Atenolol Sandoz 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Atenolol Sandoz 50 mg film-coated tablets EFG

Atenolol Sandoz 100 mg film-coated tablets EFG

Read this entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms as yours, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Atenolol Sandoz

3. How to take Atenolol Sandoz

4. Possible side effects

5. How to store Atenolol Sandoz

6. Contents of the pack and other information

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

Atenolol Sandoz contains a medicine called atenolol. This belongs to a group of medicines known as beta-blockers.

Atenolol Sandoz is used for:

• the treatment of high blood pressure (hypertension),
• helping to prevent chest pain “chronic stable angina”,
• ensuring regular heartbeats,
• to protect the heart during and after a heart attack.

2. What you need to know before taking Atenolol Sandoz

Do not take Atenolol Sandoz:

• if you are allergic to atenolol or to any of the other ingredients of this medicine (listed in section 6),
• if you have had or currently have any of the following heart conditions:
• uncontrolled heart failure (this usually causes shortness of breath and swelling of the ankles),
• second- or third-degree heart block (a condition that may be treated with a pacemaker),
• very slow or irregular heartbeats, very low blood pressure, or very poor blood circulation (circulatory failure),
• if you have cardiogenic shock. This means that the heart is not pumping blood through the body effectively enough. Signs may include confusion, sweating, rapid heartbeat, and paleness,
• if you have an untreated tumour of the adrenal glands called phaeochromocytoma,
• if you have been fasting,
• if your doctor has told you that you have excessive acidity in the blood (metabolic acidosis).

Do not take Atenolol Sandoz in any of the above cases. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting Atenolol Sandoz if:

• you have asthma, wheezing, or any similar breathing problems, or if you have allergic reactions, for example, to insect stings. If you have ever had asthma or wheezing, do not take this medicine without speaking to your doctor,
• you have a type of chest pain (angina) called Prinzmetal's angina,
• you have first-degree heart block,
• you have diabetes. Atenolol may alter your normal response to low blood sugar (hypoglycaemia), which usually includes an increased heart rate. You may feel your heart beating faster. 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 thyrotoxicosis (a condition caused by an overactive thyroid gland). Your medicine may mask the symptoms of thyrotoxicosis,
• you have kidney problems. You may need to have medical check-ups during treatment,
• you have a skin condition called psoriasis,
• you may notice that your pulse is slower while taking these tablets. This is normal, but if you are concerned, inform your doctor,
• you are elderly,
• you are pregnant, think you may be pregnant, or are breastfeeding. See “Pregnancy and breastfeeding”,
• you have ever had an allergic reaction to anything, for example, an insect sting,
• if you are admitted to hospital, inform the healthcare staff, and especially the anaesthetist, that you are being treated with atenolol.

If you think any of the above apply to you, or if you are unsure, consult your doctor or pharmacist before taking this medicine.

Taking Atenolol Sandoz with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, homeopathic remedies, herbal medicines, and other health-related products, as it may be necessary to stop or adjust the dose of one or more of them.

Some medicines can affect the action of others.

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

• clonidine (for high blood pressure or migraine). If you are taking clonidine and atenolol together, do not stop taking clonidine unless your doctor tells you to. If you need to stop clonidine, your doctor will give you detailed instructions on how to do so,
• verapamil, diltiazem, and nifedipine (for high blood pressure and chest pain),
• disopyramide, quinidine, amiodarone, and any other medicines for irregular heartbeat,
• digoxin (for heart failure), adrenaline (also known as epinephrine) (medicines that stimulate the heart),
• ibuprofen or indomethacin (anti-inflammatory medicines for pain relief),
• insulin or oral medicines for diabetes such as drugs called sulphonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide),
• ampicillin, for bacterial infections,
• barbiturates, for sleep problems and epilepsy,
• sultopride and phenothiazines, for more serious mental health conditions (psychosis),
• medicines from the groups called “tricyclic antidepressants” or “MAO inhibitors”,
• nasal decongestants or other cold or sinus congestion medicines (including over-the-counter medicines),
• if you are going to hospital for surgery, inform the anaesthetist or medical staff that you are taking atenolol. This is because you may experience a drop in blood pressure (hypotension) if you receive certain anaesthetics or iodine-containing substances (called “contrast media”) for X-rays while taking atenolol.

If you think any of the above apply to you, or if you are unsure, consult your doctor or pharmacist before taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

There are insufficient data on the safety of atenolol during the first month of pregnancy. Your doctor will decide whether treatment during the second and third trimesters is beneficial for you.

Breastfeeding

Inform your doctor if you are being treated with atenolol at the time of delivery or during breastfeeding, as your baby may be at risk of low blood sugar and slow heart rate.

Breastfeeding women should consult their doctor before taking this medicine, as atenolol passes into breast milk.

Driving and using machines

• It is unlikely that this medicine will affect your ability to drive or use machines.
• However, it is best to wait and see how the medicine affects you before engaging in these activities.
• If you feel dizzy or tired when taking this medicine, do not drive or operate tools or machinery.

Use in athletes

This medicine contains atenolol, which may result in a positive doping test.

Atenolol Sandoz contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Atenolol Sandoz

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Your doctor will tell you how many tablets to take each day and when to take them.
• Check the packaging to remind yourself of the information your doctor gave you.
• Try to take the tablets at the same time each day.
• Swallow the tablets whole with a glass of water. The score mark is only intended for dividing the tablet if you have difficulty swallowing it whole.

Adults

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

Hypertension

• The usual starting dose is 25 mg daily.
• Afterwards, you will usually take between 50 mg and 100 mg daily.

Chest pain

The usual dose is 50 to 100 mg daily. If you take 100 mg, your doctor may instruct you to take it in two separate doses: 50 mg in the morning and 50 mg at night.

Irregular heartbeat

The usual dose is 50 to 100 mg daily.

Protection after a heart attack

The usual dose is 100 mg daily. Your doctor may instruct you to take it in two separate doses: 50 mg in the morning and 50 mg at night.

Elderly patients

If you are elderly, your doctor may choose 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 prescribe a lower dose of atenolol or advise you to take it less frequently.

Use in children

This medicine must not be given to children.

If you take more Atenolol Sandoz than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

• If you take more Atenolol Sandoz than you should, consult a doctor or go to a hospital immediately.
• Take the medicine container with you so the doctor can identify what you have taken.
• You may experience a slower pulse, dizziness due to low blood pressure, and difficulty breathing. In addition, your heart may have difficulty pumping blood to the rest of the body (acute heart failure).

If you forget to take Atenolol Sandoz

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

If you stop taking Atenolol Sandoz

Do not stop treatment with Atenolol Sandoz without consulting your doctor. Your doctor may need to gradually reduce the dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking Atenolol Sandoz and consult a doctor or go immediately to a hospital if you experience any of the following serious adverse effects:

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

• abnormal heartbeat, feeling dizzy, tiredness, or fainting. These could be signs of heart block,
• shortness of breath or swelling of the ankles. These could be signs of heart failure or worsening of existing heart failure,
• breathing problems, such as wheezing. These could be signs of worsening asthma,
• numbness or coldness in feet and fingers.

Frequency not known (cannot be estimated from available data)

• swelling of the face or throat, difficulty breathing, or feeling dizzy. These could be signs of a severe allergic reaction.

Stop taking Atenolol Sandoz and consult a doctor or go to a hospital immediately if you notice any of the above adverse effects.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

• feeling cold or poor circulation in hands and feet,
• slower pulse. This is normal, but if you are concerned, consult your doctor,
• diarrhoea,
• constipation,
• digestive problems,
• dizziness or nausea,
• feeling tired,
• sweating.

Uncommon (may affect up to 1 in 100 people)

• difficulty sleeping,
• high levels of an enzyme called “aminotransferase” (in blood tests).

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

• purple spots on the skin,
• sensation of numbness or spasms in the fingers, followed by a feeling of heat and pain (“Raynaud’s disease”),
• tingling or prickling sensations in hands and feet,
• poor circulation (intermittent claudication), which may worsen when starting the medicine,
• low blood pressure that may cause dizziness, mild dizziness, or fainting,
• headache,
• dizziness,
• mood changes, nightmares, confusion, anxiety or fear,
• nightmares,
• changes in personality (psychosis) or seeing or hearing things that are not real (hallucinations),
• depression,
• dry mouth,
• hair loss,
• dry eyes,
• skin rash,
• dry, flaky skin (psoriasis), which may worsen when starting the medicine,
• vision problems,
• increased tendency to bruise or purple marks on the skin,
• inability to achieve erection in men (impotence),
• changes in libido,
• yellowing of the skin or whites of the eyes (jaundice),
• blood disorders such as changes in blood cells. Your doctor may take blood samples regularly to check whether Atenolol Sandoz has affected your blood.

Frequency not known (cannot be estimated from available data)

• allergic reactions (hypersensitivity) such as skin rash with itching,
• lupus-like syndrome (a disease in which the immune system produces antibodies that mainly attack the skin and joints),
• atenolol may mask the symptoms of “thyrotoxicosis” and hypoglycaemia (diabetes) (see “Section 2. What you need to know before taking Atenolol Sandoz”).

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es . By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atenolol Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Keep in the original packaging to protect from light and moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atenolol Sandoz 50 mg tablets:

The active substance is atenolol. Each tablet contains 50 mg of atenolol.

Composition of Atenolol Sandoz 100 mg tablets:

The active substance is atenolol. Each tablet contains 100 mg of atenolol.

The other components are:

Core:

corn starch, sodium lauryl sulfate, heavy magnesium carbonate, magnesium stearate (E470b), gelatin.

Coating: lactose, hypromellose, titanium dioxide (E171), polyethylene glycol 4000.

Appearance of the medicinal product and contents of the pack

Film-coated tablets, white, round, with a score line on one side. The score line is intended only to facilitate breaking the tablet for ease of swallowing and does not allow division into equal doses.

Atenolol Sandoz is available in Alu/PP blisters in packages containing 30, 60, and 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A. Parque Norte Business Center Roble Building C/ Serrano Galvache, 56 28033 Madrid Spain

Manufacturer

Salutas Pharma GmbH Otto-von-Guericke Allee 1 39179 Barleben Germany

or

Hexal AG Industriestrasse, 25 83607 Holzkirchen Germany

Date of the most recent revision of this leaflet: February 2026

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/