Parapres 8 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Parapres 8 mg tablets

candesartan cilexetil

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

Contents of the leaflet

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

1. What Parapres is and what it is used for

Your medicine is called Parapres. The active substance is candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor antagonists. It works by relaxing and widening the blood vessels, which helps lower blood pressure. It also helps the heart pump blood more easily to all parts of the body.

This medicine is used for:

• the treatment of high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 years up to but less than 18 years.
• the treatment of heart failure in adult patients with heart failure and reduced heart muscle function, when angiotensin-converting enzyme (ACE) inhibitors cannot be used, or as an add-on to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRAs) cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure.)

2. What you need to know before taking Parapres

Do not take Parapres:

• if you are allergic to candesartan cilexetil or any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during early pregnancy – see Pregnancy section).
• if you have severe liver disease or biliary obstruction (a problem with bile flow from the gallbladder).
• if the patient is under one year of age.
• 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 apply to you, consult your doctor or pharmacist before taking Parapres.

Warnings and precautions

Talk to your doctor before starting to take Parapres:

• if you have heart, liver or kidney problems or are on dialysis.
• if you have recently received a kidney transplant.
• if you have vomiting, have recently had severe vomiting, or have diarrhoea.
• if you have an adrenal gland disorder called Conn’s syndrome (also known as primary hyperaldosteronism).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you are pregnant, think you might be pregnant, or are planning to become pregnant, you must inform your doctor. Use of Parapres is not recommended during early pregnancy (first 3 months), and under no circumstances should it be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby – see Pregnancy section.
• 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 are taking an ACE inhibitor together with a medicine belonging to a class of medicines known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure. (See “Use of Parapres with other medicines”).

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Parapres. Your doctor will decide whether to continue treatment. Do not stop taking Parapres 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 information in the section “Do not take Parapres”.

If any of the above situations apply to you, your doctor may want to see you more frequently and carry out certain tests.

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

Children and adolescents

Parapres has been studied in children. For further information, consult your doctor. Parapres should not be given to children under 1 year of age due to the potential risk of kidney development impairment.

Use of Parapres with other medicines

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

Parapres may affect how some medicines work, and some medicines may influence the effect of Parapres. 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 salt substitutes containing potassium (medicines that increase the amount of potassium in your blood).
• Heparin (a medicine to increase blood fluidity).
• Diuretics (medicines that promote urine elimination).
• Lithium (a medicine used for mental health conditions).
• If you are taking an ACE inhibitor or aliskiren (see also information in sections “Do not take Parapres” and “Warnings and precautions”).
• If you are being treated with an ACE inhibitor together with other specific medicines for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone).

Taking Parapres with food, drinks and alcohol

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

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant. Generally, your doctor will advise you to stop taking Parapres before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Parapres is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that stage.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as Parapres is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable if you wish to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

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

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

3. How to take Parapres

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. It is important that you continue taking Parapres every day.

You may take Parapres with or without food.

Swallow the tablet with some water.

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

Parapres 4 mg, 8 mg, 16 mg and 32 mg tablets: The tablet may be divided into equal doses.

High blood pressure:

• The recommended dose of Parapres is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily and then to 32 mg once daily depending on your blood pressure response.
• In some patients, such as those with liver problems, kidney problems, or those who have recently lost body fluids (for example due to vomiting, diarrhoea, or diuretic use), your doctor may prescribe a lower starting dose.
• Some black patients may have a reduced response to this type of medicine when used alone, and may require a higher dose.

Use in children and adolescents

Children aged 6 years to under 18 years:

The recommended starting dose is 4 mg once daily.

For patients weighing less than 50 kg: In some patients whose blood pressure is not adequately controlled, your doctor will decide whether the dose may be increased to a maximum of 8 mg once daily.

For patients weighing 50 kg or more: In some patients whose blood pressure is not adequately controlled, your doctor will decide whether the dose may be increased to 8 mg once daily and then to 16 mg once daily.

Heart failure in adults:

• The recommended dose of Parapres is 4 mg once daily. Your doctor may increase this dose by doubling it at intervals of at least 2 weeks up to 32 mg once daily. Parapres may be taken together with other medicines for heart failure, and your doctor will decide which treatment is suitable for you.

If you take more Parapres than you should

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

If you forget to take Parapres

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

If you stop taking Parapres

If you stop taking Parapres, your blood pressure may rise again. Therefore, do not stop taking Parapres before consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. It is important that you are aware of what these adverse effects could be.

Stop taking Parapres and see a 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)

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

Other possible adverse effects include:

Frequent (affects 1 to 10 in every 100 patients)

• Dizziness

• Headache

• Respiratory infection

• Low blood pressure. This may cause dizziness or fainting

• Changes in blood test results:

• Increase 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.

• Effects on kidney function, especially if you already have kidney problems or heart failure. In very rare cases, kidney failure may occur.

Very rare (affects less than 1 in every 10,000 patients)

• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea

• Swelling of the face, lips, tongue and/or throat

• Decrease in red blood cells or white blood cells. You may feel tired, or have an infection or fever

• Skin rash, hives

• Itching

• Back pain, joint 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 flu-like symptoms

• Cough

• Nausea

• Changes in blood test results:

• Reduction in blood sodium levels. If severe, you may feel weak, lack energy, or have muscle cramps.

Frequency not known (cannot be estimated from available data)

• Diarrhea

In children treated for high blood pressure, adverse effects appear to be similar to those observed in adults, but occur more frequently. Sore throat is a very common adverse effect in children, but no cases were reported in adults; nasal discharge, fever, and increased heart rate are common adverse effects in children, but no cases were reported in adults.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Parapres

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the container or blister pack. The expiry date refers to the last day of the month indicated.
• Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Instead, dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, 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 Parapres

• The active substance of Parapres is candesartan cilexetil. The tablets contain 8 mg of candesartan cilexetil.

• The other components are: calcium carmellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, corn starch, macrogol, and iron oxide (E172).

Appearance of the product and contents of the pack

• Parapres 8 mg tablets are round, biconvex, scored tablets on both sides, pale pink in colour.

Parapres 8 mg is marketed in packs containing 28 tablets.

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)

Date of the most recent revision of this leaflet: February 2025

Other sources of information

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (https://www.aemps.gob.es/)