Package Leaflet: Information for the User

Atenolol Aurovitas 100 mg Film-Coated Tablets

Read 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. Do not give it to others even if they have similar symptoms to 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 Aurovitas contains a medication called atenolol. It belongs to a group of medications known as beta blockers.

Atenolol tablets are used for:

• Treating high blood pressure (hypertension).
• Helping to prevent chest pain (angina).
• Treating irregular heartbeats (arrhythmias).
• Protecting the heart in early treatment after a heart attack (myocardial infarction).
• Making your heart beat slower and with less force.

Do not take Atenolol Aurovitas:

• If you are allergic to atenolol or any of the other components of this medication (listed in section 6).
• If you have ever had any of the following heart problems:

• Uncontrolled heart failure (this usually leaves you breathless and makes your ankles swell)
• Second- or third-degree heart block (a condition that can be treated with a pacemaker)
• Very slow or irregular heartbeats, very low blood pressure, or poor circulation.

• If you have a tumor called "pheochromocytoma" that is not being treated. This is usually located near your kidney and can cause high blood pressure. If you are receiving treatment for pheochromocytoma, your doctor will prescribe another medication, called an alpha-blocker, for you to take in addition to atenol.
• If your doctor has told you that you have higher-than-normal levels of acid in your blood (metabolic acidosis).
• Do not take atenolol if you are in any of the above situations. If you are unsure, consult with your doctor or pharmacist before taking atenolol.

Warnings and precautions

Consult your doctor or pharmacist before starting to take atenolol if:

• You have asthma, bronchitis, or any other respiratory problem, or have allergic reactions, for example, to insect bites. If you have ever had asthma or bronchitis, do not take this medication without first consulting your doctor.
• You have a type of chest pain (angina) called Prinzmetal's angina.
• You have poor circulation or controlled heart failure.
• You have first-degree heart block.
• You have diabetes. This medication may change your normal response to low blood sugar. You may feel that your heart is beating faster.
• You have hyperthyroidism (a condition caused by an overactive thyroid gland). This medication may mask the symptoms of hyperthyroidism.
• You have kidney problems. You may need to undergo some checks during your treatment.

If you are unsure whether any of the above applies to you, consult with your doctor or pharmacist before taking this medication.

Taking Atenolol Aurovitas with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes over-the-counter medications and herbal medications. This is because atenolol may affect how other medications work, and some medications may have an effect on atenolol.

In particular, inform your doctor if you are taking any of the following medications:

• Verapamil, diltiazem, and nifedipine - for high blood pressure or chest pain.
• Clonidine - for high blood pressure or migraine. If you are taking clonidine and atenolol together, do not stop taking clonidine unless your doctor tells you to. If you need to stop taking clonidine, your doctor will give you detailed instructions on how to do it.
• Digoxin - for heart problems.
• Disopyramide, quinidine, or amiodarone (for irregular heartbeats).
• Adrenaline, also known as epinephrine (a medication that stimulates the heart).
• Ibuprofen or indomethacin (for pain or inflammation).
• Insulin or other medications you take orally for diabetes.
• Medications to treat nasal or sinus congestion or other cold remedies (This includes medications you can buy at the pharmacy).

Operations and X-rays

• If you are admitted to the hospital for surgery, inform the anesthesiologist or medical staff that you are taking atenolol. This is because you may have low blood pressure (hypotension) if you are given certain anesthetics while taking this medication.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

It is likely that your medication will not affect your ability to drive or use tools or machines.

However, it is best to wait and see how your medication affects you before trying these activities. If you feel dizzy or tired while taking this medication, do not drive or use tools or machines.

Sodium

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

Important information about some of the components of atenolol:

It is reported to athletes that this medication contains a component that may result in a positive analytical result for doping control

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.

• Your doctor will tell you how many tablets to take each day and when to take them.
• Read the label on the packaging to remember what your doctor said.
• Try to take your tablet at the same time every day.
• Swallow the atenolol tablet whole with a glass of water.

Adults

High blood pressure (hypertension):The recommended dose is

• 50 mg and 100 mg per day.

Chest pain (angina):The recommended dose is 100 mg per day or 50 mg twice a day.

Irregular heartbeats (arrhythmias):The recommended dose is

50 mg and 100 mg per day.

Early treatment of a heart attack (myocardial infarction):The recommended dose is 50 mg to 100 mg per day.

Older adults

If you are an older adult, your doctor may decide to give you a lower dose, especially if you have kidney problems.

People with severe kidney problems

If you have severe kidney problems, your doctor may prescribe a lower dose.

Use in children

This medication should not be given to children.

If you take more Atenolol Aurovitas than you should

If you take more atenolol tablets than prescribed by your doctor, consult a doctor or go to the hospital immediately.

• Bring the medication packaging with you to identify the tablets.

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

If you forget to take Atenolol Aurovitas

If you forget to take a dose, take it as soon as you remember.

If you interrupt treatment with Atenolol Aurovitas

Do not stop taking the atenolol tablets without consulting your doctor. You may need to stop taking it gradually.

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

Allergic reactions:

If you have an allergic reaction, consult a doctor immediately. Symptoms may include raised bumps on the skin (hives) or swelling of the face, lips, mouth, tongue, or throat.

Other possible side effects

Common (may affect up to 1 in 10 people)

• You may notice that your heart rate becomes slower while taking the tablets. This is normal, but if you are concerned, inform your doctor.
• Cold hands and feet.
• Diarrhea.
• General feeling of being unwell.
• Tiredness.

Uncommon (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 dizziness, abnormal heart rhythm, tiredness, or fainting).
• Numbness or spasm in your fingers followed by heat and pain (“Raynaud’s phenomenon”).
• Changes in mood.
• Nightmares.
• Confusion.
• Changes in personality (psychosis or hallucinations).
• Headache.
• Dizziness (especially when standing up).
• Tingling in your hands.
• Dry mouth.
• Hair loss.
• Dry eyes.
• Vision problems.
• Skin rash.
• Purple patches on the skin.
• Inability to achieve an erection in men (impotence).
• Icterus (causing yellow discoloration of the skin or white of the eyes).
• Reduced platelet count in the blood (increased tendency to bruise).

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

• Changes in some cells or other components of the blood. Your doctor may wish to perform a blood test to check if atenolol has had any effect on your blood.

Frequency not known (cannot be estimated from available data)

• Syndrome similar to lupus (a disease in which the immune system produces antibodies that attack mainly the skin and joints).

Conditions that may worsen

• If you have any of the following conditions, they may worsen when you start taking your medicine. This occurs rarely affecting less than 1 in 1,000 people.
• Psoriasis (a skin condition).
• Difficulty breathing or inflammation of the ankles (if you have heart failure).
• Asthma or respiratory problems.
• Poor circulation.

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 the 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.

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

This medication does not require special conditions for conservation.

Medications should not be thrown into the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition ofAtenolol Aurovitas

• The active ingredient is atenolol.

Each tablet contains 100 mg of atenolol.

• The other components are:

Tablet core: magnesium carbonate (heavy), cornstarch, sodium lauryl sulfate, gelatin, magnesium stearate.

Tablet coating: hypromellose 2910, talc, macrogol 6000, and titanium dioxide (E171).

Appearance of the product and contents of the package

Coated tablet.

White, round, biconvex coated tablets, engraved with ‘A100’ on one face and with a notch on the other. The tablet can be divided into equal doses. [size: approximately 10.5 mm].

Atenolol Aurovitas coated tablets are available in transparent PVC/PVdC-Aluminum blister packs.

Pack sizes:30, 42, 50, 60, and 90 coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica S.A.

Rua Joao de Deus, nº 19 Amadora, Venda Nova

2700-487

Portugal

O

Arrow Generiques-Lyon

26 avenue Tony Garnier, Lyon, 69007

France

This medicine is authorized in the member states of the European Economic Area with the following names:

France:Atenolol Arrow lab 100 mg coated tablet

Italy:Atenololo Aurobindo Italia

Portugal:Atenolol Generis Phar

Spain:Atenolol Aurovitas 100 mg coated tablets EFG

Last review date of this leaflet: May 2019

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