Leaflet: information for the user

Parapres 16 mg tablets

candesartán cilexetilo

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Parapres is and what it is used for

2.What you need to know before you start taking Parapres

3.How to take Parapres

4.Possible side effects

5.Storage of Parapres

6.Contents of the pack and additional information

Your medication is called Parapres. The active ingredient is candesartán cilexetilo. This belongs to a group of medications called angiotensin II receptor antagonists. It works by causing blood vessels to relax and dilate. This facilitates a decrease in blood pressure. It also facilitates your heart pumping blood to all parts of your body.

This medication is used for:

• the treatment of high blood pressure (hypertension) in adult patientsand in children and adolescents from 6 years old to less than 18 years old.
• the treatment of heart failure in adult patients withheart failure withreduced cardiac muscle function,when it is not possible to use Angiotensin-Converting Enzyme (ACE) inhibitors,oradded toACE inhibitorswhen symptoms persist despite treatment and it is not possible to use mineralocorticoid receptor antagonists (MRAs).(ACE inhibitorsand MRAsare medicationsthat areusedto treatheart failure).

Do not take Parapres:

• if you are allergic to candesartán cilexetilo or any of the other components of this medication (listed in section 6).
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medication also at the beginning of your pregnancy – see Pregnancy section).
• if you have severe liver disease or biliary obstruction (problem with the bile flow from the gallbladder).
• if the patient is under one year of age.
• if you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.

If you are unsure whether you are in any 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 condition called Conn's syndrome (also known as primary aldosteronism).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant, inform your doctor. Parapres is not recommended for use at the beginning of pregnancy (first 3 months) andshould not be administered at all from the third month of pregnancybecause it can cause serious damage to your baby, see Pregnancy section.
• if you are taking any of the following medications used to treat high blood pressure:
• • a ACE inhibitor (for example,enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskirén
• if you are taking an ACE inhibitor along with a medication that belongs to the class of medications known as mineralocorticoid receptor antagonists (MRAs). These medications are for the treatment of heart failure. (see “Use of Parapres with other medications”).

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 monitor your kidney function, blood pressure, and electrolyte levels (such as potassium) at regular intervals.

See also the information in the section “Do not take Parapres”

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

If you are to undergo 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 with your doctor. Parapres should not be administered to children under 1 year of age due to the potential risk of kidney damage.

Use of Parapres with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Parapres may affect the way some medications work and some medications may influence the effect of Parapres. If you are using certain medications, your doctor may need to perform blood tests at regular intervals.

Especially, inform your doctor if you are using any of the following medications, as your doctor may need to change your dose and/or take other precautions:

• Other medications to lower your blood pressure, including beta-blockers, diazoxide, and the so-called ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medications to relieve pain and inflammation).
• Aspirin (if you take more than3gper day) (medication to relieve pain and inflammation).
• Potassium supplements or salt substitutes that contain potassium (medications that increase the amount of potassium in your blood).
• Heparin (a medication to increase blood fluidity).
• Diuretics (medications to promote urine elimination).
• Lithium (a medication for mental health problems).
• If you are taking an ACE inhibitor or aliskirén (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 medications for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example, spironolactone, eplerenone).

Parapres with food, drinks, and alcohol

• You can take Parapres with or without food.
• When Parapres is prescribed, consult your doctor before taking alcohol. Alcohol may cause dizziness or drowsiness.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant. Your doctor will usually advise you to stop taking Parapres before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Parapres is not recommended for use at the beginning of pregnancy and should not be administered at all from the third month of pregnancy because it can cause serious damage to your baby when administered from that point on.

Breastfeeding

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

Driving and operating machinery

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 told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.It is important that you continue to take 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 every day. This will help you remember to take it.

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

Hypertension:

• 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 the 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, your doctor may prescribe a lower initial dose.
• Some black patients may have a reduced response to this type of medication, when given as a single treatment, and these patients may need a higher dose.

Use in children and adolescents

Children from 6 years to less than 18 years old:

The recommended initial dose is 4 mg once a day.

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

For patients weighing 50 kg or more: In some patients whose blood pressure is not adequately controlled, your doctor must 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. Your doctor may increase this dose by doubling the dose in intervals of at least 2 weeks to 32 mg once a day. Parapres can be taken with other medications for heart failure, and your 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Parapres

Do not take a double dose to compensate for the missed doses. Simply take the next dose.

If you interrupt treatment with Parapres

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. It is important that you know which side effects could occur.

Stop taking Parapres 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 skin itching (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 fever. If this occurs, inform your doctor. It is possible that your doctor will perform a blood test at regular intervals to check that Parapres is not affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (affects 1 to 10 of every 100 patients)

• Dizziness.
• Headache.
• Respiratory infection.
• Low blood pressure. This may 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 is severe, you will feel tired, weak, have irregular heartbeats, or numbness.

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

Rare (affects less than 1 in 10,000 patients)

• Intestinal angioedema: swelling in the intestine that is accompanied by 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 fever.
• Skin rash, hives.
• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, including inflammation of the liver (hepatitis). You will feel tired, have a yellowish discoloration of the skin and the white of the eyes, and symptoms similar to the flu.
• Cough.
• Nausea.
• Changes in blood test results:

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

Unknown frequency (cannot be estimated from available data)

• Diarrhea

In children treated for high blood pressure, side effects appear to be similar to those observed in adults, but occur more frequently. Throat pain is a very common side effect in children, but not reported in adults, and nasal secretion, fever, and increased heart rate are common side effects in children, but not reported in adults.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keepthis medicationout of sight andout of reach of children.
• Do not use this medication after the expiration date that appears on the packaging or blister. The expiration date is the last day of the month indicated.
• Store below30°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Parapres

• The active ingredient of Parapres is candesartan cilexetilo. The tablets contain 16 mg of candesartan cilexetilo.
• The other components are: calcium carmelose, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, cornstarch, macrogol, and iron oxide (E172).

Appearance of the product and content of the packaging

• Parapres 16 mg tablets areround, scored, pale pink tablets with a convex face marked with 16 in relief and a flat, scored face..

Parapres 16 mg tablets are presented in packaging of 28 and 500 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Almirall, S.A.

General Mitre, nº 151

08022 - Barcelona (Spain)

Responsible manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

Last review date of this leaflet: February 2025

Other sources of information

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