Atenolol Zentiva

Package leaflet: Information for the patient

ATENOLOL ZENTIVA 100 mg tablets

Generic medicine
Please read all of this leaflet carefully before taking 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, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ATENOLOLO ZENTIVA is and what it is used for

ATENOLOLO ZENTIVA contains atenolol.
Atenolol belongs to a group of medicines called beta-blockers, which work by slowing down the heartbeat (reducing heart rate and cardiac contractility).
ATENOLOLO ZENTIVA is indicated in adults for:

• treating high blood pressure (arterial hypertension)
• treating angina pectoris attacks (heart disease characterized by chest pain)
• treating irregular heartbeat (arrhythmias)
• helping to prevent the occurrence of another heart attack (acute myocardial infarction)

Talk to your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking ATENOLOL ZENTIVA

Do not take ATENOLOL ZENTIVA

• if you are allergic to atenolol or to any of the other ingredients of this medicine (listed in section 6)
• if you have heart diseases, including uncontrolled heart failure not managed by adequate therapy, or heart block
• if you have slow or irregular heartbeats, very low blood pressure, or severe circulatory disorders
• if you have a heart condition occurring when blood is inadequately oxygenated (cardiogenic shock)
• if your doctor has diagnosed abnormally high levels of acid in your blood (metabolic acidosis)
• if you have a tumor called "pheochromocytoma" that is not being treated (this tumor usually develops near a kidney and may cause high blood pressure)

If you are in any of the above situations, inform your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking ATENOLOL ZENTIVA:

• if you have kidney problems
• if you have thyroid problems (a gland located in the neck)
• if you have diabetes (a condition characterized by excess sugar in the blood)
• if you have heart or circulatory problems, even if controlled by adequate therapy
• if you have respiratory problems or asthma
• if you have a type of chest pain called "Prinzmetal's angina"
• if you are pregnant, planning to become pregnant, or breastfeeding (See section “Pregnancy and Breast-feeding”)
• if you have previously experienced allergic reactions (e.g., from insect stings)
• if you are being treated with verapamil or diltiazem

Reduced heart rate (lower number of heartbeats per minute)
During treatment with ATENOLOL ZENTIVA, you may experience a reduced heart rate (see section 4 “Possible side effects”). This effect is normal, but if it causes concern, consult your doctor.
Diabetes or hypoglycemia (low blood sugar levels)
If you have diabetes and are taking antidiabetic medicines (medicines for treating diabetes), this medicine may increase your blood sugar levels. This usually causes an increased heart rate.
Anaesthesia
If you need to be admitted to hospital, you must inform medical staff that you are being treated with ATENOLOL ZENTIVA, and particularly inform the anaesthetist (the doctor administering anaesthesia) if you are undergoing surgery.
For athletes
Using this medicine without a therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
Children and adolescents
ATENOLOL ZENTIVA must not be given to children and adolescents under 18 years of age.
Other medicines and ATENOLOL ZENTIVA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines:

• medicines for high blood pressure or chest pain (especially verapamil, diltiazem, clonidine, or nifedipine). At least 48 hours must elapse between stopping a previous treatment with verapamil or diltiazem and starting treatment with ATENOLOL ZENTIVA, or vice versa;
• medicines for irregular heartbeats (disopyramide or amiodarone);
• medicines for heart failure (digoxin, a medicine used for heart disorders);
• nasal decongestants or other medicines (containing, for example, pseudoephedrine) used to treat colds;
• painkillers such as indometacin or ibuprofen;
• clonidine (a medicine for treating high blood pressure or preventing migraine). If you are taking both clonidine and ATENOLOL ZENTIVA, do not stop either treatment without first consulting your doctor.

Pregnancy and breast-feeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Babies born to mothers who have taken ATENOLOL ZENTIVA before delivery or during breast-feeding may be at risk of hypoglycemia (low blood sugar) or bradycardia (reduced heart rate).
Consult your doctor before taking this medicine.
Driving and using machines
It is unlikely that taking ATENOLOL ZENTIVA will affect your ability to drive or operate machinery.
However, dizziness and fatigue may occasionally occur; if you experience these symptoms, it is advisable not to perform such activities.

3. How to take ATENOLOL ZENTIVA

Take this medicine exactly as instructed 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, depending on your condition.
The tablets should be taken whole with a glass of water, preferably always at the same time.

Adults
High blood pressure (arterial hypertension)
The recommended dose is one tablet daily.
The desired blood pressure-lowering effect is usually achieved after one or two weeks of treatment.

Angina pectoris (heart disease causing chest pain)
Most patients respond to the administration of one tablet daily.

Irregular heartbeat (arrhythmias)
The recommended maintenance dose is half or one tablet daily.

Prevention of a further heart attack
The recommended maintenance dose is one tablet daily.

Elderly patients
If you are elderly, your doctor may decide to prescribe a lower dose of ATENOLOL ZENTIVA.

If you have severe kidney problems
If you suffer from severe kidney problems, your doctor may decide to prescribe a lower dose of ATENOLOL ZENTIVA.

Use in children and adolescents
ATENOLOL ZENTIVA must not be given to children and adolescents under 18 years of age.

If you take more ATENOLOL ZENTIVA than you should
In case of accidental ingestion or overdose of ATENOLOL ZENTIVA, contact your doctor immediately or go to the nearest hospital.

If you forget to take ATENOLOL ZENTIVA
Do not take a double dose to make up for the missed tablet.
If you forget to take a dose, take it as soon as possible.
Do not take two doses at the same time.

If you stop taking ATENOLOL ZENTIVA
Do not stop treatment because you feel better, unless instructed by your doctor.
Discontinuation of treatment should be done gradually.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
During treatment with ATENOLOL ZENTIVA, as with any medicine, the following side effects may occur according to the frequency listed below:

Common (may affect up to 1 in 10 people):

• slow heartbeat
• cold fingers of the hands and feet
• gastrointestinal disorders (e.g. nausea, diarrhoea)
• changes in blood tests related to liver function (increase in transaminases)
• fatigue

Uncommon (may affect up to 1 in 100 people):

• sleep disorders

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

• worsening of heart function up to heart block (a condition that may cause abnormal heartbeat, dizziness, fatigue or fainting), difficulty breathing and/or swelling of the ankles if you have heart failure
• sudden drop in blood pressure when standing up, possibly leading to loss of consciousness, worsening of intermittent claudication (difficulty walking that improves with rest), numbness and cramps in the fingers followed by a sensation of heat and pain (Raynaud's phenomenon)
• dizziness, headache, tingling in the hands or feet (paraesthesia)
• mood changes, nightmares, confusion, psychosis (mental disorders), hallucinations (seeing things that are not there), worsening of nervous system disorders with mental depression, catatonia (apathy and reduced motor activity), and memory disturbances
• dry mouth
• liver toxicity including intrahepatic cholestasis (reduced bile flow to the duodenum due to internal obstruction in the liver), which may lead to yellowing of the skin and eyes
• purpura (purple skin spots), thrombocytopenia (reduced number of platelets in the blood)
• hair loss, skin rashes including worsening of psoriasis (chronic skin inflammation), skin redness, and worsening of loss of skin pigment in patients with vitiligo (a skin disease characterized by the appearance of white patches)
• dry eyes, visual disturbances
• impotence (inability to achieve an erection)
• worsening of breathing difficulties if you have asthma or have previously suffered from asthma-related problems

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

• increase in antinuclear antibodies (ANA)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ATENOLOL ZENTIVA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
Store in the original packaging to protect from light and moisture.
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 Atenolol Zentiva contains

• The active substance is atenolol. Each tablet contains 100 mg of atenolol.
• The other components are: heavy magnesium carbonate, maize starch, sodium lauryl sulfate, magnesium stearate.

Description of the appearance of Atenolol Zentiva and package contents
Tablets packaged in blisters containing 42 white, round, flat tablets with a score line (divisible).

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zentiva Italia S.r.l. - Viale Luigi Bodio 37/B - 20158 Milan, Italy
Manufacturer
Laboratorio Farmaceutico CT - Via Dante Alighieri, 71 - 18038 Sanremo (Imperia), Italy