Leaflet: information for the user

Blokium 100 mg tablets

atenolol

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not mentioned in this leaflet.

1. What is Blokium 100 mg and what it is used for

2. What you need to know before you start taking Blokium 100 mg

3. How to take Blokium 100 mg

4. Possible side effects

5. Storage of Blokium 100 mg

6. Contents of the pack and additional information

Blokium 100 mgbelongs to a group of medicines calledbeta‑blockerscardioselective adrenergicthat actpreferentially on the heart.

Doctors prescribe this medication to people withhigh blood pressure(hypertension), to prevent chest pain or discomfort of coronary origin (angina) and to regulate heartbeats in arrhythmias. It also protects the heart during and after a heart attack (myocardial infarction).

Do not takeBlokium 100 mg

• if you are allergic to atenolol or any of the other components of this medication (listed in section 6).
• if you have or have had heart diseases such as: uncontrolled heart failure (the heart does not pump enough blood to the rest of the body), bradycardia (very slow pulse), second- or third-degree heart block, or sinoatrial disease (diseases in which the pulse is irregular).
• if you have ever had very low blood pressure, circulatory failure, or cardiac shock.
• if you have been informed that you have pheochromocytoma and are not being treated, or metabolic acidosis.

Warnings and precautions

Consult your doctor before starting to take this medication.

If you have any doubts about any of the above points, consult your doctor before taking Blokium.

If you are to undergo any diagnostic tests (including blood tests, urine tests, skin tests that use allergens, etc...) inform your doctor that you are taking this medication, as it may alter the results. See section 4.

Other medications and Blokium 100 mg

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Be especially careful and inform your doctor if you are taking disopyramide (for irregular heartbeats), other treatments for hypertension or angina (in particular, see verapamil, diltiazem, nifedipine, clonidine), treatment for heart failure (digoxin), indomethacin or ibuprofen (for the treatment of inflammation and/or pain), adrenaline (used in case of cardiac arrest or severe allergic reactions) or reserpine (for hypertension).

The administration of other beta-blockers such as celiprolol, propranolol, metoprolol, timolol, bisoprolol, carvedilol, oxprenolol, or nebivolol may increase the depressive effect of atenolol (active principle of this medication) on the heart.

You should also inform your doctor if you are being treated with any medication for nasal congestion or other over-the-counter cold products that you may have purchased yourself at a pharmacy.

If you are taking clonidine for hypertension or to prevent migraines, do not interrupt the treatment of either without consulting your doctor first.

You should never take another medication on your own initiative without your doctor's recommendation, as some combinations should be avoided.

Pregnancy, breastfeeding, and fertility

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

This medication is not recommended for use during breastfeeding; if your doctor considers that you need to take it, it is recommended to substitute breastfeeding.

Children and adolescents

This medication should not be used in children.

Use in patients over 65 years

Older patients have a higher risk of experiencing adverse reactions due to the use of this medication, so it should be used with caution in these patients (see section 3).

Use in athletes

Inform athletes that this medication contains a component that may produce a positive result in doping control tests.

Driving and operating machinery

Some people may occasionally experience dizziness and fatigue while being treated with this medication. If you feel these effects, you should not drive vehicles or operate machinery.

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 as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

This medication is for oral administration.Swallow the tablet whole with the help of water.

Try to take your tablet at the same time every day.

Your doctor will decide the dose of this medication that you should take according to your individual needs. The usual doses are:

Hypertension:The usual dose is usually 100 mg, taken once a day.Some patients may need a maintenance dose of only 50 mg once a day.The evaluation of the response should only be made after 1 or 2 weeks of continuous treatment.

In the case that the reduction of blood pressure, after this time, is insufficient, your doctor will evaluate the need to add to the treatment a diuretic or another antihypertensive.

Angina pectoris:The effective dose is generally 100 mg in a single dose or in two doses of 50 mg per day. It usually does not increase the efficacy if this dose is exceeded.

Arrhythmias:After initial treatment with atenolol by intravenous route, a maintenance therapy with 50 or 100 mg of atenolol, oral, in a single daily dose may be established.

Myocardial infarction:It is possible that during the early phase of a myocardial infarction, you will be administered a dose of atenolol intravenously after the appearance of chest pain. Subsequently, if no adverse effects have appeared, you should take this medication orally as indicated. The dose after this acute phase will be 100 mg per day orally.If adverse effects such as a significant decrease in pulse and/or blood pressure appear, treatment will be suspended.

Use in patients over 65 years old

Your doctor should adjust the dose of this medication if you are over 65 years old.

Use in patients with some kidney disease

Your doctor should adjust the dose of this medication if you have some kidney disease.

Use in patients with some liver disease

Your doctor should adjust the dose of this medication if you have some liver disease.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more than the prescribed dose of Blokium 100 mg

You may have difficulty breathing or a decrease in pulse or blood pressure. Contact your doctor or go to the nearest hospital as soon as possible. Bring this leaflet with you.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Telephone 915 620 420.

If you forgot to take Blokium 100 mg

If you forgot to take this medication, take a dose as soon as you remember it. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Blokium 100 mg

Your doctor will indicate the duration of your treatment with this medication. Do not stop taking the tablets before completing the treatment, even if you feel well, unless your doctor tells you to do so.If your doctor tells you to stop taking this medication, you should discontinue treatment gradually.

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

Like all medications, Blokium 100 mg mayproduce side effects, although not all people will experience them.

If any ofthe followingside effects occur, inform your doctor, who will indicate whether you should discontinue treatment and how to do so correctly.

The side effects thathave been observedwiththis medicationarethefollowing:

-Very common (affects more than 1 in 10 patients): fatigue, drowsiness, headache, insomnia, depression, difficulty breathing(bronchospasm), circulation problems, cold extremities, and a sensation of numbness.

-Common (affects between 1 and 10 in 100 patients): severe circulatory disturbances (decreased blood pressure and/or pulse, cardiac block, heart failure), hallucinations, drowsiness, confusion, neurological disorderssuch asparesthesias(sensation of numbness and drowsiness in the extremities) orperipheral neuropathy(pain, loss of sensation, and inability to control muscles),muscular disordersand eye disorders.

-Rare (affects between 1 and 10 in 1,000 patients): diarrhea, constipation, nausea, vomiting, abdominal cramps(abdominal pain), allergic reactions, skin rashes, itching, reversible hair loss,decreased platelets, decreased white blood cells, non-thrombocytopenic purpura (blood disorder characterized by bruising and bleeding tendency), increased eosinophils in the blood,impotence(erectile dysfunction), decreased libido,lung fibrosis and pleural effusion.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 of 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 medication.

Do not store at a temperature above30°C.

Keep this medicationout ofthe sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging.The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. In this way,, you will help protect the environment.

Composition of Blokium 100 mg

• The active ingredient is atenolol. Each tablet contains 100 mg of atenolol.
• The other components aremicrocrystalline cellulose (E-460), magnesium stearate (E-572), sodium starch glycolate (from potato), povidone.

Appearance of the product and contents of the packaging

Blokium 100 mg tablets are white, biconvex, scored in a cross on the upper face and with a smooth lower face.

Blokium 100 mg tablets are presented in packaging containing 30 or 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Almirall, S.A.

General Mitre, 151

08022 Barcelona (Spain)

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A.

Ctra.de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

This leaflet has been approved in:December 2002

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