Candesartan KRKA 32 mg Tablets

2. What you need to know before you take Candesartan Krka

Do not take Candesartan Krka

• 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 Candesartan Krka also at the start of your pregnancy – see section Pregnancy),
• if you have severe liver disease or biliary obstruction (problem with bile leaving the gallbladder),
• if the patient is a child under 1 year of age,
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren,

If you are not sure if you are in one of these situations, consult your doctor or pharmacist before taking Candesartan Krka.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Candesartan Krka:

• if you have heart, liver or kidney problems, or are on dialysis,
• if you have recently had a kidney transplant,
• if you are vomiting, have recently had severe vomiting or have diarrhea,
• if you have a disease of the adrenal gland 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 Candesartan Krka at the start of pregnancy and it must not be taken after the third month of pregnancy as it may cause serious harm to 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 kidney problems related to diabetes.
• Aliskiren.
• 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 used to treat heart failure (see "Other medicines and Candesartan Krka").

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 heading "Do not take Candesartan Krka".

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

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

Children and adolescents

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

Other medicines and Candesartan Krka

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

Candesartan Krka 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 perform blood tests from time to time.

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

• Other medicines to lower 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, diclofenac, celecoxib, or etoricoxib (medicines to relieve pain and inflammation).
• Acetylsalicylic acid (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).
• Cotrimoxazole (an antibiotic) also known as trimethoprim/sulfamethoxazole.
• Diuretics (medicines to promote 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 heading "Do not take Candesartan Krka" and "Warnings and precautions").
• If you are being treated with an ACE inhibitor along with other medicines for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Taking Candesartan Krka with food, drinks, and alcohol

Candesartan Krka can be taken with or without food.

When prescribed Candesartan Krka, consult your doctor before taking alcohol. Alcohol may make you feel dizzy or faint.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 that you take a different blood pressure medicine instead of candesartan. Candesartan should not be used during the first trimester of pregnancy and must not be used after the third month of pregnancy as it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are about to start breastfeeding. Candesartan is not recommended for women who are breastfeeding, and your doctor may decide to give you a different treatment, especially if you want to breastfeed a newborn or premature baby.

Driving and using machines

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

Candesartan Krka contains lactose and sodium

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

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

3. How to take Candesartan Krka

Follow exactly the instructions of administration of this medicine indicated by your doctor. If you are not sure, consult your doctor or pharmacist again. It is important that you continue to take 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 each day. This will help you remember to take it.

High blood pressure

The recommended dose of candesartan 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 problems, 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 from 6 to <18 years of age:< 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 up to a maximum of 8 mg per day.

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. Candesartan can be taken with other medicines 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Candesartan Krka

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

Just take the next dose as usual.

If you stop taking Candesartan Krka

If you stop taking candesartan, your blood pressure may increase again. Therefore, do not stop taking candesartan without consulting your doctor first.

If you have any further questions on the use of this medicine, 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 Candesartan Krka and go to your 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 skin itching (with rash).

Candesartan Krka may cause a decrease in white blood cells. Your resistance to infections may be decreased and you may feel tired, have an infection, or have a fever. If this happens, tell your doctor. Your doctor may perform a blood test from time to time to check that Candesartan Krka is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common (affects 1 to 10 users in 100)

• 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 already have kidney problems or heart failure. If this situation is severe, you may feel tired, weak, or have irregular heartbeats.
• 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 have a 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, the side effects seem to be similar to those seen in adults, but they occur more frequently. 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 experience 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 Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan Krka

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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartan Krka

• The active substance is candesartan cilexetil. Each tablet contains 32 mg of candesartan cilexetil.
• The other ingredients are lactose monohydrate, maize starch, dibutyl sebacate, sodium lauryl sulfate, hydroxypropyl cellulose, calcium carmellose, magnesium stearate (E572), and red iron oxide (E172). See section 2 "Candesartan Krka contains lactose and sodium".

Appearance of the product and pack contents

Candesartan Krka 32 mg tablets are round, almost pink, biconvex, and scored on one side. On one side of the score line is marked "3" and on the other side of the score line is marked "2".

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

Boxes of 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100 tablets in blisters are available.

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 ask for more information about 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 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/).