Leaflet: information for the user

Blokium-Diu 100 mg/25 mg tablets

atenolol/clortalidona

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, 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. See section 4.

1. What is Blokium-Diu and what it is used for

2. What you need to know before starting to take Blokium-Diu

3. How to take Blokium-Diu

4. Possible side effects

5. Storage of Blokium-Diu

6. Contents of the pack and additional information

Blokium-Diu is a medication that contains an association of two components capable of reducing elevated blood pressure. One of the components (atenolol) belongs to a group of medications called beta-blockers adrenergic cardioselective and acts preferentially on the heart; the other component (clortalidona) is a diuretic (a medication that favors the elimination of urine).

Doctors prescribe this medication to people with elevated blood pressure (hypertension) if their blood pressure is not adequately controlled with atenolol or clortalidona separately.

Do not take Blokium-Diu

- if you are allergic to atenolol, clortalidona (or to sulfonamide-derived medications), to any medication in the same family as the above (beta-blockers and thiazide diuretics) or to 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 sinus 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 (a tumor of the glands located above the kidneys called the adrenal glands), and you are not being treated, metabolic acidosis, severe liver disorders, uncorrected hypokalemia (low potassium in the blood), or acute gout.

- if you are pregnant or breastfeeding

- if you have severe kidney problems.

Warnings and precautions

Consult your doctor before starting to take this medication.

- consult your doctor if you have any health problems such as asthma or breathing difficulties, if you have diabetes, depression, circulatory disorders, kidney, liver, or thyroid problems, or heart problems other than those mentioned in the previous section.

- if you have been diagnosed with a type of chest pain called Prinzmetal's angina.

- if you have ever had an allergic reaction to something, for example, an insect bite, you should be careful when taking this medication, as it may increase the severity of these allergic reactions.

- if you notice that your pulse is slower while taking these tablets. This is normal, but if you are concerned, inform your doctor of this.

- if you are using eye drops that contain a medication from the beta-blocker family, as it may potentiate the effect of this medication.

- if you are diabetic, this medication may mask a drop in blood sugar (hypoglycemia), reducing the tachycardia, palpitations, and sweating that occur during hypoglycemia. The manifestations of hyperthyroidism or thyrotoxicosis (disorders in which the levels of thyroid hormones in the blood are increased) may also be masked.

- clortalidona, one of the components of this medication, may favor an increase in blood sugar (hyperglycemia), so it is necessary to have a closer control of blood glucose.

- if you are going to have a study of parathyroid function, you should inform your doctor, as this medication may interfere with the levels of calcium in the blood.

- this medication may cause an increase in uric acid in the blood, so your doctor will put you on additional treatment with another medication if this elevation is prolonged.

- your doctor should perform regular checks, especially in the following situations: if you are over 65 years old, if you are being treated with a type of heart medication called digitals, if you are following a low-potassium diet, or if you have any gastrointestinal disease that causes potassium loss, because this medication may decrease the levels of potassium in the blood.

- in case of hospital admission, inform the healthcare staff and, in particular, the anesthesiologist, that you are being treated with this medication, as certain medications used in anesthesia may be incompatible with Blokium-Diu.

- avoid exposure to the sun (even on cloudy days) and ultraviolet lamps (UVA), while using this medication.

- if you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure, and they may occur within a few hours to a week after taking Blokium-Diu. This may lead to permanent vision loss if not treated. If you have previously had an allergy to sulfonamides or penicillin, you may have a higher risk of developing this.

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

Other medications and Blokium-Diu

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 (particularly verapamil, diltiazem, nifedipine, clonidine), treatment for heart failure (digoxin), non-steroidal anti-inflammatory drugs such as indomethacin or ibuprofen (for the treatment of inflammation and/or pain), baclofen (used as a muscle relaxant), adrenaline (used in case of cardiac arrest or severe allergic reactions), reserpine (for hypertension), or lithium (for treating a type of depression).

The administration of other beta-blockers such as celiprolol, propranolol, metoprolol, timolol, bisoprolol, carvedilol, oxprenolol, or nebivolol may increase the depressive effect of atenolol (one of the active principles 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 products for colds 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.

Use in children and adolescents

Blokium-Diu should not be used in children.

Use in people over 65 years old

Older patients have a higher risk of experiencing adverse reactions due to the use of this medication, so Blokium-Diu should be used with caution in these patients (see section 2, warnings and precautions, and section 3).

Use in athletes

It is reported to athletes that this medication contains a component that may produce a positive result in doping control tests.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication. This medication should not be used during pregnancy or breastfeeding (see section 2, do not take Blokium-Diu).

Driving and operating machinery

Some people may experience occasional dizziness and fatigue while being treated with Blokium-Diu. 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 for 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 each day depending on your situation. Normally, one tablet is taken per day in the morning.

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 any kidney disease

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

Use in patients with any liver disease

No adjustment of the dose of this medication is necessary if you have any liver disease.

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

If you take more Blokium-Diu than you should

You may experience 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. Phone 915 620 420.

If you forgot to take Blokium-Diu

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

If you interrupt treatment with Blokium-Diu

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. If your doctor tells you to stop taking this medication, you should discontinue treatment gradually.

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

Like all medications, it may cause adverse effects, although not all people will experience them.

If any of the following adverse effects occur, inform your doctor, who will indicate whether you should interrupt treatment and how to do it correctly.

The adverse effects thathave been observed withthis medicationare as follows:

Adverse effects associated with atenolol:

Very common (may affect more than 1 in 10 people):

• insomnia, drowsiness
• depression

Common (may affect up to 1 in 10 people):

• peripheral neuropathy (pain, loss of sensation, and inability to control muscles), drowsiness, fatigue
• circulation problems with cold extremities and a sensation of tingling
• decreased blood pressure and/or slow or irregular pulse
• muscle disorders

Rare (may affect up to 1 in 100 people):

• sleep disorders
• pulmonary fibrosis, pleural effusion
• diarrhea, nausea, vomiting
• allergic reactions, skin rashes, itching
• decreased white blood cells, increased eosinophils in the blood
• decreased libido
• increased transaminases (a type of liver enzyme)

Very rare (may affect up to 1 in 10,000 people):

• Very rarely, changes in some blood components may occur, for example, antinuclear antibodies (ANA)

Unknown frequency:

• Constipation
• Syndrome similar to lupus (a disease in which the immune system produces antibodies that attack mainly the skin and joints)

Adverse effects associated with clortalidona:

Common (may affect up to 1 in 10 people):

• metabolic disorders (increased glucose in the blood and urine), increased uric acid in the blood with possible gout, hypochloremic alkalosis (increased bicarbonate in the blood as a result of a decrease in chloride), decreased sodium and potassium, and increased calcium in the blood, altered glucose tolerance
• weakness, sedation, drowsiness
• muscle pain and cramps
• dry mouth, gastrointestinal disturbances including nausea, loss of appetite, vomiting, constipation, diarrhea, dyspepsia (difficulty digesting), pancreatic disorders (pancreatitis)

Rare (may affect up to 1 in 100 people):

• metabolic disorders (decreased magnesium in the blood and decreased calcium in the urine, increased cholesterol and triglycerides in the blood)
• headache, dizziness, neurological disorders such as paresthesias (tingling and numbness in the extremities)
• orthostatic hypotension (sudden decrease in blood pressure when standing up), altered heart rhythm
• impotence (erectile dysfunction)
• pulmonary edema
• exanthematous eruptions, photodermatitis (allergic reaction caused by sunlight)
• liver disorders (yellowing of the skin)

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

• hepatic toxicity, pancreatitis
• decreased platelets, decreased white blood cells, decreased red blood cells in the blood (hemolytic anemia and aplastic anemia)

Unknown frequency:

• Decreased vision or eye pain due to increased pressure (possible signs of accumulation of fluid in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)

Reporting adverse effects:

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

Store below 25°C.

Keep this medication out of sight and reach of children.

Do not usethis medicationafter the expiration date shown 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. Dispose of packaging and unused medications at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition ofBlokium-Diu

• The active principles are atenolol and clortalidona. Each tablet contains 100 mg of atenolol and 25 mg of clortalidona.
• The other components aremicrocrystalline cellulose (E-460), magnesium stearate (E-572), sodium croscarmellose, macrogol 6000, sodium lauryl sulfate, colloidal silica (E-551), talc (E-553b).

Appearance of the product and contents of the packaging

The Blokium-Diu tablets are greyish white, flat, round, and engraved with BLOKIUM-DIU on the upper face and a central groove on the lower face.

Blokium-Diu is presented in packaging of 28 or 56 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)

Revision date of this leaflet: May 2021

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/