Tenormin 0.5 mg/ml solution for injection

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

TENORMIN 0.5 mg/ml injection solution

atenolol

Read the entire leaflet carefully before you are given 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Tenormin 0.5 mg/ml injection solution is and what it is used for
2. What you need to know before using Tenormin 0.5 mg/ml injection solution
3. How to use Tenormin 0.5 mg/ml injection solution
4. Possible side effects
5. How to store Tenormin 0.5 mg/ml injection solution
6. Contents of the pack and other information

1. What Tenormin 0.5 mg/ml injectable solution is and what it is used for

Tenormin 0.5 mg/ml injectable solution belongs to a group of medicines called beta-blockers, which means it acts on the heart and circulatory system.

Tenormin 0.5 mg/ml injectable solution is indicated for the treatment of cardiac arrhythmias and acute myocardial infarction (early intervention in the acute phase).

2. What you need to know before using Tenormin 0.5 mg/ml injection solution

Do not use Tenormin 0.5 mg/ml injection solution:

• 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 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).

• Tenormin 0.5 mg/ml injection solution must not be administered to children.

• These injections must not be given to anyone other than the patient for whom they were prescribed.

Warnings and precautions

Talk to your doctor or pharmacist before using Tenormin 0.5 mg/ml injection solution:

• If you have 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 be pregnant, or are breastfeeding. See “Pregnancy and breastfeeding”.

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

• If you are diabetic, Tenormin 0.5 mg/ml injection solution may alter your normal response to low blood glucose levels, which usually 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).

• Your treatment with Tenormin 0.5 mg/ml injection solution should only be stopped when instructed by your doctor.

Children

Must not be used in children. See “Do not use Tenormin 0.5 mg/ml injection solution”.

Use of Tenormin 0.5 mg/ml injection solution 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 indometacin or ibuprofen).
• Nasal decongestants or other cold remedies you may have purchased over the counter.
• 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 are planning 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 0.5 mg/ml injection solution 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.

Important information about some of the ingredients of Tenormin 0.5 mg/ml injection solution:

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

3. How to use Tenormin 0.5 mg/ml injection solution

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

Your doctor will tell you how long to continue treatment with Tenormin 0.5 mg/ml injection solution. Do not stop treatment before your doctor tells you to.

Tenormin 0.5 mg/ml injection solution will be administered to you by your doctor or a nurse.

Your doctor will decide the dose of Tenormin 0.5 mg/ml injection solution to be injected and how often it will be given.

The injection will be administered intravenously.

The injection is usually given in emergency situations. In many cases, you may continue receiving Tenormin in tablet form.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

For Tenormin administered in tablet form over long periods of time, these adverse effects may include the following. Do not be alarmed by this list of possible adverse reactions, as you may not experience any of them if you have been given the injection only for a short period (in an emergency situation):

Frequent (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 may cause an abnormal heartbeat, dizziness, fatigue, or fainting)
• Worsening of breathing 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 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 bruise)
• Purpura (purple spots on the skin)
• Jaundice (which may appear as yellowing of the skin and eyes)

Very rare (affects fewer than 1 in every 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 affected 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

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 can also report them directly via 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 0.5 mg/ml injection solution

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

Store the container protected from light, below 25°C.

Do not use this medicine after the expiry date stated on the carton. 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 containers and unused medicines at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tenormin 0.5 mg/ml injectable solution

• The active substance is atenolol.
• The other components are: sodium chloride, citric acid, sodium hydroxide and water for injections.

Appearance of the product and contents of the pack

This medicinal product is presented in a pack containing 5 ampoules, each containing 5 mg of atenolol in 10 ml of isotonic aqueous solution buffered with citrate for intravenous administration.

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:

Cenexi SAS

52 rue Marcel et Jacques Gaucher

94120 Fontenay Sous Bois

France

Date of the most recent review of this leaflet: March 2026

This information is intended for healthcare professionals only.

Instructions for correct administration

No special handling is required. No incompatibilities have been reported for this medicinal product.

Tenormin 0.5 mg/ml injectable solution is compatible with 0.9% w/v sodium chloride and 5% w/v dextrose.

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