Candezek Combi

PATIENT INFORMATION LEAFLET

Enclosed leaflet: patient information

Candezek Combi, 8 mg + 5 mg, hard capsules

Candezek Combi, 8 mg + 10 mg, hard capsules

Candezek Combi, 16 mg + 5 mg, hard capsules

Candezek Combi, 16 mg + 10 mg, hard capsules

Candesartan cilexetil + Amlodipine

Read the 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Candezek Combi and what is it used for
• 2. Important information before taking Candezek Combi
• 3. How to take Candezek Combi
• 4. Possible side effects
• 5. How to store Candezek Combi
• 6. Contents of the pack and other information

1. What is Candezek Combi and what is it used for

Candezek Combi contains two active substances called amlodipine and candesartan. Both of these substances help to control high blood pressure.
Amlodipine belongs to a group of substances known as "calcium channel blockers". Amlodipine prevents calcium from entering the walls of blood vessels, which prevents the blood vessels from constricting.
Candesartan belongs to a group of substances known as "angiotensin II receptor blockers". Angiotensin II is produced in the body and causes blood vessels to constrict, leading to an increase in blood pressure. Candesartan works by blocking the action of angiotensin II.
Both of these substances help to prevent blood vessels from constricting. As a result, blood vessels relax and blood pressure decreases.
Candezek Combi is used to treat high blood pressure in patients whose blood pressure is already adequately controlled by taking candesartan and amlodipine separately, in the same doses as in Candezek Combi.

2. Important information before taking Candezek Combi

When not to take Candezek Combi

• if you are allergic to amlodipine or to any other calcium channel blockers, to candesartan cilexetil or to any of the other ingredients of this medicine (listed in section 6);
• if you have very low blood pressure (hypotension);
• if you have a narrowing of the aortic valve in your heart (aortic stenosis) or cardiogenic shock (a condition where your heart is not able to supply enough blood to your body);
• if you have heart failure after a heart attack;
• if you are more than 3 months pregnant (see section: Pregnancy and breastfeeding);
• if you have severe liver disease or biliary obstruction (problems with bile flow from the gallbladder);
• if you are taking aliskiren-containing products and have diabetes or kidney problems (GFR <60 ml min 1.73 m²).< li>

Warnings and precautions

Before taking Candezek Combi, tell your doctor or pharmacist if:

• you have recently had a heart attack;
• you have heart failure;
• you have had a sudden increase in blood pressure (hypertensive crisis);
• you have low blood pressure (hypotension);
• you are elderly and need a dose increase;
• you have liver or kidney problems, or if you are on dialysis;
• you have recently had a kidney transplant;
• you are vomiting, have recently had severe vomiting or have diarrhea;
• you have adrenal gland disease, known as Conn's syndrome (also known as primary hyperaldosteronism);
• you have had a stroke;
• you have taken any of the following medicines for high blood pressure: an ACE inhibitor (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes; or aliskiren.

Your doctor may recommend regular checks of your kidney function, blood pressure, and electrolyte levels (such as potassium). See also the section "When not to take Candezek Combi".
Your doctor may want you to come in for visits more often to have certain tests done if you have any of the conditions listed.
If you are going to have surgery, tell your doctor or dentist that you are taking Candezek Combi. This is important, as Candezek Combi, in combination with certain anesthetics, may cause a significant drop in blood pressure.
If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candezek Combi, discuss this with your doctor. Your doctor will decide on further treatment. Do not stop taking Candezek Combi on your own.
Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Candezek Combi is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm your baby if taken after the third month of pregnancy (see section "Pregnancy and breastfeeding").

Children and adolescents

There is no experience with the use of Candezek Combi in children (under 18 years of age).
Therefore, this medicine should not be given to children and adolescents.

Candezek Combi and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.
Candezek Combi may affect the way other medicines work, or other medicines may affect the way Candezek Combi works. These include:

• ketokonazole, itraconazole (antifungal medicines);
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV infection);
• rifampicin, erythromycin, clarithromycin (antibiotics);
• St. John's Wort (Hypericum perforatum);
• verapamil, diltiazem (heart medicines);
• dantrolene (intravenous infusion used to treat severe disturbances in body temperature);
• simvastatin (cholesterol-lowering medicine);
• other medicines that help lower blood pressure, including beta-blockers, diazoxide, and
• ACE inhibitors (such as enalapril, captopril, lisinopril, or ramipril) or aliskiren (see also the information under the heading "When not to take Candezek Combi" and "Warnings and precautions");
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac;
• celecoxib or etoricoxib (medicines used to reduce pain and inflammation);
• acetylsalicylic acid (a medicine used to reduce pain and inflammation), at a dose above 3 g per day;
• potassium supplements or potassium-sparing diuretics (medicines that increase potassium levels in the blood);
• heparin (a medicine used to thin the blood);
• diuretics (water pills);
• lithium (a medicine used to treat mental disorders)
• tacrolimus, sirolimus, temsirolimus, and everolimus (used to control the body's immune response, allowing the body to accept a transplanted organ);
• cyclosporin (an immunosuppressive medicine used mainly after organ transplantation to prevent the body from rejecting the transplanted organ)

Taking Candezek Combi with food and drink

Do not drink grapefruit juice or eat grapefruits while taking Candezek Combi. Grapefruit and grapefruit juice can lead to increased levels of the active substance amlodipine in the blood, which can cause unpredictable increases in the blood pressure-lowering effect of Candezek Combi.

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
If you are pregnant or think you may be pregnant, you must tell your doctor. Your doctor will probably advise you to stop taking Candezek Combi before you become pregnant or as soon as you find out you are pregnant, and will advise you to take a different medicine instead of Candezek Combi.
Candezek Combi should not be taken during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm your baby if taken after the third month of pregnancy (see section "Pregnancy and breastfeeding").
Breastfeeding
It has been shown that small amounts of amlodipine pass into breast milk.
Tell your doctor if you are breastfeeding or plan to breastfeed. Candezek Combi is not recommended for breastfeeding women, and if you want to breastfeed, your doctor may choose a different treatment, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

Candezek Combi may have a moderate influence on your ability to drive and use machines. If the capsules cause nausea, dizziness, fatigue, or headache, do not drive or operate machinery and contact your doctor immediately.

Candezek Combi contains lactose monohydrate

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

3. How to take Candezek Combi

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The usual dose is one capsule once a day.
Patients who are already taking candesartan and amlodipine as separate tablets may instead take Candezek Combi capsules, which contain the same ingredients in the same doses.

Take more Candezek Combi than prescribed

Taking too many capsules may cause your blood pressure to become too low or even dangerously low.
You may feel dizzy, lightheaded, faint, or weak. If the drop in blood pressure is very large, it can lead to shock.
Your skin may become cool and moist, and you may lose consciousness.
Even up to 24-48 hours after taking the medicine, shortness of breath may occur due to excess fluid accumulating in the lungs (pulmonary edema).
If you have taken too many capsules, seek medical attention immediately.

Miss a dose of Candezek Combi

If you forget to take a capsule, skip that dose. Take the next dose at the scheduled time.
Do not take a double dose to make up for a forgotten dose.

Stop taking Candezek Combi

Your doctor will tell you how long to take Candezek Combi. Stopping treatment too early may cause your symptoms to return. Therefore, do not stop taking Candezek Combi without first discussing it with your doctor.
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.
If you experience any of the following side effects, stop taking Candezek Combi and seek medical attention immediately:

• sudden wheezing, chest pain, shortness of breath, or difficulty breathing;
• swelling of the eyelids, face, or lips;
• swelling of the tongue and throat, causing great difficulty in breathing;
• severe skin reactions, including severe rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome) or other allergic reactions;
• heart attack, irregular heartbeat;
• pancreatitis, which can cause severe abdominal and back pain, and very poor general health.

Candesartan may cause a decrease in white blood cell count. Your resistance to infection may be reduced, and you may experience fatigue, infection, or fever. Contact your doctor in this case. Your doctor may order periodic blood tests to check if Candezek Combi is affecting your blood in any way (agranulocytosis).

Other possible side effects

Since Candezek Combi contains two active substances, the side effects reported are related to both amlodipine and candesartan.

Side effects related to amlodipine

The following side effects have been reported. If any of the following side effects cause problems or last longer than a week, contact your doctor.
Very common (may affect more than 1 in 10 people)

• swelling of the ankles

Common (may affect up to 1 in 10 people)

• headache, dizziness, drowsiness (especially at the start of treatment);
• palpitations (awareness of heartbeat), flushing of the face;
• abdominal pain, nausea;
• changes in bowel movements, diarrhea, constipation, indigestion;
• fatigue, weakness;
• vision disturbances, double vision;
• muscle cramps.

Uncommon (may affect up to 1 in 100 people).

• mood changes, anxiety, depression, insomnia;
• trembling, taste disturbances, loss of consciousness;
• tingling in the limbs, lack of sensation;
• ringing in the ears;
• low blood pressure;
• rhinitis (runny nose) and (or) hay fever;
• cough;
• dry mouth, vomiting;
• hair loss, excessive sweating, itching, red spots on the skin, skin discoloration;
• urination disorders, increased need to urinate at night, increased frequency of urination;
• impotence; breast discomfort or enlargement in men;
• pain, poor general health;
• joint or muscle pain, back pain;
• weight gain or loss.

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

• confusion.

Very rare (may affect up to 1 in 10,000 people)

• decrease in white blood cell count, decrease in platelet count, which can lead to unusual bruising or bleeding;
• high blood sugar levels (hyperglycemia);
• nerve disorders, which can cause weakness, tingling;
• gum swelling;
• abdominal bloating (gastritis);
• liver function disorders, including hepatitis (inflammation of the liver), jaundice (yellowing of the skin and eyes), and changes in liver enzyme levels, which can affect some medical test results;
• increased muscle tension;
• vasculitis (inflammation of blood vessels), often with a skin rash;
• photosensitivity;
• disorders affecting muscle stiffness, tremors, and (or) movement disorders.

Frequency not known

• tremors, stiffness, mask-like face, slow movements, and shuffling gait, toxic epidermal necrolysis.

Side effects related to candesartan

Common (may affect up to 1 in 10 people)

• dizziness (feeling of spinning);
• headache;
• respiratory tract infections;
• low blood pressure - may cause dizziness or lightheadedness;
• 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 tingling;
• effects on kidney function, especially in patients with existing kidney problems or heart failure. In very rare cases, kidney failure may occur.

Very rare (may affect up to 1 in 10,000 people)

• swelling of the face, lips, tongue, and (or) throat;
• decrease in red or white blood cell count - may cause fatigue, infection, or fever;
• skin rash, urticaria (hives);
• itching;
• back pain, joint or muscle pain;
• liver function changes, including hepatitis (inflammation of the liver). May cause fatigue, yellowing of the skin and eyes, and flu-like symptoms;
• cough;
• nausea;
• changes in blood test results;
• decrease in sodium levels in the blood. If the decrease is significant, you may experience weakness, lack of energy, or painful muscle cramps;
• gastrointestinal angioedema: swelling in the intestines with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

• diarrhea

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects 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, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects 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 Candezek Combi

Store in a temperature below 30°C.
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/blisters after EXP. The expiry date refers to the last day of that month.
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

What Candezek Combi contains

The active substances are candesartan cilexetil and amlodipine.
Candezek Combi, 8 mg + 5 mg, hard capsules
Each capsule contains 8 mg of candesartan cilexetil and 5 mg of amlodipine, which corresponds to 6.935 mg of amlodipine besylate.
Candezek Combi, 8 mg + 10 mg, hard capsules
Each capsule contains 8 mg of candesartan cilexetil and 10 mg of amlodipine, which corresponds to 13.87 mg of amlodipine besylate.
Candezek Combi, 16 mg + 5 mg, hard capsules
Each capsule contains 16 mg of candesartan cilexetil and 5 mg of amlodipine, which corresponds to 6.935 mg of amlodipine besylate.
Candezek Combi, 16 mg + 10 mg, hard capsules
Each capsule contains 16 mg of candesartan cilexetil and 10 mg of amlodipine, which corresponds to 13.87 mg of amlodipine besylate.
Other ingredients are: lactose monohydrate, corn starch, calcium carmellose, macrogol 8000, hydroxypropylcellulose/Type EXF (250-800 cP (for a 10% solution)), hydroxypropylcellulose/Type LF (65-175 cP (for a 5% solution)), magnesium stearate.
Cap color (8 mg + 5 mg, 8 mg + 10 mg): quinoline yellow (E104), yellow iron oxide (E172), titanium dioxide (E171), gelatin
Cap color (16 mg + 5 mg): quinoline yellow (E104), titanium dioxide (E171), gelatin
Cap color (16 mg + 10 mg): titanium dioxide (E171), gelatin
Ink (8 mg + 10 mg, 16 mg + 5 mg): shellac (E904), black iron oxide (E172), propylene glycol, concentrated ammonia solution, potassium hydroxide.

What Candezek Combi looks like and contents of the pack

Candezek Combi, 8 mg + 5 mg, hard capsules: hard gelatin capsules, size 3, white opaque body, dark yellow cap, filled with white or almost white granules.
Candezek Combi, 8 mg + 10 mg, hard capsules: hard gelatin capsules, size 1, white opaque body with black printing "CAN 8", yellow cap with black printing "AML 10", filled with white or almost white granules.
Candezek Combi, 16 mg + 5 mg, hard capsules: hard gelatin capsules, size 1, white opaque body with black printing "CAN 16", light yellow cap with black printing "AML 5", filled with white or almost white granules.
Candezek Combi, 16 mg + 10 mg, hard capsules: hard gelatin capsules, size 1, white opaque body, white opaque cap, filled with white or almost white granules.
Pack sizes: 30, 56, 60, 90, 98, 100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Importer
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice

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

Poland
Candezek Combi
Bulgaria
Candezek Combi
Repido AM

Date of last revision of the leaflet: 02.2025