Package Insert: Information for the Patient

TENORMIN 0.5 mg/mL Injectable Solution

atenolol

Read this entire package insert carefully before you receive this medication, because 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 medication has been prescribed for you only and should not be given to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Tenormin 0.5 mg/ml injectable solution belongs to a group of medications called beta blockers, which act on your 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).

Do not use Tenormin 0.5 mg/ml injectable solution:

• if you are allergic to atenolol or any of the other components of this medication (listed in section6).
• if you have experienced or have heart conditions such as uncontrolled heart failure or blockage (conduction disorder of the heart).
• if you have ever experienced very slow or irregular heartbeats, very low blood pressure, or circulatory insufficiency.
• if you have 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).

• Tenormin 0.5 mg/ml injectable solution should not be administered to children.
• These injections should not be administered to anyone other than the patient for whom they were prescribed.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Tenormin 0.5 mg/ml injectable solution:

• if you have health problems such as asthma or breathing difficulties, diabetes, circulatory disorders, heart problems, kidney problems, or thyroid problems.
• if you have 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.
• if you are diabetic, Tenormin 0.5 mg/ml injectable solution may modify your normal response to blood glucose lowering, which typically involves an increase in heart rate.
• Your treatment with Tenormin 0.5 mg/ml injectable solution will only be interrupted when your doctor instructs you to do so.

Children

It should not be used in children. See “Do not use Tenormin 0.5 mg/ml injectable solution”.

Use of Tenormin 0.5 mg/ml injectable solution with other medications

Inform your doctor or pharmacist if you are using, have used recentlyor may need to useany 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 dose 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 (particularly, 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 relief (such as indomethacin or ibuprofen).
• Decongestants or other products for colds that you may have purchased yourself at a pharmacy.

Pregnancy and breastfeeding

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

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 trimesters is beneficial for you.

Breastfeeding:

Inform your doctor if you are being treated with Tenormin 0.5 mg/ml injectable solution at the time of delivery or during breastfeeding, as your baby may be at risk of low blood sugar and slower heart rate.

Women breastfeeding should consult their doctor before taking this medication as atenololpasses into breast milk.

Important information about some of the components of Tenormin 0.5 mg/ml injectable solution:

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

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

Your doctor will inform you of the duration of your treatment with Tenormin 0.5 mg/ml injectable solution. Do not stop treatment before your doctor tells you to.

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

Your doctor will decide the dose of Tenormin 0.5 mg/ml injectable solution that will be injected and how often.

The injection will be administered intravenously.

The injection is normally administered in emergency situations. In many circumstances, you may continue to receive Tenormin in tablet form.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

For Tenormin administered in tablets over long periods of time, these side effects may be the following. Do not be alarmed by this list of possible adverse reactions, since if you have been administered the injection only for a short period of time (in emergency situations) you may not experience any of them:

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 disorders.

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

• Cardiac arrest (which can cause abnormal heartbeats, 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 disorders.
• Hair loss.
• Skin rash, including worsening of psoriasis.
• Thrombocytopenia (easier bleeding tendency).
• Purpura (purple spots on the skin).
• Icterus (which can be detected as yellow discoloration of the skin and eyes).

Very rare:(affects fewerthan 1 in 10,000 patients)

• Very rarely, changes in some cells or components of the blood may occur. It may be that your doctor wants 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 mainly attack the skin and joints).
• Depression.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this prospectus, 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 that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not use this medication after the expiration date that appears on the box. 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 containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tenormin 0.5 mg/ml injectable solution

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

Appearance of the product and contents of the packaging

This medication is presented in a package with 5 ampoules containing 5 mg of atenolol in 10 ml of isotonic aqueous solution buffered with citrate for intravenous administration.

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:

Cenexi SAS

52 rue Marcel and Jacques Gaucher

94120 Fontenay Sous Bois

France

Last review date of this leaflet : May 2024

This information is intended solely for doctors or healthcare professionals

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Instructions for correct administration

No special handling is required. No incompatibilities have been described for this medication.

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

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