BLOPRESS PLUS 16/12.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Blopress Plus 16 mg/12.5 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 Plus and what is it used for
2. What you need to know before you take Blopress Plus
3. How to take Blopress Plus
4. Possible side effects
5. Storage of Blopress Plus
6. Contents of the pack and other information

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

Your medicine is called Blopress Plus. It is used to treat high blood pressure (hypertension). It contains two active ingredients: 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 your blood vessels relax and dilate. 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 Plus 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 Plus

Do not take Blopress Plus:

• 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 if you are in this situation, consult your doctor.
• if you are more than 3 months pregnant. (It is also better to avoid Blopress Plus 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 (problem with bile leaving the gallbladder).
• if you have persistently low potassium levels in your blood.
• if you have persistently 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 that contains aliskiren.

If you are not sure 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 been 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 disease 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 to treat high blood pressure:
• an ACE inhibitor (such as 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 certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Blopress Plus.
• 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 increased pressure in the eye and can occur within hours to a week after taking Blopress Plus. 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 it.
• 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 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 check 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 Plus".

Tell your doctor if you are pregnant (or think you might be). Your doctor will generally advise you to stop taking Blopress Plus before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Blopress Plus. Blopress Plus is not recommended during the first trimester of pregnancy, and must not be taken after the third month of pregnancy as it may cause serious harm to your baby when administered from that time on (see section on Pregnancy).

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

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

Blopress Plus may increase the sensitivity of your skin to the sun.

Use in children

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

Taking Blopress Plus with other medicines

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

Blopress Plus may affect the way some medicines work and some medicines may affect the way Blopress Plus 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 per day) (medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes that contain 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 the treatment of cancer.
• 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 Plus, 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 Plus" and "Warnings and precautions").

Taking Blopress Plus with food, drinks, and alcohol

• You can take Blopress Plus with or without food.
• When Blopress Plus is prescribed for you, consult 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 generally advise you to stop taking Blopress Plus before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Blopress Plus. Blopress Plus is not recommended during the first trimester of pregnancy, and must not be taken after the third month of pregnancy as it may cause serious harm to your baby when administered from that time on.

Breastfeeding

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

Consult your doctor or pharmacist before taking 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 use 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 some sugars, consult 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 Plus

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

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

The tablet can be divided into equal doses.

If you take more Blopress Plus than you should

If you have taken more Blopress Plus than your doctor prescribed, contact your doctor or pharmacist immediately. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Blopress Plus

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

If you stop taking Blopress Plus

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

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

4. Possible side effects

Like all medicines, Blopress Plus 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 Plus are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop taking Blopress Plus and go to your 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 can cause difficulty swallowing.
• severe itching of the skin (with 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 happens, tell your doctor. Your doctor may do blood tests from time to time to check that Blopress Plus 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 situation is severe, you may feel tired, weak, have irregular heartbeats, or tingling.
• An increase in cholesterol, glucose, or uric acid levels in your blood.

• 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 can cause dizziness or fainting.
• Lack of appetite, diarrhea, constipation, stomach upset.
• 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 the whites of the eyes). If this happens, 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 pinching in arms and legs.
• Blurred vision for a short time.
• Abnormal heartbeats.
• Difficulty breathing (including lung inflammation and fluid in the lungs).
• High temperature (fever).
• Pancreatitis. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels that cause 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 that develops rapidly, causing 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 that causes symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• Swelling of the face, lips, tongue, and/or throat.
• Acute difficulty breathing (signs 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 a 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 short-sightedness.
• 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, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side 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 is the last day of the month indicated.

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 protect the environment.

6. Packaging Content and Additional Information

Blopress Plus Composition

• The active ingredients 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, corn starch, macrogol, and red iron oxide (E172).

Product Appearance and Packaging Content

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

The tablets are presented in aluminum blisters with a calendar of 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 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