Atenolol Doc Generici

Patient Information Leaflet

ATENOLOLO DOC Generici 100 mg tablets

Generic Medicine
Please read all of 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 give it to others, 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ATENOLOLO DOC Generici is and what it is used for

This medicine contains the active substance atenolol, which belongs to a group of medicines called beta-blockers that work by slowing down the heartbeat and reducing the force of the heart's contractions.
ATENOLOLO DOC Generici is indicated for:

• the treatment of high blood pressure (hypertension), including renal-origin hypertension;
• the treatment of chest pain caused by heart problems (angina pectoris);
• the treatment of certain types of irregular heartbeat (arrhythmia);
• helping to prevent the occurrence of another heart attack (acute myocardial infarction).

2. What you should know before taking ATENOLOLO DOC Generici

Do not take ATENOLOLO DOC Generici

• if you are allergic to atenolol or to any of the other ingredients of this medicine (listed in section 6);
• if you have a very slow heartbeat (bradycardia);
• if you have a serious heart condition known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout the body;
• if you have low blood pressure (hypotension);
• if your doctor has told you that the acidity level of your blood is higher than normal (metabolic acidosis);
• if you have severe circulation problems in the limbs (peripheral arterial disease);
• if you have a heart conduction disorder (second- or third-degree atrioventricular block) or a sinoatrial node disease;
• if you have an untreated tumor of the adrenal gland called pheochromocytoma;
• if your heart function is inadequate and not controlled by appropriate therapy (uncontrolled heart failure);
• if you are taking medicines containing verapamil (used to treat high blood pressure) or diltiazem (used to treat high blood pressure, angina pectoris, and other heart conditions);
• if the person who needs to take this medicine is a child.

Warnings and precautions
Talk to your doctor or pharmacist before taking ATENOLOLO DOC Generici.
Be especially careful and consult your doctor before taking this medicine:

• if your heart function is inadequate (heart failure) but is controlled by appropriate therapy;
• if your heart's ability to increase the amount of blood pumped to the body is poor (low cardiac reserve);
• if you suffer from a type of chest pain called "Prinzmetal's angina";
• if you have thyroid problems (thyrotoxicosis), because atenolol may mask its symptoms;
• if you have previously experienced severe allergic reactions (anaphylactic reactions). If you develop an allergic reaction, standard doses of adrenaline may not be sufficient;
• if you have respiratory diseases or suffer from asthma; in the latter case, ATENOLOLO DOC Generici may worsen your breathing difficulties;
• if you have severe kidney problems (severe renal impairment);
• if you are undergoing blood filtration (hemodialysis);
• if you are pregnant, planning to become pregnant, or breastfeeding (see section "Pregnancy and Breastfeeding").

During long-term treatment with this medicine, have regular blood tests.
Reduced heart rate (reduced number of heartbeats per minute)
During treatment with ATENOLOLO DOC Generici, your heart rate will decrease.
However, if this effect is excessive, consult your doctor, who may reduce the dosage.
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 increase in heart rate.
Atenolol may also increase the risk of severe hypoglycemia when used together with certain types of antidiabetic drugs called sulfonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide).
Your doctor may prescribe tests to monitor your blood sugar levels.
Anesthesia
If you are admitted to hospital, inform medical staff that you are currently being treated with ATENOLOLO DOC Generici, especially the anesthetist (the doctor responsible for anesthesia) if you are undergoing surgery.
For athletes
Using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
The use of ATENOLOLO DOC Generici is contraindicated in children and adolescents under 18 years of age.
Other medicines and ATENOLOLO DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take this medicine if you have been administered medicines containing verapamil or diltiazem, used to treat high blood pressure. At least 48 hours must pass after stopping verapamil or diltiazem before starting treatment with ATENOLOLO DOC Generici.
Be especially careful and consult your doctor if you are taking:

• medicines used to treat irregular heartbeats (class I antiarrhythmics such as disopyramide, digitalis glycosides, amiodarone);
• medicines that stimulate the heart (adrenaline and noradrenaline);
• medicines used for high blood pressure or chest pain (nifedipine);
• a medicine used to treat heart failure (digoxin);
• clonidine, a medicine used to treat high blood pressure. If treatment with ATENOLOLO DOC Generici is to replace clonidine therapy, stop clonidine several days before starting this medicine. If both medicines are used together, clonidine should be discontinued several days after stopping this medicine;
• medicines used to treat high blood pressure (ACE inhibitors);
• medicines used for inflammation and pain relief (e.g., ibuprofen, indomethacin);
• medicines used to induce anesthesia (see Warnings and precautions);
• medicines used to treat diabetes such as sulfonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide).

ATENOLOLO DOC Generici and alcohol
Alcoholic beverages may enhance the blood pressure-lowering effect of ATENOLOLO DOC Generici.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Since a risk to the fetus cannot be ruled out, the use of ATENOLOLO DOC Generici requires careful assessment of the benefits of treatment against possible risks, especially during the first and second trimesters of pregnancy.
ATENOLOLO DOC Generici should be used with caution during breastfeeding because atenolol is excreted in breast milk.
Driving and using machines
This medicine does not affect your ability to drive or operate machinery. However, if you experience dizziness or fatigue, do not drive or operate machinery.
ATENOLOLO DOC Generici contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take ATENOLOL DOC Generici

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 tablets should be swallowed whole with a little water, preferably always at the same time.

Treatment of high blood pressure (hypertension)
The recommended starting dose is half a tablet daily. If you do not obtain benefit, the dose should be
increased to 1 tablet (100 mg) daily during the second week. The maximum blood pressure-lowering effect is
achieved after 1 to 2 weeks of treatment. To further lower your blood pressure, depending on your health
status, your doctor may prescribe atenolol in combination with another medicine for high blood pressure (such as a
diuretic).

Treatment of chest pain caused by heart problems (angina pectoris)
The recommended dose is 1 tablet (100 mg) daily. Do not take a higher dose, as this will not provide additional benefit.

Treatment of certain types of heart rhythm disorders (arrhythmias)
The recommended dose is half a tablet or 1 tablet (100 mg) daily.

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

Use in the elderly
A dose reduction may be necessary, particularly if kidney function is impaired.

Use in children and adolescents
There is no experience with the use of atenolol in children and adolescents under 18 years of age; therefore,
ATENOLOL DOC Generici is not recommended in children and adolescents under 18 years of age.

Use in patients with impaired renal function
If you suffer from severe impairment of kidney function, your doctor will adjust the dose according to your
health status.

Use in patients undergoing haemodialysis
The recommended dose is 50 mg after each blood filtration session (haemodialysis); administration should
occur in a hospital setting, as severe reductions in blood pressure may occur.

If you take more ATENOLOL DOC Generici than you should
In case of accidental ingestion/overdose of ATENOLOL DOC Generici, 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 breathing difficulties (bronchospasm).

If you forget to take ATENOLOL DOC Generici
Do not take a double dose to make up for the forgotten tablet.
Take the missed tablet as soon as possible, unless it is almost time for the next dose.

If you stop taking ATENOLOL DOC Generici
Do not stop treatment with this medicine without consulting your doctor.
Treatment with this medicine should be discontinued gradually, especially if you suffer from heart circulation
disorders (ischaemic heart disease).

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 everyone experiences them.
The following side effects may occur:

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

• slowed heart rate;
• cold fingers of the hands and feet;
• gastrointestinal disturbances (e.g. nausea, diarrhoea);
• 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 cardiac 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;
• low blood pressure, sudden drop in blood pressure when standing up with possible 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;
• mood changes, nightmares, confusion, psychosis (mental disorders), hallucinations (seeing inexplicable things), 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 flow of bile to the duodenum due to an obstruction within the liver), which may lead to yellowing of the skin and eyes;
• skin disease manifesting as bleeding-prone blisters (purpura), thrombocytopenia (reduced number of platelets in the blood), granulocytopenia (reduced number of a type of white blood cells);
• hair loss (alopecia), skin rashes including worsening of psoriasis (chronic skin inflammation), skin eruptions, skin redness, and worsening of pigment loss in the skin in patients with vitiligo (a skin condition characterized by 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 asthmatic conditions.

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

• increase in antinuclear antibodies, a type of antibody that the body produces against itself.

Frequency not known (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).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via 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 ATENOLOL DOC Generics

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 packaging after “Expiry”.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What ATENOLOLO DOC Generici contains

• The active substance is atenolol. Each tablet contains 100 mg of atenolol.
• The other components are: monohydrate lactose, microcrystalline cellulose, magnesium stearate, sodium starch glycolate, stearic acid, colloidal silicon dioxide.

Description of the appearance of ATENOLOLO DOC Generici and pack contents
Packs containing 14, 42 or 50 tablets.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 – 20121 Milan
Manufacturer
Lamp San Prospero S.p.A. - Via della Pace 25/A - 41030 San Prospero S.S. (MO)
Fine Foods & Pharmaceuticals N.T.M. S.p.A. - Via Grignano 43 - 24041 Brembate (BG)
Lachifarma S.r.l. Laboratorio Chimico Farmaceutico Salentino - S.S. 16 Zona Industriale - 73010 Zollino (LE)