ATENOLOL NORMON 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Atenolol Normon 100 mg Film-Coated 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Atenolol Normon and what is it used for
2. What you need to know before you take Atenolol Normon
3. How to take Atenolol Normon
4. Possible side effects
5. Storage of Atenolol Normon

Contents of the Pack and Further Information

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

Atenolol belongs to a group of medicines called beta-blockers, 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.

2. What you need to know before you take Atenolol Normon

• Do not take Atenolol Normon:

• 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 conditions 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 ever been told that you have a pheochromocytoma (a tumor in the adrenal glands).
• if you have been fasting.
• if you have been told that you have metabolic acidosis (a metabolic disorder that causes excessive blood acidity).

These tablets are for your 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, kidney, or thyroid problems.

• If you have ever been told 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 breast-feeding. See “Pregnancy and Breast-feeding”.

• If you have ever had an allergic reaction to anything, for example, an insect bite.

• You may notice that your pulse is slower while taking these tablets. This is normal, but if it concerns you, inform your doctor.
• If you are diabetic, atenolol may change your normal response to low blood sugar, which usually involves an increase in heart rate.
• In case of hospitalization, inform the healthcare staff and, in particular, the anesthesiologist, that you are being treated with atenolol.
• Stop taking your tablets only if your doctor tells you to do so, and in that case, do it gradually.

• Children and Adolescents

Should not be used in children. See “Do not take Atenolol Normon”.

• Other Medicines and Atenolol Normon:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained 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 medicines can 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 (in particular, verapamil, diltiazem, nifedipine, clonidine). If you are taking clonidine for high blood pressure or to prevent migraines, do not stop treatment with it or atenolol without consulting your doctor first.
• Treatment for heart failure (digoxin).
• Anti-inflammatory medicines for pain treatment (such as indomethacin or ibuprofen).
• Decongestants or other cold products that you may have bought yourself at a pharmacy.

See “Warnings and Precautions”.

• Pregnancy and Breast-feeding

Pregnancy:

Consult your doctor or pharmacist before taking a medicine. Inform your doctor if you are pregnant, think you may be pregnant, or are breast-feeding.

There is not enough data on the safety of atenolol during the first month of pregnancy. Your doctor will decide if treatment during the second and third trimester is beneficial for you.

Breast-feeding:

Inform your doctor if you are being treated with atenolol at the time of delivery or during breast-feeding, as your baby may be at risk of low blood sugar and slower heartbeats.

Atenolol passes into breast milk.

• Driving and Using Machines

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.

?Important Information about Some of the Ingredients of Atenolol

Athletes are informed that this medicine contains a component that may result in a positive doping test.

• Atenolol Normon contains Sodium

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

3. How to Take Atenolol Normon

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

Remember to take your medicine.

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

Usual Dose for Adults:

Your doctor will decide the dose of atenolol that you should take each day depending on your situation. The Table included below shows the usual total daily dose for an adult. The dose is taken, normally, once a day.

• Swallow the tablet whole with the help of water.
• 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 to do so; in that case, do it gradually.

If you take more Atenolol Normon than you should:

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

In case of overdose or accidental ingestion, consult the Toxicology Information Service. (Tel. 91 562 04 20). It is recommended to take the packaging and the package leaflet of the medicine to the healthcare professional.

• If you forget 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 forgotten doses.

4. Possible Side Effects

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

Common (may affect up to 1 in 10 people)

• Slower heartbeats.
• Cold 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 can cause an abnormal heartbeat, dizziness, fatigue, or fainting).
• Worsening of breathing difficulties, if you have or have had 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 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.
• Tingling sensation in the hands.
• Impotence.
• Dry mouth.
• Dry eyes.
• Vision disorders.
• Hair loss.
• Skin rash, including worsening of psoriasis.
• Thrombocytopenia (greater ease of bruising).
• Purpura (purple spots on the skin).
• Jaundice (which can be detected as a yellowish color of your skin and eyes).

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

• Very rarely, changes in some blood cells or components may occur. It is possible that your doctor may want to perform a blood test to check if atenolol has had any effect on the 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)

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atenolol Normon

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

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

Do not use this medicine after the expiry date which is stated on the packaging and blister (after “EXP”). The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Atenolol Normon

The active ingredient is atenolol. Each film-coated tablet contains 100 mg of atenolol.

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

Appearance of the Product and Contents of the Pack

Atenolol Normon is presented in the form of white or slightly creamy film-coated tablets, round, biconvex, with a break line and serigraphic on one face and anonymous on the other.

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

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the Last Revision of this Leaflet:April 2019

Other Sources of Information

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

You can access detailed information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/61493/P_61493.html