Atenolol Hexal

Package leaflet: Information for the patient

Atenololo Hexal 50 mg film-coated tablets, 100 mg film-coated tablets

Equivalent medicine
Please read all of this leaflet carefully before you start 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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Atenololo Hexal 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.
Atenololo Hexal is indicated for:

• the treatment of high blood pressure (hypertension), including renal origin hypertension;
• the treatment of angina pectoris (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 Hexal

Do not take Atenololo Hexal

• if you are allergic to the active substance 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 slow or irregular heartbeats, very low blood pressure, or severe circulatory disorders;
• in case of shock (a condition 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" that is not being treated (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 have severe asthma or severe chronic obstructive pulmonary disease;

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• 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 Hexal:

• if you have kidney problems;
• if you have thyroid problems (a gland located in the neck);
• if you have heart or circulation problems, even if controlled by appropriate therapy;
• if you suffer from a type of chest pain called "Prinzmetal's angina";
• if you have diabetes (a condition characterized by high blood sugar levels) or hypoglycemia (a condition characterized by low blood sugar levels), as this medicine may mask changes in heart rate (tachycardia);
• if you have previously experienced allergic reactions (e.g., from insect stings);
• if you have respiratory problems or asthma;
• if you are pregnant, planning to become pregnant, or breastfeeding (see section "Pregnancy and Breast-feeding");
• if you are being treated with verapamil or diltiazem;
• do not stop taking Atenololo Hexal abruptly, especially if you have insufficient oxygen supply to the heart (ischemic heart disease). If you need to stop or discontinue treatment with Atenololo Hexal after prolonged use, the dose should always be reduced gradually in a stepwise manner, as sudden withdrawal may lead to reduced oxygenated blood flow to a more or less extensive area of the heart (myocardial ischemia), worsening of angina pectoris (a heart condition causing chest pain), myocardial infarction, or exacerbation of hypertension;
• if you have severe impairment of kidney function, a dose adjustment is necessary because Atenololo Hexal is eliminated via the kidneys.

Special caution should be exercised when using anesthetic agents during treatment with Atenololo Hexal. If you are scheduled for surgery, treatment with Atenololo Hexal 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 Hexal.

Reduced heart rate (number of heartbeats per minute)
During treatment with Atenololo Hexal, 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 blood sugar levels. This generally causes an increased heart rate.

Anesthesia
If you are admitted to hospital, you must inform the medical staff about your ongoing treatment with Atenololo Hexal, and particularly the anesthesiologist (the doctor responsible for anesthesia) in case of surgery.

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

Children and adolescents
Atenololo Hexal must not be administered to children and adolescents under 18 years of age.

Other medicines and Atenololo Hexal
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and consult your doctor if you are taking:

• 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 lead to a severe drop in blood pressure (severe hypotension), a heart rate below 60 beats per minute (bradycardia), or heart failure. At least 48 hours must elapse after discontinuation of any prior intravenous treatment with verapamil or diltiazem before starting treatment with Atenololo Hexal, 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 (e.g., containing pseudoephedrine) used to treat colds;
• analgesics such as indomethacin or ibuprofen;
• clonidine (a medicine used to treat high blood pressure or prevent migraine). If you are taking clonidine and Atenololo Hexal together, do not stop treatment with either clonidine or Atenololo Hexal without first consulting your doctor. Also consult your doctor if you are switching from clonidine to Atenololo Hexal;
• insulin or medicines that lower blood glucose concentration (hypoglycemic agents).

Pregnancy and breast-feeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breast-feeding, consult your doctor or pharmacist before taking this medicine.
Infants born to mothers who took Atenololo Hexal 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 Atenololo Hexal 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 Hexal contains lactose and sodium
This medicine contains lactose:
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

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

3. How to take Atenololo Hexal

Take this medicine exactly as instructed 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 adequate blood flow to meet the body's needs), bradycardia (heart rate below 60 beats per minute), or bronchial symptoms can be promptly recognized.

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 50 mg once daily.
The desired blood pressure-lowering effect is usually achieved after one or two weeks of treatment. If this effect is not satisfactory, take one 100 mg tablet daily during the second week.

If necessary, further reduction in blood pressure may be achieved by taking Atenololo Hexal 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.

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

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

If you take more Atenololo Hexal than you should
If you accidentally take too much of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to take Atenololo Hexal
Do not take a double dose to make up for the forgotten dose.
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 Atenololo Hexal
Do not stop treatment just because you feel better, unless your doctor tells you to do so.
Treatment should be discontinued gradually.

If you have any questions about how to use this medicine, ask 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 Hexal, as with any medicine, 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 disorders (e.g. nausea, vomiting, diarrhoea, abdominal pain);
• Changes in blood tests related to liver function (increased 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 if you have 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 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);
• Dry eyes, vision problems;
• Impotence (inability to achieve an erection);
• Bronchospasm (worsening of breathing difficulties) if you have asthma or have had asthma-related problems;
• Hair loss, skin rashes including worsening of psoriasis (chronic skin inflammation), skin redness, and worsening of loss of skin pigmentation in patients affected by vitiligo (a skin disease characterized by the appearance of white patches);
• Reduction in the number of platelets;
• Purpura.

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);
• 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 Hexal

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 "Exp.".
The expiry date refers to the last day of that month.
Store below 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 Hexal contains
Atenololo Hexal 50 mg film-coated tablets

• The active substance is: atenolol. Each tablet contains 50 mg of atenolol.
• The other components are: Tablet core: maize starch, magnesium carbonate, sodium lauryl sulfate, gelatin, magnesium stearate. Tablet coating: lactose, methylhydroxypropylcellulose, polyethylene glycol 4000, titanium dioxide.

Atenololo Hexal 100 mg film-coated tablets

• The active substance is: atenolol. Each tablet contains 100 mg of atenolol.
• The other components are: Tablet core: maize starch, magnesium carbonate, sodium lauryl sulfate, gelatin, magnesium stearate. Tablet coating: lactose, methylhydroxypropylcellulose, polyethylene glycol 4000, titanium dioxide.

Description of the appearance of Atenololo Hexal and contents of the pack
Atenololo Hexal 50 mg film-coated tablets
PP/Al blister containing 50 tablets.
Atenololo Hexal 100 mg film-coated tablets
PP/Al blister containing 42 or 50 tablets.
Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy
Manufacturer
Salutas Pharma GmbH
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Otto-von-Guericke-Allee, 1-D
39179 Barleben
Germany
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