Candesartan Normon 32 mg Tablets

2. What you need to know before taking Candesartan Normon

Do not take Candesartan Normon:

• if you are allergic to candesartan cilexetil or any of the other components of this medication (listed in section 6).
• if you are pregnant for more than 3 months. (It is also recommended to avoid this medication during the first months of pregnancy - see section Pregnancy).
• if you have severe liver disease or biliary obstruction (problem with bile output from 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 aliskiren.

If you are not sure if you are in any of these situations, consult your doctor or pharmacist before taking Candesartan Normon.

Warnings and precautions

Consult your doctor before starting to take Candesartan 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 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 (or if you suspect you may be pregnant). It is not recommended to use candesartan at the start of pregnancy (first 3 months) and in no case should it be administered if you are pregnant for more than three months, as it may cause serious harm to your baby when administered from that time (see section Pregnancy).
• if you are taking any of the following medications used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACEI) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren

• if you are taking an ACEI along with a medication belonging to the class of drugs called mineralocorticoid receptor antagonists (MRAs). These medications are used to treat heart failure (see "Taking Candesartan Normon with other medications").

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

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

See also the information under the heading "Do not take Candesartan 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 going to undergo surgery, inform your doctor or dentist that you are taking Candesartan. This is because candesartan, in combination with some anesthetics, can cause a drop in blood pressure.

Children and adolescents

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

Taking Candesartan Normon with other medications

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

Candesartan may affect how some medications work, and some medications may affect the effect of candesartan. If you are taking certain medications, your doctor may need to perform blood tests from time to time.

In particular, inform your doctor if you are taking any of the following medications, as your doctor may need to adjust your dose and/or take precautions:

• Other medications to lower your blood pressure, including beta-blockers, diazoxide, and ACEIs such as enalapril, captopril, lisinopril, or ramipril.
• Non-steroidal anti-inflammatory 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 that contain potassium (medications that increase the amount of potassium in your blood).
• Heparin (a medication to increase blood fluidity).
• Cotrimoxazole (an antibiotic medication) also known as trimethoprim/sulfamethoxazole.
• Diuretics (medications to promote urine elimination).
• Lithium (a medication for mental health problems).
• If you are taking an ACEI or aliskiren (see also the information under the headings "Do not take Candesartan Normon" and "Warnings and precautions")
• If you are being treated with an ACEI along with other specific medications for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone).

Taking Candesartan Normon with food, drinks, and alcohol

• You can take Candesartan Normon with or without food.
• When prescribed Candesartan Normon, consult your doctor before consuming alcohol. Alcohol may make you feel dizzy or lightheaded.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant (or if you suspect you may be pregnant). Your doctor will generally recommend that you stop taking candesartan before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of candesartan. It is not recommended to use candesartan at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time.

Breastfeeding

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

Driving and using machines

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

Candesartan Normon contains lactose.

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Candesartan Normon

Follow the administration instructions for this medication exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. It is important that you continue taking Candesartan 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 divided into equal doses.

Hypertension:

• The recommended dose of candesartan 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 based on your blood pressure response.
• In some patients, such as those with liver problems, kidney problems, or those who have recently lost body fluids (e.g., due to vomiting, diarrhea, or diuretic use), the doctor may prescribe a lower initial dose.
• Some patients of black race may have a reduced response to this type of medication when given as monotherapy, and these patients may require a higher dose.

Use in children and adolescents with high blood pressure:

Children from 6 to <18 years of age:< p>

The recommended starting dose is 4 mg once a day.

For patients weighing <50 kg: in some patients whose blood pressure is not adequately controlled, the doctor may decide to increase dose a maximum of 8 mg per day.< p>

For patients weighing ≥ 50 kg: in some patients whose blood pressure is not adequately controlled, the 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 usual initial dose of this medication 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. Candesartan 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 Candesartan Normon than you should

If you have taken more candesartan 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 medication and the amount ingested.

If you forget to take Candesartan Normon

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

If you stop taking Candesartan Normon

If you stop taking this medication, your blood pressure may increase again. Therefore, do not stop taking it without consulting your doctor.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. It is important that you know what these possible side effects may be.

Stop taking Candesartan Normon and go to the 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 skin itching (with rash).

Candesartan 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. Your doctor may perform a blood test from time to time to check that candesartan is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common (affects 1 to 10 of every 100 patients)

• 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 may feel tired, weak, have irregular heartbeats, or have 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 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 have a fever.
• Skin rash, hives.
• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, including liver inflammation (hepatitis). You may feel tired, have a yellowish color of the skin and the whites of the eyes, and symptoms similar to those of 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.

Frequency not known (cannot be estimated from available data)

• Diarrhea

Other side effects in children

In children treated for hypertension, the side effects seem to be similar to those seen in adults, but they occur more frequently. Sore throat is a very common side effect in children but has not been reported in adults, and runny nose, fever, and increased heart rate are common in children but have not been reported in adults.

Reporting side effects:

If you experience any side effects, consult your doctor, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Candesartan Normon

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

• Do not store above 30 °C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Candesartan Normon composition

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

Product appearance and packaging contents

Candesartan Normon 32 mg tablets are round, pink, and scored on one side. They are available in blister packs of 28 tablets.

Only certain package sizes may be marketed.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Candesartan Normon 8 mg tablets EFG

Candesartan Normon 16 mg tablets EFG

Date of last revision of this package leaflet:February 2025.

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