Package Leaflet: Information for the Patient

Candesartán Krka 8 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 or pharmacist.
• This medicine has been prescribed for you only, and you must not give it 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

The name of the medication is Candesartán Krka. The active ingredient is candesartan cilexetilo. It belongs to a group of medications called angiotensin II receptor antagonists. It works by relaxing and widening blood vessels. This facilitates a decrease in blood pressure. It also facilitates your heart pumping blood to all parts of your body.

This medication is used for:

• The treatment of high blood pressure (hypertension) in adult patients and children and adolescents aged 6 to 18 years.
• Candesartán can be used to treat heart failure in adult patients with reduced cardiac muscle function when it is not possible to use Angiotensin-Converting Enzyme (ACE) inhibitors, or added to ACE inhibitors when symptoms persist despite treatment and it is not possible to use mineralocorticoid receptor antagonists (MRAs) (ACE inhibitors and MRAs are a group of medications used to treat heart failure).

Do not take Candesartán Krka

• if you are allergic to candesartán cilexetilo or any of the other ingredients of this medicine (listed in section 6),
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking Candesartán Krka at the beginning of your pregnancy – see Pregnancy section),
• if you have severe liver disease or bile duct obstruction (problem with the bile flow from the gallbladder),
• if the patient is less than 1 year old,
• if you have diabetes or damaged kidney function and are being treated with a blood pressure-lowering medicine that contains aliskireno,

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Candesartán Krka:

-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 (or if you plan to become pregnant) inform your doctor. Candesartán Krka is not recommended for use at the beginning of pregnancy and should not be administered from the third month of pregnancy because it may cause serious harm to your baby (see Pregnancy section).

-if you are taking any of the following blood pressure-lowering medicines:

• a type of medicine called an angiotensin-converting enzyme (ACE) inhibitor (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskireno.
• if you are taking an ACE inhibitor together with a medicine belonging to the class of drugs called mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see “Other medicines and Candesartán Krka”).

Your doctor may monitor your kidney function, blood pressure, and the amount of electrolytes (such as potassium) in your blood at regular intervals.

See also the information under the title "Do not take Candesartán Krka".

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 Candesartán Krka. This is because candesartán, in combination with some anesthetics, may cause excessive lowering of blood pressure.

Children and adolescents

Candesartán Krka has been studied in children. For more information, consult your doctor or pharmacist. Candesartán Krka should not be administered to children under 1 year of age due to the potential risk to kidney development.

Other medicines and Candesartán Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Candesartán Krka 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:

• • 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 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) (medicines to relieve pain and inflammation).
• Supplements of potassium or salt substitutes containing potassium (medicines that increase the amount of potassium in your blood).
• Heparin (a medicine to increase blood fluidity).
• Cotrimoxazol (an antibiotic) also known as trimetroprima/sulfametoxazol.
• Diuretics (medicines to promote urine elimination).
• Lithium (a medicine for mental health problems).

Your doctor may need to change your dose and/or take other precautions:

• if you are taking an ACE inhibitor or aliskireno (see also the information under the title “Do not take Candesartán Krka” and “Warnings and precautions”).
• if you are being treated with an ACE inhibitor together with other medicines to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example, spironolactone, eplerenone).

Taking Candesartán Krka with food, drinks, and alcohol

Candesartán Krka can be taken with or without food.

When you are prescribed Candesartán Krka, consult your doctor before taking alcohol. Alcohol may make you feel dizzy or lightheaded.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should inform your doctor if you are pregnant (or if you may be). Your doctor will usually advise you to stop taking candesartán as soon as you become pregnant and to take another blood pressure-lowering medicine instead of candesartán. Candesartán is not recommended for use at the beginning of pregnancy and should not be administered from the third month of pregnancy because it may cause serious harm to your baby when administered from that time.

Breastfeeding

Inform your doctor if you are planning to start or are breastfeeding. Candesartán is not recommended for women who are breastfeeding, your doctor may decide to administer a treatment that is more suitable if you want to breastfeed, especially to newborns or premature babies.

Driving and operating machines

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

Candesartán Krka contains lactose and sodium

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

This medicine contains less than 1 mmol (23 mg) of sodium per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. It is essential that you continue taking candesartan every day.

You can take candesartan 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 recommended dose of candesartan 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.

Use in children and adolescents with high blood pressure

Children from 6 to <18

The recommended starting dose is 4 mg once a day.

For patients weighing <50

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

Heart failure

The recommended dose is 4 mg once a day. Your doctor will increase this dose by doubling the dose in intervals of at least 2 weeks up to 32 mg once a day. Candesartan 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 Krka than you should

If you take more candesartan 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 forgot to take Candesartan Krka

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

Simply take the next dose.

If you interrupt the treatment with Candesartan Krka

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

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

Like all medications, this medication may have side effects, although not everyone may experience them. It is essential that you know which side effects could occur.

Stop taking Candesartán Krka 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 Krka 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 Krka is affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (affects 1 to 10 of every 100 patients)

• Dizziness or vertigo sensation.
• Headache.
• Respiratory infection.
• Low blood pressure. This may cause dizziness or fainting.
• Changes in blood test results. An increase in blood potassium levels, especially if you already have kidney problems or heart failure. If this is severe, you will feel tired, weak, or experience heart palpitations.
• Irregular or tingling sensations.
• Effects on kidney function, especially if you already have kidney problems or heart failure. In very rare cases, it may cause kidney failure.

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 (urticaria).
• 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.
• Cough.
• Nausea.
• Changes in blood test results: a decrease in blood sodium levels. If severe, you may feel weak, lack energy, or experience muscle cramps.

Unknown frequency (cannot be estimated from available data)

• Diarrhea.

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

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 national notification system: Spanish System of 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 after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

Composition of Candesartán Krka

- The active ingredient is candesartan cilexetil. Each tablet contains 8 mg of candesartan cilexetil.

- The other components are, lactose monohydrate, cornstarch, dibutyl sebacate, sodium lauryl sulfate, hydroxypropyl cellulose, calcium carmellose, magnesium stearate (E572) and iron oxide red (E172). See section 2 “Candesartán Krka contains lactose and sodium”.

Appearance of the product and contents of the packaging

Candesartán Krka 8 mg tablets are round, pink, biconvex, scored on one face and engraved with an “8”.

The score serves to break and facilitate swallowing but not to divide into equal doses.

Blister packs containing 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100 tablets are available.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom with the following names:

Last review date of this leaflet:June 2023

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