Atenolol Combix 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Atenolol Combix 50 mg film-coated tablets EFG

Atenolol Combix 100 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 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 you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Atenolol Combix 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 Combix

Do not take Atenolol Combix

• If you are allergic to atenolol or to any of the other components 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 disorder that may be treated with a pacemaker),

• bradycardia (very slow or very irregular heartbeat),

• very low blood pressure (hypotension),

• circulatory disorders (peripheral arterial disease),

• or circulatory insufficiency.

  • If you have a tumor called a pheochromocytoma (a tumor of the adrenal glands).
  • If you have been fasting.
  • If you have been told that you have abnormally high levels of acid in your blood (metabolic acidosis).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Atenolol Combix.

• 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 told that you have 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 glucose, which usually includes an increased heart rate. Atenolol may also increase the risk of severe hypoglycemia when used together 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 anaesthetist, that you are being treated with atenolol.
• Stop taking your tablets only if your doctor tells 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 Combix

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 heartbeats).
• Other treatments for hypertension or angina (particularly verapamil, diltiazem, nifedipine, clonidine). If you are taking clonidine for hypertension 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 relief (such as indomethacin or ibuprofen).
  • Nasal decongestants or other cold remedies that you may have purchased yourself from a pharmacy.
  • Insulin or oral antidiabetic medicines such as drugs called 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 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 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.

Women who are breastfeeding should consult their doctor before taking this medicine, as atenolol passes into breast milk.

Driving and use of machines

Be aware of how this medicine affects you, as dizziness and fatigue have occurred in some cases at usual doses. If this happens, do not drive or operate dangerous machinery.

Use in athletes

Athletes are advised that this medicine contains a component that may result in a positive analytical finding in doping controls.

Atenolol Combix contains lactose and sodium

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

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

3. How to take Atenolol Combix

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.

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 some 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 this case, you should gradually discontinue it.

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 heartbeat (arrhythmias): the recommended dose is 50 mg to 100 mg per day.
• Early treatment of heart attack (myocardial infarction): the recommended dose is 50 mg to 100 mg per day.
• Late treatment of 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 Combix 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 Combix

If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for a missed 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 produce adverse effects, although not everyone experiences them.

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

• Cold fingers and toes.
• 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 an 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 bruise).
• 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 condition 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atenolol Combix

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

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

Do not store above 25 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused 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 Combix 50 mg film-coated tablets EFG:

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

Composition of Atenolol Combix 100 mg film-coated tablets EFG:

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

The other components (excipients) are:

Core: maize starch, microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, colloidal anhydrous silica, hypromellose, magnesium stearate, povidone and talc.

Coating: talc, titanium dioxide (E-171), macrogol, hypromellose, microcrystalline cellulose, polyoxyl 40 stearate, 30% polacrylate dispersion and 30% simethicone emulsion.

Appearance of the product and contents of the pack

Film-coated tablets, white, round, scored on one side and flat on the other side.

Atenolol Combix is available in PVC/PVDC-Aluminum blisters, in pack sizes of 30 or 60 tablets.

Atenolol Combix 50 mg film-coated tablets EFG

The diameter of the tablet is approximately 8.1 mm.

Atenolol Combix 100 mg film-coated tablets EFG

The diameter of the tablet is approximately 11.1 mm.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

Or

Pharmex Advanced Laboratories S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

Or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Or

Netpharmalab consulting services

Carretera de Fuencarral 22,

Alcobendas,

28108 Madrid

Spain

Or

Flavine pharma france

3 Voie d’Allemagne

13127 Vitrolles

France

Date of the most recent revision of this leaflet: January 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/).