Esmolol hydrochloride 10 mg/ml solution for injection

• 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.

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

• You are allergic to esmolol hydrochloride. The signs of an allergic reaction include shortness of breath, wheezing, rash, itching or swelling of your face and lips.
• You have a very slow heart beat (less than 50 beats per minute).
• You have a fast or alternating fast and slow heartbeat.
• You have something called “severe heart block”. Heart block is a problem with the electrical messages that control your heartbeat.
• You have low blood pressure.
• You have a problem with the blood supply to your heart.
• You have serious heart failure symptoms.
• You are receiving or have recently received verapamil. You must not be given Esmolol. hydrochloride 10 mg/ml within 48 hours of when you stop receiving verapamil.
• You have a gland disease called phaeochromocytoma which has not been treated. Phaeochromocytoma arises from the adrenal gland and may cause a sudden increase in blood pressure, severe headache, sweating and increased heartbeat.
• You have increased blood pressure in the lung (pulmonary hypertension).
• You have asthma symptoms that are worsening rapidly.
• You have increased level of acids in your body (a problem called metabolic acidosis).

You will not be given Esmolol hydrochloride 10 mg/ml if any of the above applies to you. If you are not sure if you have any of these conditions, talk to your doctor or nurse before having Esmolol hydrochloride 10 mg/ml.

Talk to your doctor or nurse before being given Esmolol hydrochloride 10 mg/ml. Your doctor will take special care with this medicine if:

• You are being treated for certain heart rhythm disorders called supraventricular arrhythmias and you:
  • Have other heart problems or
  • Are taking other heart medicines
  Use of Esmolol hydrochloride 10 mg/ml in this way can lead to severe reactions which may be fatal including:
  
  • Loss of consciousness
  • Shock (when your heart does not pump enough blood)
  • Heart attack (cardiac arrest)
• You develop low blood pressure (hypotension). The signs of this may be feeling dizzy or light headed, especially when standing up. This is rapidly reversible with dosage reduction or discontinuation. Usually, your blood pressure and ECG will be continously monitored if you are treated with Esmolol hydrochloride 10 mg/ml solution for injection. Low blood pressure usually gets better within 30 minutes of the end of your Esmolol hydrochloride 10mg/ml treatment.
• You have a low heart rate before treatment.
• Your heart rate decreases to less than 50 to 55 beats per minute. If this happens your doctor may give you a lower dose or stop treatment with Esmolol hydrochloride 10 mg/ml
• You have heart failure.
• You have problems with the electrical messages that control your heartbeat (heart block).
• You have a gland disease called phaeochromocytoma which has been treated with medicines. called alpha-receptor blockers.
• You are being treated for high blood pressure (hypertension) which has been caused by low body temperature (hypothermia).
• You have narrowing of your airways or wheezing, such as with asthma.
• You have diabetes or low blood sugar (hypoglycaemia). You require special monitoring because esmolol can mask the symptoms of a low blood sugar. Esmolol hydrochloride 10 mg/ml can increase the effects of your diabetes medicines.
• You develop skin problems. These can be caused by the solution leaking around the site of the injection. If this happens your doctor will use a different vein for your injection.
• You have a particular type of angina (chest pain) called ‘Prinzmetal’s angina’.
• You have low blood volume (with low blood pressure). You could develop circulatory collapse more easily.
• You have circulatory problems, such as paleness of your fingers (Raynaud’s disease) or aching, tired and sometimes burning pains in your legs.
• You have kidney problems. If you have kidney disease or you need kidney dialysis you could develop high blood potassium levels (hyperkalemia). This can cause serious heart problems.
• You have any allergies or are at risk of anaphylactic reactions (severe allergic reactions). Esmolol hydrochloride 10 mg/ml can make allergies more severe and more difficult to treat
• You or any of your family have a history of psoriasis (where your skin produces scaly patches).
• You have a disease called hyperthyroidism (an overactive thyroid gland).

Changing the dose is not usually necessary if you have liver problems.

If any of the above apply to you (or you are not sure), talk to your doctor or nurse before being given this medicine. You may need to be checked carefully and your treatment may be changed.

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, herbal medicines, or natural products.

Your doctor will check that any medicines you are taking will not alter the way that Esmolol hydrochloride 10 mg/ml works.

In particular, tell your doctor or nurse if you are taking any of the following:

• Medicines that can lower the blood pressure or slow the heart rate
• Medicines used to treat heart rhythm problems or chest pain (angina) such as verapamil and diltiazem. You should not receive Esmolol hydrochloride 10 mg/ml within 48 hours of stopping verapamil
• Nifedipine, which is used to treat chest pain (angina), high blood pressure and Raynaud’s disease
• Medicines used to treat both heart rhythm problems (such as quinidine, disopyramide, amiodarone) and heart failure (such as digoxin, digitoxin, digitalis)
• Medicines used to treat diabetes, including insulin and medicines taken by mouth
• Medicines known as ganglion blocking agents (such as trimetaphan)
• Medicines used as pain killers, such as non-steroidal anti-inflammatory drugs known as NSAIDs
• Floctafenine, which is a pain killer
• Amisulpride, a medicine that is used to treat mental problems
• ‘Tricyclic’ antidepressant medicines (such as imipramine and amitriptyline) or any other drugs for mental health problems
• Barbiturates (such as phenobarbital, used to treat epilepsy) or phenothiazines (such as chlorpromazine, used to treat mental disorders)
• Clozapine which is used to treat mental disorders
• Epinephrine, which is used to treat allergic reactions
• Medicines used to treat asthma
• Medicines used to treat colds or a blocked nose, called nasal ‘decongestants’
• Reserpine, which is used to treat high blood pressure
• Clonidine, which is used to treat high blood pressure and migraine
• Moxonidine, which is used to treat high blood pressure
• Ergot derivates, medicines mainly used to treat Parkinson's disease
• Warfarin, which is used to thin your blood
• Morphine, which is a strong pain killer
• Suxamethonium chloride (also known as succinylcholine or scoline) or mivacurium, which is used to relax your muscles, usually during an operation. Your doctor will also take special care when using Esmolol hydrochloride 10 mg/ml solution for injection during operations, when you will be having anaesthetics and other treatments.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before having Esmolol hydrochloride 10 mg/ml.

The use of medicines such as Esmolol hydrochloride 10 mg/ml over a long period of time can cause a reduction in the force of your heartbeat.

Since Esmolol hydrochloride 10 mg/ml is only used for a limited time, this is unlikely to happen to you. During treatment you will be carefully monitored and Esmolol hydrochloride 10 mg/ml treatment will be reduced or stopped if the force of your heartbeat is reduced.

Your doctor will also check your blood pressure while you are being treated with Esmolol hydrochloride 10 mg/ml.

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.

Insufficient data are available about the use of esmolol during pregnancy in humans to prove safety. However, there are no indicators of increased risk of birth defects in humans. Because of the lack of experience the use of Esmolol hydrochloride 10 mg/ml during pregnancy is not recommended.

Tell your doctor if you are breast-feeding. Esmolol hydrochloride 10 mg/ml may pass into breast milk, so you should not be given Esmolol hydrochloride 10 mg/ml if you are breast-feeding. Ask your doctor for advice before taking any medicine.

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

Your doctor will start your treatment with a lower dose.

The safety and efficacy of Esmolol hydrochloride 10 mg/ml have not been established in children and adolescents. Children up to the age of 18 years should not receive Esmolol hydrochloride 10 mg/ml.

As you are being given Esmolol hydrochloride 10 mg/ml by a trained and qualified person, it is unlikely that you will have too much. However, if this happens the doctor will stop Esmolol hydrochloride 10 mg/ml and give you additional treatment, if necessary.

As you are being given Esmolol hydrochloride 10 mg/ml by a trained and qualified person, it is unlikely that you will miss a dose. However, if you think that you have missed a dose, talk to your doctor or nurse as soon as possible.

Suddenly stopping Esmolol hydrochloride 10 mg/ml may cause symptoms of rapid heartbeat (tachycardia) and high blood pressure (hypertension) to return. To avoid this your doctor should stop your treatment gradually. If you are known to have coronary artery disease (this may be associated with a history of angina or heart attack) your doctor will take special care when stopping treatment with Esmolol hydrochloride 10 mg/ml.

Very common (may affect more than 1 in 10 people):

• Fall in blood pressure. This can be rapidly corrected by reducing the dose of Esmolol hydrochloride 10 mg/ml or stopping the treatment. Your blood pressure will be measured often during treatment.
• Excessive sweating

Common (may affect up to 1 in 10 people):

• Loss of appetite
• Feeling anxious or depressed
• Dizziness
• Feeling sleepy
• Headache-
• Tingling or “pins and needles”
• Difficulty concentrating
• Feeling confused or agitated
• Feeling or being sick (nausea and vomiting)
• Feeling weak
• Feeling tired (fatigue)
• Irritation and hardening of your skin where Esmolol hydrochloride 10 mg/ml was injected

Uncommon (may affect up to 1 in 100 people):

• Abnormal thoughts
• Sudden loss of consciousness
• Feeling faint of fainting
• Fits (seizures or convulsions)
• Problems with speech
• Problems with eyesight
• Slow heart rate
• Problems with the electrical messages that control your heartbeat
• Increased pressure in the arteries of the lungs
• Inability of the heart to pump enough blood (heart failure)
• A disruption in the rhythm of the heart sometimes known as palpitations (ventricular extrasystoles)
• A heartbeat disorder (nodal rhythm)
• Chest discomfort caused by poor blood flow through the blood vessels of the heart muscle (angina pectoris)
• Poor circulation in your arms or legs
• Looking pale or flushed
• Fluids on your lungs
• Shortness of breath or tightness of the chest making it difficult to breathe
• Wheezing
• Blocked nose
• Abnormal rattling/crackling sounds when breathing
• Changes in your sense of taste
• Indigestion
• Constipation
• Dry mouth
• Pain in your stomach area
• Discoloured skin
• Reddening of the skin
• Pain in your muscles or tendons, including around the shoulder blades and ribs
• Problems passing urine (urinary retention)
• Chest pain
• Feeling cold or high temperature (fever)
• Pain and swelling (oedema) of your vein where Esmolol hydrochloride 10 mg/ml solution for injection was injected
• Burning feeling at the site of injection

Very rare (may affect up to 1 in 10,000 people):

• Severe reduction in heart rate (sinus arrest)
• No electrical activity in the heart (asystole)
• Tender blood vessels with an area of hot red skin (thrombophlebitis)
• Dead skin caused by the solution leaking around the site of injection

Not known (the number of people affected is unknown):

• Increased levels of potassium in the blood (hyperkalemia)
• Increased levels of acids in your body (metabolic acidosis)
• Increased rate of contraction of the heart (accelerated idioventricular rhythm)
• Spasm of the artery in the heart
• Failure of the normal circulation of the blood (cardiac arrest)
• Psoriasis (where your skin produces scaly patches)
• Swelling of the skin of the face, limbs, tongue or throat (angioedema)
• Hives (urticaria)
• Inflammation of a vein or blistering at the site of infusion

If you get any side effects, talk to your doctor 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 at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is esmolol hydrochloride.
• Each vial of 10 ml solution for injection contains 100 mg esmolol hydrochloride. 1 ml aqueous solution contains 10 mg esmolol hydrochloride.
• The other ingredients are sodium acetate trihydrate, acetic acid 99%, hydrochloric acid (for pH adjustment), water for injections.

Esmolol hydrochloride 10 mg/ml solution for injection is clear and colourless, available in glass vials containing 10 ml solution each.

The vial is of colourless glass (type I) and has a chlorobutyl rubber stopper.

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