ESMOLOLO 10 mg /Ml Roztwór Do Wstrzykiwań

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1. ESMOLOLO CLORIDRATO HIKMA 10 mg/ml Injectable Solution
   1. What is Esmololo cloridrato Hikma and what it is used for
   2. What you need to know before you take Esmololo Hydrochloride Hikma
   3. How to take Esmololo Hydrochloride Hikma
   4. Possible side effects
   5. How to store Esmololo cloridrato Hikma
   6. Contents of the pack and other information
2. Esmololo hydrochloride Hikma is a 10mg/ml solution ready for use recommended for

ESMOLOLO CLORIDRATO HIKMA 10 mg/ml Injectable Solution

Equivalent Medicinal Product

because it contains important information for you.

• If you have any doubts, ask your doctor or nurse
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of this leaflet

• 1. What Esmololo cloridrato Hikma is and what it is used for
• 2. What you need to know before you are given Esmololo cloridrato Hikma
• 3. How to administer Esmololo cloridrato Hikma
• 4. Possible side effects
• 5. How to store Esmololo cloridrato Hikma
• 6. Contents of the pack and other information

1. What is Esmololo cloridrato Hikma and what it is used for

Esmololo cloridrato Hikma contains a medicine called esmolol. It belongs to a
group of medicines called “beta-blockers”. It works by controlling the speed and force of
your heartbeat. It can also help to reduce blood pressure.
It is used to treat:

• heart problems, when your heart beats too fast
• heart problems and an increase in your blood pressure if this happens during or immediately after surgery

2. What you need to know before you take Esmololo Hydrochloride Hikma

Do not take Esmololo Hydrochloride Hikma if:

• you are allergic to esmolol, to other beta-blocker medicines or to any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include shortness of breath, dyspnea, rash, itching or swelling of the face and lips.
• you have a very slow heartbeat (less than 50 beats per minute)
• you have a fast heartbeat or an irregular, fast-slow heartbeat
• you suffer from a condition called “severe cardiac block”. Cardiac block is a problem that affects the electrical impulses that control your heartbeat
• you have low blood pressure
• you have problems with the blood flow to your heart
• you have symptoms of severe heart failure
• you are taking or have recently taken verapamil. Esmololo should not be given to you within 48 hours of stopping verapamil.
• you have a disease of a gland called pheochromocytoma that has not been treated. Pheochromocytoma originates from the adrenal gland and can cause a sudden increase in blood pressure, severe headache, sweating and increased heartbeat.
• you have increased blood pressure in the lungs (pulmonary hypertension)
• you have asthma symptoms that are rapidly worsening
• you have increased levels of acids in your body (metabolic acidosis)

Esmololo Hydrochloride Hikma will not be given to you if any of the conditions above apply to you. If you are not sure if any of these conditions apply to you, talk to your doctor or nurse before taking Esmololo Hydrochloride Hikma.

Warnings and precautions
Talk to your doctor or nurse before taking Esmololo Hydrochloride Hikma.
Your doctor will pay particular attention 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 medicines for the heart. The use of Esmololo Hydrochloride Hikma in such conditions can lead to serious reactions that can be fatal, including: . loss of consciousness . shock (when your heart does not pump enough blood) . heart attack (cardiac arrest)
• you experience low blood pressure (hypotension). Symptoms may include feeling dizzy or lightheaded, especially when standing up. Low blood pressure usually improves within 30 minutes of stopping treatment with Esmololo Hydrochloride Hikma.
• you have a slow heart rate before treatment
• your heart rate falls to less than 50-55 beats per minute. If this happens your doctor may give you a reduced dose or stop treatment with Esmololo Hydrochloride Hikma.
• you suffer from heart failure
• you have problems with the electrical impulses that control your heartbeat (cardiac block)
• you have a gland condition called pheochromocytoma that has been treated with medicines called alpha-receptor blockers
• you are being treated for high blood pressure (hypertension) that has been caused by low body temperature (hypothermia)
• you have narrowing of the airways or wheezing, as happens with asthma
• you suffer from diabetes or low blood sugar levels. Esmololo Hydrochloride Hikma can increase the effects of diabetes medicines
• you develop skin problems. This may be caused by the solution leaking into the injection site. If this happens your doctor will use a different vein for administration.
• you suffer from a particular type of chest pain (angina) called “Prinzmetal's angina”.
• you have a low blood volume (with low blood pressure). You may more easily develop circulatory collapse.
• you have circulation problems, such as pale fingers (Raynaud's disease) or pain, fatigue and sometimes burning in your legs.
• you have kidney problems. If you have kidney disease or need kidney dialysis you may develop high levels of potassium in your blood (hyperkalemia). This can cause serious heart problems.
• you have any allergies or are at risk of anaphylactic reactions (severe allergic reactions). Esmololo Hydrochloride Hikma can make allergies more severe and difficult to treat.
• you or a family member has a history of psoriasis (where your skin produces scaly patches.
• you have a condition called hyperthyroidism (overactive thyroid gland)

A dosage adjustment is not generally necessary if you have liver problems.
If any of the above conditions apply to you (or you are not sure), talk to your doctor or nurse before you are given this medicine. You may need to be carefully monitored and your treatment may be adjusted.
For athletes: the use of the drug without therapeutic need constitutes doping and may still result in a positive doping test.

Other medicines and Esmololo Hydrochloride Hikma
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines you have bought without a prescription, including herbal medicines and natural products. Your doctor will check that any other medicines you are taking do not alter the mechanism of action of Esmololo Hydrochloride Hikma.
In particular, tell your doctor or nurse if you are taking any of the following medicines:

• medicines that can lower blood pressure or slow down the heartbeat
• medicines used to treat heart rhythm problems or chest pain (angina) such as verapamil or diltiazem. You should not take Esmololo Hydrochloride Hikma within 48 hours of stopping verapamil.
• Nifedipine, used to treat chest pain (angina), high blood pressure and Raynaud's disease.
• Medicines used to treat 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 trimetapan)
• Medicines used as painkillers, such as non-steroidal anti-inflammatory drugs (NSAIDs)
• Floctafenine, a painkiller
• Amisulpride, a medicine used to treat mental problems
• Tricyclic antidepressant medicines (such as imipramine and amitriptyline) or any other medicine for mental disorders
• Barbiturates (such as phenobarbital, used to treat epilepsy) or phenothiazines (such as chlorpromazine, used to treat mental disorders)
• Clozapine used to treat mental disorders
• Epinephrine used to treat allergic reactions
• Medicines used to treat asthma
• Medicines used to treat colds or a stuffy nose, called “nasal decongestants”
• Reserpine used to treat high blood pressure
• Clonidine used to treat high blood pressure and migraine
• Moxonidine used to treat high blood pressure
• Ergotamine derivatives, medicines mainly used to treat Parkinson's disease
• Warfarin used to thin the blood
• Morphine a strong painkiller
• Succinylcholine chloride (also known as succinylcholine or scoline) or mivacurium, used to relax your muscles, usually during an operation. Your doctor will also pay particular attention to using Esmololo Hydrochloride Hikma during operations, when you are taking anesthetics or other treatments.

If you are not sure if the conditions above apply to you, talk to your doctor, nurse or pharmacist before taking Esmololo Hydrochloride Hikma.
Tests that may be carried out while you take Esmololo Hydrochloride Hikma
The use of medicines like Esmololo Hydrochloride Hikma over a long period of time can cause a reduction in the strength of your heartbeat.
Because Esmololo Hydrochloride Hikma is only used for a short period of time, this is unlikely to happen to you. During treatment you will be carefully monitored and treatment with Esmololo Hydrochloride Hikma will be reduced or stopped if the strength of your heartbeat decreases.
The doctor will also check your blood pressure while you are being treated with Esmololo Hydrochloride Hikma.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
You should not be given Esmololo Hydrochloride Hikma if you are pregnant or think you might be pregnant.
Tell your doctor if you are breastfeeding. Esmololo Hydrochloride Hikma can pass into breast milk, so you should not be given Esmololo Hydrochloride Hikma if you are breastfeeding.

Esmololo Hydrochloride Hikma contains sodium
This medicinal product contains less than 1 mmol of sodium (23 mg) per vial, therefore it is essentially “sodium-free”.

3. How to take Esmololo Hydrochloride Hikma

Recommended dosage
Your doctor will decide how much medicine you need and for how long it will be
administered to you. Esmololo Hydrochloride Hikma will not usually be administered for more than
24 hours.

How Esmololo Hydrochloride Hikma is administered
Esmololo Hydrochloride Hikma is ready for use. Esmololo Hydrochloride
Hikma will be administered to you via a slow injection (infusion) through a needle inserted into a vein in your arm.
Esmololo Hydrochloride Hikma must not be mixed with sodium bicarbonate or other medicines.
The treatment involves 2 steps:

• first stage: a high dose is given over one minute. This quickly increases the levels in your blood
• second stage: a lower dose is then administered over four minutes.
• Stage 1 and 2 can then be repeated and adjusted depending on your heart's response. As soon as an improvement is observed, stage 1 (the higher dose) will be stopped and stage 2 (the lower dose) will be reduced as deemed necessary.
• After reaching a stable condition, another medicine for the heart may be administered to you, while your dose of Esmololo Hydrochloride Hikma is gradually reduced. If your heart rate or blood pressure increases during surgery or immediately after the end of it, you will be given higher doses of Esmololo Hydrochloride Hikma for a short period of time.

Use in the elderly
Your doctor will start your treatment with a reduced dose.

Use in children
Children under 18 years of age should not receive Esmololo Hydrochloride Hikma.

If you receive more Esmololo Hydrochloride Hikma than you should
Since Esmololo Hydrochloride Hikma is administered by qualified and trained personnel,
it is unlikely that you will receive too much. In any case, if this happens, the doctor will stop
Esmololo Hydrochloride Hikma and administer substitute treatment if necessary.

If you think you have forgotten a dose of Esmololo Hydrochloride Hikma
Since Esmololo Hydrochloride Hikma is administered by qualified and trained personnel,
it is unlikely that you will forget a dose. In any case, if you think you have forgotten a
dose, talk to your doctor, nurse or pharmacist as soon as possible.

If you stop taking Esmololo Hydrochloride Hikma
Suddenly stopping Esmololo Hydrochloride Hikma can cause symptoms of rapid heartbeat
(tachycardia) and rebound high blood pressure (hypertension). To avoid this, your
doctor must stop your treatment gradually. If you are aware of suffering
from coronary artery disease (this may be associated with a history of angina or
heart attack) your doctor will pay particular attention when stopping treatment
with Esmololo Hydrochloride Hikma.
If you have any doubts about using this medicine, tell your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most side effects disappear within 30 minutes of stopping treatment with Esmololo cloridrato Hikma.
Tell your doctor or nurse immediately if you notice any of the side effects, which can also be serious. It may also be necessary to stop the infusion.
The following side effects have been reported with Esmololo cloridrato Hikma:

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

• Drop in blood pressure. This effect can be quickly corrected by reducing the dose of Esmololo cloridrato Hikma or stopping treatment. Your blood pressure will be measured frequently during treatment.
• Excessive sweating

Common (may affect up to 1 in 10 people)

• Loss of appetite
• Feeling of anxiety or depression
• Dizziness
• Feeling sleepy
• Headache
• Tingling or “pins and needles”
• Difficulty concentrating
• Feeling confused or agitated
• Feeling unwell (nausea and vomiting)
• Feeling weak
• Feeling tired (fatigue)
• Irritation and hardening of the skin at the site where Esmololo cloridrato Hikma was administered

Uncommon (may affect up to 1 in 100 people)

• Abnormal thoughts
• Sudden loss of consciousness
• Feeling of fainting or passing out
• Convulsions (seizures or fits)
• Problems with speech
• Problems with vision
• Slowing of the heartbeat
• Problems with the electrical impulses that control your heartbeat
• Increased pressure in the arteries of the lungs
• Inability of the heart to pump enough blood (heart failure)
• Interruption of the heart rhythm sometimes known as palpitations (ventricular extrasystoles)
• Heart rhythm disturbances (nodal rhythm)
• Chest discomfort caused by poor blood flow through the blood vessels of the heart muscle (angina pectoris)
• Poor circulation in your legs or arms
• Pale or flushed appearance
• Fluid in the lungs
• Shortness of breath or tightness in the chest making it difficult to breathe
• Dyspnea
• Stuffy nose
• Abnormal crackling/noises when breathing
• Changes in the sense of taste
• Indigestion
• Constipation
• Dry mouth
• Pain in the stomach area
• Discoloration of the skin
• Skin redness
• Muscle or tendon pain, including the area around the shoulder blades and ribs
• Problems with passing urine (urinary retention)
• Feeling cold or having a high temperature (fever)
• Pain and swelling (edema) of your veins at the site where Esmololo cloridrato Hikma was administered
• Burning sensation or bruising at the injection site

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

• Severe slowing of the heartbeat (sinus arrest)
• Absence of electrical activity in the heart (asystole)
• Softening of blood vessels with an area of red and warm skin (thrombophlebitis)
• Dead skin caused by leakage of solution around the administration site

Not known (the number of people affected is not known)

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili”. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Esmololo cloridrato Hikma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the package after
EXP.
Do not store above 25°C.
The chemical and physical stability during use has been demonstrated for 24 hours at 2°C – 8°C.
Store the vial in the outer carton to protect from light.

6. Contents of the pack and other information

What Esmololo cloridrato Hikma contains

• the active ingredient is esmolol hydrochloride
• the other ingredients are sodium acetate trihydrate, glacial acetic acid, sodium hydroxide and/or hydrochloric acid for pH adjustment and water for injections.

Each ml of solution contains 10mg of esmolol hydrochloride, equivalent to 8.9mg of esmolol.
Each 10ml vial of solution contains 100mg of esmolol hydrochloride, equivalent to
89mg of esmolol.

Description of the appearance of Esmololo cloridrato Hikma and contents of the pack
Esmololo cloridrato Hikma is a clear, colourless to pale yellow solution, contained in
10 ml transparent glass vials, type I, packaged in cardboard boxes.
Pack size: 10 vials.

Marketing authorisation holder and manufacturer:
Hikma Farmacêutica (Portugal) S.A.
Estrada do Rio da Mò n.8, 8A e 8B
Fervença
2705-906 Terrugem SNT
Portugal

This medicinal product is authorised in the Member States of the EEA with the following
names:
Austria: Esmolol Hikma 10 mg/ml, Injection solution
Germany: Esmolol Hikma 10 mg/ml, Injection solution
Italy: Esmololo cloridrato Hikma
Portugal: Esmolol Hikma
Netherlands: Esmolol HCl Hikma 10 mg/ml, solution for injection
United Kingdom: Esmolol 10 mg/ml, Solution for injection

This leaflet was last revised in
The following information is intended for healthcare professionals only:

• Dosage and method of administration

Esmololo hydrochloride Hikma is a 10mg/ml solution ready for use recommended for

intravenous administration.
The dosage form is used to administer the appropriate loading dose of Esmololo
hydrochloride Hikma or the bolus dose via manual syringe.
The dosage is summarized in the following tables:

Table 1
Volume of Esmololo hydrochloride Hikma 10 mg/ml required for an
INITIAL LOADING DOSE of 500 mcg/kg/minute

Table 2
Volume of Esmololo hydrochloride Hikma 10 mg/ml required to deliver
MAINTENANCE DOSES at an infusion rate between 12.5 and 300 mcg/kg/minute

Perioperative Tachycardia and Hypertension
For perioperative tachycardia and hypertension, the dosage regimen may vary as follows:

For intraoperative treatment– during anesthesia when immediate control is required:

• A bolus injection of 80mg is administered over 15 - 30 seconds followed by an infusion of 150 micrograms/kg/min. Titrate the infusion rate as required up to 300micrograms/kg/min. The infusion volume required for patients of different weights is indicated in table 2.

Upon emergence from anesthesia

• An infusion of 500 micrograms/kg/min is administered for 4 minutes followed by an infusion of 300micrograms/kg/min. The infusion volume required for patients of different weights is indicated in table 2.

For post-operative situations when titration time is available

• A loading dose of 500micrograms/kg/min is administered over 1 minute before each titration step to achieve a rapid onset of action. Use titration steps of 50, 100, 150, 250 and 300 micrograms/kg/min administered over 4 minutes and stop once the desired therapeutic effect is achieved. The infusion volume required for patients of different weights is indicated in table 2.
• IncompatibilitiesIn the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or with sodium bicarbonate solutions.
• Special precautions for disposal and handlingFor single use only. Avoid contact with alkalis. The solution must be visually inspected for the presence of particles in solution and discoloration before administration. Only a clear and colorless or slightly colored solution can be used. Unused medicines or waste products must be disposed of in accordance with local regulations.