ATENOLOL CINFA 50 mg TABLETS

2. What you need to know before taking atenolol cinfa

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 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 problems (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 informed that you have metabolic acidosis (a metabolic disorder that causes excessive blood acidity) that is not being treated. It is usually located near the kidney and can cause high blood pressure.
• If you have been fasting.
• If you have been informed that you have higher than normal blood acid levels (metabolic acidosis).

• Atenolol should not be administered to children.

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

Warnings and Precautions

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

• If you have health problems such as asthma or respiratory difficulties, diabetes, circulatory disorders, heart, kidney, or thyroid problems.
• If you have 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 anything, for example, an insect bite.
• You may notice that your pulse is slower while taking these tablets. This is normal, but if it concerns you, inform 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 of hospitalization, 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 Medications and atenolol cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription, homeopathic products, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them. Some medications can 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, verapamil, diltiazem, nifedipine, clonidine). If you are using clonidine for hypertension or to prevent migraines, do not stop treatment with it or atenolol without consulting your doctor first.
• Treatment for heart failure (digoxin).
• Anti-inflammatory medications for pain treatment (such as indomethacin or ibuprofen).
• Nasal decongestants or other cold products that you may have purchased yourself at a pharmacy.

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 medication.

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

Inform your doctor if you are being treated with atenolol during childbirth or 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 Using Machines

Observe your response to the medication, as dizziness and fatigue have been reported at usual doses. If this is the case, do not drive or operate hazardous machinery.

Use in Athletes

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

atenolol cinfa contains sodium

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

3. How to Take atenolol cinfa

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 50-100 mg per day.

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

• The 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 time recommended by your doctor.
• Do not stop taking this medication even if you feel well, unless your doctor tells you to; in this case, it should be done 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 cinfa 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 medication 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 missed doses.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience 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 respiratory difficulties, if you have or have had 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 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.
• Tingling sensation in the hands.
• Impotence.
• Dry mouth.
• Dry eyes.
• Vision disorders.
• Hair loss.
• Skin rash, including worsening of psoriasis.
• Thrombocytopenia (increased risk of bruising).
• Purpura (purple spots on the skin).
• Jaundice (which can be detected as a yellowish discoloration 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 some blood cells or components can 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 available data):

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

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

Reporting Side Effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of atenolol cinfa

Keep this medication out of sight and reach of children.

Do not store above 30°C.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of atenolol cinfa

• The active ingredient is atenolol. Each tablet contains 50 mg of atenolol.
• The other ingredients are: magnesium carbonate, gelatin, cornstarch, sodium lauryl sulfate, and magnesium stearate.

Appearance of the Product and Package Contents

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

It is presented in PVC/ALU blisters. Each package 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 Last Revision of this Package Leaflet:July 2021

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. 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