ATENOLOLO 100 mg Tablet

Зміст інструкції

1. ATENOLOLO ZENTIVA 100 mg tablets
   1. What is ATENOLOLO ZENTIVA and what it is used for
   2. What you need to know before taking ATENOLOLO ZENTIVA
2. ATENOLOLO ZENTIVA should not be administered to children and adolescents under
   1. How to take ATENOLOLO ZENTIVA
   2. Possible side effects
   3. How to store ATENOLOLO ZENTIVA
   4. Contents of the pack and other information

ATENOLOLO ZENTIVA 100 mg tablets

Generic medicine

Read this leaflet carefully before you start 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 their symptoms are the same as yours, as it could 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 ZENTIVA is and what it is used for
• 2. What you need to know before you take ATENOLOLO ZENTIVA
• 3. How to take ATENOLOLO ZENTIVA
• 4. Possible side effects
• 5. How to store ATENOLOLO ZENTIVA
• 6. Contents of the pack and other information

1. What is ATENOLOLO ZENTIVA 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 contractility).
ATENOLOLO ZENTIVA is indicated in adults for:

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

See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking ATENOLOLO ZENTIVA

Do not takeATENOLOLO ZENTIVA

• if you are allergic to atenolol or any of the other ingredients of this medicine (listed in section 6)
• if you have heart disease, including uncontrolled heart failure or cardiac block
• if you suffer from slow or irregular heartbeat, very low blood pressure, or severe circulatory disorders
• in case of a heart condition that occurs when the blood is not adequately oxygenated (cardiogenic shock)
• if your doctor has diagnosed you with abnormally high levels of acid in the blood (metabolic acidosis)
• 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 in any of the above situations, tell your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking ATENOLOLO ZENTIVA:

• if you have kidney problems
• if you have thyroid problems (a gland located in the neck)
• if you have diabetes (a disease characterized by an excess of sugars in the blood)
• if you have heart problems or blood circulation problems even if controlled by appropriate therapy
• if you have respiratory problems or asthma
• if you suffer from a type of chest pain called “Prinzmetal's angina”
• if you are pregnant or planning to become pregnant or if you are breastfeeding (See section “Pregnancy and Breastfeeding”)
• if you have had allergic reactions in the past (for example, from insect bites)
• if you are taking verapamil or diltiazem

Reduced heart rate (reduced number of heartbeats per minute)
During treatment with ATENOLOLO ZENTIVA you may experience a reduction in heart
rate (see section 4 “Possible side effects”). This effect is normal, but if
it becomes a cause for concern for you, consult your doctor.

Diabetes or hypoglycemia (low blood sugar levels)
If you have diabetes and are taking antidiabetic drugs (medicines to treat diabetes), this
medicine may increase blood sugar levels. This generally causes an
increase in heart rate.

Anesthesia
If you need to be hospitalized, you should inform the medical staff about the treatment in
progress with ATENOLOLO ZENTIVA and, in particular, the anesthesiologist (the doctor who takes care
of the anesthesia) in case of surgery.

For those who practice sports
The use of the drug without a therapeutic need constitutes dopingand may still
result in a positive doping test.

Children and adolescents

ATENOLOLO ZENTIVA should not be administered to children and adolescents under

the age of 18 years.

Other medicines andATENOLOLO ZENTIVA
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor if you are taking any of the following medicines:

• for the treatment of high blood pressure or chest pain (in particular verapamil, diltiazem, clonidine, or nifedipine). Before starting treatment with ATENOLOLO ZENTIVA at least 48 hours must have passed since stopping any previous therapy with verapamil or diltiazem, or vice versa;
• medicines for the treatment of irregular heartbeats (disopyramide or amiodarone);
• medicine for the treatment of heart failure (digoxin, a medicine used for heart disorders);
• nasal decongestants or other medicines (containing for example pseudoephedrine) for the treatment of the common cold;
• pain relievers such as indometacin or ibuprofen;
• clonidine (medicine for the treatment of high blood pressure or to prevent migraine). If you are taking clonidine and ATENOLOLO ZENTIVA together do not stop treatment with clonidine or ATENOLOLO ZENTIVA without first consulting your doctor.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
Babies born to mothers who have taken ATENOLOLO ZENTIVA before delivery or during
breastfeeding may be at risk of hypoglycemia (low blood sugar) or
bradycardia (reduced heart rate per minute).

Consult your doctor before taking this medicine.
Driving and operating machinery
It is unlikely that taking ATENOLOLO ZENTIVA will affect your ability to drive
vehicles and operate machinery.
However, dizziness and fatigue may sometimes occur; if you experience these
symptoms, it is advisable not to perform these activities.

3. How to take ATENOLOLO ZENTIVA

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, depending on your
condition.
The tablets must be swallowed whole with a little water, preferably always at the
same time.

Adults

High blood pressure (arterial hypertension)
The recommended dose is one tablet a day.
Usually the desired effect of lowering blood pressure is achieved after one or two
weeks of therapy.

Angina pectoris (heart disease that manifests with chest pain)
Most patients respond to the administration of one tablet a day.

Irregular heartbeat (arrhythmias)
The recommended dose as maintenance therapy is half or one tablet a day.

Prevention of another heart attack
The recommended dose as maintenance therapy is one tablet a day.

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

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

Use in children and adolescents
ATENOLOLO ZENTIVA must notbe administered to children and adolescents under the age of
18 years.

If you use more ATENOLOLO ZENTIVA than you should
In case of accidental ingestion/intake of an excessive dose of ATENOLOLO ZENTIVA
immediately inform your doctor or go to the nearest hospital.

If you forget to take ATENOLOLO ZENTIVA
Do not take a double dose to make up for the missed tablet.
If you forget to take a dose, it is advisable to take it as soon as possible.
Two doses must not be taken at the same time.

If you stop taking ATENOLOLO ZENTIVA
Improvement of your health condition should not lead to discontinuation of treatment, unless
requested by your doctor.
Discontinuation of treatment must occur gradually.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with ATENOLOLO ZENTIVA, as with any medicine, the following side effects may occur with the following frequency:

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

• slowed heartbeat
• cold fingers of the hands and feet
• gastrointestinal disorders (e.g. nausea, diarrhea)
• alterations of blood tests related to liver function (increased transaminases)
• fatigue

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

• sleep disturbances

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

• worsening of heart function up to cardiac block (condition that can cause an abnormal heartbeat, dizziness, fatigue or fainting), shortness of breath and/or swelling of the ankles if you have heart failure
• sudden drop in blood pressure when standing up with possibility of loss of consciousness, worsening of intermittent claudication (difficulty walking that improves with rest), numbness and cramps in the fingers followed by a sensation of warmth and pain (Raynaud's phenomenon)
• dizziness, headache, tingling in the hands or feet (paresthesia)
• changes in mood, nightmares, confusion, psychosis (mental disorders), hallucinations (seeing inexplicable things), worsening of nervous system diseases with mental depression, catatonia (apathy and reduced motor activity) and memory disorders
• dry mouth
• liver toxicity including intrahepatic cholestasis (reduction of bile flow to the duodenum due to an internal obstruction in the liver) which can lead to a yellowish discoloration of the skin and eyes
• purpura (purple spots on the skin), thrombocytopenia (reduction in the number of platelets in the blood)
• hair loss, skin rashes including worsening of psoriasis (chronic skin inflammation), skin redness and worsening of skin pigment loss in subjects affected by vitiligo (skin disease with the appearance of white spots)
• dry eyes, visual disturbances
• impotence (inability to obtain an erection)
• worsening of breathing difficulties if you have asthma or have suffered from asthma problems

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

• increase in antinuclear antibodies (ANA)

Reporting of side effects
If you get 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 through the national reporting system at:
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 ATENOLOLO ZENTIVA

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 pack after
“Expiry”.
The expiry date refers to the last day of that month.
Store in the original packaging to protect it from light and moisture.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What the medicine containsATENOLOLO ZENTIVA

• The active ingredient is atenolol. Each tablet contains 100 mg of atenolol.
• The other ingredients are: heavy magnesium carbonate, corn starch, sodium lauryl sulfate, magnesium stearate. Description of the appearance ofATENOLOLO ZENTIVAand contents of the packTablets packaged in blisters of 42 white, round, flat tablets with a score line (divisible).

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Zentiva Italia S.r.l. - Viale Luigi Bodio 37/B - 20158 Milano
Manufacturer
Laboratorio Farmaceutico CT - Via Dante Alighieri, 71 - 18038 Sanremo (Imperia)