Leaflet: information for the user

Candesartán Kern Pharma 16 mg tablets EFG

Candesartán cilexetilo

Read this leaflet carefully before you start taking this 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, pharmacist or nurse.
• This medicine has been prescribed for you only and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Your medicine is called Candesartán Kern Pharma. 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.

This medicine is used for:

• the treatment of high blood pressure (hypertension) in adult patients.
• the treatment of adult patients with heart failure with reduced cardiac muscle function when 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 Kern Pharma

• if you are allergic to candesartán cilexetilo or any of the other ingredients of Candesartán Kern Pharma (listed in section 6).
• if you are more than 3 months pregnant. (In any case, it is best to avoid taking this medicine also at the beginning of your pregnancy – see Pregnancy section).
• if you have severe liver disease or bile duct obstruction (problem with the bile leaving the gallbladder).
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskirén.

If you are unsure whether you are in any of these situations, consult your doctor or pharmacist before taking Candesartán Kern Pharma.

Warnings and precautions

Before taking, or while taking Candesartán Kern Pharma, inform your doctor:

• 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).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant, you must inform your doctor. Candesartán is not recommended for use in the first 3 months of pregnancy and should not be administered at all after the third month of pregnancy because it can cause serious harm to your baby, 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.
• aliskirén.

• 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 "Use of Candesartán Kern Pharma with other medicines").

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 Candesartán Kern Pharma”.

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

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

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

Children and adolescents

There is no experience with the use of candesartán in children (under 18 years). Therefore, candesartán should not be administered to children.

Use of Candesartán Kern Pharma with other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Candesartán may affect the way some medicines work and some medicines may influence the effect of candesartán. If you are using certain medicines, your doctor may need to perform blood tests at regular intervals.

Especially, inform your doctor if you are using any of the following medicines, as your doctor may need to modify your dose and/or take other 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.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines to relieve pain and inflammation).
• Aspirin (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).
• Diuretics (medicines to promote urine excretion). Lithium (a medicine for mental health problems).

• if you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Candesartán Kern Pharma” 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).

Use of Candesartán Kern Pharma with food, drink, and alcohol

• You can take Candesartán Kern Pharma with or without food.
• When you are prescribed Candesartán Kern Pharma, consult your doctor before taking alcohol. Alcohol may make you feel dizzy or lightheaded.

Pregnancy, breastfeeding, and fertility

Pregnancy

You must inform your doctor if you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant. Your doctor will usually advise you to stop taking Candesartán before becoming pregnant or as soon as you become pregnant, and will recommend taking another blood pressure-lowering medicine instead. Candesartán is not recommended for use in the first 3 months of pregnancy and should not be administered at all after the third month of pregnancy because it can cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding, as Candesartán is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machines

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

Candesartán Kern Pharma contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Follow exactly the administration instructions for Candesartán Kern Pharma as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. It is essential to continue taking Candesartán Kern Pharma every day.

You can take Candesartán Kern Pharma 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.

Hypertension:

- The normal dose of Candesartán is 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, the 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.

Heart Failure:

- The initial normal dose of Candesartán 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 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 Kern Pharma than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Candesartán Kern Pharma

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

If you interrupt treatment with Candesartán Kern Pharma

If you stop taking Candesartán Kern Pharma, your blood pressure may increase again. Therefore, do not stop taking Candesartán Kern Pharma before consulting your doctor.

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

Like all medicines, Candesartán Kern Pharma may cause side effects, although not everyone will experience them. It is essential that you know which side effects could occur.

Stop taking Candesartán Kern Pharma 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)

Candesartán Kern Pharma 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. It is possible that your doctor will perform a blood test from time to time to check if Candesartán Kern Pharma is 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:
• • A reduction in sodium levels in the blood. If severe, you may feel weak, lack energy, or have muscle cramps.
  • An increase in potassium levels in the blood, especially if you already have kidney problems or heart failure. If this is severe, you will feel tired, weak, have irregular heartbeats, or experience numbness.
• 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 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 discoloration of the skin and the white of the eyes, and symptoms similar to the flu.
• 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 that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown frequency (cannot be estimated from available data)

• Diarrhea.

If you consider that any of the side effects you experience are severe or if you notice any side effects not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Candesartán Kern Pharma

• The active ingredient is candesartán cilexetilo. Each tablet contains 16 mg of candesartán cilexetilo.
• The other components are: lactose monohydrate, maize pregelatinized starch, macrogol 8000, povidone K-25, microcrystalline cellulose, hydroxypropylcellulose, and magnesium stearate.

Appearance of the product and content of the packaging

Candesartán Kern Pharma 16 mg tablets are round white tablets, scored on one face and with a K on the other. The tablet can be divided into two equal halves.

Candesartán Kern Pharma 16 mg tablets are presented in packs of 28 tablets and 500 tablets (clinical pack) packaged in PVC/PVDC/Aluminum blisters.

Other presentations

Candesartán Kern Pharma 4 mg tablets EFG

Candesartán Kern Pharma 8 mg tablets EFG

Candesartán Kern Pharma 32 mg tablets EFG

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This leaflet has been reviewed in February 2025

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) www.aemps.gob.es