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Package Insert: Information for the Patient

Atenolol Sandoz 50 mg Film-Coated Tablets

Atenolol Sandoz 100 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this package insert. See section 4.

Package Contents and Additional Information

Atenolol Sandoz contains a medicine called atenolol. This belongs to a group of medicines called beta-blockers.

AtenololSandozis used for:

• treatment of high blood pressure (hypertension),
• helping to prevent chronic stable angina chest pain,
• ensuring regular heartbeats,
• to protect the heart during and after a heart attack.

.

Do not take Atenolol Sandoz:

• if you are allergic to atenolol or any of the other ingredients in this medication (listed in section 6),
• if you have experienced or have any of the following heart problems:
• uncontrolled heart failure (usually causing shortness of breath and swelling of the ankles),
• second- or third-degree heart block (a condition that can be treated with a pacemaker),
• very slow or irregular heartbeats, very low blood pressure, or poor blood circulation (circulatory insufficiency),
• if you have cardiogenic shock. This means that your heart is not pumping enough blood through your body. Symptoms may include confusion, sweating, rapid heartbeat, and paleness,
• if you have an untreated adrenal gland tumor called pheochromocytoma,
• if you have fasted,
• if your doctor has told you that you have excessive blood acidity (metabolic acidosis),

Do not take Atenolol Sandoz in any of the above cases. If you are unsure, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Atenolol Sandoz if:

• you have asthma, wheezing, or any other respiratory problem, or have allergic reactions, for example, from insect bites. If you have ever had asthma or wheezing, do not take this medication without discussing it with your doctor,
• you have a type of chest pain (angina) called Prinzmetal's angina,
• you have first-degree heart block,
• you have diabetes. Atenolol may alter your normal response to low blood sugar (hypoglycemia), which usually involves an increase in heart rate. Your blood sugar levels should be closely monitored,
• you have hyperthyroidism (a condition caused by an overactive thyroid gland). Your medication may mask the symptoms of hyperthyroidism,
• you have kidney problems. You may need to undergo medical checks during your treatment,
• you have a skin condition called psoriasis,
• you notice that your pulse is slower while taking these tablets. This is normal, but if you are concerned, inform your doctor.,
• you are an elderly person,
• you are pregnant, think you may be, or are breastfeeding. See “Pregnancy and breastfeeding”,
• you have ever had an allergic reaction to something, for example, an insect bite,
• in case you are admitted to a hospital, inform the medical staff and, in particular, the anesthetist that you are being treated with atenolol,

If you think any of the above cases apply to you, or if you are unsure, consult your doctor or pharmacist before taking this medication.

Use of Atenolol Sandoz with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription, homeopathic, herbal, or other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

Some medications may affect the action of others.

Inform your doctor or pharmacist if you are taking any of the following medications:

• clonidine (for hypertension or migraine). If you are taking clonidine and atenolol concurrently, do not stop taking clonidine unless your doctor tells you to. If you need to stop taking clonidine, your doctor will give you detailed instructions on how to do so,
• verapamil, diltiazem, and nifedipine (for high blood pressure and chest pain),
• disopyramide, quinidine, amiodarone, and any other medication for irregular heartbeat,
• digoxin (treatment for heart failure), adrenaline, also known as epinephrine (medications that stimulate the heart),
• ibuprofen or indomethacin (anti-inflammatory medications for pain treatment),
• insulin or other oral medications for diabetes,
• ampicillin, for bacterial infections,
• barbiturates, for sleep problems and epilepsy,
• sultopride and phenothiazines, for more serious mental health problems (psychosis),
• medications in the groups called “tricyclic antidepressants” or “MAO inhibitors”,
• decongestants or other medications for colds or sinus blockages (including over-the-counter medications),
• if you are going to a hospital for surgery, inform the anesthetist or medical staff that you are taking atenolol. This is because you may experience a drop in blood pressure (hypotension) if you take certain anesthetics, or substances containing iodine (called “contrast media”) for X-rays, while taking atenolol.

If you think any of the above cases affect you, or if you are unsure, consult your doctor or pharmacist before taking this medication.

Pregnancy and breastfeeding

If you are pregnant, think you may be, or are breastfeeding, consult your doctor or pharmacist before using this medication.

Pregnancy

There is not enough data on the safety of atenolol during the first month of pregnancy. Your doctor will decide if treatment during the second and third trimesters is beneficial for you.

Breastfeeding

Inform your doctor if you are being treated with atenolol at the time of delivery or during breastfeeding, as your baby may be at risk of low blood sugar and slower heartbeats.

Women who are breastfeeding should consult their doctor before taking this medication as atenolol passes into breast milk.

Driving and operating machinery

• It is unlikely that this medication will affect your ability to drive or operate machinery.
• However, it is best to wait and see how the medication affects you before engaging in these activities.
• If you feel dizzy or tired while taking this medication, do not drive or operate tools or machinery.

Use in athletes

This medication contains atenolol, which may produce a positive result in doping control tests.

Atenolol Sandoz contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• Your doctor will tell you how many tablets you have to take each day and when you should take them.
• Read the packaging to remember the information your doctor gave you.
• Try to take the tablets at the same time every day.
• Swallow the tablets whole with the help of a glass of water. The groove is only for breaking the tablet if it is difficult for you to swallow it whole.

Adults

Your doctor will decide how many atenolol tablets you have to take each day depending on your illness.

Hypertension

• The usual initial dose is 25 mg per day.
• Subsequently, you will usually take between 50 mg and 100 mg per day.

Chest pain

The usual dose is 50 to 100 mg per day. If you take 100 mg, your doctor may give you instructions to take them in two separate doses, 50 mg in the morning and 50 mg at night.

Irregular heartbeat

The usual dose is 50 to 100 mg per day.

Protection after a heart attack

The usual dose is 100 mg per day. Your doctor may give you instructions to take them in two separate doses, 50 mg in the morning and 50 mg at night.

Advanced age

If you are an elderly patient, your doctor may opt to prescribe a lower dose, especially if you have kidney problems.

People with severe kidney problems

If you have severe kidney problems, your doctor may prescribe a lower dose of atenolol or indicate that you take it less frequently.

Use in children

This medication should not be administered to children.

If you take more Atenolol Sandoz than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

• If you take more Atenolol Sandoz than you should, consult a doctor or go to the hospital immediately.
• Bring the packaging of the medication with you so that the doctor can identify what you have taken.
• You may feel a slower pulse, dizziness due to hypotension, and difficulty breathing. In addition, your heart may have problems supplying blood to the rest of the body (acute heart failure).

If you forgot to take Atenolol Sandoz

• If you forgot to take a dose, take it as soon as you remember.
• However, if it is almost time for the next dose, do not take the missed dose.
• Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Atenolol Sandoz

Do not interrupt the treatment with Atenolol Sandoz without consulting your doctor. Your doctor may need to gradually reduce the dose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Atenolol Sandoz and consult a doctor or go to the hospital immediately if you observe any of the following severe side effects:

Rare (may affect up to 1 in 1,000 people)

• abnormal heart rhythm, feeling of dizziness, fatigue, or fainting. These could be signs of heart blockage,
• shortness of breath or swelling of the ankles. These could be signs of heart failure or worsening of this condition,
• respiratory problems, such as wheezing. These could be signs of worsening asthma,
• numbness or coldness in feet and toes.

Frequency unknown (cannot be estimated from available data)

• swelling of the face or throat, difficulty breathing, or feeling of dizziness. These could be signs of a severe allergic reaction.

Stop taking Atenolol Sandoz and consult a doctor or go to the hospital immediately if you observe any of the previous side effects.

Other side effects include:

Frequent (may affect up to 1 in 10 people)

• feeling of coldness or poor circulation in hands and feet,
• slower pulse. This is normal, but if you are concerned, consult your doctor,
• diarrhea,
• constipation,
• digestive problems,
• feeling of dizziness or vomiting,
• feeling of fatigue,
• sweating.

Less frequent (may affect up to 1 in 100 people)

• sleep problems,
• high levels of an enzyme called “aminotransferase” (in blood tests).

Rare (may affect up to 1 in 1,000 people)

• purple spots on the skin,
• feeling of numbness or spasms in fingers, followed by feeling of heat and pain (“Raynaud’s disease”),
• tingling or pinching in hands and feet,
• poor circulation (intermittent claudication) that may worsen when starting to take the medicine,
• low blood pressure that may cause dizziness, mild confusion, or fainting,
• headache,
• feeling of dizziness,
• changes in mood, nightmares, feeling of confusion, anxiety, or fear,
• nightmares,
• changes in personality (psychosis) or seeing or hearing things that do not exist (hallucinations),
• depression,
• dry mouth,
• hair loss,
• dry eyes,
• skin rash,
• dry and flaky skin (psoriasis) that may worsen when starting to take the medicine,
• vision problems,
• greater tendency to bruising or purple marks on the skin,
• impossibility of achieving erection in men (impotence),
• alterations in libido,
• yellow discoloration of the skin or sclera (jaundice),
• blood problems such as changes in blood cells. Your doctor may take blood samples regularly to check if Atenolol Sandoz has affected your blood.

Frequency unknown (cannot be estimated from available data)

• allergic reactions (hypersensitivity) such as skin rash with itching,
• syndrome similar to lupus (a disease in which the immune system produces

antibodies that attack mainly the skin and joints)

• atenolol may mask the symptoms of “thyrotoxicosis” and hypoglycemia (diabetes) (see “Section 2. What you need to know before starting to take Atenolol Sandoz”).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and the blister pack after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Store in the original packaging to protect it from light and moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Atenolol Sandoz 50 mg tablets:

The active ingredient is atenolol. Each tablet contains 50 mg of atenolol.

Composition of Atenolol Sandoz 100 mg tablets:

The active ingredient is atenolol. Each tablet contains 100 mg of atenolol.

The other components are:

Core:

cornstarch, sodium lauryl sulfate, heavy magnesium carbonate, magnesium stearate (E470b), gelatin.

Coating: lactose, hypromellose, titanium dioxide (E171), polyethylene glycol 4000.

Appearance of the product and content of the container

Coated tablets with a film, white, round, scored on one side.The score is only for breaking and facilitating swallowing but not for dividing into equal doses.

Atenolol Sandoz is available in Alu/PP blisters in containers containing 30, 60, and 500 tablets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Germany

or

Hexal AG

Industriestrasse, 25

83607 Holzkirchen

Germany

Last review date of this leaflet: May 2020

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/