Atenolol Alter 50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Atenolol Alter 50 mg tablets EFG

Atenolol

Read all of this 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.

Contents of this leaflet

1. What Atenolol Alter is and what it is used for
2. What you need to know before taking Atenolol Alter
3. How to take Atenolol Alter
4. Possible adverse effects
5. How to store Atenolol Alter
6. Contents of the pack and other information

1. What Atenolol Alter is and what it is used for

Atenolol belongs to a group of medicines called beta-blockers, which means it acts on your heart and circulatory system.

Atenolol 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 taking Atenolol Alter

Do not take Atenolol Alter

• 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).
• atenolol must not be administered to children.
• this medicine is for your personal use only and should not be given to anyone else.

Warnings and precautions

Consult your doctor before starting to take this medicine.

• if you have health problems 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 might be 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. 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 this medicine.
• Stop taking your tablets only if your doctor instructs you to do so, and in that case, do so gradually.

Children and adolescents

This medicine must not be used in children (see Do not take Atenolol Alter).

Taking Atenolol Alter with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. 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, 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 migraine, do not stop treatment with clonidine or atenolol 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 over the counter.

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 are insufficient data on the safety of atenolol during the first trimester 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 atenolol 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 have been reported at usual doses in some cases. If this occurs, do not drive or operate dangerous machinery.

Use in athletes

This medicine contains atenolol, which may result in a positive doping test.

Atenolol Alter contains wheat starch

This medicine contains very low levels of gluten derived from wheat starch. It is considered "gluten-free" and is very unlikely to cause problems if you have coeliac disease.

Each tablet contains no more than 5 micrograms of gluten.

If you have a wheat allergy (different from coeliac disease), you must not take this medicine.

3. How to take Atenolol Alter

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

Remember to take your medicine.

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

Usual adult dose

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

Swallow the tablet whole with water. The score line is only intended for dividing the tablet if you have difficulty swallowing it whole.

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; in such a case, you should do so gradually.

If you take more Atenolol Alter than you should

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

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

If you forget to take Atenolol Alter

If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for the missed dose.

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.

The adverse effects observed with this medicine are:

Frequent (may affect up to 1 in 10 people)

• Slower heart rate.
• Cold fingers of hands and feet.
• Nausea.
• Diarrhea.
• Fatigue.

Uncommon (may affect up to 1 in 100 people)

• Sleep disorders.

Rare (may affect up to 1 in 1,000 people)

• 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 bruise).
• Purpura (purple spots on the skin).
• Jaundice (which may appear as yellowing of the skin and eyes).

Very rare (may affect up to 1 in 10,000 people)

• Very rarely, changes in certain blood cells or blood components may occur. Your doctor may wish to perform a blood test to check whether atenolol has had any effect on your blood.

Frequency not known (frequency 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).

Do not be alarmed by this list of adverse reactions, as you may not experience any of them.

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 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 Atenolol Alter

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

Do not store above 30°C. Keep in the original packaging to protect it from light and moisture.

Do not use this medicine after the expiry date stated on the container. 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 medicines and their containers at the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atenolol Alter

• The active substance is atenolol. Each tablet contains 50 mg of atenolol.
• The other components are: pregelatinized corn starch, crospovidone, light magnesium carbonate, wheat starch, calcium carmellose, microcrystalline cellulose, calcium phosphate dibasic dihydrate, talc, stearate G, stearic acid, heavy magnesium carbonate.

Appearance of the product and contents of the pack

White, biconvex tablets, with a score line on one side.

Available in packs of 30 or 60 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

or

Laboratorios Alter, S.A.

C/ Zeus, 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

Date of the most recent revision of this leaflet: February 2026

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/