TENORMIN 50 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Tenormin 50 mg Tablets

atenolol

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 Tenormin and what is it used for
2. What you need to know before you take Tenormin
3. How to take Tenormin
4. Possible side effects
5. Storage of Tenormin

Contents of the pack and further information

1. What is Tenormin and what is it used for

Tenormin belongs to a group of medicines called beta-blockers, 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.

2. What you need to know before you take Tenormin

Do not take Tenormin:

• 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 problems such as uncontrolled heart failure or blockage (disorder of heart conduction).
• if you have ever had very slow or irregular heartbeats, very low blood pressure, or circulatory failure.
• if you have ever been told you have a pheochromocytoma (a tumor in the adrenal glands).
• if you have been fasting.
• if you have been told you have metabolic acidosis (a metabolic disorder that causes excessive blood acidity).

• These tablets are for your use only and should not be given to anyone else.

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, 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 breast-feeding. See "Pregnancy and breast-feeding".
• 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, Tenormin may change your normal response to low blood sugar, which usually involves an increase in heart rate.
• If you are admitted to hospital, inform the medical staff and, in particular, the anesthetist, that you are being treated with Tenormin.
• Stop taking your tablets only if your doctor tells you to, and in that case, do so gradually.

Children

Should not be used in children.

Taking Tenormin with other medicines

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 stop treatment or adjust the dose of one of them. Some medicines may affect the action of others, in particular, tell your doctor if you are taking:

• Disopyramide or amiodarone (for irregular heartbeats).
• Other treatments for high blood pressure or angina (in particular, verapamil, diltiazem, nifedipine, clonidine). If you are taking clonidine for high blood pressure or to prevent migraines, do not stop treatment with it or with Tenormin 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 breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:

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

Breast-feeding:

Tell your doctor if you are being treated with Tenormin at the time of delivery or during breast-feeding, as your baby may be at risk of low blood sugar and slower heartbeats.

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

Driving and using machines:

Be aware of your response to the medication because in some cases, dizziness and fatigue have been reported at usual doses. If this happens, do not drive or operate hazardous machinery.

Important information about some of the ingredients of Tenormin:

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

Tenormin contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

3. How to take Tenormin

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Remember to take your medicine.

Your doctor will tell you how long to take Tenormin. Do not stop treatment before your doctor tells you to.

Recommended dose for adults:

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

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

If you take more Tenormin than you should

If you take more than you should, 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 taken.

If you forget 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 forgotten doses.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. With Tenormin, these can be:

Common(affects between 1 and 10 in every 100 patients)

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

Uncommon(affects between 1 and 10 in every 1,000 patients)

• Sleep disorders.

Rare(affects between 1 and 10 in every 10,000 patients)

• Heart block (which can cause an abnormal heartbeat, dizziness, fatigue, or fainting).
• Worsening of breathing difficulties if you have asthma.
• Shortness of breath and/or swelling of the ankles if you also have heart failure.
• Worsening of your 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 tendency to bruise).
• Purpura (purple spots on the skin).
• Jaundice (which can be detected as a yellowish color of your skin and eyes).

Very rare(affects less than 1 in every 10,000 patients)

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

Do not be alarmed by this list of possible side effects. You may not get any of them.

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 via the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tenormin

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

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

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

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 further information

Composition of Tenormin

• The active substance is atenolol.
• The other ingredients (excipients) are: heavy magnesium carbonate, gelatin, corn starch, sodium lauryl sulfate, and magnesium stearate.

Appearance of the product and pack contents

This medicinal product is presented in a pack containing 60 scored tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Manufacturer

AstraZeneca AB

Karlebyhusentren, Astraallen,

Sodertalje, 152 57,

Sweden

or

Corden Pharma GmbH

Otto-Hahn-Strasse 1

68723 Plankstadt,

Germany

Date of last revision of this leaflet: May 2024

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