TENORMIN 0.5 mg/ml INJECTABLE SOLUTION

2. What you need to know before you are given Tenormin 0.5 mg/ml Solution for Injection

Do not use Tenormin 0.5 mg/ml Solution for Injection:

• 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 (heart conduction disorder).
• if you have ever had very slow or irregular heartbeats, very low blood pressure, or circulatory failure.
• if you have 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).

• Tenormin 0.5 mg/ml Solution for Injection must not be given 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 you are given Tenormin 0.5 mg/ml Solution for Injection:

• 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 breastfeeding. See "Pregnancy and breastfeeding".
• If you have ever had an allergic reaction to anything, for example, an insect bite.
• If you are diabetic, Tenormin 0.5 mg/ml Solution for Injection may change your normal response to low blood sugar, which usually involves an increase in heart rate.
• Your treatment with Tenormin 0.5 mg/ml Solution for Injection will only be stopped when your doctor tells you to.

Children

Must not be used in children. See "Do not use Tenormin 0.5 mg/ml Solution for Injection".

Using Tenormin 0.5 mg/ml Solution for Injection with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those bought without a prescription, homeopathic medicines, herbal remedies, 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 using:

• Disopyramide or amiodarone (for irregular heartbeats).
• Other treatments for high blood pressure or angina (especially verapamil, diltiazem, nifedipine, clonidine). If you are using clonidine for high blood pressure or to prevent migraine, do not stop treatment with this or Tenormin without first talking to your doctor.
• Treatment for heart failure (digoxin).
• Anti-inflammatory medicines for pain relief (such as indomethacin or ibuprofen).
• Nasal decongestants or other cold remedies that you may have bought yourself at a pharmacy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, talk to your doctor or pharmacist before using 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.

Breastfeeding:

Tell your doctor if you are being treated with Tenormin 0.5 mg/ml Solution for Injection during childbirth or breastfeeding, as your baby may be at risk of low blood sugar and slower heartbeats.

Women who are breastfeeding should talk to 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 Solution for Injection:

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

3. How to use Tenormin 0.5 mg/ml Solution for Injection

Follow your doctor's instructions for administering this medicine exactly. If you are unsure, talk to your doctor or pharmacist again.

Your doctor will tell you how long to use Tenormin 0.5 mg/ml Solution for Injection. Do not stop treatment before your doctor tells you to.

Tenormin 0.5 mg/ml Solution for Injection will be given to you by your doctor or a nurse.

Your doctor will decide the dose of Tenormin 0.5 mg/ml Solution for Injection to be injected and how often.

The injection will be given intravenously.

The injection is usually given in emergency situations. In many cases, you may continue to receive Tenormin in tablets.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

For Tenormin given in tablets for long periods, these side effects may be:

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

• Slower heartbeats.
• Cold fingers and toes.
• 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 abnormal heartbeats, 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 (increased tendency to bruise).
• Purpura (purple spots on the skin).
• Jaundice (which can be detected as yellowing of the 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 do 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.

If you think you have experienced any of these side effects or any other side effects, talk to your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare 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 0.5 mg/ml Solution for Injection

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 which is stated on the carton. The expiry date is the last day of the month stated.

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 0.5 mg/ml Solution for Injection

• The active substance is atenolol.
• The other ingredients are sodium chloride, citric acid, sodium hydroxide, and water for injection.

Appearance and pack contents

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

Marketing authorisation holder and manufacturer

Marketing authorisation 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 last revision of this leaflet:May 2024

This information is intended only for healthcare professionals

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Instructions for correct administration

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

Tenormin 0.5 mg/ml Solution for Injection is compatible with sodium chloride 0.9% w/v and dextrose 5% w/v.

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/