Kanpiduo

Package leaflet: Information for the patient

Kanpiduo, 8 mg + 2.5 mg, tablets
Kanpiduo, 16 mg + 2.5 mg, tablets
Candesartan cilexetil + Indapamide
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Kanpiduo is and what it is 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 Kanpiduo is and what it is used for

Kanpiduo contains two active substances called candesartan and indapamide.
Candesartan belongs to a group of medicines known as angiotensin II receptor antagonists. It causes
relaxation and widening of blood vessels. This helps lower blood pressure.
Indapamide is a diuretic medicine. Most diuretics increase the volume of urine produced by the kidneys. However,
indapamide differs from other diuretics in that it causes only a slight increase in urine volume.
This medicine is used to treat high blood pressure (hypertension) in adults. Your doctor may prescribe
Kanpiduo to patients who are already taking candesartan and indapamide at the same doses as in
Kanpiduo, but as separate tablets.

2. Important information before using Kanpiduo

When not to use Kanpiduo

• if the patient is allergic to candesartan, indapamide, or to other drugs of this type (so-called sulfonamides), or to any of the other ingredients of this medicine (listed in section 6);
• after the 3rd month of pregnancy (Kanpiduo should also be avoided during early pregnancy – see section "Pregnancy");
• if the patient has severe liver disease or biliary obstruction (impaired bile flow from the gallbladder), or hepatic encephalopathy (a degenerative brain disorder caused by liver disease);
• in children under 1 year of age;
• if the patient has diabetes or kidney problems and is being treated with aliskiren, a blood pressure-lowering medicine;
• if the patient has low blood potassium levels.

If in doubt whether any of the above situations apply to the patient, consult a doctor or pharmacist before using Kanpiduo.

Warnings and precautions

Before starting Kanpiduo, discuss with your doctor or pharmacist:

• if there are heart, liver or kidney problems, or if the patient is on dialysis;
• if a kidney transplant has recently been performed;
• if there have been or are severe vomiting or diarrhoea;
• if the patient has a disease of the adrenal glands called Conn's syndrome (also known as primary hyperaldosteronism);
• if the patient has low blood pressure;
• if the patient has ever had a stroke;
• if the patient has diabetes;
• if the patient has gout;
• if the patient has any heart rhythm disorders;
• if the patient is scheduled for a test assessing parathyroid function;
• if the patient has muscle disorders, including pain, tenderness, weakness or cramps;
• inform the doctor if pregnancy is suspected or suspected to be possible. Kanpiduo is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy");
• if the patient is taking any of the following medicines for high blood pressure:
• an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if the patient has kidney problems related to diabetes,
• aliskiren;
• if the patient is taking an ACE inhibitor together with a medicine belonging to a group of medicines called mineralocorticoid receptor antagonists (MRAs). These medicines are used in the treatment of heart failure (see "Kanpiduo and other medicines");
• if the patient experiences blurred 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 may occur within hours or weeks of taking Kanpiduo. Untreated, these symptoms may lead to permanent vision loss. If the patient has previously been allergic to penicillin or sulfonamides, there is an increased risk of developing these disorders.

Your doctor may recommend regular monitoring of kidney function, blood pressure and blood levels of electrolytes (e.g. potassium or calcium).

See also the section "When not to use Kanpiduo".

If any of the above conditions apply to the patient, the doctor may recommend more frequent check-ups and tests.

If the patient is to undergo surgery, inform the doctor or dentist about taking Kanpiduo. This is because Kanpiduo, in combination with certain anaesthetics, may cause low blood pressure.

Inform the doctor if the patient has a photosensitivity reaction.

Athletes should be aware that Kanpiduo contains an active substance that may lead to a positive anti-doping test.

If the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Kanpiduo, discuss this with the doctor. The doctor will decide on further treatment. Do not stop taking Kanpiduo without medical advice.

If the patient thinks any of the above situations apply, or has any questions or doubts about using Kanpiduo, they should contact their doctor or pharmacist.

Children and adolescents

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

Kanpiduo and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those not mentioned here.

Kanpiduo may affect the action of other medicines, and other medicines may affect the action of Kanpiduo. If the patient is taking certain medicines, the doctor may periodically recommend blood tests.

In particular, inform the doctor if the patient is taking 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 drugs (NSAIDs), such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines that relieve pain and inflammation);
• acetylsalicylic acid (at doses above 3 g per day) (a medicine that relieves pain and inflammation);
• potassium supplements, potassium-containing salt substitutes (medicines that increase blood potassium levels);
• heparin (a medicine that reduces blood clotting);
• co-trimoxazole, also known as trimethoprim/sulfamethoxazole (an antibiotic);
• lithium (a medicine used to treat psychiatric disorders);
• medicines used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, cardiac glycosides, bretylium);
• medicines used to treat psychiatric disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics, neuroleptics such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol);
• bepridil (used to treat ischaemic heart disease causing chest pain);
• cisapride, difenamil (used to treat gastrointestinal disorders);
• antibiotics used to treat bacterial infections (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin);
• intravenous vinpocetine (used to treat symptomatic cognitive disorders in elderly patients, 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);
• intravenous amphotericin B (a medicine used to treat fungal infections);
• oral corticosteroids, used to treat various diseases, including severe asthma and rheumatoid arthritis;
• stimulant laxatives;
• baclofen (used to treat muscle stiffness occurring in diseases such as multiple sclerosis);
• allopurinol (used to treat gout);
• metformin (used to treat diabetes);
• iodine-containing contrast agents (used during diagnostic X-ray procedures);
• calcium tablets 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 rheumatic or dermatological conditions;
• tetracosactide (used to treat Crohn's disease);
• methadone (used to treat addiction).

The doctor may recommend a dose adjustment and/or additional precautions:

• If the patient is taking an ACE inhibitor or aliskiren (see also sections "When not to use Kanpiduo" and "Warnings and precautions").
• If the patient is taking an ACE inhibitor together with certain medicines used to treat heart failure called mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Kanpiduo with food, drink and alcohol

Kanpiduo may be taken with or without food.

Before drinking alcohol while taking Kanpiduo, consult your doctor. Alcohol may cause fainting or dizziness.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you are pregnant, suspect pregnancy or plan to become pregnant. Your doctor will usually advise stopping Kanpiduo before planning pregnancy or immediately after pregnancy is confirmed, and will recommend another medicine instead of Kanpiduo. Kanpiduo is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Kanpiduo is not recommended during breastfeeding, and your doctor may recommend alternative treatment if you wish to breastfeed, especially if breastfeeding a newborn or premature infant. The active ingredient indapamide passes into human milk.

Driving and using machines

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

Kanpiduo contains lactose

If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Kanpiduo

This medicine should always be taken exactly as directed by the doctor or pharmacist. In case of
doubt, consult the doctor or pharmacist. It is important to take Kanpiduo
every day.
The recommended dose of Kanpiduo is one tablet daily, preferably taken in the morning.
Kanpiduo may be taken during meals or independently of meals. The tablet should be
swallowed with water. Do not break or chew the tablet. It is recommended to take the medicine
at the same time each day. This will help the patient remember to take the dose. Treatment of high blood pressure is usually long-term.
Taking more Kanpiduo than recommended
If too many tablets are taken, contact a 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.
Missing a dose of Kanpiduo
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time.
Stopping Kanpiduo treatment
Since treatment of high blood pressure usually lasts for life, consult a doctor before stopping the medicine. If Kanpiduo is discontinued, blood pressure may rise again.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
It is important for the patient to be aware of the possibility of their occurrence.
If the patient experiences any of the following adverse effects, which may be
severe, treatment must be discontinued and the patient should contact a doctor immediately:

• angioedema and (or) urticaria. Angioedema is characterized by swelling of the skin of the limbs and face, lips or tongue, or mucous membranes of the throat or airways, causing breathlessness or difficulty swallowing. If such symptoms occur, immediate medical advice must be sought (very rare – may occur in less than 1 in 10,000 patients);
• the medicine Kanpiduo may cause a reduction in white blood cells. This may lead to decreased resistance to infections, so the patient may experience fatigue, infection, and fever. If such symptoms occur, the patient should contact a doctor. The doctor may periodically recommend blood tests to check whether Kanpiduo is causing blood disorders (agranulocytosis) (very rare – may occur in less than 1 in 10,000 patients);
• severe skin reactions, including severe rash, redness of the entire body's skin, intense itching, formation of blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome) or other allergic reactions (very rare – may occur in less than 1 in 10,000 patients);
• life-threatening heart rhythm disturbances (torsade de pointes) (frequency unknown – frequency cannot be determined from available data);
• pancreatitis, which may cause severe upper abdominal pain radiating to the back and very poor general condition (very rare – may occur in less than 1 in 10,000 patients);
• brain disease caused by liver disease (hepatic encephalopathy; frequency unknown);
• hepatitis (liver inflammation) (frequency unknown – frequency cannot be determined from available data);
• muscle weakness, cramps, tenderness or muscle pain, especially when the patient simultaneously feels unwell or has a high temperature, which may be due to abnormal muscle breakdown (rhabdomyolysis) (frequency unknown – frequency cannot be determined from available data).

Other possible adverse effects include:
Common (occur in 1 to 10 patients out of 100)

• respiratory tract infection;
• changes in blood test results: increased potassium levels in blood, especially if the patient has kidney function disorders or heart failure. In case of significant increase, symptoms such as fatigue, weakness, irregular heartbeat, or tingling and prickling sensations may occur;
• dizziness/spinning sensation;
• headache;
• allergic reactions, mainly affecting the skin, in patients prone to allergies and asthmatic reactions;
• red, raised rash.

Uncommon (occur in less than 1 in 100 patients)

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

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

• low chloride levels in blood, low magnesium levels in blood;
• feeling of fatigue, tingling and prickling (paresthesia);
• gastrointestinal disturbances (such as nausea, constipation), dry mouth.

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

• changes in blood cell composition, such as thrombocytopenia (reduced number of platelets, leading to easy bruising and nosebleeds), leukopenia (reduced number of white blood cells, which may cause unexplained fever, sore throat or other flu-like symptoms – if these occur, contact a doctor), and anemia (reduced number of red blood cells);
• high calcium levels in blood;
• heart rhythm disturbances (causing palpitations, sensation of rapid heartbeat), low blood pressure;
• cough;
• abnormal liver function, increased liver enzyme activity, which may lead to changes in laboratory test results;
• skin rash, itching;
• back pain, joint and muscle pain;
• kidney disorders (causing fatigue, increased frequency of urination, itching, nausea, limb swelling);
• intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency unknown (frequency cannot be determined from available data)

• fainting;
• worsening of vision or eye pain due to high pressure (possible symptoms of fluid accumulation in the eye's choroid layer (choroidal effusion) or acute angle-closure glaucoma);
• diarrhea;
• in case of systemic lupus erythematosus (an immune system disorder leading to inflammation and damage of joints, tendons, and organs, with symptoms such as skin rash, fatigue, loss of appetite, weight gain, and joint pain), symptoms may worsen;
• photosensitivity reactions (skin changes) have also been reported following exposure to sunlight or artificial UVA radiation;
• muscle cramps and weakness;
• abnormal electrocardiogram (ECG) findings;
• changes in laboratory test results (blood tests) may occur, and the doctor may recommend blood testing. The following changes in laboratory results may occur:
• increased uric acid levels, a substance that may cause or exacerbate gout (joint pain, particularly in the feet);
• increased blood glucose levels in patients.

Reporting of adverse effects
If any adverse effects occur, including any not listed
in this leaflet, the patient should inform their doctor or pharmacist. Adverse effects can
be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store Kanpiduo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the word
EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
Keep 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 no longer required. Such measures will help
protect the environment.

6. Contents of the package and other information

What Kanpiduo contains

• The active substances 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, monohydrate lactose, corn starch, calcium carmellose, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, iron oxide red (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
Tablets 8 mg + 2.5 mg: white or almost white, round, biconvex tablets marked CI1 on one side. Tablet diameter: 7 mm.
Tablets 16 mg + 2.5 mg: light pink speckled, round, biconvex tablets marked 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 blister packs
• 14, 28, 56, 84, 98 tablets in blister packs, calendar pack

Not all pack sizes may be marketed.
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries under the following names:

For more detailed information about this medicinal product, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Poland
Phone: +48 22 57 37 500