Atenolol Mylan Generics

Package leaflet: Information for the patient

Atenolol Mylan Generics 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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Atenolol Mylan Generics 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 heart rate and making the heart beat with less force.
Atenolol Mylan Generics is indicated in adults for:

• the treatment of high blood pressure (hypertension);
• the treatment of 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 need to know before taking Atenololo Mylan Generics

Do not take Atenololo Mylan Generics

• 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 heart block
• if you have abnormally slow or irregular heartbeats, 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 you with abnormally high levels of acid in the 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 have a rare condition 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 have severe asthma or severe chronic obstructive pulmonary diseases
• 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 Mylan Generics:

• 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 it may mask changes in heart rate (tachycardia)
• 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, planning to become pregnant, or breastfeeding (See section “Pregnancy and breastfeeding”)
• if you have previously experienced allergic reactions (e.g., from insect stings)
• if you are taking verapamil or diltiazem
• do not stop taking Atenololo Mylan Generics abruptly, especially if you have inadequate oxygen supply to the heart (ischemic heart disease). If you need to stop or discontinue treatment with Atenololo Mylan Generics after prolonged use, the dose should always be reduced gradually in a stepwise manner, as sudden discontinuation may lead to reduced delivery of oxygenated blood to a more or less extensive area of the heart (myocardial ischemia), worsening of angina pectoris (a heart condition causing chest pain), or myocardial infarction, or may provoke worsening of hypertension
• if you have severely impaired kidney function, dose adjustment is necessary because Atenololo Mylan Generics is eliminated through the kidneys. Particular caution must be exercised when using anesthetic agents during treatment with Atenololo Mylan Generics. If you are scheduled for surgery, treatment with Atenololo Mylan Generics should be discontinued at least 24 hours before the procedure, as there is an increased risk of low blood pressure (hypotension). Consult your doctor regarding the risk-benefit assessment of stopping Atenololo Mylan Generics.

Reduced heart rate (number of heartbeats per minute)
During treatment with Atenololo Mylan Generics, 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, this medicine may alter your response to low blood sugar levels. You may not feel your heart beating faster. 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).
Anesthesia
If you are admitted to hospital, you must inform the medical staff that you are being treated with Atenololo Mylan Generics, and particularly the anesthesiologist (the doctor responsible for anesthesia) if undergoing surgery.
For athletes
Using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
Children and adolescents
Atenololo Mylan Generics 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 Mylan Generics
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 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 a severe drop in blood pressure (severe hypotension), a heart rate below 60 beats per minute (bradycardia), and heart failure. At least 48 hours must have passed after stopping any previous intravenous treatment with verapamil or diltiazem before starting treatment with Atenololo Mylan Generics, and vice versa;
• medicines used to treat 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;
• clonidine (a medicine used to treat high blood pressure or to prevent migraine). If you are taking clonidine and Atenololo Mylan Generics together, do not stop treatment with clonidine or Atenololo Mylan Generics without first consulting your doctor. Also consult your doctor if you need to switch from clonidine to Atenololo Mylan Generics;
• analgesics such as ibuprofen or indomethacin;
• insulin or oral antidiabetic medicines such as sulfonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide).

Atenololo Mylan Generics and alcohol
Alcoholic beverages may enhance the blood pressure-lowering effect of Atenololo Mylan Generics.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Infants born to mothers who have taken Atenololo Mylan Generics before delivery or during breastfeeding 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 breastfeeding.
Driving and using machines
It is unlikely that this medicine will impair 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 Mylan Generics

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 relative to the body's actual needs), bradycardia (reduction in heart rate below 60 beats per minute), and bronchial symptoms.
The tablets should 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 aid swallowing.

Adults
High blood pressure (arterial hypertension)
The recommended starting dose is ½ 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 tablet daily during the second week.
If necessary, further reduction in blood pressure may be achieved by taking Atenolol Mylan Generics together with other medicines used to control high blood pressure (antihypertensive medicines).

Angina pectoris
Most patients respond to a daily dose of one tablet.

Elderly patients
If you are elderly, your doctor may decide to prescribe a lower dose of Atenolol Mylan Generics.

If you have severe kidney problems
If you have severe impairment of kidney function, your doctor may decide to prescribe a lower dose.

Use in children and adolescents
Atenolol Mylan Generics must not be given to children and adolescents under 18 years of age.

If you take more Atenolol Mylan Generics than you should
If you accidentally ingest or take an excessive amount of this medicine, contact your doctor or go to the nearest hospital emergency department immediately.

If you forget to take Atenolol Mylan Generics
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 Mylan Generics
Do not stop treatment just because you feel better, unless instructed by your doctor.
Treatment should be discontinued gradually.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
During treatment with Atenololo Mylan Generics, 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):

• slowed heart rate
• cold fingers of the hands and feet
• gastrointestinal disorders (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 swelling of the ankles in patients with 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 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 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), granulocytopenia (reduced number of a type of white blood cells)
• hair loss, skin rashes including worsening of psoriasis (chronic skin inflammation), skin redness, and worsening of loss of skin pigmentation in patients with vitiligo (a skin disease characterized by appearance of 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 asthma-related problems

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

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 Mylan Generics

• Do not store above 25°C. Keep the medicine in the original packaging to protect it from light and moisture.
• 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 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 Atenololo Mylan Generics contains

• The active substance is atenolol 100 mg.
• The other components are: magnesium carbonate, corn starch, pregelatinized starch, sodium lauryl sulfate, gelatin, magnesium stearate.

Description of the appearance of Atenololo Mylan Generics and contents of the pack
Packs of 42 or 50 white tablets with a central break line.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Grignano 43, 24041 Brembate (BG)