Blokium-Diu 100 mg/25 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Blokium-Diu 100 mg/25 mg tablets

atenolol/chlorthalidone

Read this entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Blokium-Diu is and what it is used for
2. What you need to know before taking Blokium-Diu
3. How to take Blokium-Diu
4. Possible side effects
5. How to store Blokium-Diu
6. Package contents and additional information

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

Blokium-Diu is a medicine that contains a combination of two components capable of reducing high blood pressure. One of the components (atenolol) belongs to a group of medicines called cardioselective beta-adrenergic blockers and acts primarily on the heart; the other component (chlorthalidone) is a diuretic (a medicine that promotes the elimination of urine).

Doctors prescribe this medicine for people with high blood pressure (hypertension) when their blood pressure is not adequately controlled with atenolol or chlorthalidone used separately.

2. What you need to know before taking Blokium-Diu

Do not take Blokium-Diu

• if you are allergic to atenolol, chlorothalidone (or sulfonamide-derived medicines), other medicines in the same class (beta-blockers and thiazide diuretics), or any of the other ingredients of this medicine (listed in section 6).
• if you have had or currently have heart conditions 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 sick sinus syndrome (conditions in which the pulse is irregular).
• if you have ever experienced very low blood pressure, circulatory failure, or cardiogenic shock.
• if you have been diagnosed with phaeochromocytoma (a tumor of the glands located above the kidneys, called adrenal glands) and are not being treated for it, metabolic acidosis, severe liver disorders, uncorrected hypokalaemia (low potassium levels 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 medicine.

• consult your doctor if you have health problems such as asthma or breathing difficulties, diabetes, depression, circulatory disorders, or kidney, liver, or thyroid problems, or other heart conditions different from those mentioned above.
• if you have been diagnosed with a type of coronary chest pain called Prinzmetal's angina.
• if you have ever had an allergic reaction to anything, for example an insect sting, you should be cautious when taking this medicine, as it may increase the severity of such allergic reactions.
• if you notice your pulse is slower while taking these tablets. This is normal, but if you are concerned, inform your doctor.
• if you are using eye drops containing a medicine from the beta-blocker class, as the effect of this medicine may be enhanced.
• if you are diabetic, this medicine may mask symptoms of low blood sugar (hypoglycaemia), such as tachycardia, palpitations, and sweating. Atenolol may also increase the risk of severe hypoglycaemia when used with certain types of antidiabetic medicines called sulfonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide). Symptoms of hyperthyroidism or thyrotoxicosis (conditions in which thyroid hormone levels in the blood are increased) may also be masked.
• chlorothalidone, one of the components of this medicine, may lead to increased blood sugar (hyperglycaemia), so closer monitoring of blood glucose levels is necessary.
• if you are undergoing tests for parathyroid function, inform your doctor, as this medicine may interfere with blood calcium levels.
• this medicine may cause an increase in blood uric acid levels; your doctor may prescribe additional treatment if this elevation is prolonged.
• your doctor should perform regular check-ups, especially in the following situations: if you are over 65 years old, if you are taking heart medications called digitalis glycosides, if you are on a low-potassium diet, or if you have gastrointestinal disorders causing potassium loss, as this medicine may reduce blood potassium levels.
• if you are admitted to hospital, inform healthcare staff, and especially the anaesthetist, that you are being treated with this medicine, as certain anaesthetic drugs may be incompatible with Blokium-Diu.
• avoid exposure to sunlight (even on cloudy days) and ultraviolet (UVA) lamps while using this medicine.
• if you experience blurred vision or eye pain, these could be signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within 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, your risk of developing this condition may be higher.

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

Other medicines and Blokium-Diu

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Be especially careful and inform your doctor if you are taking insulin or oral antidiabetic medicines such as sulfonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide), 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 indometacin or ibuprofen (for inflammation and/or pain), baclofen (used as a muscle relaxant), adrenaline (used in cardiac arrest or severe allergic reactions), reserpine (for hypertension), or lithium (to treat a type of depression).

Concomitant use of other beta-blockers such as celiprolol, propranolol, metoprolol, timolol, bisoprolol, carvedilol, oxprenolol, or nebivolol may increase the cardiac depressant effect of atenolol (one of the active ingredients of this medicine).

You should also inform your doctor if you are being treated with nasal decongestants or other cold remedies that you may have purchased without prescription.

If you are taking clonidine for hypertension or to prevent migraine, do not stop treatment with clonidine or Blokium-Diu without first consulting your doctor.

Never take another medicine on your own initiative without medical advice, as some combinations should be avoided.

Use in children and adolescents

Blokium-Diu must not be used in children.

Use in patients over 65 years of age

Elderly patients have a higher risk of adverse reactions due to the use of this medicine; therefore, Blokium-Diu should be used with caution in these patients (see section Warnings and precautions in section 2 and section 3).

Use in athletes

Athletes are advised that this medicine contains a component that may result in a positive doping test.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. This medicine must not be used during pregnancy or breastfeeding (see section Do not take Blokium-Diu in section 2).

Driving and using machines

Some people may occasionally experience dizziness and fatigue while being treated with Blokium-Diu. If you experience these effects, you should not drive or operate machinery.

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

3. How to take Blokium-Diu

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

This medicine is for oral administration. Swallow the tablet whole with water.

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

Your doctor will decide the dose of this medicine you should take each day, depending on your condition. Usually, one tablet per day is taken in the morning.

Use in patients over 65 years of age

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

Use in patients with kidney disease

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

Use in patients with liver disease

Dose adjustment of this medicine is not necessary if you have any liver disease.

If you think that the effect of this medicine 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. Take this leaflet with you.

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

If you forget to take Blokium-Diu

If you forget to take this medicine, take a dose as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking Blokium-Diu

Your doctor will indicate how long you should take this medicine. Do not stop taking the tablets before completing the treatment, even if you feel well, unless your doctor tells you otherwise. If your doctor advises you to stop taking this medicine, you should discontinue treatment gradually.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

The adverse effects observed with this medicine are listed below:

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 causing cold extremities and tingling sensations
• decreased blood pressure and/or slow or irregular pulse
• muscle disorders

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

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

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

• dizziness, headache, neurological disorders such as paraesthesias (tingling and numbness in limbs)
• mood changes, nightmares, confusion, psychosis, hallucinations
• breathing difficulty (bronchospasm)
• orthostatic hypotension (sudden drop in blood pressure upon standing)
• numbness and spasms in fingers, followed by warmth and pain (Raynaud's phenomenon)
• severe circulatory disorders (heart block, heart failure)
• dry eyes and visual disturbances
• dry mouth
• hair loss, skin rash, including worsening of psoriasis
• non-thrombocytopenic purpura (a blood disorder characterized by bruising and easy bleeding), decreased platelets
• impotence (erectile dysfunction)

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

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

Frequency not known:

• Constipation
• Lupus-like syndrome (a condition in which the immune system produces antibodies that primarily attack the skin and joints)

Adverse effects associated with chlorthalidone

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

• metabolic disturbances (increased blood and urine glucose), increased blood uric acid with possible gout development, hypochloremic alkalosis (increased blood bicarbonate due to decreased chloride), decreased sodium and potassium levels and increased calcium in blood, impaired glucose tolerance
• weakness, sedation, drowsiness
• muscle pain and cramps
• dry mouth, gastrointestinal disturbances including nausea, loss of appetite, vomiting, constipation, diarrhoea, dyspepsia (difficulty digesting), pancreatic disorders (pancreatitis)

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

• metabolic disturbances (decreased blood magnesium and urinary calcium, increased blood cholesterol and triglycerides)
• headache, dizziness, neurological disorders such as paraesthesias (tingling and numbness in limbs)
• orthostatic hypotension (sudden drop in blood pressure upon standing), heart rhythm disturbances
• impotence (erectile dysfunction)
• pulmonary edema
• exanthematous rashes, photosensitivity (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 blood (haemolytic anaemia and aplastic anaemia)

Frequency not known:

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Blokium-Diu

Store below 25ºC.

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

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Blokium-Diu

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

Appearance of the medicine and contents of the pack

Blokium-Diu tablets are greyish-white, round and flat, marked with "BLOKIUM-DIU" on the upper side and a central groove on the reverse.

Blokium-Diu is available in packs of 28 or 56 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Almirall, S.A.

General Mitre, 151

08022 Barcelona (Spain)

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

Date of revision of this leaflet: January 2026

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/