Blopress Plus 16/12.5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Blopress Plus 16 mg/12.5 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; 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 side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

• Candesartan cilexetil 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 reduce blood pressure.

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

2. What you need to know before starting to take Blopress Plus

Do not take Blopress Plus:

• 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 Plus 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 drainage from 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 Plus.

Warnings and precautions

Consult your doctor before starting to take Blopress Plus:

• if you have diabetes.
• if you have heart, liver, or kidney problems.
• if you have recently had a kidney transplant.
• if you are experiencing vomiting, have had frequent vomiting recently, or have diarrhea.
• if you have a disease of the adrenal gland called Conn’s syndrome (also known as primary hyperaldosteronism).
• 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 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 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 and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Blopress Plus.
• 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, occurring within hours to a week after taking Blopress Plus. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk.
• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe 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 whether to continue treatment. Do not stop taking Blopress Plus 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 may be). Use of Blopress Plus is not recommended during early pregnancy, and you must not take it after 3 months of pregnancy as it may cause severe harm to your baby when used from that point onward (see Pregnancy section).

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

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

Blopress Plus may increase skin sensitivity to sunlight.

Use in children

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

Taking Blopress Plus with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Blopress Plus may affect how some medicines work, and some medicines may influence the effect of Blopress Plus. If you are taking certain medicines, your doctor may need to carry out 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 to relieve pain and inflammation).
• Acetylsalicylic acid (if taking more than 3 g per day) (medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines to increase potassium levels in the blood).
• Calcium or vitamin D supplements.
• Cholesterol-lowering medicines 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 to increase blood fluidity).
• Diuretics (medicines to promote urine elimination).
• Laxatives.
• Penicillin (an antibiotic).
• Amphotericin (for treating fungal infections).
• Lithium (a medicine for mental health conditions).
• Steroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines for cancer treatment.
• Amantadine (for treating Parkinson’s disease or serious viral infections).
• Barbiturates (a type of sedative, also used to treat epilepsy).
• Carbenoxolone (for treating esophageal disease or oral ulcers).
• Anticholinergic agents such as atropine and biperidene.
• Cyclosporine, a medicine used in organ transplants to prevent organ rejection.
• Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine for relieving spasms), amifostine (used in cancer treatment), and some antipsychotic medicines.
• If you are taking an ACE inhibitor or aliskiren (see also information in sections “Do not take Blopress” and “Warnings and precautions”).

Taking Blopress Plus with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

Pregnancy

Inform your doctor if you are pregnant (or suspect you may be). Your doctor will usually advise you to stop taking Blopress Plus before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Blopress Plus is not recommended during early pregnancy, and it must not be used from the third month of pregnancy onward, 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 breastfeed. Use of Blopress Plus 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 Plus. If this happens to you, do not drive or operate tools or machinery.

Blopress Plus contains lactose

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

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

3. How to take Blopress Plus

Follow exactly the administration instructions for Blopress Plus given by your doctor. Consult your doctor or pharmacist if you have any doubts.

It is important that you continue taking Blopress Plus 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 may be divided into equal doses.

If you take more Blopress Plus than you should

If you have taken more Blopress Plus 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 Blopress Plus

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

If you stop taking Blopress Plus

If you stop taking Blopress Plus, your blood pressure may rise again. Therefore, do not stop taking Blopress Plus 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 Plus can cause adverse effects, although not everyone experiences them.

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

Blopress Plus may reduce white blood cell counts. Your resistance to infections may decrease, and you may feel tired, develop an infection, or have a fever. If this occurs, inform your doctor. Your doctor may perform periodic blood tests to ensure that Blopress Plus 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 experience fatigue, weakness, irregular heartbeat, or tingling sensations.

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

• Presence of glucose in 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.
• Loss of appetite, diarrhoea, constipation, stomach irritation.
• Skin rash, hives, skin reaction caused by 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 heartbeat.
• Difficulty breathing (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 reduction 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 skin peeling, 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 inflammation of the liver (hepatitis). You may feel tired, have yellowing of the skin and whites of the eyes, and experience 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 type of adverse effect, consult 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 Plus

• Keep out of the sight and reach of children.
• No special storage conditions are required.
• Do not use Blopress Plus after the expiry date stated on the packaging or blister. The expiry date refers to the last day of the month indicated.

Medicines must 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, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Blopress Plus

• The active substances are candesartan cilexetil and hydrochlorothiazide. The tablets contain 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• The other components are: calcium carmellose, hypromellose, lactose monohydrate (lactose), magnesium stearate, maize starch, macrogol, and red iron oxide (E172).

Appearance of the medicine and contents of the pack

Blopress Plus is available as tablets approximately 8.5 mm by 5.1 mm, pale pink in colour, oval-shaped, flat, scored, and engraved with "16¦C" on both sides.

The tablets are supplied in aluminum blister packs with calendar packaging containing 14, 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

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 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