Atenolol Sanofi 25

Package Leaflet: Information for the Patient

ATENOLOL SANOFI 25,25 mg, tablets
ATENOLOL SANOFI 50,50 mg, tablets
(Atenololum)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Atenolol Sanofi and what is it used for
• 2. Important information before taking Atenolol Sanofi
• 3. How to take Atenolol Sanofi
• 4. Possible side effects
• 5. How to store Atenolol Sanofi
• 6. Contents of the pack and other information

1. What is Atenolol Sanofi and what is it used for

Atenolol Sanofi is available in tablet form and contains the active substance atenolol.
Atenolol is a beta-adrenergic receptor blocker that acts on the heart. The drug protects
the heart during physical exertion or stress, slows down the heart rate, reduces contractility and
the heart muscle's need for oxygen, which leads to a decrease in blood pressure.
In the treatment of high blood pressure, the full therapeutic effect is achieved after

• 1-2 weeks of treatment. The use of atenolol in angina pectoris reduces the frequency and severity of angina attacks, increases exercise tolerance, and slows down the accelerated heart rate. Early administration of atenolol in acute myocardial infarction (initially intravenously, then orally) reduces the area of myocardial necrosis, the intensity of pain, and the frequency of rhythm disturbances.

Atenolol Sanofi is used to treat:

• high blood pressure,
• angina pectoris,
• arrhythmias with rapid heart rate,
• myocardial infarction (early intervention in the acute phase of infarction).

2. Important information before taking Atenolol Sanofi

When not to take Atenolol Sanofi:

• in the case of cardiogenic shock;

Warnings and precautions

Before starting treatment with Atenolol Sanofi, discuss it with your doctor or
pharmacist.

• Do not stop taking the medicine on your own. This can cause a sudden increase in blood pressure, worsening of angina symptoms, and/or arrhythmias. The decision to increase the dose or stop the medicine is made only by the doctor.
• In the case of patients scheduled for surgery, the decision to discontinue beta-blocker therapy should be made at least 24 hours before surgery. The assessment of risk and benefit should be made individually for each patient. If treatment with atenolol is continued, anesthetic drugs with minimal negative inotropic effect should be used to reduce the risk of cardiodepressive effect. The administration of intravenous atropine reduces the risk of vagal reaction.
• Although the administration of atenolol is contraindicated in uncontrolled heart failure, the drug may be used with caution in patients whose heart failure is controlled. Particular caution should be exercised in patients with limited cardiac reserve.
• Atenolol may increase the frequency and duration of angina attacks in patients with Prinzmetal's angina due to the lack of alpha-receptor-mediated coronary vasoconstriction. Atenolol is a beta-selective beta-blocker and should therefore be used with caution.
• Atenolol is contraindicated in patients with severe peripheral arterial circulatory disorders (see section "When not to take Atenolol Sanofi"). Particular caution should be exercised in patients with less advanced peripheral arterial circulatory failure.
• Great caution should be exercised in patients with first-degree atrioventricular block.
• Diabetes: atenolol may enhance the effect of glucose-lowering drugs and mask the symptoms of hypoglycemia (e.g., increased heart rate). Regular glucose monitoring is recommended, especially in labile diabetes.
• Atenolol may mask the symptoms of hyperthyroidism.
• Atenolol may exacerbate psoriasis.
• In rare cases, due to the pharmacological effect, there is a slowing of the heart rate (resting heart rate to 50-55 beats per minute), in which case the dose should be reduced.
• Atenolol may increase sensitivity to allergens and exacerbate anaphylactic reactions in patients who have had such reactions in the past. These patients may not respond to the usual dose of adrenaline.
• Cautious use is recommended in patients with renal impairment, and dosage adjustment is recommended for these patients based on creatinine clearance.
• Cautious use is recommended in elderly patients. Treatment should be started with the lowest dose.
• The drug should not be used in patients with reversible airway obstruction unless absolutely necessary. In such cases, caution should be exercised.
• In patients with bronchial asthma, increased airway resistance may occur, and symptoms may subside after the use of bronchodilators such as salbutamol or isoprenaline.
• In patients with pheochromocytoma, an alpha-adrenergic blocker should be used before atenolol.

Atenolol Sanofi with food and drink

The drug can be taken regardless of meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
The drug passes into breast milk. Before taking the drug, consult your doctor.

Driving and using machines

Atenolol does not affect the ability to drive vehicles or operate machinery in motion: However, it should be taken into account that very rarely during treatment, especially in the initial period, dizziness and fatigue may occur.

Atenolol Sanofi and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription.
Some medicines may interact with each other. It is especially important for your doctor to be informed if you are taking the following medicines:
increased risk of significant blood pressure lowering, slowing of heart rate, and heart failure may occur when:

• beta-blockers are used concomitantly with calcium channel blockers such as verapamil, diltiazem, or other antiarrhythmic drugs, especially in patients with impaired ventricular function and/or atrioventricular conduction disorders. This may cause severe hypotension, bradycardia, or heart failure.

Intravenous administration of calcium channel blockers during beta-blocker therapy and within 48 hours after their discontinuation is contraindicated;

• concomitant use with dihydropyridine derivatives, such as nifedipine, may cause increased risk of hypotension and heart failure in patients with latent heart failure;
• digitalis glycosides in combination with beta-blockers may prolong atrioventricular conduction time;
• beta-blockers may enhance the rebound effect when clonidine is discontinued; if clonidine and beta-blockers are used concomitantly, beta-blocker therapy should be discontinued several days before clonidine is discontinued. If clonidine therapy is to be replaced by beta-blocker therapy, beta-blocker administration should be started several days after clonidine administration has been discontinued.

Cautious use is recommended when:

• concomitantly using antiarrhythmic drugs of class I: disopyramide and quinidine;
• concomitantly using sympathomimetic drugs: e.g., adrenaline, which may reduce the effect of beta-blockers;
• concomitantly using insulin and oral hypoglycemic agents, which may lead to significant hypoglycemia. Symptoms of hypoglycemia, especially tachycardia, may be masked;
• concomitantly using prostaglandin synthesis inhibitors: e.g., ibuprofen and indomethacin, which may increase the antihypertensive effect of beta-blockers;
• concomitantly using anesthetics;
• concomitantly using calcium channel blockers (diltiazem), as this may lead to increased risk of depression;
• concomitantly using drugs for heart diseases, such as amiodarone, digoxin, diltiazem, verapamil, flecainide, and ivabradine.

3. How to take Atenolol Sanofi

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The dose should be determined individually, depending on the patient's clinical condition and blood pressure and heart rate values; treatment starts with the lowest initial dose.
Hypertension:
The initial dose of the drug is 50 mg per day, then the doctor may increase the dose
to 100 mg per day, given in one daily dose or in divided doses.
Therapeutic effect is achieved after 1 to 2 weeks of treatment. Additional
blood pressure lowering can be achieved by using atenolol with other blood pressure-lowering drugs, such as diuretics.
Angina pectoris:
Atenolol is used in a dose of 50 to 100 mg per day, in one daily dose or in divided doses.
In patients with coronary artery disease, atenolol should not be abruptly discontinued, as this may cause worsening of angina symptoms, and even the occurrence of a new myocardial infarction.
Arrhythmias with rapid heart rate:
The initial dose of atenolol is 2.5 mg administered intravenously over 2.5 minutes (i.e., 1 mg/1 minute). The dose of 2.5 mg may be repeated at 5-minute intervals until the desired therapeutic effect is achieved, up to a maximum dose of 10 mg. In intravenous infusion, atenolol is used in a dose of 0.15 mg/kg body weight over 20 minutes. If necessary, intravenous injections or infusions can be repeated every 12 hours. After achieving control of arrhythmias with intravenous atenolol, oral treatment should be continued with a dose of 50 mg to 100 mg once daily.
Myocardial infarction:
Patients requiring intravenous beta-blocker therapy are given atenolol in a dose of 5 mg to 10 mg in slow intravenous injection (1 mg/1 minute) within 12 hours of the onset of chest pain. After intravenous administration and in the absence of adverse effects, treatment is continued with oral atenolol in a dose of 50 mg 15 minutes after intravenous administration, and then 50 mg and 100 mg per day after the next 12 hours.
If adverse effects occur - bradycardia and/or hypotension or other - atenolol treatment should be discontinued.
Dosing in renal impairment:
In patients with renal impairment, the dose of atenolol should be reduced.
No accumulation of atenolol has been observed in patients with creatinine clearance greater than 35 ml/min/1.73 m (normal value is 100-150 ml/min/1.73 m). In patients with creatinine clearance 15-35 ml/min/1.73 m (corresponding to serum creatinine 300-600 micromol/liter), the oral dose should be 50 mg per day, and the intravenous dose should be 10 mg every 2 days.
In patients with creatinine clearance less than 15 ml/min/1.73 m (corresponding to serum creatinine above 600 micromol/liter), the oral dose should be 25 mg per day or 50 mg every other day.
Dialysis patients should receive a dose of 50 mg orally after each dialysis; treatment should be performed in a hospital setting due to the possibility of significant hypotension.
Elderly patients:
Dose reduction may be necessary, especially in the presence of renal impairment.
Children:
Due to the lack of experience with atenolol in children, the use of the medicinal product is not recommended in this age group.
If you feel that the effect of Atenolol Sanofi is too strong or too weak, consult your doctor.

Taking a higher dose of Atenolol Sanofi than recommended

As a result of atenolol overdose, the following symptoms may occur: bradycardia, hypotension, acute heart failure, bronchospasm.
The patient should be hospitalized and closely monitored. Symptomatic treatment should be applied.
After acute poisoning, in order to prevent absorption of the drug from the gastrointestinal tract, gastric lavage should be performed, activated charcoal should be administered, and laxatives should be given.
Transfusion of plasma may be used to treat hypotension or shock.
The use of hemodialysis and hemoperfusion should be considered.
Severe bradycardia should be treated with atropine 1-2 mg intravenously and/or a pacemaker. If necessary, treatment should be continued with intravenous administration of 10 mg of glucagon. Depending on the response, glucagon may be administered at a dose of 1-10 mg per hour. Instead of glucagon, dobutamine can be administered.
Bronchospasm usually subsides after the use of bronchodilators.
If you have taken more than the recommended dose of the medicine, seek medical attention immediately.

Missing a dose of Atenolol Sanofi

If you miss a dose, take it as soon as possible.
If it is almost time for your next dose, do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The drug is generally well tolerated.
Some patients may experience the following side effects. If you experience any of the following symptoms, consult your doctor immediately:
Common side effects(occurring in at least 1 in 100 patients and less than 1 in 10)

• bradycardia,
• worsening of heart failure,
• exacerbation of atrioventricular block,
• cold extremities,
• gastrointestinal disorders,
• fatigue.

Uncommon side effects(occurring in at least 1 in 1000 patients and less than 1 in 100)

• sleep disorders,
• increased activity of liver enzymes.

Rare side effects(occurring in at least 1 in 10,000 patients and less than 1 in 1000)

• purpura,
• thrombocytopenia,
• mood changes,
• nightmares,
• confusion,
• psychosis,
• hallucinations,
• depression,
• dizziness and headaches,
• paresthesia (tingling and numbness),
• dry eyes,
• visual disturbances,
• worsening of heart failure, exacerbation of atrioventricular block,
• hypotension related to changes in body position, which may be accompanied by fainting,
• in sensitive patients, Raynaud's phenomenon may occur,
• bronchospasm in patients with asthma or a history of asthma,
• dry mouth,
• cases of toxic effects on the liver, including cholestasis,
• hair loss,
• psoriatic skin reactions,
• exacerbation of psoriasis,
• rash,
• impotence.

Very rare side effects(occurring in less than 1 in 10,000 patients)
increased antinuclear antibody titers have been observed, but the clinical significance is unclear.
Side effects of unknown frequency(occurring with a frequency that cannot be determined from available data)

• occurrence of irregular or slow heartbeat, changes in heart rhythm, or cessation of heart function. The patient may also experience dizziness, unusual fatigue, and shortness of breath. These symptoms may occur especially in people over 65 years of age or in people with other diseases related to heart rhythm disorders,
• increased sweating,
• hypersensitivity reactions: angioedema, urticaria,
• lupus-like syndrome (a disease in which the immune system produces antibodies that primarily attack the skin and joints)

In some patients, during treatment with Atenolol Sanofi, other side effects may occur.
Reporting side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atenolol Sanofi

There are no special storage instructions.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
There are no special storage instructions for the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Atenolol Sanofi contains

• The active substance of the medicine is atenolol. Each tablet of Atenolol Sanofi 25 contains 25 mg of atenolol. Each tablet of Atenolol Sanofi 50 contains 50 mg of atenolol.
• The excipients are: potato starch, microcrystalline cellulose, povidone 90F, sodium lauryl sulfate, magnesium stearate, talc.

What Atenolol Sanofi looks like and contents of the pack

Tablet
The pack contains 60 tablets of Atenolol Sanofi 25 or 30 tablets of Atenolol Sanofi 50
packaged in PVC/Aluminum blisters in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sanofi-Aventis Sp. z o.o.
Bonifraterska Street 17
00-203 Warsaw
Manufacturer
Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszow
Lubelska Street 52
35-233 Rzeszow
To obtain more detailed information, please contact:
Sanofi-Aventis Sp. z o.o.
Bonifraterska Street 17
00-203 Warsaw
Phone: +48 22 280 00 00
Date of last revision of the leaflet:March 2022