KARBIS 4 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Karbis 4 mg Tablets EFG

candesartan cilexetil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Karbis and what is it used for
2. What you need to know before you take Karbis
3. How to take Karbis
4. Possible side effects
5. Storage of Karbis
6. Contents of the pack and other information

1. What is Karbis and what is it used for

The name of the medicine is Karbis. The active substance is candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor antagonists. It works by relaxing and widening the blood vessels. This makes it easier to get the blood to all the parts of your body.

This medicine is used for:

• Treatment of high blood pressure (hypertension) in adult and children and adolescents aged 6 to 18 years.
• Karbis can be used for the treatment of heart failure in adult patients with reduced kidney function when ACE inhibitors are not suitable, or added to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRAs) cannot be used (ACE inhibitors and MRAs are medicines used for the treatment of heart failure).

2. What you need to know before you take Karbis

Do not take Karbis

• 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. (In any case, it is better to avoid taking Karbis also at the start of your 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 any of these apply to you, talk to your doctor or pharmacist before taking Karbis.

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 an adrenal gland problem 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 plan to become pregnant) you must inform your doctor. It is not recommended to use Karbis at the start of pregnancy and it should not be taken after the third month of pregnancy as it may harm your baby (see section Pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems.
• aliskiren.
• if you are being treated with an ACE inhibitor together with a medicine that belongs to the class of medicines known as mineralocorticoid receptor antagonists (MRAs). These medicines are used for the treatment of heart failure (see "Other medicines and Karbis").

Your doctor may check 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 heading "Do not take Karbis".

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

If you are going to have surgery, tell your doctor or dentist that you are taking Karbis. This is because candesartan, in combination with some anesthetics, can cause a pronounced drop in blood pressure.

Children and adolescents

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

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

Other medicines and Karbis

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Karbis 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 do blood tests from time to time.

In particular, tell your doctor if you are using any of the following medicines:

• Other medicines for lowering your blood pressure, including beta-blockers, diazoxide and ACE inhibitors such as enalapril, captopril, lisinopril or ramipril.
• Non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen, naproxen or diclofenac, celecoxib or etoricoxib (medicines to relieve pain and inflammation).
• Aspirin (if you take more than 3 g a 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).
• Co-trimoxazole (an antibiotic) also known as trimethoprim/sulfamethoxazole.

• Diuretics (medicines to increase urine production).
• 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 aliskiren (see also the information under the headings "Do not take Karbis" and "Warnings and precautions").
• if you are being treated with an ACE inhibitor together with other specific medicines for treating 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 prescribed Karbis, consult your doctor before taking alcohol. Alcohol can make you feel dizzy or faint.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You must tell your doctor if you are pregnant (or think you might be). Normally, your doctor will advise you to stop taking candesartan before you become pregnant or as soon as you find out you are pregnant, and recommend an alternative medicine to take instead of candesartan. It is not recommended to take candesartan during the first trimester of pregnancy and it must not be taken after the third month of pregnancy as it may harm your baby.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Karbis is not recommended for women who are breast-feeding, and your doctor may decide to give you a different treatment, especially if you want to breast-feed a newborn or premature baby.

Driving and using machines

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

Karbis contains lactose and sodium

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

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

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3. How to take Karbis

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. It is important that you take 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 each day. This will help you remember to take it.

High blood pressure

The recommended dose of Karbis 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 or kidney problems, or those who have recently lost body fluids (e.g. due to vomiting, diarrhea, or because they are taking diuretics), your doctor may prescribe a lower initial dose.

Some black patients may have a reduced response to this type of medicine, when given as the only 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 less than 50 kg: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose to a maximum of 8 mg daily.

For patients weighing 50 kg or more: 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 may increase this dose by doubling the dose at intervals of at least 2 weeks up to 32 mg once a day. Karbis can be taken with other medicines 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Karbis

Do not take a double dose to make up for a forgotten dose.

Just take the next dose as normal.

If you stop taking Karbis

If you stop taking Karbis, your blood pressure may increase again. Therefore, do not stop taking Karbis without talking to your doctor first.

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 Karbis and see a 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 may cause difficulty swallowing,
• Severe itching of the skin (with rash).

Karbis may cause a decrease in white blood cells. Your resistance to infection may be decreased and you may feel tired, have an infection or fever. If this happens, tell your doctor. Your doctor may do regular blood tests to check that Karbis is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common (affects 1 to 10 users in 100)

• Dizziness or lightheadedness.
• Headache.
• Respiratory tract 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 may feel tired, weak, have 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.
• Rash, hives (urticaria).
• Itching.
• Back pain, pain in the joints and muscles.
• Changes in liver function, including liver inflammation (hepatitis). You may feel tired, have yellowing of the skin and the whites of the eyes and flu-like symptoms.
• Cough.
• Nausea.
• Changes in blood test results: a decrease in sodium levels in the blood. If severe, you may feel weak, lack energy or have muscle cramps.

Frequency not known (cannot be estimated from the available data)

• Diarrhea.

In children treated for high blood pressure, side effects seem to be similar to those seen in adults, but they occur more often. 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: Spanish Medicines Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Karbis

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 after EXP. The expiry date refers to the last day of that month.

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 Karbis

• The active substance is candesartan cilexetil. Each tablet contains 4 mg of candesartan cilexetil.
• The other ingredients are lactose monohydrate, maize starch, dibutyl sebacate, sodium lauryl sulfate, hydroxypropyl cellulose, calcium carmellose and magnesium stearate.

See section 2 "Karbis contains lactose and sodium".

Appearance and packaging of the product

Karbis 4 mg tablets are round, white, biconvex, scored on one side and marked with a "4".

The score line is to facilitate breaking and swallowing but not to divide into equal doses.

Packs of:

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

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

You can obtain further information on this medicine from the representative of the marketing authorisation holder:

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

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this leaflet:June 2023

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