Leaflet: Information for the User

Candesartán Kern Pharma 32 mg Tablets EFG

Candesartán cilexetilo

Read this 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, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you and should not be given 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, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What Candesartán Kern Pharma is and what it is used for

2.What you need to know before you start taking Candesartán Kern Pharma

3.How to take Candesartán Kern Pharma

4.Possible side effects

5.Storage of Candesartán Kern Pharma

6.Contents of the pack and additional information

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:

• treatment of high blood pressure (hypertension) in adult patients.
• 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 components of Candesartán Kern Pharma (listed in section6).
• if you are more than 3months pregnant. (In any case, it is best to avoid taking this medication also at the beginning of your pregnancy – see section Pregnancy, breastfeeding and fertility).
• if you have severe liver disease or bile duct obstruction (problem with the bile flow from the gallbladder).
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén.

If you are unsure whether you fall into 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) affecting the adrenal gland.
• if you have low blood pressure.
• if you have ever had a stroke.
• if you are pregnant, think you may be pregnant, or plan to become pregnant, inform your doctor. Candesartán is not recommended for use at the beginning of pregnancy (first 3 months) andshould not be administered at all after the third month of pregnancybecause it can cause serious harm to your baby, see section Pregnancy.
• if you are taking any of the following medications 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 medication belonging to the class of drugs called mineralocorticoid receptor antagonists (MRAs). These medications are for the treatment of heart failure (see "Use of Candesartán Kern Pharma with other medications").

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 Kern Pharma”.

If you fall into 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 about to undergo surgery, inform your doctor or dentist that you are taking Candesartán Kern Pharma. This is because Candesartán Kern Pharma, 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 18years). Therefore, candesartán should not be administered to children.

Use of Candesartán Kern Pharma with other medications

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

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 other 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.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medications to relieve pain and inflammation).
• Acetylsalicylic acid (if you take more than3gper 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).
• Diuretics (medications to promote urine excretion).
• Lithium (a medication for mental health problems).
• If you are being treated with 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 medications specifically for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Taking Candesartán Kern Pharma with food, drinks, and alcohol

• You can take Candesartán Kern Pharma with or without food.
• When Candesartán Kern Pharma is prescribed, consult your doctor before taking alcohol. Alcohol may cause dizziness or fainting.

Pregnancy, breastfeeding, and fertility

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. In general, your doctor will advise you to stop taking Candesartán before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Candesartán is not recommended for use at the beginning of pregnancy andshould not be administered at all after the third month of pregnancybecause it can cause serious harm to your baby when administered from that point on.

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 treatment that is more suitable if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machinery

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

Candesartán Kern Pharma contains lactose

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

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 Kern Pharma 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 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.

Heart Failure:

• The initial normal dose of Candesartán Kern Pharma is 4 mg once a day. Your doctor may increase this dose by doubling it in intervals of at least 2 weeks up to 32 mg once a day. Candesartán Kern Pharma 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.

If you forget to take Candesartán Kern Pharma

Do not take a double dose to compensate for the missed dose. 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 medications, 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. Your doctor may 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 (may affect up to 1 to 10 out of 10 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 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 have kidney problems or heart failure. In very rare cases, it may cause kidney failure.

Rare (may affect up to 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 experience muscle cramps.
• 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.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition ofCandesartán Kern Pharma

-The active ingredient is candesartan cilexetilo. The tablets contain 32 mg of candesartan cilexetilo.

-The other components are:docusate sodium, lauryl sulfate sodium, calcium carmelose, pregelatinized cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, iron oxide red (E172), and purified water.

Appearance of the product and contents of the packaging

Candesartán Kern Pharma 32 mg tabletsare elliptical, biconvex, light red, and have the imprint CC on one side and the imprint 32 on the same face(length: 16.0 ±0.2 mm).

Candesartán Kern Pharma 32 mg tablets are marketed in PVC-PVDC-Aluminum blisters of28 tablets.

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

Responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

or

Bluepharma Indústria Farmacêutica, S.A.

S. Martinho do Bispo,

3045-016 Coimbra,

Portugal

Last review date of this leaflet: February 2025

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