Package Leaflet: Information for the User

atenolol cinfa 100 mg tablets EFG

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

atenolol cinfabelongs to a group of medicines called beta blockers, which act on your heart and circulatory system.

atenolol cinfais 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.

Do not take atenolol cinfa

• If you are allergic to atenolol or any of the other components of this medication (listed in section 6).
• If you have had or have 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)
• Peripheral arterial disease (circulation disease)
• Or circulatory insufficiency.

• If you have a tumor called pheochromocytoma (a tumor in the adrenal glands).
• If you have fasted.
• If you have been informed that you have metabolic acidosis (a metabolic disorder that causes excessive blood acidity) that is not being treated. It usually affects the kidneys and can cause high blood pressure.
• If you have fasted.
• If you have been informed that you have higher-than-normal levels of acid in your blood (metabolic acidosis).

• Atenolol should not be administered to children.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take atenolol cinfa.

• If you have any health problems such as asthma or breathing difficulties, diabetes, circulatory disorders, heart problems, kidney problems, or thyroid problems.
• If you have ever been informed that you have a special type of chest pain (angina) called Prinzmetal's angina.
• If you are pregnant, think you may be pregnant, or are breastfeeding. See the "Pregnancy and breastfeeding" section.
• If you have ever had an allergic reaction to something, for example, an insect bite.
• You may notice that your pulse is slower while taking these tablets. This is normal, but if this concerns you, inform your doctor.
• If you are diabetic, atenolol may modify your normal response to a decrease in blood glucose, which usually involves an increase in heart rate.
• In the event of hospital admission, inform the healthcare staff and, in particular, the anesthetist that you are being treated with atenolol.
• Stop taking your tablets only if your doctor tells you to 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 medications and atenolol cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription, homeopathic, herbal, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them. Some medications may affect the action of others, in particular, inform your doctor if you are using:

• Disopyramide or amiodarone (for irregular heartbeats).
• Other treatments for hypertension or angina (in particular, see verapamil, diltiazem, nifedipine, clonidine). If you are using clonidine for hypertension or to prevent migraines, do not interrupt treatment with this or atenolol without consulting your doctor first.
• Treatment for heart failure (digoxin).
• Anti-inflammatory medications for pain treatment (such as indomethacin or ibuprofen).
• Decongestants or other products for colds that you may have purchased yourself at a pharmacy.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

Inform your doctor if you are being treated withatenololat 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 medication as atenolol passes into breast milk.

Driving and operating machinery

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

This medication contains atenolol, which may produce a positive result in doping control tests.

Atenolol cinfa contains sodium

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

Follow exactly the administration instructions for this medication as 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.

This medication is usually taken once a day, although it can also be divided into two doses per day.

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

Adults

• Hypertension (high blood pressure):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.

Patients with kidney insufficiency:

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 ingest a higher dose 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take atenolol cinfa

If you miss a dose, take it as soon as you remember. Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

• Cold hands and feet.
• Slower heartbeats.
• Nausea.
• Diarrhea.
• Fatigue.

Less frequent (may affect up to 1 in 100 people):

• Sleep disorders.

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

• Cardiac arrest (which may cause an abnormal heartbeat, dizziness, fatigue, or fainting).
• Worsening of respiratory difficulties, if you have or have had asthma.
• Lack of breathing and/or inflammation 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 of the hands, followed by heat and pain (Raynaud's phenomenon).
• Mood changes.
• Nightmares.
• Confusion.
• Psychosis or hallucinations (mental disorders).
• Headache.
• Dizziness, especially when standing up.
• Prickling sensation in the hands.
• Impotence.
• Dry mouth.
• Dry eyes.
• Vision disorders.
• Hair loss.
• Skin rash, including worsening of psoriasis.
• Thrombocytopenia (easier bleeding tendency).
• Purpura (purple spots on the skin).
• Icterus (which may be detected as yellow discoloration of the skin and eyes).
• Elevated serum enzyme values (transaminases).

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

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

Unknown frequency(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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of atenolol cinfa

• The active ingredient is atenolol. Each tablet contains 100 mg of atenolol.
• The other components are: magnesium carbonate, gelatin, cornstarch, sodium lauryl sulfate, and magnesium stearate.

Appearance of the product and contents of the packaging

White, cylindrical, biconvex, scored tablets on one side and with the inscription “A100C” on the other side.

It is presented in PVC/ALU blisters. Each package contains 30 or 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Date of the last review of this leaflet:July 2021

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/63146/P_63146.html

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