Prospect: information for the user

Blopress Forte 32 mg/25 mg tablets

candesartán cilexetilo / hidroclorotiazida

Read this prospect carefully before starting to takethismedicine,because 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 any adverse effects, consult your doctoror pharmacist, even if they are not listed in this prospect. See section 4.

1. What isBlopress Forteand for what it is used

2. What you need to know before startingtotakeBlopress Forte

3. How to takeBlopress Forte

4. Possible adverse effects

5. Storage ofBlopress Forte

6. Contents of the package and additional information

Your medication is called Blopress Forte. 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 cilexetilo belongs to a group of medications called angiotensin II receptor antagonists. It causes blood vessels to relax and dilate. This facilitates a decrease in blood pressure.
• Hydrochlorothiazide belongs to a group of medications called diuretics. It promotes the body to eliminate water and salt, such as sodium, in urine. This facilitates a decrease in blood pressure.

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

Do not take Blopress Forte:

• 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 whether you are in this situation, consult your doctor.
• if you are more than 3 months pregnant. (It is better to avoid Blopress Forte 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 from 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 medicine that contains aliskiren.

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

Warnings and precautions

Consult your doctor before starting to take Blopress Forte:

• 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 allergies or asthma.
• if you are taking any of the following medicines to treat high blood pressure:
• a type of medicine called an ACE inhibitor (for example, 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 Forte.
• if you experience a decrease in vision or eye pain, they may be symptoms 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 Forte. 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 Forte, see your doctor immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Blopress Forte. Your doctor will decide whether to continue treatment. Do not stop taking Blopress Forte 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 section “Do not take Blopress”.

Inform your doctor if you are pregnant (or if you suspect you may be). Blopress Forte 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 onwards (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 Forte. This is because Blopress Forte, combined with some anesthetics, may cause a drop in blood pressure.

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

Use in children

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

Taking Blopress Forte with other medicines

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

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

Especially, inform your doctor if you are taking 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 the so-called ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines to relieve pain and inflammation).
• Acetylsalicylic acid (if you take more than3 gper day) (medicines to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines to increase potassium levels in the blood).
• Calcium supplements or vitamin D.
• Medicines to lower cholesterol, such as colestipol or colestiramine.
• Medicines for diabetes (tablets or insulin).
• Medicines to control heart rhythm (antiarrhythmic agents) such as digoxin and beta-blockers.
• Medicines that may be affected by potassium levels in the blood, such as some antipsychotic medicines.
• Heparin (a medicine to increase blood fluidity).
• Diuretics (medicines to promote urine excretion).
• Laxatives.
• Penicillin (an antibiotic).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medicine for mental health problems).
• Glucocorticoids such as prednisolone.
• Pituitary hormone (ACTH).
• Cancer medicines.
• 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 medicine used for organ transplants, to prevent organ rejection.
• Other medicines that may increase the antihypertensive effect, such as baclofen (a medicine for muscle spasms), amifostine (used in cancer treatment), and some antipsychotic medicines.
• If you are taking an ACE inhibitor or aliskiren (see also the information in the sections “Do not take Blopress” and “Warnings and precautions”).

Taking Blopress Forte with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

Pregnancy

Inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you stop taking Blopress Forte before becoming pregnant or as soon as you know you are pregnant, and will recommend taking another medicine instead of Blopress Forte. Blopress Forte 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 onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Blopress Forte 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 medicine.

Driving and operating machines

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

Blopress Forte 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 medicine.

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

Follow exactly the administration instructions for Blopress Forte as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

It is essential to continue taking Blopress Forte 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 groove is only for helping to break the tablet in half if you have difficulty swallowing the entire tablet.

If you take moreBlopressForte than prescribed

If you have taken more Blopress Forte 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 takeBlopressForte

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

If you interrupt treatment withBlopressForte

If you stop taking Blopress Forte, your blood pressure may increase again. Therefore, do not stop taking Blopress Forte 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 Forte may cause side effects, although not everyone will experience them.

It is essential that you know which side effects may occur. Some side effects of Blopress Forte are due to candesartan cilexetil, and others are due to hydrochlorothiazide.

Stop taking Blopress Forte 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 Forte 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 blood tests at regular intervals to check if Blopress Forte 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, lacking energy, or have 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, have 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

Infrequent (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)

• Ictericia (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 sensations 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 distress (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 Forte 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 Forte

• The active principles are candesartan cilexetilo and hydrochlorothiazide. The tablets contain 32 mg of candesartan cilexetilo and 25 mg of hydrochlorothiazide.
• The other components are: calcium carbonate, hydroxypropylcellulose, lactose monohydrate (lactose), magnesium stearate, cornstarch, macrogol, and iron oxide red (E172).

Appearance of the product and contents of the package

Blopress Forte is presented in the form of approximately 11 mm by 6.5 mm, pale pink, oval, flat, scored, and with the engraving 32¦C2 on both sides.

The tablets are presented in an aluminum blister pack with a calendar of 28, 56, and 98 tablets.

It may not be marketed in all sizes of packaging 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

Industrias Farmacéuticas Almirall S.A., Ctra Nacional II, km 593, E-08740 Sant Andreu de la Barca, Barcelona, Spain

or

LUSOMEDICAMENTA SOCIEDADE TECNICA FARMACEUTICA, 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 medication 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 medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es