PARAPRES 32 mg TABLETS

Introduction

Package Leaflet: Information for the User

Parapres 32 mg Tablets

candesartan cilexetil

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

1. What is Parapres and what is it used for

Your medicine is called Parapres. The active ingredient is candesartan cilexetil. This belongs to a group of medicines called angiotensin II receptor antagonists. It works by making your blood vessels relax and widen. This helps to lower your blood pressure. It also helps your heart to pump blood to all parts of your body.

This medicine is used for:

• treatment of high blood pressure (hypertension) in adult patients and in children and adolescents from 6 years to less than 18 years.
• treatment of heart failure in adult patients with heart failure and reduced kidney function, when it is not possible to use Angiotensin-Converting Enzyme (ACE) inhibitors, or added to ACE inhibitors when symptoms persist despite treatment and it is not possible to use mineralocorticoid receptor antagonists (MRAs). (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. What you need to know before you take 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 at the start of your pregnancy – see section Pregnancy).
• if you have severe liver disease or biliary obstruction (problem with the release of bile from the gallbladder).
• if the patient is under 1 year of age.
• if you have diabetes or kidney impairment and are being treated with a medicine containing aliskiren.

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

Warnings and precautions

Consult your doctor before starting to take Parapres:

• if you have heart, liver or kidney problems or are undergoing dialysis.
• if you have recently had a kidney transplant.
• if you have vomiting, have recently had severe vomiting or have diarrhea.
• if you have a disease of the adrenal gland 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 may be pregnant or are planning to become pregnant, you must inform your doctor. It is not recommended to use Parapres at the start of pregnancy (first 3 months) and in no case should it be administered from the third month of pregnancybecause it can cause serious harm to your baby, see section Pregnancy.
• 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 are taking an ACE inhibitor along with a medicine that belongs to the class of medicines known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure. (see “Using Parapres with other medicines”).

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

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

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

Children and adolescents

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

Using Parapres with other medicines

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

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

Taking Parapres with food, drinks, and alcohol

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

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. In general, your doctor will advise you to stop taking Parapres before you become pregnant or as soon as you find out you are pregnant, and recommend that you take another anti-hypertensive medicine instead. It is not recommended to use Parapres at the start of pregnancy and in no case should it be administered from the third month of pregnancybecause it can cause serious harm to your baby when administered from that time on.

Breastfeeding

Inform your doctor if you are about to start or are breastfeeding, as it is not recommended to administer Parapres to women during this period. Your doctor may decide to administer a treatment that is more suitable if you want to breastfeed, especially newborns or premature babies.

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 machines.

Parapres 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.

3. How to take Parapres

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. It is important that you continue taking Parapres every day.

You can take Parapres with or without food.

Swallow the tablet with a little water.

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

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

High blood pressure:

• The recommended dose of Parapres is 8 mg once a day. Your doctor may increase this dose to 16 mg once a day and then to 32 mg once a day 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, diarrhea, or because they are taking diuretics, the doctor may prescribe a lower initial dose.
• Some black patients may have a reduced response to this type of medicine when given as sole treatment, and these patients may need a higher dose.

Use in children and adolescents

Children from 6 years to less than 18 years of age:

The recommended initial dose is 4 mg once a day.

For patients who weigh less than 50 kg: In some patients whose blood pressure is not adequately controlled, the doctor should decide whether the dose can be increased to a maximum of 8 mg once a day.

For patients who weigh 50 kg or more: In some patients whose blood pressure is not adequately controlled, the doctor should decide whether the dose can be increased to 8 mg once a day and to 16 mg once a day.

Heart failure in adults:

• The recommended dose of Parapres is 4 mg once a day. The doctor may increase this dose by doubling the dose at intervals of at least 2 weeks up to 32 mg once a day. Parapres can be taken with other medicines for heart failure, and the doctor will decide what 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 can also call the Toxicology Information Service, phone 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.

If you stop taking Parapres

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. It is important that you know what these side effects might be.

Stop taking Parapres 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)

Parapres 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, inform your doctor. It is possible that your doctor will perform a blood test from time to time to check that Parapres is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common (affects 1 to 10 users in 100)

• Dizziness.
• Headache.
• Respiratory infection.
• Low blood pressure. This can cause dizziness or fainting.
• Changes in blood test results:

• An increase in potassium levels in the blood, especially if you already have kidney problems or heart failure. If this situation is severe, you will feel tired, weak, 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 user in 10,000)

• Intestinal angioedema: swelling in the intestine that occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• Swelling of the face, lips, tongue, and/or throat.
• A decrease in red or white blood cells. You may feel tired, have an infection, or have a fever.
• Rash, hives.
• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, including liver inflammation (hepatitis). You will feel tired, have a yellowish color of the skin and the whites of the eyes, and symptoms similar to those of the flu.
• Cough.
• Nausea.
• Changes in blood test results:

• A decrease in sodium levels in the blood. If it is severe, you may feel weak, lack energy, or have muscle cramps.

Frequency not known (cannot be estimated from the available data)

• Diarrhea

In children treated for high blood pressure, the side effects seem to be similar to those observed in adults, but they occur more frequently. Sore throat is a very common side effect in children, but no cases were reported in adults, and runny nose, fever, and increased heart rate are common side effects in children, but no cases were reported in adults.

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. Storing Parapres

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton or blister. The expiry date is the last day of the month shown.
• Store below 30°C.

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. Contents of the pack and other information

Composition of Parapres

• The active substance of Parapres is candesartan cilexetil. The tablets contain 32 mg of candesartan cilexetil.
• The other ingredients are: calcium carmellose, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, corn starch, macrogol, and iron oxide (E172).

Appearance of the product and contents of the pack

• Parapres 32 mg tablets are pink, round, biconvex tablets with one face marked with 32 and the other face scored.

Parapres 32 mg tablets are available in packs of 28 and 300 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Almirall, S.A.

General Mitre, 151

08022 - Barcelona (Spain)

Manufacturer

Takeda Ireland Ltd.

Bray Business Park - Kilruddery

Co. Wicklow (Ireland)

or

Delpharm Novara, S.r.l.

Via Crosa, 86

28065 Cerano (No) – Italy

or

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

Date of last revision of this leaflet: February 2025

Other sources of information

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