ATENOLOL AUROVITAS 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Atenolol Aurovitas 50 mg Film-Coated Tablets EFG

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 Aurovitas and what is it used for
2. What you need to know before you take Atenolol Aurovitas
3. How to take Atenolol Aurovitas
4. Possible side effects
5. Storage of Atenolol Aurovitas
6. Contents of the pack and other information

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

Atenolol Aurovitas contains a medicine called atenolol. It belongs to a group of medicines called beta-blockers.

Atenolol tablets are used to:

• Treat high blood pressure (hypertension).
• Help prevent chest pain (angina).
• Treat irregular heartbeats (arrhythmias).
• Protect the heart in the early treatment after a heart attack (myocardial infarction).
• Make your heart beat more slowly and with less force.

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

Do not take Atenolol Aurovitas:

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

• uncontrolled heart failure (this usually makes you short of breath and causes your ankles to swell)
• second or third degree heart block (a condition that can be treated with a pacemaker)
• very slow or very irregular heartbeats, very low blood pressure or very 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 being treated for pheochromocytoma, your doctor will prescribe another medicine, called an alpha-blocker, for you to take in addition to atenolol.
• If your doctor has told you that you have high levels of acid in your blood (metabolic acidosis).
• Do not take atenolol if you are in any of the above situations. If you are not sure, consult your doctor or pharmacist before taking atenolol.

Warnings and precautions

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

• You have asthma, wheezing or any other similar breathing problems, or you have allergic reactions, for example to insect bites. If you have ever had asthma or wheezing, do not take this medicine 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 medicine may change your normal response to low blood sugar. You may feel that your heart is beating faster.
• You have thyrotoxicosis (a condition caused by an overactive thyroid gland). This medicine may hide the symptoms of thyrotoxicosis.
• You have kidney problems. You may need to have some checks while you are taking this medicine.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking this medicine.

Taking Atenolol Aurovitas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because atenolol can affect the way that other medicines work and some medicines can have an effect on atenolol.

In particular, tell your doctor if you are taking any of the following medicines:

• 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 have 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 medicine that stimulates the heart).
• Ibuprofen or indometacin (for pain or inflammation).
• Insulin or other medicines that you take by mouth for diabetes.
• Medicines to treat nasal or sinus congestion or other cold remedies (including medicines that you can buy at the pharmacy).

Operations and X-rays

• If you are going to have an operation, tell the anaesthetist or medical staff that you are taking atenolol. This is because you may have low blood pressure (hypotension) if you are given certain anaesthetics while taking this medicine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

It is unlikely that your medicine will affect your ability to drive or use tools or machines.

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

Sodium

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

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 control test

3. How to take Atenolol Aurovitas

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

• Your doctor will tell you how many tablets to take each day and when to take them.
• Read the label on the carton to remind you what the 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.

Elderly

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

Patients with severe kidney problems

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

Use in children

This medicine should not be given to children.

If you take more Atenolol Aurovitas than you should

If you take more tablets than you should, consult a doctor or go to the hospital immediately.

• Take the medicine pack with you, so that you can show what you have taken.

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

If you forget to take Atenolol Aurovitas

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

• However, if it is almost time for the next dose, skip the missed dose.
• Do not take a double dose to make up for the missed dose.

If you stop taking Atenolol Aurovitas

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

4. Possible side effects

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

Allergic reactions:

If you have an allergic reaction, see a doctor immediately. The signs 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 pulse rate becomes slower while you are taking the tablets. This is normal, but if you are worried, tell your doctor.
• Cold fingers and toes.
• Diarrhoea.
• General feeling of being unwell.
• Tiredness.

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 dizziness, abnormal heartbeat, tiredness or fainting).
• Numbness or spasm in your fingers followed by warmth and pain ("Raynaud's phenomenon").
• Mood changes.
• Nightmares.
• Confusion.
• Changes in personality (psychosis or hallucinations).
• Headache.
• Dizziness (especially when standing up).
• Tingling in your hands.
• Dry mouth.
• Thinning of hair.
• Dry eyes.
• Vision disorders.
• Rash.
• Purple spots on the skin.
• Impotence in men.
• Jaundice (causing yellowing of your skin or the whites of your eyes).
• Low platelet count in the blood (which may make you more prone to bruising).

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

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

Conditions that may worsen

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atenolol Aurovitas

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Atenolol Aurovitas

• The active substance is atenolol.

Each tablet contains 50 mg of atenolol.

• The other ingredients are:

Core of the tablet: magnesium carbonate (heavy), maize starch, sodium lauryl sulfate, gelatin, magnesium stearate.

Coating of the tablet: hypromellose 2910, talc, macrogol 6000 and titanium dioxide (E171).

Appearance and packaging of the product

Film-coated tablet.

White, round, biconvex film-coated tablets, engraved with 'A50' on one face and with a score line on the other. The tablet can be divided into equal doses. [size: approximately 8.6 mm].

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

Package sizes:20, 30, 50, 60 and 90 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 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

Or

Generis Farmacêutica S.A.

Rua Joao de Deus, nº 19 Amadora, Venda Nova

2700-487

Portugal

Or

Arrow Generiques-Lyon

26 avenue Tony Garnier, Lyon, 69007

France

This medicine is authorised in the Member States of the European Economic Area under the following names:

France: Atenolol Arrow lab 50 mg film-coated tablet, scored

Italy: Atenololo Aurobindo Italia

Portugal: Atenolol Generis Phar

Spain: Atenolol Aurovitas 50 mg film-coated tablets EFG

Date of last revision of this leaflet: May 2019

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