Atenolol AHCL

Italy
Brand name Atenolol AHCL
Form tablets
Active substance / Dosage
ATENOLOL
Prescription type Prescription only
ATC code
C07AB03
Registration number 041098
Manufacturer ACCORD HEALTHCARE, S.L.U.

Table of Contents

PACKAGE LEAFLET: INFORMATION FOR THE USER

Atenolol AHCL 25 mg tablets, 50 mg tablets, 100 mg tablets

Read this entire 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, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any side effect, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Atenololo AHCL is and what it is used for

Atenololo AHCL contains an active substance called atenolol, which belongs to a group of
medicines known as beta-blockers.
Atenololo AHCL is indicated for:

  • treating high blood pressure (hypertension);
  • treating chest pain caused by "chronic stable angina pectoris";
  • treating certain types of irregular heartbeat (arrhythmias);
  • preventing the occurrence of another heart attack.

The medicine works by slowing down the heart rate and reducing the force of the heart contractions.

2. What you need to know before taking Atenolol AHCL

Do not take Atenolol AHCL:

  • If you are allergic (hypersensitive) to atenolol or to any of the other ingredients of this medicine (listed in section 6).
  • If you have untreated or uncontrolled heart failure. Symptoms may include shortness of breath and swelling of the ankles.
  • If you have a very irregular heartbeat (such as sick sinus syndrome) or second- or third-degree heart block (you may have a pacemaker).
  • If you have a very slow heartbeat (less than 50 beats per minute before starting treatment).
  • If you have very low blood pressure.
  • If you have circulation problems.
  • If you are in cardiogenic shock. This occurs when your heart does not pump enough blood throughout the body. Symptoms may include confusion, sweating, rapid heartbeat, and pale skin.
  • If you have an untreated tumour called "pheochromocytoma". It is usually located near the kidney and can cause high blood pressure.
  • If you are taking adrenergic beta-blockers (e.g. floctafénine).
  • If your doctor has told you that you have higher than normal levels of acidity in your blood (metabolic acidosis).
  • If you have asthma.
  • If you are taking other antihypertensive medicines such as beta-blockers, verapamil or diltiazem.

If any of these conditions apply to you, do not take Atenolol AHCL tablets. If you have any doubts,
consult your doctor or pharmacist before taking this medicine.
Warnings and precautions
Before starting treatment with Atenolol AHCL, consult your doctor, pharmacist or nurse if:

  • You have breathing problems such as wheezing.
  • You have allergic reactions, for example to insect stings.
  • You have kidney problems.
  • You experience a type of chest pain called "Prinzmetal's angina".
  • You have blood circulation problems.
  • You have a slow heartbeat (50 to 55 beats per minute).
  • You have first-degree heart block (impulses from the upper part of the heart to the lower chambers are slowed).
  • You have diabetes. Atenolol tablets may alter your awareness of low blood sugar levels. Symptoms of low blood sugar may be masked by atenolol, so you might not notice a rapid or stronger heartbeat or sweating caused by low blood sugar. Blood sugar levels must be closely monitored. Atenolol may also increase the risk of severe hypoglycaemia when used with certain types of antidiabetic medicines called sulphonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).
  • You have a skin condition called psoriasis.
  • You have thyroid problems such as "thyrotoxicosis". Atenolol tablets may mask symptoms of thyrotoxicosis such as rapid heartbeat, tremor or excessive sweating.
  • You have a tumour called "pheochromocytoma", you should also be treated with medicines called alpha-blockers in addition to Atenolol AHCL. Blood pressure must be closely monitored.
  • You wish to stop taking the tablets. Especially patients who suffer from a significant reduction in oxygen supply to the heart due to poor blood circulation (ischaemic heart disease) must not stop taking the tablets suddenly. Sudden discontinuation may also cause a rapid increase in blood pressure.
  • You are due to undergo surgery. In this case, it is important that medical staff, particularly the anaesthetist, know that you are taking atenolol.
  • You are elderly. In this case, dose adjustment may be necessary.

For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
If any of these conditions apply to you (or if you have any doubts), consult your doctor or pharmacist
before taking this medicine.
Other medicines and Atenolol AHCL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
In particular, inform your doctor if you are taking any of the following medicines: DO NOT take
this medicine and consult your doctor or pharmacist if:

  • You are taking floctafénine (for pain and swelling).
  • You are taking verapamil, diltiazem or nifedipine (for high blood pressure or chest pain).

Tell your doctor or pharmacist if you are taking any of the following medicines:

  • Clonidine: for treating high blood pressure or migraine. Do not stop taking clonidine unless instructed by your doctor. If you need to stop taking clonidine, your doctor will give you specific instructions on how to proceed.
  • Digoxin: for heart problems.
  • Lidocaine, procainamide, disopyramide, amiodarone or quinidine: for irregular heartbeat.
  • Adrenaline and noradrenaline: medicines that stimulate the heart.
  • Ibuprofen or indomethacin: for pain and swelling.
  • Baclofen: for muscle cramps.
  • Insulin or other oral antidiabetic medicines, such as sulphonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).
  • Ampicillin: for bacterial infections.
  • Barbiturates: for sleep disorders.
  • Sulpiride and phenothiazines: for severe mental health problems (psychosis).
  • Medicines for depression belonging to the classes of "tricyclic antidepressants" or "MAO inhibitors".
  • Medicines for cold or sinusitis, including over-the-counter medicines.
  • Diuretics: medicines that help reduce the amount of water in the body through urine.
  • Vasodilators: medicines that widen blood vessels.
  • Peripheral muscle relaxants (e.g. suxamethonium chloride, tubocurarine): concomitant use of atenolol may increase and prolong the muscle-relaxing effect of these medicines.

If any of these conditions apply to you, consult your doctor or pharmacist before taking this
medicine.
Surgery and radiological examinations
Inform your doctor or medical staff that you are taking Atenolol AHCL if:

  • You are about to undergo surgery. This is because administration of certain anaesthetics while taking this medicine may cause low blood pressure (hypotension).
  • You are about to undergo a radiological examination involving the use of iodine-containing substances (so-called "contrast media") to closely examine a part of your body.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Atenolol AHCL is not recommended during pregnancy or breastfeeding.
Driving and using machines
Atenolol AHCL may impair your ability to drive or use machines due to dizziness and fatigue.
Therefore, before performing these activities, it is better to wait and observe how this medicine affects you.
If you feel dizzy or tired after taking this medicine, you must not drive or use machinery.

3. How to take Atenolol AHCL

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Your doctor will tell you how many tablets to take each day and when to take them.
Read the label on the carton to remind yourself of what your doctor said.
Try to take the tablets at the same time every day.
Swallow the tablets whole with a glass of water.

Adults
Your doctor will decide how many Atenolol tablets you should take each day, depending on your condition.

High blood pressure

  • The usual starting dose is 50 mg once daily.
  • Your dose may later be adjusted to between 50 mg and 100 mg once daily.

Chest pain
The usual dose ranges from 50 mg to 100 mg once daily. If you are to take 100 mg, your doctor may instruct you to take this as two divided doses: 50 mg in the morning and 50 mg in the evening.

Irregular heartbeat
The usual dose ranges from 50 mg to 100 mg once daily.

To prevent another heart attack
The usual dose is 100 mg once daily. Your doctor may instruct you to take this as two divided doses: 50 mg in the morning and 50 mg in the evening.

Elderly patients
If you are elderly, your doctor may decide to prescribe a lower dose, especially if you have kidney problems.

Patients with severe kidney problems
If you have severe kidney problems, your doctor may decide to prescribe a lower dose of Atenolol AHCL tablets or to have you take the medicine less frequently.

Use in children and adolescents under 18 years of age
Atenolol is not recommended for use in children and adolescents under 18 years of age.

If you take more Atenolol AHCL than you should
If you take more Atenolol AHCL tablets than prescribed, contact a doctor immediately or go to the nearest hospital.
Take the medicine pack with you so the doctor knows what you have taken.
You may experience a slow heartbeat, dizziness due to low blood pressure, and difficulty breathing. Your heart may also have trouble pumping blood to the rest of the body (acute heart failure).

If you forget to take Atenolol AHCL
If you forget to take a dose, take it as soon as you remember.
However, if it is almost time for your next dose, skip the missed dose.
Do not take a double dose to make up for the forgotten dose.

If you stop taking Atenolol AHCL
Do not stop taking Atenolol AHCL without first consulting your doctor. Your doctor may consider it necessary to gradually reduce the dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Atenololo AHCL and contact a doctor or go to hospital immediately if you notice any of
the following side effects.
Rare (affects less than 1 in 1,000 people)
Abnormal heartbeat, dizziness, tiredness or fainting. These may be symptoms of heart block.
Shortness of breath or swollen ankles. These may be symptoms of heart failure or worsening of existing heart failure.
Breathing problems such as wheezing. These may be symptoms of worsening asthma.
Not known (frequency cannot be estimated from the available data):
Swelling of the face or throat, difficulty breathing or dizziness. These may be symptoms of a severe allergic reaction.
Stop taking Atenololo AHCL and contact a doctor or go to hospital immediately if you notice any of the above side effects.
Other side effects include:
Common (affects less than 1 in 10 people)
Coldness or circulation problems in the hands and feet.
Slower heart rate. This is a normal effect, but if it concerns you, inform your doctor.
Diarrhoea.
Constipation.
Indigestion.
Nausea or vomiting.
Feeling tired.
Sweating.
Uncommon (affects less than 1 in 100 people)
Sleep disorders.
Elevated levels of an enzyme called "transaminase" (detected by blood tests).
Rare (affects less than 1 in 1,000 people)
Numbness or spasms in the fingers, followed by warmth and pain ("Raynaud's disease").
Tingling or "pins and needles" sensations in the hands and feet.
Circulatory problems (intermittent claudication), which may worsen when starting this medicine.
Low blood pressure.
Headache.
Feeling dizzy.
Feeling confused, anxious or frightened.
Nightmares.
Personality changes (psychosis) or seeing or perceiving things that are not there (hallucinations).
Depression.
Dry mouth.
Thinning of hair.
Dry eyes.
Skin rash.
Dry, scaly skin (psoriasis), which may worsen when starting this medicine.
Vision problems.
Tendency to bruise easily or develop purple spots on the skin.
In men, inability to achieve an erection (impotence).
Yellowing of the skin or whites of the eyes (jaundice).
Blood disorders such as changes in blood cells. Your doctor may occasionally take blood samples to check whether Atenololo AHCL is affecting your blood.
Not known (frequency cannot be estimated from the available data):
Allergic reactions (hypersensitivity) such as itchy rashes.
Atenololo AHCL may mask the symptoms of "thyrotoxicosis" and low blood sugar levels in diabetes (see Section 2 "What you need to know before taking Atenololo AHCL").
Lupus-like syndrome (a condition in which the immune system produces antibodies that mainly attack the skin and joints).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects via the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atenolol AHCL

  • Keep out of the sight and reach of children.
  • Do not use this medicine after the expiry date stated on the packaging after the word “Exp.”. The expiry date refers to the last day of that month.
  • This medicine does not require any special storage conditions.
  • Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Atenololo AHCL contains
The active substance is atenolol.
Atenololo AHCL contains 25 mg, 50 mg or 100 mg of atenolol.
The other components are: heavy magnesium carbonate, maize starch, sodium lauryl sulfate, gelatin,
magnesium stearate (E572), microcrystalline cellulose, talc.

Description of the appearance of Atenololo AHCL and package contents
Atenololo AHCL 25 mg tablets (white, round, flat, bevelled tablets, marked with “AA” on one side and a score line on the other). The tablet can be divided into two equal doses.
Atenololo AHCL 50 mg tablets (white, round, flat, bevelled tablets, marked with “AB” on one side and a score line on the other). The tablet can be divided into two equal doses.
Atenololo AHCL 100 mg tablets (white, round, flat, bevelled tablets, marked with “AC” on one side and a score line on the other). The tablet can be divided into two equal doses.

Atenololo AHCL 25 mg is packaged in PVC/PVDC/aluminium blisters.
Pack sizes: 14, 20, 28, 30 and 90 tablets.
Atenololo AHCL 50 mg is packaged in PVC/PVDC/aluminium blisters.
Pack sizes: 14, 20, 28, 30, 50, 90 and 100 tablets.
Atenololo AHCL 100 mg is packaged in PVC/PVDC/aluminium blisters.
Pack sizes: 14, 20, 28, 30, 50 and 90 tablets.

Atenololo AHCL 25 mg tablets are also available in HDPE containers with PP screw cap.
Pack sizes: 100, 500, 1000 and 5000 tablets.
Atenololo AHCL 50 mg and 100 mg tablets are available in HDPE containers with PP screw cap.
Pack size: 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice,
Poland
Accord Healthcare Single Member S.A.
64th Km National Road Athens, Lamia, 32009,
Greece

This medicinal product is authorised in the European Economic Area countries under the
following names:
NL: Atenolol Accord 25/50/100 mg Tabletten
FR: Atenolol Accord 50/100 mg Comprimes
IT: Atenololo AHCL 25/50/100 mg compresse
SE: Atenolol Accord 25/50/100 mg Tabletter

This summary of product characteristics was last approved in 04/2026