Candesartan Normon 16 mg Tablets

2. What you need to know before you take Candesartan Normon

Do not take Candesartan Normon:

• 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. (It is also better to avoid this medicine during the first months of pregnancy - see section Pregnancy).
• if you have severe liver disease or biliary obstruction (problem with the release of bile from the gallbladder).
• if the patient is a child under 1 year of age.
• if you have diabetes or kidney impairment and are being treated with a medicine containing aliskiren.

If you are not sure if you are in one 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 think you might be). 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 more than 3 months pregnant, as it may cause serious harm to your baby when administered from that time on (see section Pregnancy).
• 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 along with a medicine belonging to the class of drugs called mineralocorticoid receptor antagonists (MRAs). These medicines are for the treatment of heart failure (see “Taking Candesartan Normon with other medicines”).

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 check 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 one of these situations, your doctor may want to see you more frequently and perform some tests.

If you are going to have 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 given to children under 1 year of age due to a potential risk to the developing kidneys.

Taking Candesartan Normon with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

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

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and the so-called 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).

• Acetylsalicylic acid (if you take more than 3 g per day) (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).
• Cotrimoxazole (an antibiotic medicine) also known as trimethoprim/sulfamethoxazole.
• Diuretics (medicines to promote urine elimination).
• Lithium (a medicine for mental health problems).
• If you are taking an ACE inhibitor 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 ACE inhibitor along with other specific medicines 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 you are prescribed Candesartan Normon, consult your doctor before drinking alcohol. Alcohol may make you feel dizzy or faint.

Pregnancy and breastfeeding

Breastfeeding

Tell your doctor if you are breastfeeding or about 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 use tools or machines.

Candesartan Normon contains lactose.

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

3. How to take Candesartan Normon

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. It is important that you continue taking Candesartan Normon every day.

You can 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 can be divided into equal doses

High blood pressure:

• 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 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, for example due to vomiting, diarrhea, or because they are taking diuretics, the doctor may prescribe a lower initial dose.
• Some black patients may have a reduced response to this type of medicine when given as sole treatment, and these patients may need a higher dose.

Use in children and adolescents with high blood pressure:

Children aged 6 to <18 years:< 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 medicine 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 medicines 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 medicine and the amount taken.

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 medicine, your blood pressure may increase again. Therefore, do not stop taking it without consulting your doctor.

If you have any further questions on the use of this product, 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 Candesartan Normon and go to your 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 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 users in 100)

• 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 will feel tired, weak, irregular heartbeats, 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 user in 10,000)

• 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 liver inflammation (hepatitis). You will 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 will 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 the available data)

• Diarrhea

Other side effects in children

In children treated for high blood pressure, 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 of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan Normon

• 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 after EXP. The expiry date is the last day of the month stated.

• Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartan Normon

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

Appearance of the product and pack contents

• Candesartan Normon 16 mg tablets are round, pink, and scored on one side. They come in blister packs of 28 tablets.

Not all pack sizes may be marketed.

Marketing authorisation 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 32 mg tablets EFG

Date of last revision of this leaflet:February 2025

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