Atenolol Aurobindo Italia

Package leaflet: Information for the user

Atenolol Aurobindo Italia 50 mg film-coated tablets, 100 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before you take this medicine because it contains important information for you.

• Keep this leaflet. 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 other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Atenololo Aurobindo Italia is and what it is used for

Atenololo Aurobindo Italia contains a medicine called atenolol. This belongs to a group of
medicines called beta-blockers.
Atenololo Aurobindo Italia is 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).
• It works by making your heart beat more slowly and with less force.

2. What you need to know before taking Atenolol Aurobindo Italia

Do not take Atenolol Aurobindo Italia:

• If you are allergic to atenolol or to any of the other ingredients of this medicine (listed in section 6).
• If you have ever suffered from any of the following heart conditions:
  • Uncontrolled heart failure (this usually causes shortness of breath and swelling of the ankles);
  • Second- or third-degree heart block (a condition that may be treated with a pacemaker);
  • Very slow or very irregular heartbeat, very low blood pressure, or very poor circulation.
• If you have a tumour called "pheochromocytoma" that is not being treated. This tumour usually develops near a kidney and can cause high blood pressure. If you are being treated for pheochromocytoma, your doctor will prescribe another medicine, called an alpha-blocker, to use instead of Atenolol Aurobindo Italia.
• 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 any of the above conditions apply to you. If you are unsure, consult your doctor or pharmacist before taking Atenolol Aurobindo Italia.

Warnings and precautions
Consult your doctor or pharmacist before taking Atenolol Aurobindo Italia if:

• You suffer from asthma, wheezing, or any other similar respiratory problems, or if you experience allergic reactions, for example to insect stings. If you have ever had asthma or wheezing, do not take this medicine without first consulting your doctor.
• You suffer from a specific type of chest pain (angina) called Prinzmetal's angina.
• You have poor blood circulation or controlled heart failure.
• You have first-degree heart block.
• You have diabetes. The medicine may alter how your body responds to low blood sugar levels. You may feel your heart beating faster.
• You suffer from thyrotoxicosis (a condition caused by an overactive thyroid gland). The medicine may mask the symptoms of thyrotoxicosis.
• You have kidney problems. You may need regular monitoring during treatment.

If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist before taking this medicine.
For those engaged in sports: using this medicine without a medical need constitutes doping and may lead to a positive anti-doping test.

Other medicines and Atenolol Aurobindo Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription and herbal preparations. This is because Atenolol Aurobindo Italia may affect the action of other medicines, and other medicines may affect how Atenolol Aurobindo Italia works.
In particular, inform your doctor if you are taking any of the following medicines:

• Verapamil, diltiazem, and nifedipine – used for high blood pressure or chest pain.
• Clonidine – used for high blood pressure or migraine. If you are taking clonidine and Atenolol Aurobindo Italia at the same time, do not stop taking clonidine unless your doctor tells you to. If you need to stop clonidine treatment, your doctor will give you specific instructions on how to do so.
• Digoxin – used for heart problems.
• Disopyramide, quinidine, or amiodarone – used for irregular heartbeat.
• Adrenaline (also known as epinephrine) – medicines that stimulate the heart.
• Ibuprofen or indomethacin – used for pain and inflammation.
• Insulin or other oral medicines for diabetes.
• Medicines for nasal or sinus congestion, or other cold remedies (including those available over the counter).

Surgery and X-rays

• If you go to hospital for surgery, inform the anaesthetist or medical staff that you are taking Atenolol Aurobindo Italia, as you may experience low blood pressure (hypotension) if certain anaesthetics are administered while you are being treated with Atenolol Aurobindo Italia.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use machines. However, it is advisable to wait and see how the medicine affects you before engaging in these activities. If you experience dizziness or fatigue during treatment, do not drive or operate machinery.

Sodium
Atenolol Aurobindo Italia contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially "sodium-free".

3. How to take Atenololo Aurobindo Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

• Your doctor will tell you how many tablets to take each day and when to take them.
• Read the information on the packaging to help you remember what your doctor told you.
• Try to take the tablet at the same time every day.
• Swallow the atenololo tablet whole, with a little water.

Adults
High blood pressure (hypertension): the recommended dose is

• 50 mg to 100 mg per day.

Chest pain (angina): the recommended dose is 100 mg per day or 50 mg twice daily.
Irregular heartbeat (arrhythmias): the recommended dose is

• 50 mg to 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 prescribe a lower dose, especially if you have kidney problems.

Patients with severe kidney problems
If you have severe kidney problems, your doctor may decide to prescribe a lower dose.

Use in children
This medicine must not be given to children.

If you take more Atenololo Aurobindo Italia than you should
If you have taken more Atenololo Aurobindo Italia than prescribed by your doctor, contact your doctor immediately or go to the nearest hospital.

• Take the medicine pack with you so that the tablets can be identified.

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

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

If you stop taking Atenololo Aurobindo Italia
Do not stop taking Atenololo Aurobindo Italia without first talking to your doctor.
You may need to stop taking this medicine gradually.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
If you experience an allergic reaction, seek immediate medical attention. Signs may include raised lumps on the skin (wheals), 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 beats become slower while taking the tablets. This is normal, but if you are concerned, speak to your doctor.
• Cold hands and feet.
• Diarrhoea.
• Feeling unwell.
• Feeling of 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 may cause dizziness, irregular heartbeat, fatigue or fainting).
• Numbness and spasms in the fingers followed by fever and pain (Raynaud's syndrome).
• Mood changes.
• Nightmares.
• Feeling confused.
• Changes in personality (psychosis) or hallucinations.
• Headache.
• Dizziness (especially when standing up).
• Tingling in the hands.
• Dry mouth.
• Hair loss.
• Dry eyes.
• Visual disturbances.
• Skin rash.
• Purple spots on the skin.
• Inability to achieve erection (impotence).
• Jaundice (causing yellowing of the skin or whites of the eyes).
• Reduced number of platelets in the blood (this may lead to bruising more easily).

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

• Changes in certain blood cells or other blood components. Your doctor may occasionally request blood tests to monitor whether Atenololo Aurobindo Italia has had any effect on your blood.

Not known (frequency 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 suffer from any of the following diseases, they may worsen when starting treatment. This occurs rarely and affects fewer than 1 in 1,000 people.
• Psoriasis (a skin condition).
• Shortness of breath or swelling of the ankles (in case of heart failure).
• Asthma or breathing problems.
• Poor circulation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atenolol Aurobindo Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the date stated on the packaging and blister after "EXP". The expiration date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Atenololo Aurobindo Italia contains

• The active substance is atenolol. Each tablet contains 50 mg or 100 mg of atenolol.
• The other components are: Tablet core: Heavy magnesium carbonate, maize starch, sodium lauryl sulfate, gelatin, magnesium stearate (E572). Tablet coating: Hypromellose 2910, talc, macrogol 6000, titanium dioxide (E171).

Description of the appearance of Atenololo Aurobindo Italia and the contents of the pack
Film-coated tablets.
Atenololo Aurobindo Italia 50 mg film-coated tablets
White, round, biconvex film-coated tablets, marked with ‘A50’ on one side and a break line on the other side. The tablet can be divided into two equal doses [size: approximately 8.6 mm].
Atenololo Aurobindo Italia 100 mg film-coated tablets
White, round, biconvex film-coated tablets, marked with ‘A100’ on one side and a break line on the other side. The tablet can be divided into two equal doses [size: approximately 10.5 mm].
Atenololo Aurobindo Italia film-coated tablets are available in transparent PVC/PVdC-Aluminum blister packs.
Pack sizes:
50 mg: 20, 30, 50, 60 and 90 film-coated tablets.
100 mg: 30, 42, 50, 60 and 90 film-coated tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
21047 – Saronno (VA)
Italy

Manufacturers
APL Swift Services (Malta) Ltd., HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Generis Farmacêutica S.A., Rua João de Deus 19, 2700-487 Amadora, Portugal
Arrow Génériques, 26 avenue Tony Garnier, 69007 Lyon, France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
France: Atenolol Arrow lab 50 mg comprimé pelliculé sécable
Atenolol Arrow lab 100 mg comprimé pelliculé sécable
Italy: Atenololo Aurobindo Italia
Portugal: Atenolol Generis Phar
Spain: Atenolol Aurobindo 50 mg/100 mg comprimidos recubiertos con película EFG