Atenol

Package leaflet: Information for the patient

Atenol 100 mg tablets

Atenolol
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Atenol is and what it is used for
2. What you need to know before taking Atenol
3. How to take Atenol
4. Possible side effects
5. How to store Atenol
6. Contents of the pack and other information

1. What Atenol is and what it is used for

Atenol contains atenolol as the active ingredient, which belongs to the class of medicines known as beta-blockers.
This medicine is used to treat the following conditions:

• High blood pressure (arterial hypertension), including that of renal origin;
• Angina pectoris (severe chest pain in the area behind the sternum caused by insufficient blood and oxygen supply to the heart).

2. What you need to know before taking Atenol

Do not take Atenol

• if you are allergic to atenolol or to any of the other ingredients of this medicine (listed in section 6);
• if you have a slow heart rate (bradycardia);
• in case of cardiogenic shock;
• if your blood pressure is very low (hypotension);
• if you have an increased concentration of acids in your body (metabolic acidosis);
• if you have severe peripheral arterial circulatory disorders;
• if you suffer from a particular type of heart arrhythmia (irregular heartbeat) called second- or third-degree atrioventricular block;
• if you suffer from sinoatrial node disorders;
• if you have an untreated rare tumour of the adrenal glands (pheochromocytoma);
• if you have severe heart disease (heart failure) not controlled by adequate therapy;
• if you have a rare condition characterized by brief episodes of narrowing of the arteries, the blood vessels carrying blood from the heart to the rest of the body (Raynaud's syndrome);
• if you suffer from severe asthma or severe chronic obstructive pulmonary disease;
• when administered concomitantly with intravenous verapamil or diltiazem;
• if you are breastfeeding.

If you are in any of the above situations, inform your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Atenol:

• if you have kidney problems;
• if you have thyroid problems (a gland located in the neck);
• if you have diabetes (a condition characterized by high blood sugar levels) or hypoglycaemia (a condition characterized by low blood sugar levels), because atenolol may mask the signs of hypoglycaemia such as changes in heart rate (tachycardia). Atenolol may also increase the risk of severe hypoglycaemia when used with certain types of antidiabetic medicines called sulfonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide);
• if you have heart problems or circulatory problems, even if controlled by adequate therapy;
• if you have respiratory problems or asthma;
• if you have a type of chest pain called "Prinzmetal's angina";
• if you are pregnant or planning to become pregnant;
• if you have ever experienced an allergic reaction (e.g. from an insect sting);
• do not stop taking Atenol abruptly, especially if you have insufficient oxygen supply to the heart (ischaemic heart disease). If you need to stop or discontinue treatment with Atenol after prolonged use, the dose should always be reduced gradually by tapering, as sudden withdrawal may lead to reduced oxygenated blood supply to the heart (myocardial ischaemia), worsening of angina pectoris (a heart condition causing chest pain), myocardial infarction, or may cause worsening of hypertension;
• if you have severely impaired kidney function, a dose adjustment is necessary because Atenol is eliminated via the kidneys.

Anaesthesia
Particular caution must be exercised when using anaesthetic agents during treatment with Atenol.
If you are scheduled for surgery, treatment with Atenol should be discontinued at least 24 hours before the procedure, due to an increased risk of low blood pressure (hypotension). Consult your doctor regarding the risk-benefit assessment of stopping Atenol.
If you are admitted to hospital, inform the medical staff, and especially the anaesthetist in case of surgery, about your ongoing treatment with Atenol.
Reduced heart rate (number of heartbeats per minute)
During treatment with Atenol, you may experience a reduced heart rate (see section "Possible side effects"). This effect is normal, but if it becomes concerning, you should consult your doctor.
Diabetes or hypoglycaemia (low blood sugar levels)
If you have diabetes and are being treated with antidiabetic medicines (medicines for treating diabetes), Atenol may increase blood sugar levels. This generally causes an increase in heart rate.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
Children and adolescents
Atenol must not be administered to children and adolescents under 18 years of age.
Other medicines and Atenol
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, inform your doctor if you are taking:

• medicines for high blood pressure or angina (verapamil, diltiazem, nifedipine), as concomitant use with these medicines may worsen the above conditions, particularly in patients with impaired heart function. This may cause severe reduction in blood pressure (severe hypotension), reduced heart rate below 60 beats per minute (bradycardia), and heart failure. At least 48 hours must have passed after discontinuation of any previous intravenous treatment with verapamil or diltiazem before starting Atenol, and vice versa;
• medicines for heart failure (digitalis glycosides);
• medicines for irregular heartbeats (disopyramide or amiodarone);
• sympathomimetic drugs such as adrenaline;
• indometacin or ibuprofen (analgesics);
• nasal decongestants or other medicines (e.g. containing pseudoephedrine) used to treat colds;
• clonidine, a medicine used to treat high blood pressure (hypertension) or to prevent migraine; in this case, treatment with clonidine or Atenol must not be stopped without first consulting your doctor. Consult your doctor also if you are planning to switch from clonidine to Atenol;
• insulin or medicines that lower blood glucose concentration (hypoglycaemic agents), such as sulfonylurea medicines (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Infants born to mothers who have taken Atenol before delivery or during breastfeeding may be at risk of hypoglycaemia (low blood sugar levels) or bradycardia (reduced heart rate per minute).
Atenolol accumulates in breast milk; therefore, its use is contraindicated during breastfeeding.
Driving and using machines
It is unlikely that Atenol will affect your ability to drive or use machines. However, dizziness and fatigue may occasionally occur; if you experience these symptoms, avoid performing such activities.

3. How to take Atenol

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Your doctor will tell you how many tablets to take each day and when, depending on your condition. The recommended starting dose, especially in elderly patients, is the lowest possible dose in order to promptly detect the onset of symptoms of heart failure (the heart's inability to supply an adequate amount of blood relative to the body's actual needs), bradycardia (reduction in heart rate below 60 beats per minute), and bronchial symptoms.

The tablets must be swallowed whole with a glass of water, preferably always at the same time each day. The tablets should not be chewed and must be taken with sufficient liquid to aid swallowing.

Recommended doses are:

Adults

• Hypertension, including renal origin hypertension: Start treatment with 50 mg of atenolol per day using another atenolol-containing medicine for which this dosage is available/obtainable. The full blood pressure-lowering effect is usually achieved after one or two weeks of treatment. If a satisfactory effect is not obtained, take one tablet daily during the second week. If necessary, further reduction in blood pressure may be achieved by taking Atenol together with other medicines used to control hypertension (antihypertensive agents).
• Angina pectoris: One tablet per day.

Use in patients with severe renal impairment
If you suffer from severe kidney problems, your doctor may decide to prescribe a lower dose of Atenol.

Use in the elderly
Your doctor may consider it necessary to reduce the dosage.

Use in children and adolescents
Atenol must not be administered to children and adolescents under 18 years of age.

If you take more Atenol than you should
In case of accidental ingestion of higher than recommended doses, inform your doctor immediately or go to the nearest hospital.

If you forget to take Atenol
Do not take a double dose to make up for the forgotten tablet.
If you forget to take a dose, take it as soon as possible. Do not take two doses at the same time.

If you stop taking Atenol
Improvement in your health condition should not lead to discontinuation of treatment unless instructed by your doctor.
Discontinuation of treatment must be carried out gradually.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
During treatment with Atenol, as with any medicinal product, the following side effects may occur with the frequency listed below:

Common (may affect up to 1 in 10 people)

• Slow heartbeat
• Cold hands and feet
• Gastrointestinal disturbances (nausea, vomiting, diarrhoea, abdominal pain)
• Changes in blood tests related to liver function (transaminases)
• Fatigue

Uncommon (may affect up to 1 in 100 people)

• Sleep disorders

Rare (may affect up to 1 in 1,000 people)

• Breathing difficulties and/or ankle swelling in patients with heart failure
• Worsening of heart function up to heart block (which may cause abnormal heartbeat, dizziness, fatigue or fainting)
• Sudden drop in blood pressure when standing up, possibly leading to loss of consciousness
• Severe cramps and muscle pain in the legs when walking (worsening of intermittent claudication, improving with rest)
• Numbness and cramping of fingers followed by a sensation of heat and pain (Raynaud's phenomenon)
• Dizziness, headache, tingling in hands or feet
• Mood changes, nightmares, confusion, psychosis (mental disorders), hallucinations (seeing inexplicable things), worsening of nervous disorders with mental depression, catatonia (apathy and reduced motor activity), and memory disturbances
• Dry mouth
• Liver damage (hepatic toxicity), including intrahepatic cholestasis (with yellowing of the skin and eyes)
• Purpura (purple skin spots), thrombocytopenia (reduced number of platelets in the blood)
• Hair loss, skin rashes, including worsening of psoriasis, skin redness; furthermore, atenolol may worsen depigmentation in patients affected by vitiligo (a disease characterized by the appearance on the skin, hair or mucous membranes of patches lacking pigmentation)
• Dry eyes, visual disturbances
• Impotence (inability to achieve an erection)
• Bronchospasm (worsening of breathing difficulties) in patients with asthma or asthma-related conditions

Frequency not known (frequency cannot be estimated from available data):

• Lupus-like syndrome (a disease in which the immune system produces antibodies that primarily attack the skin and joints)
• Hypotension (a condition in which blood pressure is much lower than normal values)
• Dyspnoea (difficulty breathing)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Atenol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The shelf life applies to the product in its original undamaged packaging, stored correctly.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Atenol contains

• The active substance is atenolol. One tablet contains 100 mg of atenolol.
• The other components are: magnesium carbonate, pregelatinized corn starch, magnesium stearate, sodium lauryl sulfate.

Description of the appearance of Atenol and pack contents
50 tablets of 100 mg
Marketing Authorization Holder
Errekappa Euroterapici S.p.A. - Via Ciro Menotti, 1/A - Milan
Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri, 71 - Sanremo (IM)
February 2026