Candesartan Normon 16 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Candesartán Normon 16 mg tablets EFG

Candesartan cilexetil

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Your medicine is called Candesartán Normon. The active substance is candesartan cilexetil. It belongs to a group of medicines known as angiotensin II receptor antagonists. It works by causing the blood vessels to relax and widen, making it easier to reduce blood pressure. It also helps the heart pump blood to all parts of the body.

Candesartán Normon can be used for:

• the treatment of high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to <18 years.
• the treatment of adult patients with heart failure and reduced heart muscle function when angiotensin-converting enzyme inhibitors (ACE inhibitors) cannot be used, or as an add-on to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRAs) cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure.)

2. What you need to know before starting to take Candesartán Normon

Do not take Candesartán Normon:

• if you are allergic to candesartan cilexetil or to any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant. (It is also advisable to avoid this medicine during the first months of pregnancy – see Pregnancy section).
• if you have severe liver disease or biliary obstruction (a problem with bile flow 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 high blood pressure medicine containing aliskiren.

If you are unsure whether any of these apply to you, consult your doctor or pharmacist before taking Candesartán Normon.

Warnings and precautions

Talk to your doctor before starting to take Candesartán Normon

• if you have heart, liver or kidney problems, or are on dialysis.

• if you have recently received a kidney transplant.

• if you have vomiting, have recently had severe vomiting, or have diarrhea.

• if you have an adrenal gland disorder 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 suspect you might be). Candesartan is not recommended during early pregnancy (first 3 months), and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby from that stage onwards (see Pregnancy section).

  • if you are taking any of the following medicines used to treat high blood pressure (hypertension):

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

• aliskiren

• if you are taking an ACE inhibitor together with a medicine belonging to a class of drugs known as mineralocorticoid receptor antagonists (MRA). These medicines are used to treat heart failure (see “Taking Candesartán Normon with other medicines”).

Talk to 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 as monotherapy.

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

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

If any of these situations apply to you, your doctor may want to see you more frequently and carry out certain tests.

If you are scheduled for surgery, inform your doctor or dentist that you are taking candesartan. This is because candesartan, in combination with certain anesthetics, may cause a drop in blood pressure.

Children and adolescents

Candesartan has been studied in children. For further information, consult your doctor. Candesartán Normon must not be given to children under 1 year of age due to the potential risk to developing kidneys.

Taking Candesartán Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

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

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and angiotensin-converting enzyme (ACE) inhibitors such as enalapril, captopril, lisinopril or ramipril.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen,

diclofenac, celecoxib or etoricoxib (medicines used to relieve pain and inflammation).

• Acetylsalicylic acid (if taking more than 3 g per day) (a medicine used to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that increase potassium levels in your blood).
• Heparin (a medicine used to increase blood fluidity).
• Cotrimoxazole, also known as trimethoprim/sulfamethoxazole (an antibiotic medicine).
• Diuretics (medicines that promote urine elimination).
• Lithium (a medicine used for mental health conditions).
  • If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Candesartán Normon” and “Warnings and precautions”).
  • If you are being treated with an ACE inhibitor together with specific medicines for heart failure known as mineralocorticoid receptor antagonists (MRA) (e.g. spironolactone, eplerenone).

Taking Candesartán Normon with food, drinks and alcohol

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

Pregnancy and breastfeeding

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. The use of candesartan during breastfeeding is not recommended, and your doctor will choose an alternative treatment for you if you wish to breastfeed, especially if your baby is a 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 machinery.

Candesartán Normon contains lactose.

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

3. How to take Candesartán Normon

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again. It is important that you continue taking Candesartán Normon every day.

You may take this medicine 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.

The tablet may be divided into equal doses.

Arterial hypertension:

• The recommended dose of candesartan is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily and then up to 32 mg once daily 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 (e.g., due to vomiting, diarrhoea, or diuretic therapy), your doctor may prescribe a lower initial dose.
• Some black patients may have a reduced response to this type of medicine when used as monotherapy, and may require a higher dose.

Use in children and adolescents with high blood pressure:

Children aged 6 to <18 years:

The recommended starting dose is 4 mg once daily.

For patients with body weight <50 kg: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose up to a maximum of 8 mg daily.

For patients with body weight ≥50 kg: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose to 8 mg once daily and then to 16 mg once daily.

Heart failure in adults:

• The usual initial dose of this medicine is 4 mg once daily. Your doctor may increase this dose by doubling it at intervals of at least 2 weeks up to 32 mg once daily. Candesartán Normon may be taken together with other medicines for heart failure, and your doctor will decide which treatment is suitable for you.

If you take more Candesartán Normon than you should

If you have taken more candesartan than prescribed by your doctor, contact your doctor or pharmacist immediately.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Candesartán Normon

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

If you stop taking Candesartán Normon

If you stop taking this medicine, your blood pressure may rise again. Therefore, do not stop taking it without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. It is important that you are aware of what these adverse effects could be.

Stop taking Candesartán Normon and see a 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 itching of the skin (with skin rash).

Candesartán 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. Your doctor may carry out a blood test from time to time to check whether candesartán is affecting your blood (agranulocytosis).

Other possible adverse effects include:

Common (affects 1 to 10 out 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 condition is severe, you may experience fatigue, weakness, 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 in 10,000 patients)

• Swelling of the face, lips, tongue and/or throat.

• A decrease in red blood cells or white blood cells. You may feel tired, or 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 may feel tired, have yellowing of the skin and whites of the eyes, and flu-like symptoms.

• Nausea.

• Changes in blood test results:

• A reduction 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 causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known (cannot be estimated from available data)

• Diarrhea

Other adverse effects in children

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartán Normon

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date stated on the container or blister pack after EXP. The expiry date refers to the last day of the month indicated.

• Do not store above 30 ºC.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartán Normon

• The active substance is candesartan cilexetil. The tablets contain 16 mg of candesartan cilexetil.
• The other components are: hydroxypropylcellulose, brown-red iron oxide (E-172), lactose monohydrate, magnesium stearate, corn starch, and diethylene glycol monoethyl ether (Transcutol).

Appearance of the product and contents of the pack

• Candesartán Normon 16 mg tablets are round, pink, and scored on one side. They are supplied in blisters of 28 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Other presentations

Candesartán Normon 8 mg tablets EFG
Candesartán Normon 32 mg tablets EFG

Date of the most recent review of this leaflet: February 2025

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