Candezek Combi

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: 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, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, 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 packaging 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 control high blood pressure.
Amlodipine belongs to a group of substances called "calcium channel blockers". Amlodipine prevents calcium from entering the blood vessel walls, which prevents the blood vessels from constricting.
Candesartan belongs to a group of substances called "angiotensin II receptor antagonists".
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 vessel constriction. As a result, the 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 the patient is 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 the patient has very low blood pressure (hypotension);
• if the patient has narrowing of the aortic valve in the heart (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply enough blood to the body);
• if the patient has heart failure after a heart attack;
• if the patient is at least 3 months pregnant (see section: Pregnancy and breastfeeding);
• if the patient has severe liver disease or biliary obstruction (problems with bile flow from the gallbladder);
• concomitant use with aliskiren-containing products is contraindicated in patients with diabetes or with renal impairment (GFR <60 ml min 1.73 m²).< li>

Warnings and precautions

Before starting to take Candezek Combi, the patient should discuss it with their doctor or pharmacist if:

• the patient has recently had a heart attack;
• the patient has heart failure;
• the patient has experienced a sudden increase in blood pressure (hypertensive crisis);
• the patient has low blood pressure (hypotension);
• the patient is elderly and requires a dose increase;
• the patient has liver or kidney problems, or is undergoing dialysis;
• the patient has recently had a kidney transplant;
• the patient is vomiting, has recently had severe vomiting, or has diarrhea;
• the patient has adrenal gland disease, known as Conn's syndrome (also known as primary hyperaldosteronism);
• the patient has had a stroke;
• the patient has taken any of the following medicines for high blood pressure: ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes; or aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the subsection "When not to take Candezek Combi".
The doctor may want the patient to come in for visits more frequently to perform certain tests if the patient has any of the mentioned conditions.
If the patient is to undergo surgery, they should inform their doctor or dentist about taking Candezek Combi. This is important because Candezek Combi, in combination with certain anesthetics, may cause a significant drop in blood pressure.
If the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Candezek Combi, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Candezek Combi on their own.
The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. Candezek Combi is not recommended during early pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the fetus if taken during this period (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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Candezek Combi may affect the action of other medicines or other medicines may affect the action of Candezek Combi. 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 body temperature disorders);
• simvastatin (a 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), in a dose above 3 g per day;
• potassium supplements or salt substitutes containing potassium (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 immune system, allowing the body to accept a transplanted organ);
• cyclosporin (an immunosuppressive medicine used mainly after organ transplantation to prevent organ rejection by the body)

Taking Candezek Combi with food and drink

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
If the patient suspects they are pregnant (or plans to become pregnant), they should tell their doctor. The doctor will likely recommend stopping Candezek Combi before planned pregnancy or as soon as pregnancy is detected and recommend an alternative medicine instead of Candezek Combi.
Candezek Combi should not be taken during early pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the fetus if taken during this period (see section "Pregnancy and breastfeeding").
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk.
The patient should inform their doctor if they are breastfeeding or plan to breastfeed. Candezek Combi is not recommended for breastfeeding women, and if the woman wants to breastfeed, the doctor may choose an alternative treatment, especially in the case of breastfeeding a newborn or premature baby.

Driving and using machines

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

Candezek Combi contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Candezek Combi

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The usual dose is one capsule once a day.
Patients taking candesartan and amlodipine as separate medicines may instead take Candezek Combi capsules containing the same ingredients in the same doses.

Taking a higher dose of Candezek Combi than recommended

Taking too many capsules may cause blood pressure to become too low or even dangerously low.
The patient may feel dizzy, faint, or weak. If the drop in blood pressure is very large, it may lead to shock.
The skin may become cool and moist, and the patient may lose consciousness.
Even up to 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.
In case of taking too many capsules, the patient should seek medical help immediately.

Missing a dose of Candezek Combi

If the patient forgets to take a capsule, they should skip that dose. The next dose should be taken at the scheduled time.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Candezek Combi

The doctor will inform the patient how long to take the medicine. Stopping treatment earlier than recommended by the doctor may cause the symptoms of the disease to return. Therefore, the patient should not stop taking Candezek Combi without first discussing it with their doctor.
In case of further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Candezek Combi can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects, they should stop taking Candezek Combi and seek medical help immediately:

• sudden, wheezing breathing, chest pain, shortness of breath, or difficulty breathing;
• swelling of the eyelids, face, or lips;
• swelling of the tongue and throat, causing severe difficulty 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, arrhythmias;
• pancreatitis, which can cause severe abdominal and back pain, accompanied by very poor general condition.

Candesartan may cause a decrease in the number of white blood cells. The patient's resistance to infections may be weakened, and they may experience fatigue, infection, or fever. In this case, the patient should contact their doctor. The doctor may order periodic blood tests to check if Candezek Combi affects the blood count (agranulocytosis) in any way.

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 persist for more than a week, the patient should contact their 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 beginning 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;
• tremors, taste disturbances, loss of consciousness;
• tingling in the limbs, lack of sensation;
• ringing in the ears;
• low blood pressure;
• rhinitis and (or) nasal congestion;
• 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 condition;
• 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 the number of white or red blood cells, which may lead to unusual bruising or easier bleeding;
• high blood sugar levels (hyperglycemia);
• nerve disorders, which may cause weakness, tingling;
• gum swelling;
• abdominal bloating (gastritis);
• abnormal liver function, including hepatitis (liver inflammation), which may cause fatigue, yellowing of the skin and eyes, and flu-like symptoms;
• increased muscle tension;
• vasculitis, often with accompanying skin rash;
• sensitivity to light;
• disorders affecting muscle stiffness, tremors, and (or) movement disorders.

Frequency not known

• tremors, stiffness, mask-like face, slow movements, and dragging of the feet while walking, 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 fainting or dizziness;
• changes in blood test results: increased potassium levels in the blood, especially if the patient has kidney problems or heart failure - in case of significant increase, the patient may experience fatigue, weakness, irregular heartbeat, or tingling;
• effect 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 the number of red or white blood cells - may cause fatigue, infection, or fever;
• skin rash, urticaria;
• itching;
• back pain, joint or muscle pain;
• changes in liver function, including hepatitis (liver inflammation). 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, it may cause weakness, lack of energy, or painful muscle cramps;
• gastrointestinal angioedema: swelling in the intestine 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 the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Candezek Combi

Store in a temperature below 30°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton/blisters after: EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Candezek Combi contains

The active substances of Candezek Combi 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, equivalent 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, equivalent 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, equivalent 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, equivalent to 13.87 mg of amlodipine besylate.
Other ingredients are: lactose monohydrate, cornstarch, calcium carmellose, macrogol 8000, hydroxypropylcellulose/EXF type (250-800 cP (for a 10% solution)), hydroxypropylcellulose/LF type (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