Blopress Forte 32 mg/25 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Blopress Forte 32 mg/25 mg tablets

candesartan cilexetil / hydrochlorothiazide

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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

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

• Candesartan cilexetilo belongs to a group of medicines called angiotensin II receptor antagonists. It helps blood vessels relax and widen, making it easier to reduce blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps the body get rid of water and salts such as sodium through the urine. This also helps lower blood pressure.

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

2. What you need to know before taking Blopress Forte

Do not take Blopress Forte:

• if you are allergic to candesartan cilexetil or hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sulfonamides. If you are unsure whether this applies to you, consult your doctor.
• if you are more than 3 months pregnant. (It is also advisable 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 biliary obstruction (a problem with bile leaving the gallbladder).
• if you have persistently low levels of potassium in your blood.
• if you have persistently high levels of calcium in your blood.
• if you have ever had gout.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Consult your doctor before starting Blopress Forte:

• if you are diabetic.
• if you have heart, liver, or kidney problems.
• if you have recently received a kidney transplant.
• if you are experiencing vomiting, have vomited frequently recently, or have diarrhea.
• if you have a disorder of the adrenal gland called Conn's syndrome (also known as primary hyperaldosteronism).
• if you have ever had a disease 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 used to treat high blood pressure:
• 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 develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Blopress Forte.
• if you experience a decrease in vision or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, and may occur within hours to one week after taking Blopress Forte. This may lead to permanent vision loss if not treated. If you have previously been allergic to penicillin or sulfonamides, you may have a higher risk of developing this condition.
• if you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Blopress Forte, seek medical attention 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 blood levels of electrolytes (e.g., potassium) at regular intervals.

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

Inform your doctor if you are pregnant (or suspect you might be pregnant). The use of Blopress Forte is not recommended during early pregnancy, and you must not take it after the first 3 months of pregnancy as it may cause serious harm to your baby when used from that stage onward (see Pregnancy section).

If any of these situations apply to you, your doctor may wish to schedule more frequent check-ups and perform certain tests.

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

Blopress Forte may increase the skin's sensitivity to sunlight.

Use in children

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

Taking Blopress Forte with other medicines

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

Blopress Forte may affect how some medicines work, and some medicines may influence the effect of Blopress Forte. 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 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 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 potassium-containing salt substitutes (medicines used to increase potassium levels in the blood).
• Calcium or vitamin D supplements.
• Medicines to lower cholesterol, such as colestipol or cholestyramine.
• Medicines for diabetes (tablets or insulin).
• Medicines to control heart rhythm (antiarrhythmics), such as digoxin and beta-blockers.
• Medicines that may be affected by blood potassium levels, such as some antipsychotic medicines.
• Heparin (a medicine used to increase blood fluidity).
• Diuretics (medicines used to promote urine elimination).
• Laxatives.
• Penicillin (an antibiotic).
• Amphotericin (used to treat fungal infections).
• Lithium (a medicine used for mental health conditions).
• Steroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines used to treat cancer.
• Amantadine (used to treat Parkinson's disease or serious viral infections).
• Barbiturates (a type of sedative, also used to treat epilepsy).
• Carbenoxolone (used to treat oesophageal disease or oral ulcers).
• Anticholinergic agents such as atropine and biperidene.
• Cyclosporine, a medicine used in organ transplantation to prevent organ rejection.
• Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine used to relieve 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 may take Blopress Forte with or without food.
• When prescribed Blopress Forte, consult your doctor before consuming alcohol. Alcohol may make you feel faint or dizzy.

Pregnancy, breastfeeding, and fertility

Pregnancy

Inform your doctor if you are pregnant (or suspect you may be pregnant). Your doctor will usually advise you to stop taking Blopress Forte before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Blopress Forte. The use of Blopress Forte is not recommended during early pregnancy, and under no circumstances should it be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when administered from that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. The use of Blopress Forte is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you intend to breastfeed.

Consult your doctor or pharmacist before using 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 operate tools or machinery.

Blopress Forte contains lactose

Lactose is a type of sugar. If your doctor has informed 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 lead to a positive result in doping control tests.

3. How to take Blopress Forte

Follow exactly the instructions for using Blopress Forte provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

It is important that you continue taking Blopress Forte every day.

The recommended dose is one tablet once daily.

Swallow the tablet with a glass of water.

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

The tablet's score line is only intended to assist in dividing the tablet if you have difficulty swallowing the whole tablet.

If you take more Blopress Forte than you should

If you have taken more Blopress Forte than prescribed by your doctor, contact your doctor or pharmacist immediately. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take BlopressForte

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

If you interrupt treatment with Blopress Forte

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

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

4. Possible adverse effects

Like all medicines, Blopress Forte may cause adverse effects, although not everyone experiences them.

It is important that you are aware of the possible adverse effects. Some of these adverse effects are due to candesartan cilexetilo, while 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 itching of the skin (with skin rash).

Blopress Forte may cause a decrease in white blood cells. Your resistance to infections may be reduced, and you may feel tired, have an infection, or fever. If this occurs, inform your doctor. Your doctor may perform periodic blood tests to check that Blopress Forte is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Frequent (may affect up to 1 in 10 people)

• Changes in blood test results:

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

• An increase or decrease in blood potassium levels, especially if you already have kidney problems or heart failure. If this condition is severe, you may feel tired, weak, have irregular heartbeats, or tingling sensations.

• An increase in blood levels of cholesterol, glucose, or uric acid.

• Presence of glucose in urine.

• Dizziness or weakness.

• Headache.

• Respiratory infection.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This may cause dizziness or fainting.

• Loss of appetite, diarrhoea, constipation, stomach irritation.

• Skin rash, hives, skin reaction due to sensitivity to sunlight.

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

• Jaundice (yellowing of the skin and whites 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.
• Tingling or pins and needles in arms and legs.
• Blurred vision for a short period of time.
• Abnormal heartbeats.
• Breathing difficulties (including lung inflammation and fluid in the lungs).
• High temperature (fever).
• Inflammation of the pancreas. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels causing red or purple spots on the skin.
• A decrease in red blood cells, white blood cells, or platelets. You may feel tired, have an infection, fever, or bruise easily.
• Severe skin reaction developing rapidly, causing blisters and peeling of the skin, and possibly mouth ulcers.
• Worsening of pre-existing lupus-like reactions or development of uncommon skin reactions.

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

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

Not known (frequency cannot be estimated from 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 adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via 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 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 stated on the outer packaging or blister. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and packaging. This helps protect the environment.

6. Contents of the container and other information

Composition of Blopress Forte

• The active substances 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, maize starch, macrogol, and red iron oxide (E172).

Appearance of the product and contents of the container

Blopress Forte is available as tablets of approximately 11 mm by 6.5 mm, pale pink in colour, oval-shaped, flat, biconvex, scored, and marked 32¦C2 on both sides.

The tablets are packaged in aluminum calendar blister packs containing 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 most recent review of this leaflet: January 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 Health Products (AEMPS): http://www.aemps.gob.es