ESMOLOL HYDROCHLORIDE 2500 mg powder for concentrate for solution for infusion

• 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What ESMOLOL HYDROCHLORIDE 2500 mg powder is and what it is used for
2. What you need to know before you use ESMOLOL HYDROCHLORIDE 2500 mg powder
3. How to use ESMOLOL HYDROCHLORIDE 2500 mg powder
4. Possible side effects
5. How to store ESMOLOL HYDROCHLORIDE 2500 mg powder
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 are receiving or have recently received verapamil. You must not be given ESMOLOL HYDROCHLORIDE 2500 mg powder within 48 hours of when you stop receiving verapamil
• You have serious heart failure symptoms
• 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).

ESMOLOL HYDROCHLORIDE 2500 mg powder MUST BE RECONSTITUTED/DILUTED BY YOUR DOCTOR OR NURSE

Talk to your doctor or nurse before being given ESMOLOL HYDROCHLORIDE 2500 mg powder. 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 2500 mg powder 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 continuously monitored if you are treated with ESMOLOL HYDROCHLORIDE 2500 mg powder. Low blood pressure usually gets better within 30 minutes of the end of your ESMOLOL HYDROCHLORIDE 2500 mg powder 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 2500 mg powder
• 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 HYDROCHLORIDE 2500 mg powder can mask the symptoms of a low blood sugar. ESMOLOL HYDROCHLORIDE 2500 mg powder 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 2500 mg powder 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 2500 mg powder 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 2500 mg powder 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 2500 mg powder 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 nurse before having ESMOLOL HYDROCHLORIDE 2500 mg powder.

The use of medicines such as ESMOLOL HYDROCHLORIDE 2500 mg powder over a long period of time can cause a reduction in the force of your heartbeat.

Since ESMOLOL HYDROCHLORIDE is only used for a limited time, this is unlikely to happen to you. During treatment you will be carefully monitored and ESMOLOL HYDROCHLORIDE 2500 mg powder 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 2500 mg powder.

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 HYDROCHLORIDE 2500 mg powder 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 2500 mg powder during pregnancy is not recommended.

Tell your doctor if you are breast-feeding. ESMOLOL HYDROCHLORIDE 2500 mg powder may pass into breast milk, so you should not be given ESMOLOL HYDROCHLORIDE 2500 mg powder if you are breast-feeding.

Ask your doctor or nurse for advice before taking any medicine.

Your doctor will start your treatment with a lower dose.

The safety and efficacy of ESMOLOL HYDROCHLORIDE 2500 mg powder have not been established in children and adolescents. Children up to the age of 18 years should not receive ESMOLOL HYDROCHLORIDE 2500 mg powder.

As you are being given ESMOLOL HYDROCHLORIDE 2500 mg powder 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 2500 mg powder and give you additional treatment, if necessary.

As you are being given ESMOLOL HYDROCHLORIDE 2500 mg powder 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 2500 mg powder 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 2500 mg powder.

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.

One 50 ml vial contains 2500 mg esmolol hydrochloride. The product contains no other ingredients.

Each ml of reconstituted concentrate for solution for infusion contains 50 mg esmolol hydrochloride (50 mg/ml).

Each ml of the diluted solution for infusion contains 10 mg esmolol hydrochloride (10 mg/ml).

One vial contains 2500 mg white to almost white powder.

The vial consists of colourless glass (type I).

One pack ESMOLOL HYDROCHLORIDE 2500 mg powder for solution for infusion contains 1 vial.

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