Leaflet: information for the user

Blopress 16 mg tablets

candesartán cilexetilo

Read this leaflet carefully before you start taking the 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 prescribedonlyfor you and should not be given to others, even if they have the same symptomsas you, as it may harm them.
• If you experience any side effects,consult your doctor, evenifthey are not listed in this leaflet. See section 4.

1. What isBlopressand what it is used for

2. What you need to know before starting totakeBlopress

3. How to takeBlopress

4. Possible side effects

5. Storage ofBlopress

6. Contents of the pack and additional information

Your medication is called Blopress. The active ingredient is candesartán cilexetilo. This belongs to a group of medicines called angiotensin II receptor antagonists. It works by causing blood vessels to relax and dilate. This facilitates a decrease in blood pressure. It also facilitates your heart pumping blood to all parts of your body.

This medicine is used for:

• treatment of high blood pressure (hypertension) in adult patients and in children and adolescents from 6 years old to less than 18 years old.
• treatment of heart failure in adult patients with reduced cardiac muscle function, when it is not possible to use Angiotensin-Converting Enzyme (ACE) inhibitors or added to ACE inhibitors when symptoms persist despite treatment and it is not possible to use mineralocorticoid receptor antagonists (MRAs) (ACE inhibitors and MRAs are medicines used to treat heart failure).

Do not take Blopress:

• if you are allergic to candesartán cilexetilo or any of the other components of this medication (see section 6).
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medication also at the beginning of your pregnancy – see Pregnancy section).
• if you have a severe liver disease or biliary obstruction (problem with the bile flow from the gallbladder).
• if the patient is under one year of age.
• if you are taking a medication to lower blood pressure that contains aliskirén and if you have diabetes or kidney insufficiency.

If you are unsure whether you are in any of these situations, consult your doctor or pharmacist before taking Blopress.

Warnings and precautions

Consult your doctor before starting to take Blopress.

• if you have heart, liver, or kidney problems or are undergoing dialysis.
• if you have recently had a kidney transplant.
• if you have vomiting, have recently had severe vomiting, or have diarrhea.
• if you have a condition called Conn's syndrome (also known as primary aldosteronism).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you are pregnant, if you suspect you may be, or if you plan to become pregnant, inform your doctor. Blopress is not recommended for use at the beginning of pregnancy (first 3 months) and in no case should it be administered from the third month of pregnancy because it may cause serious harm to your baby, see Pregnancy section.
• if you are taking any of the following medications used to treat high blood pressure:
• an angiotensin-converting enzyme (ACE) inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskirén
• if you are taking an ACE inhibitor along with a medication that belongs to the class of medications known as mineralocorticoid receptor antagonists (MRAs). These medications are for the treatment of heart failure. (see "Use of Blopress with other medications").

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Blopress. Your doctor will decide whether to continue treatment. Do not stop taking Blopress on your own.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals.

See also the information in the section "Do not take Blopress"

If you are in any of these situations, your doctor may want to see you more frequently and perform some tests.

If you are undergoing surgery, inform your doctor or dentist that you are taking Blopress. This is because Blopress, in combination with some anesthetics, may cause a drop in blood pressure.

Children and adolescents

Blopress has been studied in children. For more information, consult your doctor. Blopress should not be administered to children under 1 year of age due to the potential risk of kidney damage.

Use of Blopress with other medications

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

Blopress may affect the way some medications work and some medications may influence the effect of Blopress. If you are using certain medications, your doctor may need to perform blood tests at regular intervals.

Especially, inform your doctor if you are using any of the following medications, as your doctor may need to change your dose and/or take other precautions:

• Other medications to lower your blood pressure, including beta-blockers, diazoxide, and the so-called ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medications to relieve pain and inflammation).
• Acetylsalicylic acid (if you take more than 3 g per day) (medication to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medications that increase the amount of potassium in your blood).
• Heparin (a medication to increase blood fluidity).
• Diuretics (medications to promote urine elimination).
• Lithium (a medication for mental health problems).
• if you are taking an ACE inhibitor or aliskirén (see also the information in the sections "Do not take Blopress" and "Warnings and precautions")
• if you are being treated with an ACE inhibitor along with other specific medications for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone).

Taking Blopress with food, drinks, and alcohol

• You can take Blopress with or without food.
• When Blopress is prescribed, consult your doctor before taking alcohol. Alcohol may cause dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, if you suspect you may be, or if you plan to become pregnant. Your doctor will usually advise you to stop taking Blopress before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medication instead. Blopress is not recommended for use at the beginning of pregnancy, and in no case should it be administered from the third month of pregnancy because it may cause serious harm to your baby when administered from that point on.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding, as Blopress is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially in newborns or premature babies.

Driving and operating machinery

Some patients may feel tired or dizzy when taking Blopress. If this happens to you, do not drive or operate tools or machinery.

Blopress contains lactose. Lactose is a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.It is important that you continue to take Blopress every day.

You can take Blopress with or without food.

Swallow the tablet with a little water.

Try to take the tablet at the same time every day. This will help you remember to take it.

Blopress 4 mg, 8 mg, 16 mg, and 32 mg tablets:The tablet can be divided into equal doses.

Hypertension:

• The recommended dose of Blopress is 8 mg once a day. Your doctor may increase this dose to 16 mg once a day and then to 32 mg once a day, depending on the blood pressure response.
• In some patients, such as those with liver problems, kidney problems, or those who have recently lost body fluids, for example, due to vomiting, diarrhea, or taking diuretics, your doctor may prescribe a lower initial dose.
• Some black patients may have a reduced response to this type of medication, when given as a single treatment, and these patients may need a higher dose.

Use in children and adolescents

Children from 6 years to less than 18 years of age:
The recommended initial dose is 4 mg once a day.
For patients weighing less than 50 kg: In some patients whose blood pressure is not adequately controlled, your doctor may decide whether to increase the dose to a maximum of 8 mg once a day.

For patients weighing 50 kg or more: In some patients whose blood pressure is not adequately controlled, your doctor should decide whether to increase the dose to 8 mg once a day and to 16 mg once a day.

Heart failure in adults:

• The recommended dose of Blopress is 4 mg once a day. Your doctor may increase this dose by doubling the dose in intervals of at least 2 weeks to 32 mg once a day. Blopress can be taken with other medications for heart failure, and your doctor will decide what treatment is suitable for you.

If you take more Blopress than you should

If you have taken more Blopress than prescribed by your doctor, contact your doctor or pharmacist immediately. You can also call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Blopress

Do not take a double dose to compensate for the missed doses. Simply take the next dose.

If you interrupt treatment with Blopress

If you stop taking Blopress, your blood pressure may increase again. Therefore, do not stop taking Blopress before consulting your doctor.

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

Like all medications, this medication may have side effects, although not everyone will experience them. It is essential that you know which side effects could occur.

Stop taking Blopress and see your doctor immediately if you experience any of the following allergic reactions:

• Difficulty breathing, with or without swelling of the face, lips, tongue, and/or throat
• Swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing
• Severe skin itching (with skin rash)

Blopress may cause a decrease in white blood cells. Your resistance to infections may decrease, and you may feel tired, have an infection, or fever. If this occurs, inform your doctor. It is possible that your doctor will perform a blood test from time to time to check if Blopress is affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (affects 1 to 10 of every 100 patients)

• Dizziness.
• Headache.
• Respiratory infection.
• Low blood pressure. This may cause dizziness or fainting.
• Changes in blood test results:

• An increase in potassium levels in the blood, especially if you already have kidney problems or heart failure. If this is severe, you will feel tired, weak, have irregular heartbeats, or experience numbness.

• Effects on kidney function, especially if you already have kidney problems or heart failure. In very rare cases, kidney failure may occur.

Very rare (affects less than 1 in 10,000 patients)

• Intestinal angioedema: swelling in the intestine accompanied by symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• Swelling of the face, lips, tongue, and/or throat.
• Decrease in red or white blood cells. You may feel tired, have an infection, or fever.
• Skin rash, hives.
• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, including inflammation of the liver (hepatitis). You will feel tired, have a yellowish discoloration of the skin and the white of the eyes, and symptoms similar to the flu.
• Cough.
• Nausea.
• Changes in blood test results:

-A decrease in sodium levels in the blood. If severe, you may feel weak, lack energy, or experience muscle cramps.

Unknown (cannot be estimated based on available data)

• Diarrhea

In children treated for high blood pressure, side effects appear to be similar to those observed in adults, but occur more frequently. Additionally, sore throat is a very common side effect in children, and nasal discharge, fever, and increased heart rate are common in children.

Reporting side effects

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

• Keepthis medicationout of the sight and reach of children.
• Do not usethis medicationafter the expiration date that appears on the packaging or blister. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Blopress

The active ingredient of Blopress is candesartan cilexetilo.Each tablet contains 16 mg of candesartan cilexetiloThe other components arecalcium carmelose, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, cornstarch, macrogol, and iron oxide red E172.

Appearance of the product and content of the container

Blopress 16 mg tablets are round, pale pink tablets with a convex face marked with 16 and a flat face with a groove.

Blopress is available in polypropylene or PVC/PVDC/Alu blisters.

Each pack contains 28, 30, 56, 90, or 98 tablets.

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Responsible for manufacturing:

Delpharm Novara S.r.l., Via Crosa 86 (Cerano) I-28065, Italy

Lusomedicamenta – Sociedade Técnica Farmacêutica, S.A.Rua Norberto de Oliveira 1 a 5, 2620-111 Póvoa de Sto. Adrião, Portugal

Lusomedicamenta – Sociedade Técnica Farmacêutica, S.A.

Estrada Consiglieri Pedroso 66, 69-B, Queluz de Baixo

2730-055 Barcarena

Portugal

Local Representative:

Laboratorios Rubió, S.A.

Industria, 29 – Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

This medicine is authorized in the Member States of the European Economic Area with the following names:

Date of the last review of this leaflet:March 2025

Other sources of information

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