Blopress 4 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Blopress 4 mg tablets

candesartan cilexetil

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Blopress is and what it is used for

Your medicine is called Blopress. The active substance is candesartan cilexetilo. It belongs to a group of medicines called angiotensin II receptor antagonists. It works by relaxing and widening the blood vessels. This helps lower blood pressure. It also helps your heart pump blood to all parts of your body.

This medicine is used for:

• the treatment of high blood pressure (hypertension) in adult patients and in children and adolescents from 6 years up to but not including 18 years of age.
• the treatment of heart failure in adult patients with reduced heart muscle function, when angiotensin-converting enzyme (ACE) inhibitors cannot be used, or added to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRAs) cannot be used (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. What you need to know before taking 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 during early pregnancy – see Pregnancy section).
• if you have severe liver disease or biliary obstruction (a problem with bile leaving the gallbladder).
• if the patient is under one year of age.
• if you are taking a blood pressure-lowering medicine containing aliskiren and you have diabetes or renal impairment.

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

Warnings and precautions

Talk to your doctor before starting to take Blopress

• if you have heart, liver or kidney problems, or if you are on dialysis.
• if you have recently received a kidney transplant.
• if you have vomiting, have recently had severe vomiting, or have diarrhoea.
• if you have an adrenal gland disorder 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 might be pregnant, or are planning to become pregnant, you must inform your doctor. Use of Blopress is not recommended during early pregnancy (first 3 months), and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby – see Pregnancy section.
• if you are taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskiren
• if you are taking an ACE inhibitor together with a medicine belonging to a class of medicines known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure. (See “Use of Blopress with other medicines”).

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea 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 blood levels of electrolytes (e.g., potassium) at regular intervals.

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

If any of these situations apply to you, your doctor may want to see you more frequently and carry out certain tests.

If you are scheduled for surgery, inform your doctor or dentist that you are taking Blopress. This is because Blopress, in combination with certain anaesthetics, may cause a drop in blood pressure.

Children and adolescents

Blopress has been studied in children. For further information, consult your doctor. Blopress must not be given to children under 1 year of age due to the potential risk of kidney development impairment.

Use of Blopress with other medicines

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

Blopress may affect how some medicines work, and some medicines may influence the effect of Blopress. If you are taking certain medicines, your doctor may need to perform blood tests periodically.

In particular, inform your doctor if you are taking any of the following medicines, as your doctor may need to adjust 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 drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines used to relieve pain and inflammation).
• Acetylsalicylic acid (if taking more than 3 g per day) (a medicine used 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 used to increase blood fluidity).
• Diuretics (medicines that promote urine elimination).
• Lithium (a medicine used for mental health conditions).
• If you are taking an ACE inhibitor or aliskiren (see also information in sections “Do not take Blopress” and “Warnings and precautions”).
• If you are being treated with an ACE inhibitor together with other specific medicines for the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone).

Taking Blopress with food, drinks and alcohol

• You may take Blopress with or without food.
• When prescribed Blopress, consult your doctor before drinking alcohol. Alcohol may make you feel faint or dizzy.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant. Generally, your doctor will advise you to stop taking Blopress before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Use of Blopress is not recommended during early pregnancy, and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that time.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as Blopress is not recommended for women during this period. Your doctor may choose a treatment that is more suitable if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

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 informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Blopress

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. It is important that you continue taking Blopress every day.

You may take Blopress with or without food.

Swallow the tablet with some 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 may be divided into equal doses.

High blood pressure:

• The recommended dose of Blopress is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily and then up to 32 mg once daily depending on your blood pressure response.
• In some patients, such as those with liver problems, kidney problems, or those who have recently lost body fluids (e.g. due to vomiting, diarrhoea, or use of diuretics), your doctor may prescribe a lower starting dose.
• Some black patients may have a reduced response to this type of medicine when used as monotherapy, and may require a higher dose.

Use in children and adolescents

Children aged 6 years to under 18 years: The recommended starting dose is 4 mg once daily.
For patients weighing less than 50 kg: In some patients whose blood pressure is not adequately controlled, your doctor may decide whether the dose should be increased to a maximum of 8 mg once daily.
For patients weighing 50 kg or more: In some patients whose blood pressure is not adequately controlled, your doctor should decide whether the dose may be increased to 8 mg once daily and then to 16 mg once daily.

Heart failure in adults:

• The recommended dose of Blopress is 4 mg once daily. Your doctor may increase this dose by doubling it at intervals of at least 2 weeks up to 32 mg once daily. Blopress may be taken together with other medicines for heart failure, and your doctor will decide which 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 may also call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Blopress

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

If you stop taking Blopress

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

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 can cause adverse effects, although not everyone experiences them. It is important that you are aware of what these adverse effects could be.

Stop taking Blopress and see a 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 itching of the skin (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. Your doctor may perform blood tests from time to time to check that Blopress is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Common (affects 1 to 10 in every 100 patients)

• Dizziness

• Headache

• Respiratory infection

• Low blood pressure. This may cause dizziness or fainting

• Changes in blood test results:

• An increase in blood potassium levels, especially if you already have kidney problems or heart failure. If this is severe, you may experience fatigue, weakness, irregular heartbeat, or 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 in every 10,000 patients)

• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.

• Swelling of the face, lips, tongue and/or throat

• Decrease in red blood cells or white blood cells. You may feel tired, or 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 may feel tired, have yellowing of the skin and whites of the eyes, and flu-like symptoms

• Cough

• Nausea

• Changes in blood test results:

• A reduction in blood sodium levels. If severe, you may feel weak, lack energy, or have muscle cramps.

Not known (frequency cannot be estimated from available data)

• Diarrhoea

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

Reporting of adverse effects

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

5. Storage of Blopress

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the container or blister pack. The expiry date refers to the last day of the month indicated.
• Do not store above 30°C.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Blopress

The active substance of Blopress is candesartan cilexetilo. Each tablet contains 4 mg of candesartan cilexetilo. The other components are calcium carmellose, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, maize starch and macrogol.

Appearance of the product and contents of the pack

Blopress 4 mg tablets are round, scored on both sides, white tablets.

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

Each carton contains 14, 28, 30, 90 or 98 tablets.

Only certain 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: March 2025

Other sources of information

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