Prospecto: information for the user

Blopress Plus 16 mg/12.5 mg tablets

candesartán cilexetilo / hidroclorotiazida

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribedonlyto you and should not be given to other people, even if they have the same symptomsas you, as it may harm them.
• If you experience adverse effects, consult your doctoror pharmacist, even if they are not listed in this prospect. See section 4.

1. What isBlopress Plusand for what it is used

2. What you need to know before starting totakeBlopress Plus

3. How to takeBlopress Plus

4. Possible adverse effects

5. Storage ofBlopress Plus

6. Contents of the package and additional information

Your medicine is called Blopress Plus. It is used for the treatment of high blood pressure (hypertension). It contains two active ingredients: candesartan cilexetilo and hydrochlorothiazide. Both work together to lower blood pressure.

• Candesartan cilexetilobelongs to a group of medicines called angiotensin II receptor antagonists.It makes blood vessels relax and dilate.This facilitates a decrease inbloodpressure.
• Hydrochlorothiazidebelongs to a group of medicines called diuretics.It promotes the body to eliminate water and salt, such as sodium, in the urine.This facilitates a decrease inbloodpressure.

Your doctor may prescribe Blopress Plus if your blood pressure has not been adequately controlled with candesartan cilexetilo or hydrochlorothiazide alone..

Do not take Blopress Plus:

• If you are allergic to candesartan cilexetilo or hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to sulfonamides. If you are unsure if you are in this situation, consult your doctor.
• If you are more than 3 months pregnant. (It is better to avoid Blopress Plus during the first months of pregnancy – see Pregnancy section).
• If you have severe kidney disease.
• If you have severe liver disease or bile duct obstruction (problem with the bile flowing out of the gallbladder).
• If you have persistent low levels of potassium in the blood.
• If you have persistent high levels of calcium in the blood.
• If you have ever had gout.
• If you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medication containing aliskiren.

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

Warnings and precautions

Consult your doctor before starting to take Blopress Plus:

• If you are diabetic.
• If you have heart, liver, or kidney problems.
• If you have recently had a kidney transplant.
• If you have frequent vomiting, have had it recently, or have diarrhea.
• If you have a condition called Conn's syndrome (also known as primary aldosteronism).
• If you have ever had a condition called systemic lupus erythematosus (SLE).
• If you have low blood pressure.
• If you have ever had a stroke.
• If you have had an allergy or asthma.
• If you are taking any of the following medications 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 have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from the sun and UV rays while taking Blopress Plus.
• If you experience a decrease in vision or eye pain, it may be a symptom of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours to a week after taking Blopress Plus. This can cause permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Blopress Plus, seek medical attention immediately.

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

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

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

Inform your doctor if you are pregnant (or if you suspect you may be). Blopress Plus is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby when administered from that point on (see Pregnancy section).

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 Plus. This is because Blopress Plus, combined with some anesthetics, may cause a drop in blood pressure.

Blopress Plus may increase your skin's sensitivity to the sun.

Use in children

There is no experience with the use of Blopress Plus in children (under 18 years). Therefore, Blopress should not be administered to children.

Taking Blopress Plus with other medications

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

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

Especially, inform your doctor if you are taking 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 than3 gper day) (medication to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medications to increase potassium levels in the blood).
• Calcium supplements or vitamin D.
• Medications to reduce cholesterol, such as colestipol or colestiramine.
• Medications for diabetes (tablets or insulin).
• Medications to control heart rhythm (antiarrhythmic agents) such as digoxin and beta-blockers.
• Medications that may be affected by potassium levels in the blood, such as some antipsychotic medications.
• Heparin (a medication to increase blood fluidity).
• Diuretics (medications to promote urine excretion).
• Laxatives.
• Penicillin (an antibiotic).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medication for mental health problems).
• Glucocorticoids such as prednisolone.
• Pituitary hormone (ACTH).
• Cancer medications.
• Amantadine (for the treatment of Parkinson's disease or severe viral infections).
• Barbiturates (a type of sedative, also used to treat epilepsy).
• Carbenoxolone (for the treatment of esophageal disease or oral ulcers).
• Anticholinergic agents such as atropine and biperiden.
• Ciclosporin, a medication used for organ transplants, to prevent organ rejection.
• Other medications that may increase the antihypertensive effect, such as baclofen (a medication for muscle spasms), amifostine (used in cancer treatment), and some antipsychotic medications.
• If you are taking an ACE inhibitor or aliskiren (see also the information in the "Do not take Blopress" and "Warnings and precautions" sections).

Taking Blopress Plus with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

Pregnancy

You must inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you stop taking Blopress Plus before becoming pregnant or as soon as you know you are pregnant, and will recommend taking another medication instead of Blopress Plus. Blopress Plus is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby when administered from that point on.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Blopress Plus is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Blopress Plus contains lactose

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

Use in athletes: This medication contains hydrochlorothiazide, which may produce a positive result in doping control tests.

Followexactly theadministration instructions for Blopress Plus as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

It is essential to continue taking Blopress Plus every day.

The recommended dose is one tablet once a day.

Swallow the tablet with a glass of water.

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

The tablet can be divided into equal doses.

If you take more Blopress Plus than youshould

Ifyou have takenmore BlopressPlus thanprescribed by your doctor,contactyour doctor or pharmacist immediately.You can also call theToxicological Information Service, phone 91 5620420, indicating the medication and the amountingested.

If you forgot to take Blopress Plus

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

If you interrupt treatment with Blopress Plus

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

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

Like all medications, Blopress Plus may cause side effects, although not everyone will experience them.

It is essential that you know which side effects could occur. Some side effects of Blopress Plus are due to candesartan cilexetilo, and others are due to hydrochlorothiazide.

Stop taking Blopress Plus 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 Plus 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 if Blopress Plus is affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (may affect up to 1 in 10 people)

• Changes in blood test results:

• A reduction in sodium levels in the blood. If severe, you may feel weak, lack energy, or experience muscle cramps.
• An increase or decrease in potassium levels in the blood, especially if you already have kidney problems or heart failure. If severe, you may feel tired, weak, experience irregular heartbeats, or experience numbness.
• An increase in cholesterol, glucose, or uric acid levels in the blood.

• Presence of glucose in urine.
• Sensation of dizziness or weakness.
• Headache.
• Respiratory infection.

Occasional (may affect up to 1 in 100 people)

• Low blood pressure. This may cause dizziness or fainting.
• Loss of appetite, diarrhea, constipation, stomach irritation.
• Skin rash, hives, skin reaction caused by sensitivity to sunlight.

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

• Icterus (yellowing of the skin and white of the eyes). If this occurs, contact your doctor immediately.
• Effects on kidney function, especially if you already have kidney problems or heart failure.
• Difficulty sleeping, depression, or restlessness.
• Itching or prickling in arms and legs.
• Blurred vision for a short period.
• Abnormal heartbeats.
• Difficulty breathing (including pulmonary inflammation and fluid in the lungs).
• Fever.
• Pancreatitis. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels that produce red or purple spots on the skin.
• Decrease in red blood cells, white blood cells, or platelets. You may feel tired, have an infection, fever, or easily bruise.
• Severe skin reaction that develops rapidly, causing blisters and skin peeling, and possibly mouth ulcers.
• Worsening of pre-existing lupus erythematosus reactions or appearance of rare skin reactions.

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

• Intestinal angioedema: swelling in the intestine that causes symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• Swelling of the face, lips, tongue, and/or throat.
• Acute respiratory difficulty (symptoms include severe difficulty breathing, fever, weakness, and confusion).
• Itching.
• Back pain, joint pain, and muscle pain.
• Changes in liver function, including inflammation of the liver (hepatitis). You may feel tired, have yellowing of the skin and white of the eyes, and experience flu-like symptoms.
• Cough.
• Nausea.

Unknown (cannot be estimated based on available data)

• Sudden myopia.
• Decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].
• Skin and lip cancer (non-melanoma skin cancer).

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside 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 on the safety of this medication.

• Keep out of sight and reach of children.
• No special storage conditions are required.
• Do not use Blopress Plus after the expiration date shown on the packaging or blister. 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 medicines you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Blopress Plus

• The active ingredients are candesartan cilexetilo and hydrochlorothiazide. The tablets contain 16 mg of candesartan cilexetilo and 12.5 mg of hydrochlorothiazide.
• The other components are: calcium carbonate, hypromellose, lactose monohydrate (lactose), magnesium stearate, cornstarch, macrogol, and iron oxide red (E172).

Appearance of the product and contents of the package

Blopress Plus is presented in the form of approximately 8.5 mm by 5.1 mm pale pink, oval, flat, scored tablets with the imprint 16¦C on both sides.

The tablets are presented in aluminum blisters with a calendar of 14, 28, 56, and 98 tablets.

It may not be commercially available in all package sizes in all countries.

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, 28065 Cerano (No), Italy

or

Takeda Ireland Ltd., Bray Business Park, Kilruddery, Co.Wicklow, Ireland.

or

LUSOMEDICAMENTA SOCIEDADE TECNICA FARMACEUTICA, S.A. Estrada Consiglieri Pedroso, 69 B P-2730-055 Queluz de Baixo, Barcarena. Lisboa, 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:

Last review date of this leaflet: January 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