BLOPRESS 8 mg TABLETS

Introduction

Package Leaflet: Information for the User

Blopress 8 mg Tablets

candesartan cilexetil

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 pack

1. What is Blopress and what is it used for
2. What you need to know before you take Blopress
3. How to take Blopress
4. Possible side effects
5. Storing Blopress
6. Contents of the pack and other information

1. What is Blopress and what is it used for

Your medicine is called Blopress. The active ingredient is candesartan cilexetil. This belongs to a group of medicines called angiotensin II receptor antagonists. It works by making your blood vessels relax and dilate. This helps to lower your blood pressure. It also makes it easier for your heart to pump 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 to less than 18 years.
• treatment of heart failure in adult patients with reduced cardiac 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).

2. What you need to know before you take Blopress

Do not take Blopress:

• if you are allergic to candesartan cilexetil or any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also at the start of your pregnancy – see section Pregnancy).
• if you have severe liver disease or biliary obstruction (problem with bile leaving the gallbladder).
• if the patient is under 1 year of age.
• if you are taking a medicine to lower your blood pressure that contains aliskiren and you have diabetes or kidney problems.

If you are not sure if you are in one 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 disease of the adrenal gland called Conn's syndrome (also known as primary hyperaldosteronism).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you are pregnant, think you may be pregnant or are planning to have a baby, you should consult your doctor. Blopress is not recommended during the first three months of pregnancy and must notbe takenfrom the third month of pregnancyas it may harm your baby, see section Pregnancy.
• if you are taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• Aliskiren
• if you are taking an ACE inhibitor along with a medicine that belongs to the class of medicines known as mineralocorticoid receptor antagonists (MRAs). These medicines are for the treatment of heart failure. (see “Using Blopress with other medicines”).

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 want to check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also the information in the section “Do not take Blopress”

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

If you are going to have surgery, tell your doctor or dentist that you are taking Blopress. This is because Blopress, in combination with some anesthetics, can 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 given to children under 1 year of age due to the potential risk of kidney damage.

Using Blopress with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Blopress may affect the way some medicines work and some medicines may affect the effect of Blopress. If you are using certain medicines, your doctor may need to perform blood tests from time to time.

In particular, tell your doctor if you are using any of the following medicines, as your doctor may need to change your dose and/or take other precautions:

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• Non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines to relieve pain and inflammation).
• Acetylsalicylic acid (if you take more than 3 g per day) (medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in your blood).
• Heparin (a medicine to increase blood fluidity).
• Diuretics (medicines to promote urine production).
• Lithium (a medicine for mental health problems).
• If you are taking an ACE inhibitor or aliskiren (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 medicines for the treatment of your 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 you are prescribed Blopress, consult your doctor before drinking alcohol. Alcohol can make you feel dizzy or faint.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby. Your doctor will normally advise you to stop taking Blopress before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead. Blopress should not be used during the first three months of pregnancy and must notbe takenfrom the third month of pregnancyas it may harm your baby.

Breastfeeding

Inform your doctor if you are about to start or are already breastfeeding, as Blopress is not recommended for use during breastfeeding. Your doctor may decide to give you a different treatment, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

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

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

3. How to take Blopress

Follow exactly the instructions of your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again. It is important that you keep taking 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 each 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.

High blood pressure:

• 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 your blood pressure response.
• In some patients, such as those with liver or kidney problems or those who have recently lost body fluids (e.g. due to vomiting, diarrhea, or because they are taking diuretics), your doctor may prescribe a lower initial dose.
• Some black patients may have a reduced response to this type of medicine when given as the only 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 who weigh less than 50 kg: In some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose to a maximum of 8 mg once a day. For patients who weigh 50 kg or more: In some patients whose blood pressure is not adequately controlled, your doctor may decide 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 at intervals of at least 2 weeks up to 32 mg once a day. Blopress can be taken with other medicines 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 contact the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Blopress

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

If you stop taking Blopress

If you stop taking Blopress, your blood pressure may increase again. Therefore, do not stop taking Blopress without consulting your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. It is important that you know what these side effects may be.

Stop taking Blopress and see a doctor immediately if you have 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 can cause difficulty swallowing
• severe itching of the skin (with 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 have a fever. If this happens, inform your doctor. Your doctor may perform a blood test from time to time to check that Blopress is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common (affects 1 to 10 users in 100)

• Dizziness.
• Headache.
• Respiratory infection.
• Low blood pressure. This can 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 situation is severe, you may feel tired, weak, have irregular heartbeats, or have tingling.

• 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 user in 10,000)

• Intestinal angioedema: swelling in the intestine that occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• Swelling of the face, lips, tongue, and/or throat.
• A decrease in red or white blood cells. You may feel tired, have an infection, or have a fever.
• Rash, hives.
• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, including liver inflammation (hepatitis). You may feel tired, have yellowing of the skin and the whites of the eyes, and symptoms similar to those of 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 have muscle cramps.

Not known (cannot be estimated from the available data)

• Diarrhea

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Blopress

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton or blister. The expiry date is the last day of the month stated.
• Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Blopress

The active substance of Blopress is candesartan cilexetil. Each tablet contains 8 mg of candesartan cilexetil. The other ingredients are calcium carmellose, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, corn starch, macrogol, and red iron oxide E172.

Appearance of the product and pack contents

Blopress 8 mg tablets are round, scored on both sides, and pale pink in color.

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

Each carton contains 7, 28, 30, 90, or 98 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer:

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 under the following names:

Date of last revision of this leaflet:March 2025

Other sources of information

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