PARAPRES PLUS 16 mg/12.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Parapres 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, as 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 Parapres Plus is and what it is used for
2. What you need to know before you take Parapres Plus
3. How to take Parapres Plus
4. Possible side effects
5. Storage of Parapres Plus
6. Contents of the pack and other information

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

Your medicine is called Parapres 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 the 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 such as sodium in your urine. This helps to lower your blood pressure.

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

2. What you need to know before you take Parapres Plus

Do not take Parapres 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 Parapres 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 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 that contains aliskiren.

If you are not sure if you are in any of these situations, consult your doctor or pharmacist before taking Parapres Plus.

Warnings and precautions

Consult your doctor before starting to take Parapres 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 been vomiting frequently lately, 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 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 certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Parapres 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 weeks after taking Parapres Plus. This can lead to permanent vision loss if not treated. If you have previously been allergic to sulfonamide or penicillin, you may have a greater 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 severe shortness of breath or difficulty breathing after taking Parapres Plus, go to the doctor immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Parapres Plus. Your doctor will decide whether to continue treatment. Do not stop taking Parapres Plus 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 Parapres Plus"

Tell your doctor if you are pregnant (or think you might be). Your doctor will generally advise you to stop taking Parapres Plus before you become pregnant or as soon as you know you are pregnant, and will recommend taking another medicine instead of Parapres Plus. Parapres Plus is not recommended during the start of pregnancy, and should 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 Parapres Plus. This is because Parapres Plus, in combination with some anesthetics, can cause a drop in blood pressure.

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

Children

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

Other medicines and Parapres Plus

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

Parapres Plus may affect the way some medicines work, and some medicines may affect the effect of Parapres Plus. If you are using certain medicines, your doctor may need to perform 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).
• Aspirin (if you take more than 3 g per day) (medicines 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 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 oral 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 antihypertensive effect, such as baclofen (a medicine for the relief of 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 Parapres Plus" and "Warnings and precautions")

Taking Parapres Plus with food, drinks, and alcohol

• You can take Parapres Plus with or without food.
• When Parapres Plus is prescribed for you, consult your doctor before drinking alcohol. Alcohol may make you feel dizzy or faint.

Pregnancy, breast-feeding, and fertility

Pregnancy

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

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Parapres Plus is not recommended during breast-feeding, and your doctor will choose another treatment for you if you want to breast-feed.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Some patients may feel tired or dizzy when taking Parapres Plus. If this happens to you, do not drive or use tools or machines.

Parapres Plus contains lactose

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

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

3. How to take Parapres Plus

Follow the instructions for taking Parapres Plus exactly as your doctor has told you. Consult your doctor or pharmacist if you are unsure.

It is important that you keep taking Parapres Plus every day.

The usual 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 Parapres Plus than you should

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

If you forget to take Parapres Plus

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

If you stop taking Parapres Plus

If you stop taking Parapres Plus, your blood pressure may increase again. Therefore, do not stop taking Parapres 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, Parapres 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 Parapres Plus are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop taking Parapres Plus and go to the 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).

Parapres Plus may cause a decrease in white blood cells. Your resistance to infections may decrease, and you may feel tired, have an infection, or have a fever. If this happens, tell your doctor. Your doctor may perform blood tests from time to time to check that Parapres Plus is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common (affects 1 to 10 users in 100)

• 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 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 (affects less than 1 user in 100)

• 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 (affects less than 1 user in 1,000)

• Jaundice (yellowing of the skin and the whites of the eyes). If this happens, contact your doctor immediately.
• Effects on your kidney function, especially if you already have kidney problems or heart failure.
• Difficulty sleeping, depression, or restlessness.
• Tingling or pinching sensations in your 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 causes 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.
• A 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 (affects less than 1 user in 10,000)

• 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 (symptoms include severe difficulty breathing, fever, weakness, and confusion).
• Itching.
• Back pain, joint and muscle pain.
• Changes in your 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 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, 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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Parapres Plus

• Keep this medicine out of the sight and reach of children.
• No special storage conditions are required.
• Do not use Parapres Plus 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Parapres Plus

• The Parapres Plus tablets contain the following active ingredients: candesartan cilexetil and hydrochlorothiazide. The tablets contain 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• The other components are: calcium carmellose, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, corn starch, macrogol, and iron oxide (E172).

Appearance of the Product and Container Content

Parapres Plus is presented in the form of pale pink, oval, flat tablets, approximately 8.5 mm by 5.1 mm, scored and engraved with 16 / C on both sides.

Parapres Plus 16 mg/12.5 mg tablets are presented in precut unit dose blisters in packs of 28 or 300 tablets.

Not all pack sizes may be marketed in all countries.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Almirall, S.A.

General Mitre nº 151

08022 - Barcelona (Spain)

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

or

Takeda Ireland Ltd.

Bray Business Park - Kilruddery - Co. Wicklow (Ireland)

or

Delpharm Novara S.r.l.

Via Crosa, 86 28065 Cerano (NO) – Italy

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