Patient Information Leaflet

Atenolol Alter 50 mg Tablets EFG

Atenolol

Read this leaflet carefully before you start taking this medicine, as 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Atenolol belongs to a group of medications known as beta blockers, which act on the 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.

Do not take Atenolol Alter

• if you are allergic to atenolol or any of the other components of this medication (listed in section 6).
• if you have or have had heart conditions such as uncontrolled heart failure or blockage (cardiac conduction disorder).
• if you have ever experienced very slow or irregular heartbeats, very low blood pressure, or circulatory failure.
• if you have ever been informed that you have phaeochromocytoma (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).
• atenolol should not be administered to children.
• this medication is only for your exclusive use and should not be given to anyone else.

Warnings and precautions

Consult your doctor before starting to take this medication.

• if you have health problems such as asthma or breathing difficulties, diabetes, circulatory disorders, heart problems, kidney problems, or thyroid problems.
• if you have ever been informed that 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 something, for example, an insect bite.
• 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, this medication may modify your normal response to a drop in blood glucose, which usually involves an increase in heart rate.
• Inform hospital staff and, in particular, the anesthetist that you are being treated with this medication.
• Stop taking your tablets only if your doctor instructs you to do so, and in that case, do so only gradually.

Children and adolescents

This medication should not be used in children (see Do not take Atenolol Alter).

Atenolol Alter with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. 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 taking:

• Disopyramide or amiodarone (for irregular heartbeats).
• Other treatments for hypertension or angina (in particular, see verapamil, diltiazem, nifedipine, clonidine).
• If you are taking clonidine for hypertension or to prevent migraine, do not interrupt treatment with this or atenolol 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 bought yourself at a pharmacy.

Pregnancy and breastfeeding

If you are pregnant, 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 atenolol during the first trimester 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 atenolol at the time of delivery or during breastfeeding, as your baby may be at risk of low blood sugar and slower heart rate.

Women who are breastfeeding should consult their doctor before taking this medication as atenolol passes into breast milk.

Driving and operating machinery

Observe your response to the medication because in some cases, dizziness and fatigue have been produced at usual doses. If so, do not drive or operate hazardous machinery.

Use in athletes

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

Atenolol Alter contains wheat starch

This medication contains very low levels of gluten from wheat starch. It is considered "gluten-free," and it is very unlikely to cause problems if you have celiac disease.

Each tablet contains no more than 5 micrograms of gluten.

If you are allergic to wheat (other than celiac disease), do not take this medication.

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

Remember to take your medication.

Your doctor will inform you of the duration of your treatment. Do not stop treatment before your doctor tells you to.

Usual dose for adults

Your doctor will decide the dose of this medication that you should take each day depending on your situation. The table below shows the usual total daily dose for an adult. The dose is usually taken once a day.

Swallow the tablet whole with water. The groove is only for breaking the tablet if it is difficult to swallow whole.

Try to take your tablet at the same time every day.

Do not stop taking your tablets even if you feel well, unless your doctor tells you to; in this case, you should do it gradually.

If you take more Atenolol Alter than you should

If you ingest a dose higher than the usual dose, contact your doctor or go to the nearest hospital.

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

If you forgot 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 doses.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

The side effects that have been observed with this medication are:

Frequent (may affect up to 1 in 10 people)

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

Infrequent (may affect up to 1 in 100 people)

• Sleep disturbances.

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

• Cardiac arrest (which may cause an abnormal heartbeat, dizziness, fatigue, or fainting).
• Worsening of breathing 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 disturbances.
• Hair loss.
• Skin rash, including worsening of psoriasis.
• Thrombocytopenia (easier bleeding tendency).
• Purpura (purple spots on the skin).
• Icterus (which may be detected as yellow discoloration of the skin and eyes).

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

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

Unknown frequency (the frequency cannot be estimated from the available data)

• Lupus-like syndrome (a disease in which the immune system produces antibodies that primarily attack the skin and joints)

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side 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 side effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 86°F (30°C). Store in the original packaging to protect it from light and humidity.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Atenolol Alter

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

Appearance of the product and content of the packaging

White, biconvex tablets with a notch on one face.

It is presented in packaging of 30 or 60 tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Date of the last review of this leaflet:April 2020.

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