Package Insert: Information for the User

Atenolol Normon 50 mg Film-Coated Tablets EFG

atenolol

Read this package insert carefully before starting to take this medicine, as 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 medicine has been prescribed only for you, and you should not give it to others even if they 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.

Contents of the Package and Additional Information

Atenolol belongs to a group of medications known as beta blockers, meaning it acts on your heart and circulatory system.

Atenolol is indicated for the treatment of high blood pressure, 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 Normon:

• If you are allergic to atenolol or any of the other components of this medication (listed in section 6).
• If you have experienced or have heart conditions such as uncontrolled heart failure or blockage (heart conduction disorder).
• If you have ever experienced very slow or irregular heartbeats, very low blood pressure, or circulatory insufficiency.
• If you have ever 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).

•These tablets are for your exclusive use only and should not be given to anyone else.

• Warnings and precautions

Consult your doctor or pharmacist before starting to take Atenolol Normon.

• 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 specific type of chest pain (Prinzmetal's angina).

• If you are pregnant, think you may be, 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 this concerns you, inform your doctor.

• If you are diabetic, atenolol may modify your normal response to blood glucose lowering, which usually involves an increase in heart rate.

• In the event of hospital admission, inform the healthcare staff and, in particular, the anesthetist that you are being treated with atenolol.

• Stop taking your tablets only if your doctor instructs you to and, in that case, do so only gradually.

• Children and adolescents

Do not use in children. See “do not take Atenolol Normon”.

• Atenolol Normon with other medications

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

• Disopyramide or amiodarone (for irregular heartbeats).
• Other treatments for hypertension or angina (particularly, see verapamil, diltiazem, nifedipine, clonidine). If you are taking clonidine for hypertension or to prevent migraines, do not interrupt treatment with this or atenolol without consulting your doctor first.
• Treatment for heart failure (digoxin).
• Anti-inflammatory medications for pain treatment (such as indomethacin or ibuprofen).
• Decongestants or other cold products that you may have purchased yourself at a pharmacy.

See “Warnings and precautions”.

• Pregnancy and breastfeeding

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

Pregnancy

There is insufficient data on the safety of atenolol 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 atenolol at the time of delivery or during breastfeeding, as your baby may be at risk of low blood sugar and slower heartbeats.

Atenolol passes into breast milk.

Driving and operating machinery

It is unlikely that these tablets will negatively affect these abilities. However, some patients may occasionally experience dizziness and fatigue while being treated with atenolol; therefore, if you feel these effects, you should not drive a vehicle or operate machinery.

?Use in athletes

Notify athletes that this medication contains a component that may result in a positive analytical result in a doping control as positive.

• Atenolol Normon contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

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

Remember to take your medication

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

Usual dose foradults:

Your doctor will decide the dose of atenolol 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.
• 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 Normon than you should:

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service.

(Tel. 91 562 04 20). It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

• If you forgot to take Atenolol Normon

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.

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

Common(may affect up to 1 in 10 patients)

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

Uncommon(may affect up to 1 in 100 patients)

• Sleep disturbances.

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

• Cardiac arrest (which may cause an abnormal heartbeat, dizziness, fatigue, or fainting).
• Worsening of breathing difficulties, if you have or have had 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 yellowish discoloration of your skin and eyes).

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

• 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 the 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)

.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 leaflet. You can also report them directly through the Spanish System for 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 medicine.

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

No special storage conditions are required. Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging and on the blister (after “CAD”).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 the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Atenolol Normon

The active ingredient is atenolol. Each coated tablet contains 50 mg of atenolol.

The other components are: microcrystalline cellulose (E-460i), pregelatinized cornstarch, sodium carboxymethyl starch (type A) (derived from potato starch), magnesium stearate (E-470b), talc (E-553b), titanium dioxide (E-171), macrogol 6000, copolymer of ammonium methacrylate type A and propylene glycol (E-1520).

Appearance of the Product and Contents of the Package

Atenolol Normon is presented in the form of coated tablets with a white or slightly cream-colored film, round, biconvex, with a breaking bar and printed on one face and anonymous on the other.

Atenolol Normon is presented in packages of 30 and 60 tablets.

Holder of the Marketing Authorization and Responsible for Manufacturing

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the Last Review of this Leaflet:April 2019

Other Sources of Information

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