Tenormin 50 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tenormin 50 mg tablets

atenolol

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

Pack contents and additional information

1. What Tenormin is and what it is used for

Tenormin belongs to a group of medicines called 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 maintain regular heartbeats, and also to protect the heart during and after a heart attack.

2. What you need to know before taking Tenormin

Do not take Tenormin:

• if you are allergic to atenolol or to any of the other ingredients of this medicine (listed in section 6).

• if you have had or currently have heart conditions such as uncontrolled heart failure or heart block (a disorder of the heart's electrical conduction system).

• if you have ever experienced very slow or very irregular heartbeats, very low blood pressure, or circulatory failure.

• if you have ever been diagnosed with phaeochromocytoma (a tumor of the adrenal glands).

• if you have been fasting.

• if you have been diagnosed with metabolic acidosis (a metabolic disorder causing excessive blood acidity).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Tenormin:

• If you have any medical conditions such as asthma or breathing difficulties, diabetes, circulatory disorders, or heart, kidney, or thyroid problems.

• If you have ever been told you have a specific type of chest pain (angina) called Prinzmetal's angina.

• If you are pregnant, think you may become pregnant, or are breastfeeding. See "Pregnancy and breastfeeding".

• If you have ever had an allergic reaction to anything, for example, an insect sting.

• You may notice that your pulse is slower while taking these tablets. This is normal, but if you are concerned, inform your doctor.

• If you are diabetic, Tenormin may alter your usual response to low blood sugar, which normally includes an increased heart rate. Atenolol may also increase the risk of severe hypoglycemia when used with certain types of antidiabetic medicines called sulfonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide).

• If you are admitted to hospital, inform healthcare staff, and especially the anaesthetist, 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 gradually.

Children

This medicine 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 need to take any other medicines, including those obtained without a prescription, homeopathic remedies, herbal medicines, and other health-related products, as it may be necessary to stop or adjust the dose of one or more of them. Some medicines may affect the action of others. In particular, inform your doctor if you are taking:

• Disopyramide or amiodarone (for irregular heartbeats).
• Other treatments for high blood pressure or angina (especially verapamil, diltiazem, nifedipine, clonidine). If you are taking clonidine for high blood pressure or to prevent migraines, do not stop treatment with clonidine or Tenormin without first consulting your doctor.
• Treatment for heart failure (digoxin).
• Anti-inflammatory medicines for pain relief (such as indomethacin or ibuprofen).
• Nasal decongestants or other cold remedies you may have purchased yourself from a pharmacy.
• Insulin or oral antidiabetic medicines such as sulfonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide).

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 medicine.

Pregnancy:

There is insufficient data on the safety of Tenormin during the first month of pregnancy. Your doctor will decide whether 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 slow heart rate.

Breastfeeding women should consult their doctor before taking this medicine, as atenolol passes into breast milk.

Driving and use of machines:

Be aware of how this medicine affects you, as dizziness and fatigue may occur at usual doses. If this happens, do not drive or operate dangerous 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 control tests.

Tenormin contains sodium

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

3. How to take Tenormin

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

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

Recommended dose for adults:

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

• 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 otherwise; if so, you should stop gradually.

If you take more Tenormin than you should

If you take more than the prescribed dose, contact your doctor or nearest hospital.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

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 missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. With Tenormin, these may include:

Frequent (affects between 1 and 10 out of every 100 patients)

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

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

• Sleep disorders.

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

• Heart block (which may cause abnormal heartbeat, dizziness, fatigue, or fainting).
• Worsening of breathing difficulties, if you suffer or have suffered from 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 insufficiency.
• 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 tendency to bruising).
• Purpura (purple spots on the skin).
• Jaundice (which may appear as yellowing of the skin and eyes).

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

• Very rarely, changes in certain blood cells or blood components may occur. Your doctor may wish to perform a blood test to check whether 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 mainly attack the skin and joints).
• Depression.

Do not be alarmed by this list of adverse reactions, as none of them may occur.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 not listed in this leaflet. You may also report them through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 packaging, below 25°C and protected from light and moisture.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tenormin

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

Appearance of the medicinal product and contents of the pack

This medicine 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 the most recent review of this leaflet: March 2026

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/