Atenolol Cinfa 50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

atenolol cinfa 50 mg tablets EFG

Read the 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; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What atenolol cinfa is and what it is used for

atenolol cinfa belongs to a group of medicines called beta-blockers, meaning it acts on your heart and circulatory system.

atenolol cinfa is indicated for the treatment of high blood pressure (hypertension), to help prevent chest pain (angina), to maintain regular heartbeats, and also to protect the heart during and after a heart attack.

2. What you need to know before taking atenolol cinfa

Do not take atenolol cinfa

• 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 heart conditions such as uncontrolled heart failure.

• If you have other heart conditions:

• second- or third-degree heart block (a condition that may be treated with a pacemaker)

• bradycardia (very slow or irregular heartbeat)

• very low blood pressure (hypotension)

• poor circulation (peripheral arterial disease)

• or circulatory failure.

• If you have a tumor called a pheochromocytoma (a tumor of the adrenal glands).

• If you have been fasting.

• If you have been diagnosed with untreated metabolic acidosis (a metabolic disorder causing excessive blood acidity). It is often related to the kidney and may cause high blood pressure.

• If you have been fasting.

• If you have been told that you have higher than normal levels of acid in your blood (metabolic acidosis).

• Atenolol must not be administered to children.

This medicine has been prescribed specifically for you by your doctor. Therefore, you must not give it to anyone else.

Warnings and precautions

Talk to your doctor or pharmacist before taking atenolol cinfa.

• If you have health problems such as asthma or breathing difficulties, diabetes, circulatory disorders, or heart, kidney, or thyroid problems.
• If you have ever been diagnosed with a specific type of chest pain (angina) called Prinzmetal's angina.
• If you are pregnant, think you may be pregnant, or are breastfeeding. See section "Pregnancy and breastfeeding".
• If you have ever had an allergic reaction to anything, for example, an insect sting.
• You may notice that your pulse is slower while taking these tablets. This is normal, but if you are concerned, inform your doctor.
• If you are diabetic, atenolol may alter your normal response to low blood sugar, which usually includes an increased heart rate. 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).
• If you are admitted to hospital, inform healthcare staff, and especially the anesthetist, that you are being treated with atenolol.
• Stop taking your tablets only if your doctor instructs you to do so, and in that case, do so only gradually.

Children

The safety of atenolol in children has not been established, and therefore, it should not be used in children.

Other medicines and atenolol cinfa

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 interrupt treatment or adjust the dose of one of them. Some medicines may affect the action of others. In particular, inform your doctor if you are taking:

• Disopyramide or amiodarone (for irregular heartbeat).
• Other treatments for high blood pressure or angina (especially verapamil, diltiazem, nifedipine, clonidine). If you are taking clonidine for high blood pressure or to prevent migraine, do not stop treatment with clonidine or atenolol without first consulting your doctor.
• Treatment for heart failure (digoxin).
• Anti-inflammatory medicines for pain (such as indomethacin or ibuprofen).
• Nasal decongestants or other cold remedies you may have purchased yourself from a pharmacy.
• Insulin or oral antidiabetic medicines such as sulfonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 trimester 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

Be aware of how this medicine affects you, as dizziness and fatigue may occur at usual doses. If this happens, do not drive or operate dangerous machinery.

Use in athletes

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

atenolol cinfa contains sodium

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

3. How to take atenolol cinfa

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

The recommended dose is 50–100 mg per day.

This medicine is usually taken once daily, although the daily dose may also be divided into two doses.

• Atenolol tablets should be swallowed whole with a little water.
• The tablet may be divided into equal doses.
• Try to take your tablet at the same time each day.
• Remember to take your medicine. Your doctor will tell you how long your treatment with atenolol should last.
• It is very important to keep taking this medicine for the length of time recommended by your doctor.
• Do not stop taking this medicine even if you feel well, unless your doctor tells you to do so; in that case, you should stop treatment gradually.

Adults

• High blood pressure (hypertension): the recommended dose is 50 to 100 mg per day.
• Chest pain (angina): the recommended dose is 100 mg per day or 50 mg twice daily.
• Irregular heartbeats (arrhythmias): the recommended dose is 50 mg to 100 mg per day.
• Early treatment of a heart attack (myocardial infarction): the recommended dose is 50 mg to 100 mg per day.
• Late treatment of a heart attack (myocardial infarction): the recommended dose is 100 mg per day.

Patients with renal impairment:

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

If you take more atenolol cinfa than you should

If you take more than the usual dose, contact your doctor or nearest hospital.

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

If you forget to take atenolol cinfa

If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for forgotten doses.

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.

Common (may affect up to 1 in 10 people):

• Cold fingers of the hands and feet.
• Slower heartbeats.
• Nausea.
• Diarrhea.
• 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 abnormal heartbeat, dizziness, fatigue, or fainting).
• Worsening of breathing difficulties, if you suffer or have suffered from asthma.
• Shortness of breath and/or swelling of the ankles, if you also have heart failure.
• Worsening of your arterial circulation, if you already have some degree of circulatory insufficiency.
• Numbness and spasms in the fingers, followed by heat and pain (Raynaud's phenomenon).
• Mood changes.
• Nightmares.
• Confusion.
• Psychosis or hallucinations (mental disorders).
• Headache.
• Dizziness, especially when standing up.
• Tingling sensation in the hands.
• Impotence.
• Dry mouth.
• Dry eyes.
• Vision disorders.
• Hair loss.
• Skin rash, including worsening of psoriasis.
• Thrombocytopenia (increased tendency to bruising).
• Purpura (purple spots on the skin).
• Jaundice (which may appear as yellowing of the skin and eyes).
• Elevated serum enzyme levels (transaminases).

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

Very rarely, changes in certain blood cells or blood components may occur. Your doctor may wish to perform 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).

Do not be alarmed by this list of adverse reactions, as you may not experience any of them.

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of atenolol cinfa

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

Do not store above 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Unwanted medicines and their containers should be taken to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unwanted medicines and containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of atenolol cinfa

• The active substance is atenolol. Each tablet contains 50 mg of atenolol.
• The other components are: magnesium carbonate, gelatin, corn starch, sodium lauryl sulfate, and magnesium stearate.

Appearance of the medicinal product and contents of the pack

White, cylindrical, biconvex tablets, scored on one side and marked with "A50C" on the other.

Presented in PVC/ALU blisters. Each pack contains 30 or 60 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the most recent review of this leaflet: December 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63147/P_63147.html

QR code to: https://cima.aemps.es/cima/dochtml/p/63147/P_63147.html