ATENOLOLO 50 mg Film-Coated Tablets

Зміст інструкції

1. Atenololo Aurobindo Italia 50 mg film-coated tablets, 100 mg film-coated tablets
   1. What is Atenololo Aurobindo Italia and what is it used for
   2. What you need to know before taking Atenololo Aurobindo Italia
   3. How to take Atenololo Aurobindo Italia
   4. Possible side effects
   5. How to store Atenololo Aurobindo Italia
   6. Package Contents and Other Information

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

Generic medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Atenololo Aurobindo Italia and what is it 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 the 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 Atenololo Aurobindo Italia

Do not take Atenololo Aurobindo Italia:

• If you are allergic to atenolol or any of the other ingredients of this medicine (listed in section 6).
• If you have ever suffered from any of the following heart problems:
• 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 heartbeats, very low blood pressure or very poor circulation.
• If you suffer from a tumor called “pheochromocytoma” that is not being treated. This tumor 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 Atenololo Aurobindo Italia.
• If your doctor has told you that you have higher than normal acid levels in your blood (metabolic acidosis).
• Do not take atenolol if any of the conditions described above occur. If you are unsure, ask your doctor or pharmacist before taking Atenololo Aurobindo Italia.

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

• You suffer from asthma, wheezing or any other similar respiratory problem, or if you developallergic reactions, for example to insect bites. If you have ever suffered from asthma or wheezing, do not take this medicine without first consulting your doctor.
• You suffer from a certain type of chest pain (angina) called Prinzmetal's angina.
• You have poor blood circulation or suffer from controlled heart failure.
• You have a first-degree heart block.
• You suffer from diabetes. The medicine may change the way your body responds to low blood sugar levels. You may feel your heart beating faster.
• You suffer from hyperthyroidism (a condition caused by an overactive thyroid gland). The medicine may hide the symptoms of hyperthyroidism.
• You have kidney problems. You may need some checks during treatment.

If you are not sure whether any of these conditions apply to you, consult your doctor or pharmacist before taking
this medicine.
For those who play sports: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.

Other medicines and Atenololo Aurobindo Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription and herbal preparations. This is because
Atenololo Aurobindo Italia can affect the action of other medicines, and other medicines can have effects
on the way Atenololo Aurobindo Italia works.
In particular, tell 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 Atenololo Aurobindo Italia at the same time, do not stop taking clonidine unless your doctor tells you to do so. If you need to stop treatment with clonidine, 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 called epinephrine - medicines that stimulate the heart.
• Ibuprofen or indometacin - used for pain and inflammation.
• Insulin or other medicines for diabetes taken by mouth.
• Medicines for the treatment of nasal or sinus congestion, or other cold remedies (including over-the-counter medicines).

Surgery and X-rays

• If you go to hospital for an operation, tell the anesthesiologist or medical staff that you are taking Atenololo Aurobindo Italia as you may experience low blood pressure (hypotension) if you are given certain anesthetics while being treated with Atenololo Aurobindo Italia.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive and use machines.
However, it is best to wait and see what effects the medicine has on you before engaging in these
activities. If you feel dizzy or tired during treatment, do not drive and do not use tools or
machinery.

Sodium
Atenololo 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 following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.

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

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

• from 50 mg to 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

• from 50 mg to 100 mg per day.

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

Elderly
If you are elderly, your doctor may decide to prescribe you a lower dose, especially if you suffer from kidney
problems.

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

Use in children
This medicine should 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, go to your doctor immediately or
go to the nearest hospital.

• Bring the medicine packaging 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 to take the next dose, skip the missed dose.
• Do not take a double dose to make up for a missed 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.
manifest.

Allergic reactions
If you have an allergic reaction, seek immediate medical attention. 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 becomes slower while taking the tablets. This is normal, but if you are concerned talk to your doctor.
• Cold hands and feet.
• Diarrhoea.
• Feeling unwell.
• Feeling tired.

Uncommon (may affect up to 1 in 100 people)

• Sleep disturbances.

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

• Heart block (which can cause dizziness, irregular heartbeat, tiredness or fainting).
• Numbness and spasm 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.
• Bruise-like spots on the skin.
• Inability to achieve an erection (impotence).
• Jaundice (which causes yellowing of the skin or whites of the eyes).
• Reduced number of platelets in the blood (this can lead to bruising more easily)

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

• Changes in some blood cells or other blood components. Your doctor may also request blood tests from time to time to check if 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 illnesses, these may worsen when you start taking the medicine. This is rare and affects less than 1 in 1,000 people.
• Psoriasis (a skin disease).
• 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 get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 Atenololo Aurobindo Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the date that is reported on the packaging and on the blister after “EXP”. The date
of expiry refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Atenololo Aurobindo Italia contains

• The active ingredient is atenolol. Each tablet contains 50 mg or 100 mg of atenolol.
• Other ingredients are: Tablet core: Heavy magnesium carbonate, corn 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 package contents
Film-coated tablets.

Atenololo Aurobindo Italia 50 mg film-coated tablets
White, round, biconvex film-coated tablets, imprinted with ‘A50’ on one side and with a
breakline 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, imprinted with ‘A100’ on one side and with
a breakline on the other side. The tablet can be divided into two equal doses [size: approximately 10.5
mm].
Atenololo Aurobindo Italia film-coated tablets is available in transparent blister packs of
PVC/PVdC-Aluminum.

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 Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102

• 21047 – Saronno (VA) Italy

Manufacturer
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 authorised in the Member States of the European Economic Area under the following
names:
France: Atenolol Arrow lab 50 mg comprimé pelliculé secable
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