Atenolol Aurovitas 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atenolol Aurovitas 50 mg film-coated tablets EFG

Read all of this leaflet carefully before you start 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

Atenolol tablets are used to:

• Treat high blood pressure (hypertension).
• Help prevent chest pain (angina).
• Treat irregular heartbeats (arrhythmias).
• Protect the heart in early treatment after a heart attack (myocardial infarction).
• Make your heart beat more slowly and with less force.

2. What you need to know before taking Atenolol Aurovitas

Do not take Atenolol Aurovitas:

• If you are allergic to atenolol or to any of the other ingredients of this medicine (listed in section 6).

• If you have ever had any of the following heart problems:

• uncontrolled heart failure (this usually leaves you breathless and causes your ankles to swell)

• 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 circulation.

• If you have a tumor called "pheochromocytoma" that is not being treated. This tumor is usually located near your kidney and can cause high blood pressure. If you are being treated for a pheochromocytoma, your doctor will prescribe another medicine, called an alpha-blocker, for you to take in addition to atenolol.

• If your doctor has told you that you have abnormally high levels of acid in your blood (metabolic acidosis).

• Do not take atenolol if you are in any of the above situations. If you are unsure, consult your doctor or pharmacist before taking atenolol.

Warnings and precautions

Talk to your doctor or pharmacist before taking atenolol if:

• You have asthma, wheezing, or any other similar breathing problems, or have allergic reactions, for example, to insect stings. If you have ever had asthma or wheezing, do not take this medicine without first consulting your doctor.
• You have a type of chest pain (angina) called Prinzmetal's angina.
• You have poor circulation or controlled heart failure.
• You have first-degree heart block.
• You have diabetes. Your medicine may alter how you respond to low blood sugar levels. You may feel your heart beating faster. Atenolol may also increase the risk of severe hypoglycemia when used with certain types of antidiabetic medicines called sulfonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide).
• You have thyrotoxicosis (a condition caused by an overactive thyroid gland). This medicine may mask the symptoms of thyrotoxicosis.
• You have kidney problems. You may need to undergo some monitoring during your treatment.

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

Taking Atenolol Aurovitas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because atenolol may affect how other medicines work, and some medicines may affect atenolol.

In particular, inform your doctor if you are taking any of the following medicines:

• Verapamil, diltiazem, and nifedipine – for high blood pressure or chest pain.
• 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 taking clonidine, your doctor will give you detailed instructions on how to do so.
• Digoxin – for heart problems.
• Disopyramide, quinidine, or amiodarone (for irregular heartbeats).
• Adrenaline, also known as epinephrine (a medicine that stimulates the heart).
• Ibuprofen or indomethacin (for pain or inflammation).
• Insulin or oral medicines for diabetes such as sulfonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide).
• Medicines for nasal or sinus congestion or other cold remedies (including medicines you can buy from the pharmacy).

Surgery and X-rays

• If you are admitted to hospital for surgery, inform the anaesthetist or medical staff that you are taking atenolol. This is because you may develop low blood pressure (hypotension) if certain anaesthetics are administered while you are taking this medicine.

Pregnancy, breastfeeding and fertility

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.

Driving and using machines

It is unlikely that your medicine will affect your ability to drive or operate tools or machines.

However, it is best to wait and see how this medicine affects you before attempting these activities. If you feel dizzy or tired while taking this medicine, do not drive or operate tools or machines.

Sodium

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

Important information about some of the ingredients of atenolol:

Athletes are advised that this medicine contains a component that may cause a positive analytical finding in doping control tests.

3. How to take Atenolol Aurovitas

Follow exactly the instructions for use of 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.
• Read the label on the packaging to remind you of what the doctor said.
• Try to take your tablet at the same time every day.
• Swallow the atenolol tablet whole with a glass of water.

Adults

High blood pressure (hypertension): the recommended dose is

• 50 mg and 100 mg per day.

Chest pain (angina): the recommended dose is 100 mg per day or 50 mg twice daily.

Irregular heartbeat (arrhythmias): the recommended dose is

50 mg and 100 mg per day.

Early treatment of a heart attack (myocardial infarction): the recommended dose is 50 mg to 100 mg per day.

Elderly patients

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

Patients with severe renal impairment

If you have severe kidney problems, your doctor may prescribe a lower dose.

Use in children

This medicine should not be given to children.

If you take more Atenolol Aurovitas than you should

If you take more atenolol tablets than prescribed by your doctor, consult a doctor or go to the hospital immediately.

• Take the medicine packaging with you so that the tablets can be identified.

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

If you forget to take Atenolol Aurovitas

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 missed dose.

If you stop taking Atenolol Aurovitas

Do not stop taking atenolol tablets without consulting your doctor. You may need to stop taking them gradually.

4. Possible adverse effects

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

Allergic reactions:

If you have an allergic reaction, consult a doctor immediately. Signs may include raised lumps on the skin (wheals) or swelling of the face, lips, mouth, tongue, or throat.

Other possible adverse effects

Frequent (may affect up to 1 in 10 people)

• You may notice that your pulse rate becomes slower while taking the tablets. This is normal, but if you are concerned, inform your doctor.
• Cold hands and feet.
• Diarrhea.
• General malaise.
• Fatigue.

Uncommon (may affect up to 1 in 100 people)

• Sleep disorders.

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

• Heart block (which may cause dizziness, irregular heartbeat, fatigue, or fainting).
• Numbness or spasm in your fingers followed by heat and pain (“Raynaud's phenomenon”).
• Mood changes.
• Nightmares.
• Confusion.
• Changes in personality (psychosis or hallucinations).
• Headache.
• Dizziness (especially when standing up).
• Tingling in your hands.
• Dry mouth.
• Hair weakening.
• Dry eyes.
• Vision disorders.
• Skin rash.
• Purple spots on the skin.
• Inability to achieve an erection in men (impotence).
• Jaundice (causing yellowing of the skin or whites of the eyes).
• Reduced number of platelets in the blood (increased tendency to bruise).

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

• Changes in certain blood cells or other blood components. Your doctor may wish to carry out a blood test to check whether atenolol has had any effect on your blood.

Frequency not known (cannot be estimated from available data)

• Lupus-like syndrome (a disease in which the immune system produces antibodies that mainly attack the skin and joints).

Conditions that may worsen

• If you have any of the following conditions, they may worsen when you start taking this medicine. This occurs rarely, affecting fewer than 1 in 1,000 people.
• Psoriasis (a skin condition).
• Difficulty breathing or swelling of the ankles (if you have heart failure).
• Asthma or breathing problems.
• Poor circulation.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect 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 Aurovitas

Keep this medicine out of the sight and reach of children.

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

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Atenolol Aurovitas

• The active substance is atenolol.

Each tablet contains 50 mg of atenolol.

• The other components are:

Tablet core: magnesium carbonate (light), corn starch, sodium lauryl sulfate, gelatin, magnesium stearate.

Tablet coating: hypromellose 2910, talc, macrogol 6000, and titanium dioxide (E171).

Appearance of the product and contents of the pack

Film-coated tablet.

White, round, biconvex film-coated tablets, marked with ‘A50’ on one side and a score line on the other. The tablet can be divided into equal doses. [Size: approximately 8.6 mm.]

Atenolol Aurovitas film-coated tablets are available in transparent PVC/PVdC-Aluminum blister packs.

Pack sizes: 20, 30, 50, 60 and 90 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica S.A.

Rua Joao de Deus, nº 19 Amadora, Venda Nova

2700-487

Portugal

Or

Arrow Generiques-Lyon

26 avenue Tony Garnier, Lyon, 69007

France

This medicinal product is authorized in the European Economic Area member states under the following names:

Italy: Atenololo Aurobindo Italia

Portugal: Atenolol Generis Phar

Spain: Atenolol Aurovitas 50 mg film-coated tablets EFG

Date of the most recent review of this leaflet: January 2026

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