Package Insert: Information for the Patient

Tenormin 50 mg Tablets

atenolol

Read this package insert carefully before taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others who 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 package insert. See section 4.

Contents of the package and additional information

Tenormin belongs to a group of medications known as beta blockers, meaning it acts on your heart and circulatory system.

Tenormin 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.

Do not take Tenormin :

• if you are allergic to atenolol or any of the other components of this medication (listed in section 6).
• if you have experienced or have heart conditions such as uncontrolled heart failure or blockage (heart conduction disorder).
• if you have ever experienced very slow or irregular heartbeats, very low blood pressure, or circulatory insufficiency.
• if you have ever been informed that you have 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).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tenormin :

• if you have 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 specific type of chest pain (angina) called Prinzmetal's angina.
• if you are pregnant, think you may be pregnant, or are breastfeeding. See “Pregnancy and breastfeeding”.
• if you have ever experienced 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, Tenormin may modify your normal response to blood glucose drops, which usually involves an increase in heart rate.
• In case of hospital admission, inform hospital staff and, in particular, the anesthesiologist that you are being treated with Tenormin.
• Stop taking your tablets only if your doctor instructs you to do so, and in that case, do so only gradually.

Children

Should not be used in children.

Taking Tenormin with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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 dosage of one of them. Some medications may affect the action of others, particularly, 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 Tenormin without consulting your doctor first.
• Treatment for heart failure (digoxin).
• Anti-inflammatory medications for pain treatment (such as indomethacin or ibuprofen).
• Decongestants or other cold products that you may have purchased yourself at a pharmacy.

Pregnancy and breastfeeding

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

Pregnancy:

There is insufficient data on the safety of Tenormin during the first month 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 with Tenormin at the time of delivery or during breastfeeding, as your baby may be at risk of low blood sugar and slower heartbeats.

Women 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 reported at usual doses. If this is the case, do not drive or operate hazardous machinery.

Important information about some of the components of Tenormin :

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

Tenormin contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially “sodium-free”.

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

Remember to take your medication.

Your doctor will inform you of the duration of your treatment with Tenormin. Do not stop treatment before your doctor tells you to.

Recommended dose for adults:

Your doctor will decide the dose of Tenormin that you should take each day depending on your situation. The table below shows the total daily dose for an adult. The dose is usually taken once a day.

• Swallow the tablet whole with water.
• Try to take your tablet at the same time every day.
• Do not stop taking your tablets even if you feel well, unless your doctor tells you to; in this case, you should do it gradually.

If you take more Tenormin 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Tenormin

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

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

Like all medications, this medication may produce side effects, although not everyone will experience them. With Tenormin, these may be:

Frequent(affects between1and 10of every 100 patients)

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

Less frequent(affects between1and 10of every 1,000 patients)

• Sleep disturbances.

Rare(affects between1and 10of every 10,000 patients)

• Cardiac arrest (which may cause an abnormal heartbeat, dizziness, fatigue, or fainting).
• Worsening of respiratory difficulties, if you suffer or have suffered from 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.
• Sensation of tingling in the hands.
• Impotence.
• Dry mouth.
• Dry eyes.
• Vision disturbances.
• Hair loss.
• Skin rash, including worsening of psoriasis.
• Thrombocytopenia (easier bleeding tendency).
• Purpura (purple spots on the skin).
• Icterus (which can be detected as yellowish discoloration of the skin and eyes).

Very rare(affects fewer than1 in every 10,000 patients)

• Very rarely, changes in some cells or components of the blood may occur. Your doctor may wish to perform a blood test to check if Tenormin 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).
• Depression.

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

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not appearing in this prospectus. You can also report them through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Store the tablets in the original packaging, below 25°C, and protected from light and moisture.

Do not use this medication after the expiration date shown on the packaging. 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 the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tenormin

• The active ingredient is atenolol.
• The other components (excipients) are: heavy magnesium carbonate, gelatin, cornstarch, sodium lauryl sulfate, and magnesium stearate.

Appearance of the product and contents of the packaging

This medication is presented in a package containing 60 scored tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5th floor

DK-2300 København S

Denmark

Responsible for manufacturing

AstraZeneca AB

Karlebyhusentren, Astraallen,

Sodertalje, 152 57,

Sweden

or

Corden Pharma GmbH

Otto-Hahn-Strasse 1

68723 Plankstadt,

Germany

Last review date of this leaflet: May 2024

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