Leaflet: information for the user

Candesartán Normon 32 mg tablets EFG

Candesartán cilexetilo

Read this leaflet carefully before you start taking the medicine, because 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. Do 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, even if they are not listed in this leaflet. See section 4.

1. What Candesartán Normon is and what it is used for

2.What you need to know before you start taking Candesartán Normon

3. How to take Candesartán Normon

4. Possible side effects

5. Storage of Candesartán Normon

6.Contents of the pack and additional information

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

Candesartán Normon can be used for:

- the treatment of high blood pressure (hypertension) in adult patients and in children and adolescents from 6 to <18 years old

- the treatment of adult patients with heart failure with reduced cardiac muscle functionwhen it is not possible to use angiotensin-converting enzyme inhibitors (ACEIs), or added to ACEIs when symptoms persist despite treatment and it is not possible to use mineralocorticoid receptor antagonists (MRAs). (ACEIs and MRAs are medicines used to treat heart failure).

Do not take Candesartán Normon:

- if you are allergic to candesartán cilexetilo or any of the other ingredients of this medication (listed in section 6).

- if you are more than 3 months pregnant. (It is also best to avoid this medication during the first months of pregnancy - see Pregnancy section).

- if you have severe liver disease or biliary obstruction (problem with the bile flowing out of the gallbladder).

- if the patient is a child under 1 year of age.

- if you have diabetes or kidney failure and are being treated with a medication to lower high blood pressure that contains aliskirén.

If you are unsure if you are in any of these situations, consult your doctor or pharmacist before taking Candesartán Normon.

Warnings and precautions

Consult your doctor before starting to take Candesartán Normon

- 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) affecting the adrenal gland.

- if you have low blood pressure.

- if you have ever had a stroke.

- if you are pregnant (or, if you suspect you may be). Candesartán is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered at all if you are more than 3 months pregnant, as it may cause serious harm to your baby when administered from that point onwards (see Pregnancy section).

• a converting enzyme inhibitor (ACEI) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskirén

- if you are taking an ACEI together with a medication belonging to the class of drugs known as mineralocorticoid receptor antagonists (MRAs). These medications are for the treatment of heart failure (see "Taking Candesartán Normon with other medications").

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

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels in your blood (e.g., potassium) at regular intervals.

See also the information under the heading "Do not take Candesartán Normon".

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

If you are about to undergo surgery, inform your doctor or dentist that you are taking Candesartán. This is because candesartán, in combination with some anesthetics, may cause a drop in blood pressure.

Children and adolescents

Candesartán has been studied in children. For more information, consult your doctor.Candesartán Normon should not be administered to children under 1 year of age due to a potential risk to the developing kidneys.

Taking Candesartán Normon with other medications

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

Candesartán may affect the way some medications work and some medications may influence the effect of candesartán.

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 modify your dose and/or take 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.

- Anti-inflammatory non-steroidal medications (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medications to relieve pain and inflammation).

- Acetylsalicylic acid (if you take more than 3 g per day) (medication to relieve pain and inflammation).

- Potassium supplements or salt substitutes containing potassium (medications that increase the amount of potassium in your blood).

- Heparin (a medication to increase blood fluidity).

- Cotrimoxazol (an antibiotic medication) also known as trimetoprima/sulfametoxazol.

- Diuretics (medications to promote urine elimination).

- Lithium (a medication for mental health problems).

• If you are taking an ACEI or aliskirén (see also the information under the headings "Do not take Candesartán Normon" and "Warnings and precautions")
• If you are being treated with an ACEI together with other medications specifically for the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone).

Taking Candesartán Normon with food, drinks, and alcohol

You can take Candesartán Normon with or without food.

When you are prescribed Candesartán Normon, consult your doctor before taking alcohol. Alcohol may make you feel dizzy or lightheaded.

Pregnancy and breastfeeding

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Candesartán is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

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

Candesartán Normon contains lactose.

This medicationcontains lactose. 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 for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. It is essential that you continue to take Candesartán Normon every day.

You can take this medication 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.

The tablet can be split into equal doses.

Hypertension:

- The recommended dose of candesartánis 8 mg once a day. Your doctor may increase this dose up to 16 mg once a day and then up to 32 mg once a day based on 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 present 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 with high blood pressure:

Children from 6 to <18

The recommended starting dose is 4 mg once a day.

For patients weighing <50

For patients weighing ≥ 50kg: 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 then to 16 mg once a day.

Heart failure in adults:

• The normal initial dose of this medication is 4 mg once a day. Your doctor may increase this dose by doubling the dose in intervals of at least 2 weeks up to 32 mg once a day. Candesartán Normon can be taken with other medications for heart failure, and your doctor will decide what treatment is suitable for you.

If you take more Candesartán Normon than you should

If you have taken more candesartánthan 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 ingested.

If you forget to take Candesartán Normon

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

If you interrupt treatment with Candesartán Normon

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

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

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

Stop taking Candesartán Normon 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).

Candesartánmay 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 ifcandesartánis 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 situation 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)

• 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.
• 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.

• Cough.
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown frequency (cannot be estimated from available data)

• Diarrhea

Other side effects in children

In children treated for hypertension, side effects appear to be similar to those seen in adults, but occur more frequently. Throat pain is a very frequent side effect in children but has not been reported in adults, and runny nose, fever, and increased heart rate are frequent in children but have not been reported in adults.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, 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 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.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging or blister after CAD.The expiration date is the last day of the month indicated.

• Do not store at a temperature above 30 °C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and

any unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask yourpharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Candesartán Normon

• The active ingredient is candesartan cilexetil. The tablets contain 32 mg of candesartan cilexetil.
• The other components are:hydroxypropylcellulose, iron oxide brown-red (E-172), lactose monohydrate, magnesium stearate, cornstarch, and monoethyl ether of diethylene glycol (Transcutol).

Appearance of the product and contents of the packaging

Candesartán Normon 32 mg tablets areround, pink, scored tablets on one side. They are presented in blisters of 28 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

CandesartánNormon 8 mg tablets EFG

CandesartánNormon 16 mg tablets EFG

Last review date of this leaflet:February 2025.

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