Atenolol EG: detailed information

Package leaflet: Information for the patient

ATENOLOLO EG 50 mg tablets, 100 mg tablets

Equivalent medicine
Please 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 they have the same symptoms as you, because it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ATENOLOLO EG is and what it is used for
What you need to know before taking ATENOLOLO EG
How to take ATENOLOLO EG
Possible side effects
How to store ATENOLOLO EG
Contents of the pack and other information

1. What Atenolol EG is and what it is used for

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

treating high blood pressure (arterial hypertension);
treating angina pectoris attacks (a heart condition characterized by chest pain).

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

2. What you should know before taking ATENOLOLO EG

Do not take ATENOLOLO EG

if you are allergic to atenolol or other similar medicines, 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 heart block;
if you suffer from slow or irregular heartbeat, very low blood pressure, or severe circulatory disorders;
in case of shock (a heart condition occurring when blood is inadequately oxygenated);
if your doctor has diagnosed abnormally high levels of acid in your blood (metabolic acidosis);
if you are being treated with intravenous medicines called calcium antagonists, such as verapamil (used to treat high blood pressure) or diltiazem (used to treat high blood pressure, angina pectoris, and other heart conditions), or medicines used to normalize heart rhythm, such as disopyramide;
if you are taking medicines used to treat depression (MAO inhibitors, except MAO-B inhibitors);
if you suffer from severe asthma or severe chronic obstructive pulmonary disease;
if you have a tumour of the adrenal gland called "pheochromocytoma" not currently under treatment (this tumour 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 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 EG:

if you have heart problems or circulatory disorders, even if controlled by adequate therapy;
if you have diabetes (a condition characterized by excess sugar in the blood) or hypoglycaemia (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 hypoglycaemia when used with certain types of antidiabetic medicines called sulphonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide);
if you have previously experienced allergic reactions (e.g. from insect stings);
if you have kidney problems;
if you are pregnant, planning to become pregnant, or breastfeeding (see section “Pregnancy and Breast-feeding”);
if you are predisposed to a skin disease called psoriasis;
if you have thyroid problems (a gland located in the neck);
if you have respiratory problems or asthma;
if you suffer from a type of chest pain called "Prinzmetal's angina";
if you are being treated with verapamil or diltiazem;
do not stop taking ATENOLOLO EG abruptly, especially if you have inadequate heart oxygenation (ischaemic heart disease). If you need to stop or discontinue treatment with ATENOLOLO EG after prolonged use, the dose should always be reduced gradually by tapering, as sudden withdrawal may lead to reduced oxygenated blood supply to a more or less extensive area of the heart (myocardial ischaemia), worsening angina pectoris (a heart disease causing chest pain), or even myocardial infarction, or may cause worsening of hypertension;
if you have severe impairment of kidney function, dose adjustment is necessary because ATENOLOLO EG is eliminated via the kidneys. Particular caution must be exercised when using anaesthetic agents during treatment with ATENOLOLO EG. If you are scheduled for surgery, treatment with ATENOLOLO EG 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 EG.

During treatment with this medicine, your doctor will prescribe periodic tests to monitor liver and kidney function.
Inform your doctor if you notice the appearance of skin disorders characterized by red spots and/or bleeding (thrombocytopenic and non-thrombocytopenic purpura).
Reduced heart rate (number of heartbeats per minute)
During treatment with ATENOLOLO EG, you may experience a reduction in heart rate (see section “Possible side effects”). This effect is normal, but if it becomes a concern for you, consult your doctor.
Diabetes or hypoglycaemia (low blood sugar levels)
If you have diabetes and are being treated with antidiabetic medicines (medicines for treating diabetes), this medicine may increase blood sugar levels. This generally causes an increase in heart rate.
Anaesthesia
If you are to be admitted to hospital, you must inform the medical staff that you are being treated with ATENOLOLO EG, and particularly the anaesthetist (the doctor responsible for anaesthesia) in case of surgery.
For athletes: the use of this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
ATENOLOLO EG must not be administered to children and adolescents under 18 years of age.
Other medicines and ATENOLOLO EG
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 treating high blood pressure or chest pain (especially verapamil, diltiazem, clonidine, or nifedipine), as 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 below 60 beats per minute (bradycardia), and heart failure. At least 48 hours must elapse between discontinuation of previous intravenous therapy with verapamil or diltiazem and starting treatment with ATENOLOLO EG, or vice versa;
medicines used to treat irregular heartbeat (reserpine, alpha-methyldopa, guanfacine, digitalis glycosides);
medicine used to treat heart failure (digoxin, a medicine used for heart disorders);
clonidine (a medicine used to treat high blood pressure or prevent migraine). If both medicines are administered simultaneously and treatment needs to be stopped, clonidine should be discontinued several days after stopping ATENOLOLO EG. If you are taking clonidine and ATENOLOLO EG together, do not stop treatment with either clonidine or ATENOLOLO EG without first consulting your doctor. Also consult your doctor if you plan to replace clonidine with ATENOLOLO EG;
medicines used to treat depression (MAO inhibitors, except MAO-B inhibitors);
medicines used to treat irregular heartbeats (disopyramide, quinidine) and amiodarone;
analgesics such as indometacin or ibuprofen;
medicines used to induce anaesthesia or to relax muscles (peripheral muscle relaxants); if you are undergoing surgery, inform the anaesthetist that you are taking ATENOLOLO EG;
insulin or medicines that lower blood glucose concentration (hypoglycaemic agents), such as sulphonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide);
medicines that stimulate the heart, such as epinephrine or norepinephrine;
medicines used to treat depression, such as tricyclic antidepressants;
medicines used to treat seizures (barbiturates);
medicines used to treat mental disorders, such as psychoses (phenothiazines);
other medicines for controlling blood pressure (vasodilators, antihypertensives, diuretics);
nasal decongestants or other medicines (containing, for example, pseudoephedrine) used to treat colds.

Pregnancy and breast-feeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Since the possibility of harm to the foetus cannot be excluded, if you are pregnant, planning a pregnancy, or breastfeeding, the use of ATENOLOLO EG requires careful assessment of risks versus benefits.
Babies born to mothers who have taken ATENOLOLO EG before delivery or during breastfeeding may be at risk of hypoglycaemia (low blood sugar) or bradycardia (reduced heart rate).
If you are pregnant and taking this medicine, treatment should be discontinued 24–48 hours before the expected date of delivery.
Atenolol accumulates in breast milk; therefore, its use is contraindicated during breastfeeding.
Driving and using machines
It is unlikely that taking ATENOLOLO EG 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.
ATENOLOLO EG contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take ATENOLOL EG

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
initial dose, especially in elderly patients, is the lowest possible dose in order to promptly detect the onset of symptoms of heart failure (the heart's inability to supply adequate blood flow according to the body's actual needs), bradycardia (reduction in heart rate below 60 beats per minute), and bronchial symptoms.
The tablets must be swallowed whole with a glass of water, preferably always at the same time each day. The tablets must not be chewed and should be taken with sufficient liquid to facilitate swallowing.

Adults
High blood pressure (arterial hypertension)
The recommended dose is one 50 mg tablet daily.
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 100 mg tablet (or two 50 mg tablets) daily during the second week. If necessary, further reduction in blood pressure may be achieved by taking ATENOLOL EG together with other medicines used to treat high blood pressure (antihypertensive medicines).

Angina pectoris
Most patients respond to a daily dose of one 100 mg tablet (or two 50 mg tablets).

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

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

Use in patients undergoing haemodialysis
The recommended dose is 50 mg after each blood filtration session (haemodialysis).

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

If you take more ATENOLOL EG than you should
In case of accidental ingestion or overdose of ATENOLOL EG, contact your doctor immediately or go to the nearest hospital. Symptoms of overdose may include: slowing of the heartbeat (bradycardia), low blood pressure (hypotension), inadequate heart function (acute heart failure and cardiogenic shock), breathing difficulties (bronchospasm), vomiting, altered consciousness, and seizures.

If you forget to take ATENOLOL EG
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 EG
Do not stop treatment simply because you feel better, unless your doctor tells you to.
Discontinuation of treatment must 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 gets them.
During treatment with ATENOLOLO EG, as with any medicinal product, the following side effects may occur, according to the following frequency:

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

Slowed heartbeat
Cold fingers and toes
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), difficulty breathing and/or swelling of the ankles in patients with heart failure
Sudden drop in blood pressure when standing, possibly leading to loss of consciousness; worsening of intermittent claudication (walking difficulty 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 hands or feet
Mood changes, nightmares, confusion, psychosis (mental disorders), hallucinations (seeing things that cannot be explained), 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 an 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 of depigmentation in patients affected by vitiligo (a skin disease characterized by white patches)
Dry eyes, visual disturbances
Impotence (inability to achieve an erection)
Bronchospasm (worsening of breathing difficulties) in patients with asthma or a history of 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 primarily attack the skin and joints)
Hypotension (a condition in which blood pressure is much lower than normal values)
Dyspnoea (difficulty breathing)

Other side effects reported include constipation, worsening of angina attacks in patients with angina pectoris, muscle weakness and cramps, inflammation of the eye mucosa (conjunctivitis), reduced tear production (to be considered by contact lens wearers), worsening of diabetes in patients with latent diabetes mellitus, sensation of emptiness in the head, increased sweating, increased frequency of dreaming, skin allergic reactions (such as erythema, itching, rashes), loss of sexual desire, reduction in blood sugar levels (hypoglycaemia), particularly after prolonged fasting or intense physical activity.

Reporting of side effects
If you experience any side effect, 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ATENOLOL EG

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.
Store at room temperature (15–25°C).
Keep in the original packaging to protect the medicine from light and moisture.
Do not dispose of any medicine 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 EG contains

The active substance is atenolol. Each tablet contains 50 mg or 100 mg of atenolol.
The other components are: maize starch, lactose, polyvidone, sodium lauryl sulfate, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of ATENOLOLO EG and package contents
ATENOLOLO EG “50 mg tablets”: pack containing 50 divisible tablets.
ATENOLOLO EG “100 mg tablets”: packs containing 42 or 50 divisible tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan
Manufacturer
Cosmo S.p.A., Via C. Colombo, 1 - 20045 Lainate (Milan)
DOPPEL Farmaceutici S.r.l., Via Volturno, 48 - Quinto De’ Stampi, Rozzano (MI)