KANPIDUO 8 MG/2.5 MG TABLETS

Introduction

Package Leaflet: Information for the Patient

Kanpiduo 8 mg/ 2.5 mg tablets

Kanpiduo 16 mg/ 2.5 mg tablets

candesartan cilexetil/indapamide

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 pack

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

1. What is Kanpiduo and what is it used for

Kanpiduo contains two active substances called candesartan and indapamide.

Candesartan 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 rid of excess water and salt, which in turn lowers the blood pressure.

Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only causes a slight increase in the amount of urine produced.

This medicine is used to lower high blood pressure (hypertension) in adults. Your doctor may prescribe this medicine if you are currently taking both active substances, candesartan and indapamide, at the same dose, but in separate tablets.

2. What you need to know before you take Kanpiduo

Do not take Kanpiduo

• if you are allergic to candesartan, indapamide or other active substances of the same type (called sulfonamides) 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 this medicine 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) or suffer from a disease called hepatic encephalopathy (degenerative brain disease),
• 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 medicine that contains aliskiren,
• if you have low potassium levels in your blood.

If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take candesartan/indapamide:

• if you have heart, liver or kidney problems, or are having 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 have diabetes,

• if you have gout,
• if you have any heart rhythm problems,
• if you need to have a test to check how your parathyroid gland is working,
• if you have muscle disorders including muscle pain, pins and needles, weakness or cramps,
• if you are pregnant (or might become pregnant) you must tell your doctor. This medicine is not recommended during pregnancy and 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 (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.
• if you are taking an ACE inhibitor together with a medicine belonging to the class of medicines known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see "Other medicines and Kanpiduo").
• if you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye, which may occur a few hours or weeks after taking this medicine. If left untreated, it can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you may be at greater risk of this.

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

See also the information under the heading "Do not take Kanpiduo".

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 candesartan/indapamide. This is because this medicine, in combination with some anesthetics, can cause a significant drop in blood pressure.

You should tell your doctor if you have had photosensitivity reactions.

Athletes should be informed that this medicine contains an active substance that may give a positive result in doping tests.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Kanpiduo. Your doctor will decide whether to continue treatment. Do not stop taking Kanpiduo on your own.

If you think any of these situations may apply to you, or if you have any doubts about your medicine, talk to your doctor or pharmacist.

Children and adolescents

Due to the lack of available information on safety and efficacy, the use of this medicine is not recommended in children and adolescents.

Other medicines and Kanpiduo

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

Candesartan/indapamide may affect the way some medicines work and some medicines may affect the way candesartan/indapamide works. 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 to lower your blood pressure, including beta-blockers, diazoxide, ACE inhibitors (such as enalapril, captopril, lisinopril, or ramipril) or diuretics, including potassium-sparing diuretics (amiloride, spironolactone, triamterene),
• 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,
• Lithium (a medicine for mental health problems),
• Medicines used to treat heart rhythm problems (such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium),
• Medicines used to treat mental disorders such as depression, anxiety, schizophrenia... (such as tricyclic antidepressants, antipsychotics, neuroleptics (e.g., amisulpride, sulpiride, sultoprida, tiaprida, haloperidol, droperidol)),
• Bepridil (used to treat angina pectoris, a condition that causes chest pain),
• Cisapride, difemanil (used to treat gastrointestinal problems),
• Antibiotics used to treat bacterial infections (sparfloxacin, moxifloxacin, erythromycin injection),
• Vincamine injection (used to treat symptomatic cognitive disorders in elderly patients, including memory loss),
• Halofantrine (antiparasitic medicine used to treat certain types of malaria),
• Pentamidine (used to treat certain types of pneumonia),
• Mizolastine (used to treat allergic reactions, such as hay fever),
• Amphotericin B injection (antifungal medicines),
• Oral corticosteroids used to treat various conditions, such as severe asthma and rheumatoid arthritis,
• Stimulant laxatives,
• Baclofen (to treat muscle stiffness that occurs in diseases such as multiple sclerosis),
• Allopurinol (for the treatment of gout),
• Metformin (to treat diabetes),
• Iodinated contrast media (used for X-ray tests),
• Calcium tablets or other calcium supplements,
• Cyclosporin, tacrolimus, or other medicines to suppress the immune system after an organ transplant, to treat autoimmune diseases or severe rheumatic or dermatological diseases,
• Tetracosactide (to treat Crohn's disease),
• Methadone (used to treat addiction).

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 Kanpiduo" 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) (e.g., spironolactone, eplerenone).

Taking Kanpiduo with food, drinks, and alcohol

Candesartan/indapamide can be taken with or without food.

When prescribed candesartan/indapamide, talk to your doctor before drinking alcohol. Alcohol can make you feel dizzy or faint.

Pregnancy and breastfeeding

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 should tell your doctor if you are pregnant (or might be). Normally, your doctor will advise you to stop taking this medicine before you become pregnant or as soon as you find out you are pregnant, and will recommend that you take a different medicine instead of this one. This medicine is not recommended during pregnancy and must not be taken after the third month of pregnancy as it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are breastfeeding. This medicine is not recommended for women who are breastfeeding, and your doctor may decide to give you a treatment that is more suitable if you want to breastfeed, especially if you have a newborn or premature baby. The active substance indapamide is excreted in breast milk.

Driving and using machines

This medicine can cause side effects such as dizziness or fatigue (see section 4) due to the lowering of blood pressure. These side effects occur more frequently at the start of treatment or when increasing the dose. If this happens to you, do not drive or use tools or machines.

Kanpiduo contains lactose

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

3. How to take Kanpiduo

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. It is important that you take candesartan/indapamide every day.

The recommended dose of candesartan/indapamide is one tablet a day, preferably in the morning. You can take this medicine with or without food. Swallow the tablet with a little water. Do not crush or chew it. Try to take the tablet at the same time each day. This will help you remember to take it. Treatment for high blood pressure is usually for life.

If you take more Kanpiduo than you should

If you take more candesartan/indapamide than prescribed by your doctor, contact your doctor or pharmacist immediately. Taking too much candesartan/indapamide can cause nausea, vomiting, low blood pressure, cramps, dizziness, fainting, confusion, and changes in the amount of urine produced by the kidneys.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Kanpiduo

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

Just take the next dose as normal.

If you stop taking Kanpiduo

As the treatment for high blood pressure is usually for life, you should talk to your doctor before stopping treatment with this medicine. If you stop taking candesartan/indapamide, your blood pressure may increase again.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can have adverse effects, although not all people suffer from them. It is essential that you know what these adverse effects could be.

Stop taking this medicine and consult your doctor immediately if you have any of the following adverse reactions that can be serious:

• Angioedema and/or urticaria. Angioedema is characterized by swelling of the skin on the extremities or face, swelling of the lips or tongue, swelling of the mucous membranes of the throat or respiratory tract, resulting in difficulty breathing or swallowing. If this occurs, contact your doctor immediately. (Very rare – may affect up to 1 in 10,000 people),
• Candesartan/indapamide 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 from time to time to check that candesartan/indapamide is not affecting your blood (agranulocytosis). (Very rare – may affect up to 1 in 10,000 people),
• Severe skin reactions, including intense skin eruptions, redness of the skin all over the body, intense itching, blisters, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions (Very rare - may affect up to 1 in 10,000 people).
• Irregular heartbeat with a life-threatening risk (Torsades de pointes) (Very rare - may affect up to 1 in 10,000 people).
• Pancreatitis, which can cause severe abdominal and back pain accompanied by intense discomfort (Very rare - may affect up to 1 in 10,000 people).
• Brain disease caused by liver disease (Hepatic encephalopathy) (Frequency not known - the frequency cannot be estimated from the available data).
• Hepatitis (inflammation of the liver) (Frequency not known – the frequency cannot be estimated from the available data).
• Muscle weakness, cramps, sensitivity, or pain, and especially if you experience discomfort or have a high body temperature, which can cause abnormal muscle breakdown (rhabdomyolysis) (Frequency not known – the frequency cannot be estimated from the available data).

Other possible adverse effects include:

Frequent (may affect up to 1 in 10 patients)

• Respiratory infection.
• 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 will notice fatigue, weakness, irregular heartbeat, or tingling and numbness.
• Dizziness/lightheadedness.
• Headache.
• Allergic reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions.
• Skin rash, redness of the skin.

Infrequent (may affect up to 1 in 100 patients)

• Low sodium levels in the blood, which can lead to dehydration and low blood pressure,
• Vomiting,
• Impotence (inability to achieve or maintain an erection).

Rare (may affect up to 1 in 1,000 patients)

• Low chloride levels in the blood, low magnesium levels in the blood,
• Feeling of fatigue, tingling, and numbness (paresthesia),
• Gastrointestinal disorders (such as nausea, constipation), dry mouth.

Very Rare (affects less than 1 in 10,000 patients)

• Changes in blood cells, such as thrombocytopenia (decrease in platelet count, which facilitates the appearance of bruises and nosebleeds), leucopenia, neutropenia (decrease in white blood cells, which can cause unexplained fever, sore throat, or other flu-like symptoms – if this occurs, contact your doctor) and anemia (decrease in red blood cells),
• High calcium levels in the blood
• Irregularities in heart rhythm (causing palpitations, feeling of a pounding heart), low blood pressure,
• Cough
• Abnormal liver function, elevation of liver enzymes that can affect other medical tests,
• Skin rash, itching,
• Back pain, pain in the joints and muscles,
• Kidney disorder (causing symptoms of fatigue, increased need to urinate, skin itching, feeling of discomfort, swelling of the extremities),
• Intestinal angioedema: swelling in the intestine that occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

• Fainting,
• Visual impairment, loss of vision, or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma),
• Diarrhea,
• If you have systemic lupus erythematosus (an immune system disorder that leads to inflammation and damage to joints, tendons, and organs with symptoms including skin rash, fatigue, loss of appetite, weight gain, and joint pain), it may worsen,
• There have been reports of photosensitivity reactions (changes in skin appearance) after sun exposure or artificial UVA rays,
• Muscle cramps, muscle weakness,
• Abnormal heart tracing on the ECG
• Changes may occur in your blood, and your doctor may need to perform blood tests to check your condition. The following changes in clinical parameters may occur:
• increase in uric acid, a substance that can cause or worsen gout (joint pain, especially in the feet),
• increase in blood glucose in diabetic patients.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the national reporting system: Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Kanpiduo

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

Do not store above 30°C.

Keep the blister pack in the outer packaging to protect it from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Kanpiduo

• The active ingredients are candesartan cilexetil and indapamide.

Each tablet contains 8 mg of candesartan cilexetil and 2.5 mg of indapamide.

Each tablet contains 16 mg of candesartan cilexetil and 2.5 mg of indapamide.

• The other components (excipients) are macrogol 8,000, hydroxypropylcellulose, lactose monohydrate, cornstarch, calcium carmellose, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, and red iron oxide (E172) – only in the 16 mg/2.5 mg tablets.

See section 2 "Kanpiduo contains lactose".

Appearance of the Product and Package Contents

Kanpiduo 8 mg/2.5 mg tablets: white or almost white, round, biconvex tablets engraved with CI1 on one side. Tablet diameter 7 mm.

Kanpiduo 16 mg/2.5 mg tablets: light pink, speckled, round, biconvex tablets engraved with CI2 on one side. Tablet diameter 7 mm.

Kanpiduo is available in package sizes containing:

• 10, 14, 28, 30, 56, 60, 84, 90, 98, 100 tablets in blisters.
• 14, 28, 56, 84, 98 tablets in blisters, calendarized packages.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

KRKA, D.D., Novo mesto,

Šmarješka cesta 6, 8501 Novo mesto,

Slovenia

Manufacturer

KRKA, d.d., Novo mesto,

Šmarješka cesta 6, 8501 Novo mesto,

Slovenia

or

KRKA d.d. NOVO MESTO

Ulica Rada Pušenjaka, 10

9240 Ljutomer,

Slovenia

or

TAD Pharma GmbH

Heinz Lohmann strasse, 5

D-27472 Cuxhaven

Germany

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 under the following names:

Date of the last revision of this prospectus:02/2025

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