ATENOLOL COMBIX 100 mg FILM-COATED TABLETS

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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Atenolol Combix belongs to a group of medicines called beta-blockers, 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 ensure regular heartbeats and also to protect the heart during and after a heart attack.

2. What you need to know before you take Atenolol Combix

Do not takeAtenolol Combix

• If you are allergic to atenolol or any of the other ingredients of this medicine (listed in section 6).
• If you have or have had heart conditions such as uncontrolled heart failure.
• If you have other heart conditions:
• second or third degree heart block (a condition that can be treated with a pacemaker),

• bradycardia (very slow or irregular heartbeats)
• very low blood pressure (hypotension),
• circulatory disorders (peripheral arterial disease)
• or circulatory failure.
• If you have a tumor called pheochromocytoma (a tumor in the adrenal glands).
• If you have been fasting.
• If you have been told you have higher than normal acid levels in your blood (metabolic acidosis).

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Atenolol Combix.

• If you have health problems such as asthma or breathing difficulties, diabetes, circulatory disorders, heart, kidney, or thyroid problems.
• If you have been told you have a special type of chest pain (angina) called Prinzmetal's angina.
• If you are pregnant, think you may be pregnant, or are planning to become pregnant. See section “Pregnancy and breastfeeding”.
• If you have ever had an allergic reaction to anything, for example, an insect bite.
• You may notice that your pulse is slower while taking these tablets. This is normal, but if it worries you, tell your doctor.
• If you are diabetic, atenolol may change your normal response to low blood sugar, which usually involves an increase in heart rate.
• In case you are hospitalized, inform the medical staff and, in particular, the anesthesiologist, that you are being treated with atenolol.
• Stop taking your tablets only if your doctor tells you to, and in that case, do it 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 take any other medicines, including those obtained without a prescription, homeopathic, herbal, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of some of them. Some medicines can affect the action of others, in particular, tell your doctor if you are using:

• Disopyramide or amiodarone (for irregular heartbeats).
• Other treatments for high blood pressure or angina (in particular, verapamil, diltiazem, nifedipine, clonidine). If you are using clonidine for high blood pressure or to prevent migraines, do not stop treatment with it or with atenolol without consulting your doctor first.
• Treatment for heart failure (digoxin).
• Anti-inflammatory medicines for pain treatment (such as indomethacin or ibuprofen).
• Nasal decongestants or other cold products that you may have bought yourself at a pharmacy.

Pregnancy and breastfeeding

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

Pregnancy

There is not enough data on the safety of atenolol during the first trimester of pregnancy. Your doctor will decide if treatment during the second and third trimester is beneficial for you.

Breastfeeding

Tell 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 slower heartbeats.

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

Driving and using machines

Observe your response to the medication because in some cases, dizziness and fatigue have been produced at usual doses. If so, do not drive or operate hazardous machinery.

Use in athletes

Athletes are warned that this medicine contains a component that may result in a positive doping test.

Atenolol Combix 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 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

3. How to take Atenolol Combix

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 50-100 mg per day.

Usually, this medicine is taken once a day, although the daily dose can also be divided into two doses.

• The atenolol tablets should be swallowed whole with the help of a little water.
• The tablet can be divided into equal doses.
• Try to take your tablet at the same time every day.
• Remember to take your medicine. Your doctor will indicate the duration of your treatment with atenolol.
• It is very important to continue taking this medicine during the time recommended by the doctor.
• Do not stop taking this medicine even if you feel well, unless your doctor tells you to; in this case, you should do it 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 a day.
• 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.

Patient with renal insufficiency:

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 ingest a dose higher than normal, contact your doctor or the nearest hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 forgotten doses.

If you have any other 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.

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

• Cold 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 can cause an abnormal heartbeat, dizziness, fatigue, or fainting).
• Worsening of breathing difficulties, if you have or have had asthma.
• Lack of breathing 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 failure.
• 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.
• Feeling of tingling in the hands.
• Impotence.
• Dry mouth.
• Dry eyes.
• Vision disorders.
• Hair loss.
• Skin rash, including worsening of psoriasis.
• Thrombocytopenia (greater ease of bruising).
• Purpura (purple spots on the skin).
• Jaundice (which can be detected as a yellowish color of your skin and eyes).
• High levels of serum enzymes (transaminases).

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

Very rarely, changes in some blood cells or components may occur. Your doctor may want to perform a blood test to check if atenolol has had any effect on your blood.

Frequency not known (cannot be estimated from the 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 side effects, you may not get any of them.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side 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 carton after EXP. The expiry date refers to the last day of the month shown.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients (excipients) are:

Core: cornstarch, microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hydrophobic colloidal silica, hypromellose, magnesium stearate, povidone, and talc.

Coating: talc, titanium dioxide (E-171), macrogol, hypromellose, microcrystalline cellulose, polyoxyethylene stearate, 30% dispersion of polyacrylate, and 30% simethicone emulsion.

Appearance and packaging

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 packs 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 authorization holder and manufacturer

Marketing authorization 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 last revision of this leaflet: April 2024

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