Atenolol PensA

Package leaflet: Information for the patient

ATENOLOLO PENSA 100 mg tablets

Atenolol
Generic medicine
Read 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 may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

ATENOLOLO PENSA contains atenolol. Atenolol belongs to a group of medicines
called beta-blockers, which work by slowing down the heart rate.
ATENOLOLO PENSA is indicated in adults for:

• treating high blood pressure (arterial hypertension)
• treating angina pectoris attacks (heart disease characterized by chest pain)

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

2. What you need to know before taking ATENOLOLO PENSA

Do not take ATENOLOLO PENSA

• 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 due to inadequate therapy or cardiac shock
• if you have abnormally slow or irregular heartbeat, very low blood pressure, or severe circulatory disorders
• if you have a heart conduction disorder (second- or third-degree atrioventricular block or sick sinus syndrome)
• in case of cardiogenic shock (a heart disorder occurring when blood is inadequately oxygenated)
• if your doctor has diagnosed abnormally high levels of acid in your blood (metabolic acidosis)
• if you have a tumor called "pheochromocytoma" not currently under treatment (this tumor usually develops near a kidney and may cause high blood pressure)
• if you have a rare disease characterized by brief episodes of narrowing of the arteries, the blood vessels carrying blood from the heart to the rest of the body (Raynaud's syndrome)
• if you suffer from severe asthma or severe chronic obstructive pulmonary disease
• if you are being treated with intravenous verapamil or diltiazem
• if you are breastfeeding. If you are in any of the above situations, inform your doctor.

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

• if you have kidney problems
• if you have thyroid problems (a gland located in the neck)
• if you have diabetes (a condition characterized by high blood sugar levels) or hypoglycemia (a condition characterized by low blood sugar levels), because atenolol may mask changes in heart rate (tachycardia). Atenolol may also increase the risk of severe hypoglycemia when used with certain types of antidiabetic medicines called sulfonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide)
• if you have heart problems or circulatory disorders, 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 or planning to become pregnant (See section "Pregnancy and Breast-feeding")
• if you have previously experienced allergic reactions (e.g. from insect stings)
• if you are taking verapamil or diltiazem.
• do not stop taking ATENOLOLO PENSA abruptly, especially if you have inadequate oxygen supply to the heart (ischemic heart disease). If you need to stop or discontinue treatment with ATENOLOLO PENSA after prolonged use, the dose should always be reduced gradually by tapering, as sudden withdrawal may lead to reduced oxygenated blood supply to the heart (myocardial ischemia), worsening of angina pectoris (a heart condition causing chest pain), myocardial infarction, or worsening of hypertension.
• if you have severe impairment of kidney function, dose adjustment is necessary because ATENOLOLO PENSA is eliminated via the kidneys.

Anesthesia
Particular caution must be exercised when using anesthetic agents during treatment with ATENOLOLO PENSA. If you are scheduled for surgery, treatment with ATENOLOLO PENSA should be discontinued at least 24 hours before the procedure, due to an increased risk of low blood pressure (hypotension). Consult your doctor regarding the risk-benefit assessment of stopping ATENOLOLO PENSA.
If you are to be hospitalized, you must inform the medical staff about your ongoing treatment with ATENOLOLO PENSA, and especially the anesthesiologist (the doctor responsible for anesthesia) in case of surgery.

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

Diabetes or hypoglycemia (low blood sugar levels)
If you have diabetes and are being treated with antidiabetic medicines (medicines for treating diabetes), this medicine may increase your blood sugar levels. This usually causes an increased heart rate.

For athletes
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Children and adolescents
ATENOLOLO PENSA must not be given to children and adolescents under 18 years of age.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

Other medicines and ATENOLOLO PENSA
Tell 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 treating high blood pressure or chest pain (especially verapamil, diltiazem, clonidine, or nifedipine), since concomitant use with these medicines may worsen the above-mentioned conditions, particularly in patients with impaired heart function. This may cause severe lowering of blood pressure (severe hypotension), heart rate reduction below 60 beats per minute (bradycardia), and heart failure. At least 48 hours must elapse between discontinuation of any prior intravenous treatment with verapamil or diltiazem and starting treatment with ATENOLOLO PENSA, and vice versa.
• medicines for treating irregular heartbeat (disopyramide or amiodarone)
• medicines for treating heart failure (digitalis glycosides)
• sympathomimetic drugs such as adrenaline
• nasal decongestants or other medicines (e.g. containing pseudoephedrine) for treating colds
• analgesics such as indomethacin or ibuprofen
• clonidine (a medicine for treating high blood pressure or preventing migraine). If you are taking clonidine and ATENOLOLO PENSA together, do not stop treatment with clonidine or ATENOLOLO PENSA without first consulting your doctor. Also consult your doctor if you need to switch from clonidine to ATENOLOLO PENSA.
• insulin or oral antidiabetic medicines such as sulfonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).

Pregnancy and breast-feeding
If you are pregnant, think 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 took ATENOLOLO PENSA before delivery or during breast-feeding may be at risk of hypoglycemia (low blood sugar) or bradycardia (reduced heart rate).
Atenolol accumulates in breast milk; therefore, its use is contraindicated during breast-feeding.

Driving and using machines
It is unlikely that taking ATENOLOLO PENSA 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 PENSA

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, depending on your condition. The recommended starting dose, especially in elderly patients, is the lowest available dose, so that symptoms of heart failure (the heart's inability to supply an adequate amount of blood according to the body's actual needs), bradycardia (reduction in heart rate below 60 beats per minute), and bronchial symptoms can be promptly recognized.
The tablets should be swallowed whole with a little water, preferably always at the same time each day. The tablets must not be chewed and should be taken with sufficient liquid to aid swallowing.

Adults
High blood pressure (arterial hypertension)
Begin treatment with 50 mg of atenolol daily, using another atenolol-containing medicine for which this dosage is available/obtainable.
The desired blood pressure-lowering effect is usually achieved after one or two weeks of treatment. If a satisfactory effect is not obtained, take one tablet daily during the second week.
If necessary, further reduction in blood pressure may be achieved by taking ATENOLOL PENSA together with other medicines used to control high blood pressure (antihypertensive medicines).

Angina pectoris
Most patients respond to the administration of one tablet daily.

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

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

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

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

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

If you stop taking ATENOLOL PENSA
Do not stop treatment because you feel better, unless your doctor tells you to.
Treatment should be discontinued gradually.

If you have any questions 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 ATENOLOL PENSA, as with any drug, the following side effects may occur according to the frequency listed below:

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

• slowed heart rate
• cold hands and feet
• gastrointestinal disturbances (e.g. nausea, vomiting, diarrhoea, abdominal pain)
• changes in blood tests related to liver function (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), breathing difficulties and/or ankle swelling if you have heart failure
• sudden drop in blood pressure when standing up, possibly leading to loss of consciousness, worsening of intermittent claudication (walking difficulty that improves with rest), numbness and cramps in fingers followed by a sensation of heat and pain (Raynaud's phenomenon)
• dizziness, headache, tingling in hands or feet
• mood changes, nightmares, confusion, psychosis (mental disorders), hallucinations (seeing inexplicable things), worsening of neurological diseases 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 obstruction within 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 loss of skin pigment in patients with vitiligo (a skin disease causing white patches)
• dry eyes, visual disturbances
• impotence (inability to achieve an erection)
• bronchospasm (worsening of breathing difficulties) if you have asthma or have previously suffered from asthmatic conditions

Frequency 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)
• hypotension (a condition in which blood pressure is much lower than normal values)
• dyspnoea (difficulty breathing)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store ATENOLOL PENSA

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 "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What ATENOLOLO PENSA contains

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

Description of the appearance of ATENOLOLO PENSA and package contents
Pack containing 42 tablets.
Pack containing 50 tablets.
Marketing Authorization Holder
Towa Pharmaceutical S.p.A., Via Enrico Tazzoli 6, 20154, Milan, Italy.
Manufacturer
DOPPEL Farmaceutici S.r.l. – Via Volturno, 48 – Quinto de’ Stampi – Rozzano (MI)
FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A. - Via Grignano, 43 - 24041 Brembate (BG)