Package Insert: Information for the Patient

Karbis 4 mg Tablets EFG

candesartán cilexetilo

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

The name of the medication is Karbis. The active ingredient is candesartán cilexetilo. It belongs to a group of medications called angiotensin II receptor antagonists. It acts 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.

-Karbis may be used for the treatment of 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 ACE inhibitors cannot be used (ACE inhibitors and mineralocorticoid receptor antagonists are medications used for the treatment of heart failure).

Do not take Karbis

-if you are allergic to candesartan 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 Karbis also 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 a child under 1 year,

-if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medication containing aliskireno.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Karbis:

-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. Karbis is not recommended for use at the beginning of pregnancy and should not be administered after 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 medications:

-a type of medication called an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have diabetes-related kidney problems.

-aliskireno.

-if you are being treated with an ACE inhibitor together with a medication that belongs to a class of drugs known as mineralocorticoid receptor antagonists (MRAs). These medications are used to treat heart failure (see "Other medications and Karbis").

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

See also the information under the title "Do not take Karbis".

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

If you are to undergo surgery, inform your doctor or dentist that you are taking Karbis. This is because candesartan, in combination with some anesthetics, may cause an excessive drop in blood pressure.

Children and adolescents

Karbis has been studied in children. For more information, consult your doctor or pharmacist.

Karbis should not be administered to children under 1 year due to the potential risk to kidney development.

Other medications and Karbis

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

Karbis may affect the way some medications work and some medications may influence the effect of candesartan. If you are taking certain medications, your doctor may need to perform blood tests at regular intervals.

Especially, inform your doctor if you are taking any of the following medications:

-other blood pressure-lowering medications, including beta-blockers, diazoxide, and the so-called ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.

-anti-inflammatory non-steroidal medications (NSAIDs) such as ibuprofen, naproxen, or diclofenac, celecoxib, or etoricoxib (medications to relieve pain and inflammation).

-aspirin (if you take more than 3 g per 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).

• Cotrimoxazol (an antibiotic) also known as trimetoprima/sulfametoxazol.

-diuretics (medications to promote urine excretion).

-lithium (a medication for mental health problems).

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

-if you are taking an ACE inhibitor oraliskireno(see also the information under the title "Do not take Karbis" and "Warnings and precautions").

• if you are being treated with an ACE inhibitor together with other medications specifically used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Taking Karbis with food, drinks, and alcohol

Karbis can be taken with or without food.

When Karbis is prescribed, consult your doctor before taking alcohol. Alcohol may cause dizziness or fainting.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should inform your doctor if you are pregnant (or if you plan to become pregnant). Your doctor will usually advise you to stop taking candesartan before becoming pregnant or as soon as you become pregnant, and recommend taking another blood pressure-lowering medication instead of candesartan. Candesartan is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy because it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

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

Driving and operating machinery

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

Karbis contains lactose and sodium

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

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

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

You can take Karbis 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 Karbis 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, depending on the 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.

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 it in intervals of at least 2 weeks up to 32 mg once a day. Karbis can be taken with other medications for heart failure, and your doctor will decide what treatment is suitable for you.

If you take more Karbis than you should

If you take more Karbis 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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forget to take Karbis

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

Simply take the next dose.

If you interrupt treatment with Karbis

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

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

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

Stop taking Karbis 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 (skin rash).

Karbis 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 at regular intervals to check if Karbis is affecting your blood (agranulocytosis)

Other possible side effects include:

Frequent (affecting 1 to 10 out of every 100 patients)

-Dizziness or vertigo.

-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 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 (affecting fewer than 1 in 10,000 patients)

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

-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 sodium levels in the blood. 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 of 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 medicine.

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 at a temperature above 30°C.

Do not dispose of medications through drains or 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 of Karbis

-The active ingredient is candesartan cilexetilo. Each tablet contains 4 mg of candesartan cilexetilo.

-The other components are, lactose monohydrate, cornstarch, dibutyl sebacate, lauryl sulfate sodium, hydroxypropyl cellulose, calcium carmelose and magnesium stearate.

See section 2 “Karbis contains lactose and sodium”.

Appearance of the product and contents of the packaging

Karbis 4 mg tablets are round, white, biconvex, scored on one face and marked with a “4”.

The score is for breaking and facilitating swallowing but not for dividing into equal doses.

Cases of:

• 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100 tablets in blisters are available.
• 250 tablets contained in a plastic container with a safety closure.

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

For more information about this medicine, please contact 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 (Northern Ireland) with the following names:

Last review date of this leaflet:June 2023

More 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/).