Kanpiduo

Package Leaflet: Information for the Patient

Kanpiduo, 8 mg + 2.5 mg, tablets

Kanpiduo, 16 mg + 2.5 mg, tablets

Candesartan cilexetil + Indapamide

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Kanpiduo and what is it used for
• 2. Important information before taking Kanpiduo
• 3. How to take Kanpiduo
• 4. Possible side effects
• 5. How to store 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 relaxes and widens the blood vessels, which helps to lower blood pressure.
Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics because it only causes a slight increase in the amount of urine produced.
This medicine is used to treat high blood pressure (hypertension) in adults. Your doctor may prescribe Kanpiduo if you are already taking candesartan and indapamide in the same doses as in Kanpiduo, but in separate tablets.

2. Important information before taking Kanpiduo

When not to take Kanpiduo

• if you are allergic to candesartan, indapamide, or other medicines of this type (sulfonamides) or any of the other ingredients of this medicine (listed in section 6);
• after the third month of pregnancy (also see section "Pregnancy");
• if you have severe liver disease or biliary obstruction (difficulty in bile flow from the gallbladder), or if you have degenerative changes in brain function caused by liver disease, called hepatic encephalopathy;
• in children under 1 year of age;
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren;
• if you have low potassium levels in your blood.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking Kanpiduo.

Warnings and precautions

Before taking Kanpiduo, discuss with your doctor or pharmacist:

• if you have heart, liver, or kidney problems, or if you are on dialysis;
• if you have recently had a kidney transplant;
• if you have had severe vomiting or diarrhea;
• if you have a condition called Conn's syndrome (also known as primary hyperaldosteronism);
• if you have low blood pressure;
• if you have had a stroke;
• if you have diabetes;
• if you have gout;
• if you have any heart rhythm problems;
• if you are going to have a test to check your parathyroid function;
• if you have muscle problems, including pain, tenderness, weakness, or cramps;
• if you suspect or plan to become pregnant (see section "Pregnancy");
• if you are taking any of the following medicines for high blood pressure:
• ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• aliskiren;
• if you are taking an ACE inhibitor and a medicine called mineralocorticoid receptor antagonists (MRAs) used to treat heart failure (see "Kanpiduo with other medicines");
• if you have worsening vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure - they can occur within a few hours or weeks after taking Kanpiduo. Untreated symptoms can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you are at greater risk of developing these problems.

Your doctor may recommend regular checks of your kidney function, blood pressure, and electrolyte levels (e.g., potassium or calcium) in your blood.
Also, see section "When not to take Kanpiduo".
If any of the above conditions apply to you, your doctor may recommend more frequent checks and tests.
If you are going to have surgery, inform your doctor or dentist that you are taking Kanpiduo. This is because Kanpiduo, in combination with certain anesthetics, can cause a drop in blood pressure.
Inform your doctor if you have a light-sensitive reaction.
Athletes should be aware that Kanpiduo contains an active substance that can cause a positive result in anti-doping tests.
If you experience stomach pain, nausea, vomiting, or diarrhea after taking Kanpiduo, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Kanpiduo on your own.
If you think any of the above situations apply to you, or if you have questions or concerns about taking Kanpiduo, consult your doctor or pharmacist.

Children and adolescents

Due to the lack of data on safety and efficacy, Kanpiduo is not recommended for use in children and adolescents.

Kanpiduo with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
Kanpiduo may affect the way other medicines work, and other medicines may affect the way Kanpiduo works.
Particularly, inform your doctor about the use of any of the following medicines:

• other blood pressure-lowering medicines, including beta-blockers, diazoxide, and ACE inhibitors, such as enalapril, captopril, lisinopril, or ramipril, diuretics, including potassium-sparing diuretics (amiloride, spironolactone, triamterene);
• non-steroidal anti-inflammatory medicines (NSAIDs), such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (pain-relieving and anti-inflammatory medicines);
• aspirin (in doses greater than 3 g per day), (pain-relieving and anti-inflammatory medicine);
• potassium supplements, potassium-containing salt substitutes (medicines that increase potassium levels in the blood);
• heparin (a medicine that reduces blood clotting);
• co-trimoxazole (an antibiotic), also known as trimethoprim/sulfamethoxazole;
• lithium (a medicine used to treat mental disorders);
• medicines used to treat irregular heartbeat (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digoxin, bretylium);
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, antipsychotics, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol));
• bepridil (used to treat angina pectoris, a condition that causes chest pain);
• cisapride, difemanil (used to treat gastrointestinal disorders);
• antibiotics used to treat bacterial infections (e.g., sparfloxacin, moxifloxacin, erythromycin given by injection);
• vincamine given by injection (used to treat cognitive disorders in the elderly, including memory loss);
• halofantrine (an 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 given by injection (a medicine used to treat fungal infections),
• oral corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis;
• laxatives that stimulate bowel movements;
• baclofen (used to treat muscle stiffness, such as in multiple sclerosis);
• allopurinol (used to treat gout);
• metformin (used to treat diabetes);
• iodine-containing contrast media used in diagnostic tests using X-rays;
• calcium or other calcium supplements;
• cyclosporine, tacrolimus, or other medicines that suppress the immune system after organ transplantation or used to treat autoimmune diseases or severe rheumatoid or dermatological diseases;
• tetracosactide (used to treat Crohn's disease);
• methadone (used to treat addiction).

Your doctor may recommend a change in dose and/or take other precautions:

• If you are taking an ACE inhibitor or aliskiren (also see sections "When not to take Kanpiduo" and "Warnings and precautions").
• If you are taking an ACE inhibitor and a medicine called mineralocorticoid receptor antagonists (MRAs) used to treat heart failure.

Kanpiduo with food, drink, and alcohol

Kanpiduo can be taken with or without food.
Before drinking alcohol while taking Kanpiduo, consult your doctor. Alcohol can cause dizziness or fainting.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually recommend stopping Kanpiduo before planned pregnancy or as soon as possible after finding out about the pregnancy, and will recommend taking a different medicine instead of Kanpiduo. Kanpiduo should not be taken during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the baby.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Kanpiduo should not be taken during breastfeeding, and your doctor may recommend a different treatment if you want to breastfeed, especially if you are breastfeeding a newborn or premature baby. The active substance indapamide passes into human milk.

Driving and using machines

Kanpiduo may cause side effects related to lowering blood pressure, such as dizziness or fatigue (see section 4). These side effects are more common at the start of treatment and after dose increases. If you experience such symptoms, do not drive, use tools, or operate machinery.

Kanpiduo contains lactose

If you have been told that you have an intolerance to some sugars, consult 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, ask your doctor or pharmacist. It is important to take Kanpiduo every day.
The recommended dose of Kanpiduo is one tablet per day, preferably taken in the morning.
Kanpiduo can be taken with or without food. Swallow the tablet with water. Do not break or chew it. It is recommended to take Kanpiduo at the same time every day. This will help you remember to take your dose. Treatment of high blood pressure usually lasts for life.

What to do if you take more Kanpiduo than you should

If you have taken too many tablets, contact your doctor or pharmacist immediately. Very high doses of Kanpiduo may cause nausea, vomiting, low blood pressure, muscle cramps, dizziness, drowsiness, disorientation, and changes in the amount of urine produced by the kidneys.

What to do if you forget to take Kanpiduo

Do not take a double dose to make up for a forgotten dose.
Take the next dose at the usual time.

What to do if you stop taking Kanpiduo

Because treatment of high blood pressure usually lasts for life, consult your doctor before stopping Kanpiduo. If you stop taking Kanpiduo, your blood pressure may increase again.
If you have any further questions about taking Kanpiduo, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Kanpiduo can cause side effects, although not everybody gets them.
It is important that you know about the possibility of these side effects.

If you experience any of the following serious side effects, stop taking Kanpiduo and contact your doctor immediately:

• angioedema and/or urticaria. Angioedema is characterized by swelling of the skin of the limbs, face, lips, tongue, mucous membranes of the throat or airways, which can cause difficulty breathing or swallowing. If you experience such symptoms, contact your doctor immediately (very rare - may occur in less than 1 in 10,000 patients);
• Kanpiduo may cause a decrease in the number of white blood cells. This can lead to reduced immunity to infections, and you may experience fatigue, infection, and fever. If you experience such symptoms, contact your doctor. Your doctor may periodically recommend blood tests to check if Kanpiduo is causing any blood disorders (agranulocytosis) (very rare - may occur in less than 1 in 10,000 patients);
• severe skin reactions, including severe rash, redness of the skin, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome) or other allergic reactions (very rare - may occur in less than 1 in 10,000 patients);
• life-threatening irregular heart rhythms (torsade de pointes) (frequency not known - cannot be estimated from available data);
• pancreatitis, which can cause severe stomach pain, radiating to the back, and very poor general condition (very rare - may occur in less than 1 in 10,000 patients);
• liver disease caused by liver disease (hepatic encephalopathy; frequency not known);
• liver inflammation (frequency not known - cannot be estimated from available data);
• muscle weakness, cramps, tenderness, or pain, especially if you feel unwell or have a high temperature, which can be caused by abnormal muscle breakdown (rhabdomyolysis) (frequency not known - cannot be estimated from available data).

Other possible side effects include:

Common (may occur in up to 1 in 10 patients)

• respiratory tract infections;
• changes in blood test results: increased potassium levels in the blood, especially if you have kidney problems or heart failure. If the increase is significant, you may experience fatigue, weakness, irregular heartbeat, or a feeling of tingling or numbness;
• dizziness/lightheadedness;
• headache;
• allergic reactions, mainly affecting the skin, in people prone to allergies and asthma-like reactions;
• red, raised rash.

Uncommon (may occur in less than 1 in 100 patients):

• low sodium levels in the blood, which can cause dehydration and low blood pressure;
• vomiting;
• impotence (inability to achieve or maintain an erection).

Rare (may occur in less than 1 in 1,000 patients)

• low chloride levels in the blood, low magnesium levels in the blood;
• feeling of tiredness, tingling, and numbness (paresthesia);
• gastrointestinal disorders (such as nausea, constipation), dry mouth.

Very rare (may occur in less than 1 in 10,000 patients)

• changes in blood cell counts, such as low platelet count (thrombocytopenia), low white blood cell count (leukopenia), or anemia (reduced red blood cell count);
• high calcium levels in the blood;
• irregular heartbeat (causing palpitations or rapid heartbeat), low blood pressure;
• cough;
• abnormal liver function, increased liver enzyme activity, which can cause changes in laboratory test results;
• skin rash, itching;
• back pain, joint and muscle pain;
• kidney problems (causing fatigue, increased urination frequency, itching, nausea, swelling of the limbs);
• intestinal angioedema: swelling in the intestine with symptoms such as stomach pain, nausea, vomiting, and diarrhea.

Frequency not known (cannot be estimated from available data)

• fainting;
• worsening vision or eye pain due to high pressure (possible symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma);
• diarrhea;
• in the case of systemic lupus erythematosus (an autoimmune disease that causes inflammation and destruction of joints, tendons, and organs, along with symptoms such as skin rash, fatigue, loss of appetite, weight gain, and joint pain), the symptoms may worsen;
• photosensitivity reactions (changes in skin appearance) have also been reported after exposure to sunlight or artificial UVA radiation;
• muscle cramps and weakness;
• abnormal electrocardiogram (ECG) tracing
• changes in laboratory test results (blood tests) and your doctor may recommend a blood test. The following changes in laboratory test results may occur:
• increased uric acid levels, a substance that can cause gout (pain in the joints, especially the feet);
• increased glucose levels in the blood in patients with diabetes.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kanpiduo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month.
Store in a temperature below 30°C.
Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Kanpiduo contains

• The active substances of Kanpiduo 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 ingredients (excipients) are: macrogol 8000, hydroxypropylcellulose, lactose monohydrate, cornstarch, calcium carmellose, colloidal silica anhydrous, microcrystalline cellulose, magnesium stearate, red iron oxide (E 172) - only in 16 mg + 2.5 mg tablets. See section 2 "Kanpiduo contains lactose".

What Kanpiduo looks like and contents of the pack

8 mg + 2.5 mg tablets: white or almost white, round, biconvex tablets marked with CI1 on one side. Tablet diameter: 7 mm.
16 mg + 2.5 mg tablets: light pink, speckled, round, biconvex tablets marked with CI2 on one side. Tablet diameter: 7 mm.
Kanpiduo is available in packs containing:

• 10, 14, 28, 30, 56, 60, 84, 90, 98, 100 tablets in blisters
• 14, 28, 56, 84, 98 tablets in blisters, calendar packaging

Not all pack sizes may be marketed.

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
Krka, d.d., Novo mesto, Ulica Rada Pušenjaka 10, 9240 Ljutomer, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

For more information about this medicine, contact your local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
phone: +48 22 57 37 500
Date of last revision of the leaflet:24.01.2025