PARAPRES 8 mg TABLETS

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 at the start of your pregnancy – see section Pregnancy).
• if you have severe liver disease or biliary obstruction (problem with the drainage of bile from the gallbladder).
• if the patient is less than 1 year old.
• if you have diabetes or kidney impairment and you are treated with a blood pressure lowering medicine containing aliskiren.

If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Parapres.

Warnings and precautions

Talk to your doctor before taking Parapres:

• if you have heart, liver or kidney problems or are on 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 affecting 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 might be pregnant or are planning to get pregnant, you must tell your doctor. Your doctor will normally advise you to stop taking Parapres before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead. It is not recommended to take Parapres during the first 3 months of pregnancy and in any case, it must not be taken after the third month of pregnancybecause it may 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 together with a medicine belonging to the class of medicines known as mineralocorticoid receptor antagonists (MRAs) for the treatment of heart failure. (See "Using Parapres with other medicines").

Talk to your doctor if you get any of the following symptoms after taking Parapres: abdominal pain, nausea, vomiting, or diarrhea. Your doctor will decide whether you should continue treatment. Do not stop taking Parapres on your own.

Your doctor may want to check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood 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 often and do some tests.

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

Children and adolescents

Parapres has been studied in children. For more information, talk to 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 way Parapres works. If you are taking certain medicines, your doctor may need to do blood tests from time to time.

In particular, tell your doctor if you are taking 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).
• Aspirin (if you take more than 3 g a day) (a 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 increase urine production).
• 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 taking an ACE inhibitor together 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, talk to your doctor before drinking alcohol. Alcohol may make you feel dizzy or faint.

Pregnancy and breastfeeding

Pregnancy

You should tell your doctor if you are pregnant, think you might be pregnant, or are planning to get pregnant. Your doctor will normally advise you to stop taking Parapres before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead. It is not recommended to take Parapres during the first 3 months of pregnancy and in any case, it must not be taken after the third month of pregnancybecause it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. It is not recommended to take Parapres if you are breast-feeding, and your doctor may decide to give you a different treatment, especially if you are breast-feeding a newborn or premature baby.

Driving and using machines

Some patients may feel tired or dizzy when taking Parapres. If this happens to you, do not drive or use 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, talk to your doctor before taking this medicine.

3. How to take Parapres

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. It is important that you 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 each day. This will help you to 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 or kidney problems or those who have recently lost body fluids (e.g. 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 medicine when given as the only treatment, and these patients may need a higher dose.

Use in children and adolescents

Children from 6 years to less than 18 years:

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, your doctor may decide to increase the dose 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, your doctor may decide to increase the dose 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 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 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 your doctor prescribed, contact your doctor or pharmacist immediately. You can also contact the Toxicology Information Service, telephone 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 a forgotten dose. Just take the next dose as normal.

If you stop taking Parapres

If you stop taking Parapres, your blood pressure may increase again. Therefore, do not stop taking Parapres without talking to your doctor first.

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 may be.

Stop taking Parapres and see a 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 may cause difficulty swallowing
• severe itching of the skin (with rash)

Parapres may cause a decrease in white blood cells. Your resistance to infections may be decreased and you may feel tired, get an infection, or have a fever. If this happens, tell your doctor. Your doctor may need to do 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 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 may feel tired, weak, have irregular heartbeats, or tingling.

• Affecting your 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 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, get an infection, or have a fever.
• Rash, hives.
• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, including liver inflammation (hepatitis). You may feel tired, have yellowing of the skin and the whites of the eyes, and flu-like symptoms.
• Cough.
• Nausea.
• Changes in blood test results:

• A decrease in sodium levels in the blood. If this 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 seen in adults, but they occur more often. Sore throat is a very common side effect in children, but it was not reported in adults, and runny nose, fever, and increased heart rate are common side effects in children, but they were not reported in adults.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 refers to 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

What Parapres contains

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

• The other ingredients are: calcium carmellose, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, maize starch, macrogol, and iron oxide (E172).

Appearance and packaging

• Parapres 8 mg tablets are round, scored tablets, pale pink in color.

Parapres 8 mg is available in packs of 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 last 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 for Medicines and Health Products (AEMPS) (https://www.aemps.gob.es/)