ATENOLOL TARBIS 50 mg TABLETS

Introduction

Package Leaflet: Information for the User

Atenolol Tarbis 50 mg Tablets EFG

Atenolol

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Atenolol Tarbis 50 mgand what is it used for
2. What you need to know before you take Atenolol Tarbis 50 mg
3. How to take Atenolol Tarbis 50 mg
4. Possible side effects
5. Storage of Atenolol Tarbis 50 mg
6. Contents of the pack and further information

1. What is Atenolol Tarbis 50 mg and what is it used for

Atenolol is an anti-hypertensive medication (prevents the increase of blood pressure) and belongs to the group of so-called “Adrenergic beta-receptor antagonists”.

Atenolol is indicated in the treatment of hypertension (high blood pressure), stable chronic angina pectoris, cardiac arrhythmias (alteration of heart rhythm), and in secondary prevention after acute myocardial infarction.

2. What you need to know before you take Atenolol Tarbis 50 mg

Do not take Atenolol Tarbis 50 mg:

• If you are allergic (hypersensitive) to atenolol or any of the other ingredients of this medication (listed in section 6).
• If you have cardiogenic shock (shock state caused by heart failure).
• If you have uncontrolled heart failure.
• If you have sinus syndrome (cardiac rhythms that alternate between fast and slow) including sino-atrial block.
• If you have a second and third degree cardiac block (slowdown of heart rhythm).
• Untreated pheochromocytoma (a type of tumor).
• Metabolic acidosis (increase in blood and tissue acidity due to metabolic problems).
• If you have bradycardia (< 45-50 bpm) (decrease in heart rate).
• If you have hypotension (low blood pressure).
• Severe peripheral circulatory disorders (severe circulation disorders in the legs).
• If you are being treated with floctafenine.
• Severe asthma and severe chronic obstructive pulmonary diseases, such as airway obstruction.

Warnings and precautions

Consult your doctor or pharmacist before taking Atenolol Tarbis 50 mg

• If you have ischemic heart disease (the heart does not receive adequate blood supply), treatment should not be interrupted abruptly.
• If you are to undergo surgery.
• If you have peripheral circulatory disorders (circulation disorders in the limbs).
• In cases of excessive bradycardia (decrease in heart rate). In this case, the dose should be reduced.
• If you have chronic obstructive pulmonary disease (persistent airway obstruction).
• If you have a heart block.
• If you have kidney disease.
• If you are an elderly patient.
• If you have Prinzmetal's angina.
• If you have psoriasis (a skin disease).
• If you have any type of allergy.
• If you are diabetic.
• If you have thyrotoxicosis (abnormal increase in thyroid hormones).
• If you have treated pheochromocytoma.

Use of Atenolol Tarbis 50 mg with other medications:

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

Also, inform your doctor if you are taking any of the following medications that may interact with atenolol:

• Floctafenine.
• Verapamil and diltiazem (to treat high blood pressure): concomitant administration of these medications with atenolol may worsen cardiac conduction disorders and ventricular alteration.
• Digitalis glycosides (heart medications): may worsen cardiac conduction disorders and ventricular alteration.
• Monoamine oxidase inhibitors (for depression treatment) except MAO-B inhibitors.
• Clonidine (to treat high blood pressure and migraine): increases the risk of rebound hypertension.
• Sultopride (for psychosis treatment): increases the risk of a type of cardiac arrhythmia.
• Class I anti-arrhythmics, such as disopyramide, quinidine (for heart rhythm disorders treatment) may cause cardiac conduction disorders.
• Insulin and oral antidiabetics: may enhance the effect of lowering blood sugar and prevent the appearance of hypoglycemia signs (low blood sugar).
• Anesthetics.
• Baclofen (for spasticity treatment): increases the effects of atenolol.
• Iodinated contrast media: if they produce any adverse reaction, atenolol prevents the body's defense mechanisms against it.
• Amiodarone (for heart rhythm disorders treatment): may cause cardiac conduction disorders.
• Calcium antagonists, such as nifedipine (to treat high blood pressure): may increase the risk of hypotension (excessive decrease in blood pressure) and heart disorders.
• NSAIDs (for inflammation treatment): may decrease the effect of atenolol.
• Adrenaline (for shock and some types of cardiac arrest treatment): may counteract the effect of atenolol.
• Tricyclic antidepressants, barbiturates (for epilepsy treatment), and phenothiazines (for nervous, mental, and emotional diseases treatment), and other antihypertensive agents: may increase the effect of atenolol.
• Ampicillin (a type of antibiotic): may decrease the effect of atenolol.

Pregnancy and lactation:

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

Avoid administration of this medication during pregnancy, especially during the first and second trimester, unless medically necessary.

Atenolol is distributed in breast milk, therefore, its use is not recommended during breastfeeding.

Use in athletes

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

Driving and using machines

This medication does not affect the ability to drive vehicles or use hazardous machinery; however, this ability may be impaired if adverse effects such as dizziness or fatigue occur.

3. How to take Atenolol Tarbis 50 mg

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Atenolol Tarbis 50 mg. Do not stop treatment before, as it may worsen your disease.

The atenolol tablets are for oral administration.

Adults

The recommended dose is:

Hypertension:An initial dose of 25 mg is recommended. Most patients respond to a single daily oral dose of 50-100 mg. The therapeutic effect is established after one or two weeks. It can be combined with another antihypertensive (e.g., diuretic) to improve blood pressure.

Angina pectoris:The effective dose is 50-100 mg per day. If desired, the daily dose of 100 mg can be divided into two doses of 50 mg. The anti-anginal efficacy is not increased by increasing this dose.

Arrhythmias:After treatment with atenolol intravenously, the oral maintenance dose is 50-100 mg per day, in a single dose.

Secondary prevention after acute myocardial infarction:

10 minutes after discontinuing intravenous administration of atenolol, 50 mg of atenolol is administered orally, followed by another 50 mg orally 12 hours later. Maintenance treatment is continued with a dose of 100 mg per day, divided into 1-2 doses, for 6 days or until hospital discharge.

Use in children

There is no pediatric experience in children, therefore, its use is not recommended in children.

Elderly patients

Treatment will be initiated with a lower dose. The dose will be assessed according to the clinical effect.

Dosage in patients with renal impairment

The dose of atenolol is not modified in patients with a creatinine clearance greater than 35 ml/min·1.73 m2. In patients with a creatinine clearance of 15-35 ml/min·1.73 m2, the dose should be 25-50 mg/day or 50-100 mg/2 days. In patients with a creatinine clearance <15 ml/min·1.73 m2, the dose should be 25-50 mg/2 days.

Patients undergoing hemodialysis will receive 50 mg of atenolol after each dialysis.

Dosage in patients with hepatic impairment

No dose modifications are required.

If you think the action of Atenolol Tarbis 50 mg is too strong or too weak, tell your doctor or pharmacist.

If you take more Atenolol Tarbis 50 mg than you should

If you take more Atenolol Tarbis 50 mg than your doctor has indicated, you may feel: decreased heart rate, hypotension, bronchospasm, and acute heart failure.

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

It is recommended to take the medication package and leaflet to the healthcare professional.

If you forget to take Atenolol Tarbis 50 mg

Do not take a double dose to make up for forgotten doses.

Take your dose as soon as you remember and, the next day, take it at the corresponding time.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everybody gets them.

The side effects that may occur with Atenolol Tarbis 50 mg are the following:

Blood and lymphatic system disorders

Thrombocytopenia (decrease in platelet count), leucopenia (decrease in white blood cell count), increase in antinuclear antibodies.

Nervous system disorders

Fatigue, headache, blurred vision, vision changes, hallucinations, psychosis, confusion, impotence, dizziness, sleep disorders, depression, nightmares, anxiety.

Eye disorders

Dry eyes.

Cardiac disorders

Bradycardia (slow pulse), worsening of heart failure, heart block.

Vascular disorders

Hypotension (low blood pressure) sometimes associated with syncope (sudden loss of consciousness), cold and cyanotic extremities, Raynaud's phenomenon (different coloration when immersing hands in cold or hot water), paresthesia of the extremities (tingling), increased intermittent claudication.

Respiratory, thoracic, and mediastinal disorders

Bronchospasm in patients with bronchial asthma or history of asthma.

Gastrointestinal disorders

Gastrointestinal changes, nausea, vomiting, diarrhea, dry mouth, and constipation.

Skin and subcutaneous tissue disorders

Skin changes, especially rashes, alopecia (hair loss), worsening of psoriasis (a skin disease), skin reactions similar to psoriasis, purpura (appearance of spots on the skin).

General disorders and administration site conditions

Sweating.

Reporting of side effects

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

5. Storage of Atenolol Tarbis 50 mg

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

Do not use this medication after the expiration date stated on the package after EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Store in the original package.

Medications should not be disposed of via wastewater or household waste. Place the packages and medications you no longer need in the SIGRE Point (or any other medication waste collection system) of the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Atenolol Tarbis 50 mg

• The active ingredient is atenolol. Each tablet contains 50 mg of atenolol.
• The other ingredients (excipients) are: microcrystalline cellulose (E 460i), crospovidone, magnesium stearate, and colloidal silica dioxide.

Appearance of the product and package contents

Atenolol Tarbis 50 mg are white, round, flat-faced, scored, and beveled-edge tablets. On one face, it features the inscription “APO” and on the other “ATE” and “50” on either side of the score line. They are available in packages of 30, 60, or 500 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

TARBIS FARMA, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona (Spain)

Manufacturer:

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona (Spain)

Date of the last revision of this leaflet: November 2016

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/