BLOPRESS FORTE 32mg/25mg TABLETS

Introduction

Package Leaflet: Information for the User

Blopress Forte 32 mg/25 mg tablets

candesartan cilexetil / hydrochlorothiazide

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

1. What is Blopress Forte and what is it used for

Your medicine is called Blopress Forte. It is used to treat high blood pressure (hypertension). It contains two active substances: candesartan cilexetil and hydrochlorothiazide. Both work together to lower your blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It makes the blood vessels relax and widen. This helps to lower your blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps your body get rid of water and salts like sodium in your urine. This helps to lower your blood pressure.

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

2. What you need to know before you take Blopress Forte

Do not take Blopress Forte:

• if you are allergic to candesartan cilexetil or hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sulfonamides. If you are not sure, consult your doctor.
• if you are more than 3 months pregnant. (It is also better to avoid Blopress Forte during the first months of pregnancy – see section on Pregnancy).
• if you have severe kidney disease.
• if you have severe liver disease or biliary obstruction (problems with the drainage of the bile from the gall bladder).
• if you have persistent low potassium levels in your blood.
• if you have persistent high calcium levels in your blood.
• if you have ever had gout.
• if you have diabetes or kidney problems and are being treated with a blood pressure medicine containing aliskiren.

If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Blopress Forte.

Warnings and precautions

Talk to your doctor before you start taking Blopress Forte:

• if you have diabetes.
• if you have heart, liver or kidney problems.
• if you have recently had a kidney transplant.
• if you have vomiting, have had vomiting recently or have diarrhea.
• if you have a condition called primary hyperaldosteronism (also known as Conn’s syndrome).
• 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 ever had an allergy or asthma.
• 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 have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Blopress Forte.
• if you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and can occur within hours to a week after taking Blopress Forte. This can lead to permanent vision loss if not treated. If you have previously been allergic to penicillin or sulfonamide, you may be at higher risk of developing this.
• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Blopress Forte, seek medical attention immediately.

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

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

Tell your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking Blopress Forte before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of Blopress Forte. Blopress Forte should not be used during the first trimester of pregnancy and must not be used after the third month of pregnancy as it may cause serious harm to your baby after this time (see section on Pregnancy).

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

If you are going to have surgery, tell your doctor or dentist that you are taking Blopress Forte. This is because Blopress Forte, in combination with some anesthetics, can cause a drop in blood pressure.

Blopress Forte may make your skin more sensitive to the sun.

Use in children

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

Taking Blopress Forte with other medicines

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

Blopress Forte may affect the way some medicines work and some medicines may affect the way Blopress Forte works. If you are using certain medicines, your doctor may need to do 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 drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines to relieve pain and inflammation).
• Acetylsalicylic acid (if you take more than 3 g a day) (medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines to increase potassium levels in your blood).
• Calcium supplements or vitamin D.
• Medicines to lower your cholesterol, such as colestipol or cholestyramine.
• Medicines for diabetes (tablets or insulin).
• Medicines to control your heart rate (anti-arrhythmic agents) such as digoxin and beta-blockers.
• Medicines that may be affected by potassium levels in your blood, such as certain antipsychotic medicines.
• Heparin (a medicine to increase blood fluidity).
• Diuretics (medicines to increase urine production).
• Laxatives.
• Penicillin (an antibiotic).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medicine for mental health problems).
• Corticosteroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines for cancer treatment.
• 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 mouth ulcers).
• Anticholinergic agents such as atropine and biperiden.
• Cyclosporin, a medicine used for organ transplants to prevent organ rejection.
• Other medicines that may increase the blood pressure-lowering effect of Blopress Forte, such as baclofen (a medicine to relieve muscle spasms), amifostine (used in cancer treatment), and certain antipsychotic medicines.
• If you are taking an ACE inhibitor or aliskiren (see also the information in the sections “Do not take Blopress Forte” and “Warnings and precautions”).

Taking Blopress Forte with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

Pregnancy

Tell your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking Blopress Forte before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of Blopress Forte. Blopress Forte should not be used during the first trimester of pregnancy and must not be used after the third month of pregnancy as it may cause serious harm to your baby after this time.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. Blopress Forte is not recommended during breastfeeding, and your doctor will choose a different treatment for you if you want to breastfeed.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Some patients may feel tired or dizzy when taking Blopress Forte. If this happens to you, do not drive or use 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 some sugars, talk to your doctor before taking this medicine.

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

3. How to take Blopress Forte

Always take Blopress Forte exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

It is important to keep 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 each day. This will help you to remember to take it.

The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

If you take more Blopress Forte than you should

If you have taken more Blopress Forte than you should, talk to a doctor or pharmacist immediately. You may need to go to the hospital. You can also contact the national poison control center at 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Blopress Forte

Do not take a double dose to make up for a forgotten dose. Just take the next dose as normal.

If you stop taking Blopress Forte

If you stop taking Blopress Forte, your blood pressure may increase again. Therefore, do not stop taking Blopress Forte without talking to your doctor first.

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

4. Possible side effects

Like all medicines, Blopress Forte can cause side effects, although not everybody gets them.

It is important that you know what these side effects may be. Some of the side effects of Blopress Forte are due to candesartan cilexetil and some are due to hydrochlorothiazide.

Stop taking Blopress Forte 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 may cause difficulty swallowing.
• severe itching of the skin (with rash).

Blopress Forte may cause a decrease in white blood cells. Your resistance to infections may be decreased and you may feel tired, get an infection, or have a fever. If this happens, talk to your doctor. Your doctor may need to do blood tests from time to time to check that Blopress Forte is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common (may affect up to 1 in 10 people)

• Changes in blood test results:

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

• Presence of glucose in your urine.
• Feeling dizzy or weak.
• Headache.
• Respiratory infection

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This may cause dizziness or fainting.
• Lack of appetite, diarrhea, constipation, stomach upset.
• Rash, itching, sensitivity to sunlight.

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

• Jaundice (yellowing of the skin and the whites of the eyes). If this happens, talk to your doctor immediately.
• Effects on kidney function, especially if you already have kidney problems or heart failure.
• Difficulty sleeping, depression, or anxiety.
• Tingling or numbness in arms and legs.
• Blurred vision for a short time.
• Abnormal heart rhythms.
• Breathing difficulties (including inflammation of the lungs and fluid in the lungs).
• High temperature (fever).
• Pancreatitis (inflammation of the pancreas). This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels, which can cause red or purple spots on the skin.
• A decrease in red or white blood cells, or platelets. You may feel tired, get an infection, have a fever, or bruise easily.
• A severe skin reaction that develops quickly, with blisters and peeling of the skin, and possibly ulcers in the mouth.
• Worsening of pre-existing lupus-like reactions or appearance of uncommon skin reactions.

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

• Intestinal angioedema: swelling in the intestine with 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 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 have flu-like symptoms.
• Cough.
• Nausea.

Not known (cannot be estimated from the available data)

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

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 via the Spanish Medicines Agency's online platform: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Blopress Forte

• Keep out of the sight and reach of children.
• No special storage conditions are required.
• Do not use Blopress Forte after the expiry date which is stated on the carton or blister. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Container Content and Additional Information

Blopress Forte Composition

• The active ingredients are candesartan cilexetil and hydrochlorothiazide. The tablets contain 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.
• The other components are: calcium carmellose, hydroxypropylcellulose, lactose monohydrate (lactose), magnesium stearate, corn starch, macrogol, and red iron oxide (E172).

Product Appearance and Container Content

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

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

Not all pack sizes may be marketed in all countries.

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

Date of the last revision of this leaflet: January 2025.

Other sources of information

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es