as pale- think that you have missed a dose, talk to your ness of your fingers (Raynaud’s disease) or doctor or nurse as soon as possible.