Candezek combi

Package leaflet: Information for the patient

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
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further 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 identical.
• If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Candezek Combi is and what it is used for
2. What you need to know 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 Candezek Combi is and what it is used for

Candezek Combi contains two active substances: amlodipine and candesartan. Both of these substances help control high blood pressure.
Amlodipine belongs to a group of medicines called "calcium channel blockers". Amlodipine prevents calcium from entering the walls of blood vessels, which helps prevent blood vessel constriction.
Candesartan belongs to a group of medicines called "angiotensin II receptor antagonists". Angiotensin II is produced in the body and causes blood vessels to constrict, thereby increasing blood pressure. Candesartan works by blocking the effects of angiotensin II.
Both substances help prevent blood vessel constriction. As a result, blood vessels relax and blood pressure is lowered.
Candezek Combi is used to treat high blood pressure in patients whose blood pressure is already adequately controlled by taking candesartan and amlodipine separately at the same doses as those contained in Candezek Combi.

2. Important information before taking Candezek Combi

When not to take Candezek Combi

• if the patient is allergic to amlodipine or any other medicines in the group of 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 aortic valve stenosis (narrowing of the heart's aortic valve) or cardiogenic shock (a condition in which the heart is unable to deliver sufficient blood to the body);
• if the patient has heart failure following a previous heart attack;
• if the patient is in the third trimester of pregnancy (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 products containing aliskiren is contraindicated in patients with diabetes or renal impairment (GFR <60 ml/min/1.73 m²).

Warnings and precautions
Before starting treatment with Candezek Combi, consult your doctor or pharmacist if:

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

The doctor may recommend regular monitoring of kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium). See also the section “When not to take Candezek Combi”.
The treating doctor may wish the patient to attend more frequent visits for certain tests if any of the above conditions are present.
If the patient is due to undergo surgery, inform the doctor or dentist that they are taking Candezek Combi. This is important because Candezek Combi, in combination with certain anaesthetics, may cause an excessive drop in blood pressure.
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Candezek Combi, discuss this with the doctor. The doctor will decide on further treatment. Do not make independent decisions to stop taking Candezek Combi.
Inform the doctor if the patient is pregnant, suspects pregnancy, or is planning a pregnancy. Candezek Combi is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if used 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
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Candezek Combi may affect the action of other medicines or other medicines may affect the action of Candezek Combi. These include:

• ketoconazole, itraconazole (antifungal medicines);
• ritonavir, indinavir, nelfinavir (protease inhibitors used in the treatment of HIV infection);
• rifampicin, erythromycin, clarithromycin (antibiotics);
• St John’s wort (Hypericum perforatum);
• verapamil, diltiazem (heart medicines);
• dantrolene (intravenous infusion used in severe disturbances of body temperature);
• simvastatin (a cholesterol-lowering medicine);
• other medicines used to lower blood pressure, including beta-blockers, diazoxide, and
• ACE inhibitors (such as enalapril, captopril, lisinopril or ramipril) or aliskiren (see also information under the headings “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 doses above 3 g per day;
• potassium supplements or salt substitutes containing potassium (medicines that increase blood potassium levels);
• heparin (a medicine used to thin the blood);
• diuretics (water tablets);
• lithium (a medicine used to treat psychiatric disorders);
• tacrolimus, sirolimus, temsirolimus and everolimus (used to control the immune system response, allowing the body to accept a transplanted organ);
• cyclosporine (an immunosuppressive medicine used mainly after organ transplantation to prevent organ rejection).

Taking Candezek Combi with food and drink
Do not drink grapefruit juice or consume grapefruits while taking Candezek Combi. Grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could lead to unpredictable intensification of the blood pressure-lowering effect of Candezek Combi.

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

Pregnancy
If the patient suspects she is pregnant (or is planning a pregnancy), she must inform her doctor. The doctor will most likely recommend discontinuing Candezek Combi before planned conception or immediately after pregnancy is confirmed, and will prescribe an alternative medicine instead of Candezek Combi.
Candezek Combi is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the unborn child if used after this time.

Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk.
Inform the doctor if the patient is breastfeeding or intends to breastfeed. Candezek Combi is not recommended for breastfeeding women. If a woman wishes to breastfeed, the treating doctor may choose an alternative treatment, especially if breastfeeding a newborn or preterm infant.

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

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

3. How to take Candezek Combi

This medicine should always be taken as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
The usual dose is one capsule once daily.
Patients receiving candesartan and amlodipine as separate medicines may instead be given Candezek Combi capsules containing the same active substances in the same doses.
Taking more Candezek Combi than prescribed
Taking too many capsules may cause blood pressure to become low or even dangerously low.
The patient may experience dizziness, lightheadedness, fainting or weakness. If blood pressure drops severely, shock may occur.
The skin may become cold and clammy and the patient may lose consciousness.
Breathlessness due to excess fluid accumulating in the lungs (pulmonary oedema) may occur even within 24–48 hours after taking the medicine.
If too many capsules have been taken, seek medical help immediately.
Missing a dose of Candezek Combi
If the patient forgets to take a capsule, that dose should be skipped completely. Take the next dose at the scheduled time.
Do not take a double dose to make up for a missed dose.
Stopping Candezek Combi
The doctor will inform the patient how long the medicine should be taken. Stopping treatment earlier than advised by the doctor may cause symptoms of the disease to return. Therefore, do not stop taking Candezek Combi without first discussing it with the doctor.
If there are any further doubts about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
If any of the following adverse symptoms occur, stop taking
Candezek Combi immediately and seek medical help 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 severe breathing difficulties;
• severe skin reactions, including severe skin rash, urticaria, redness of the skin all over the body, intense itching, formation of blisters, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome) or other allergic reactions;
• heart attack, heart rhythm disorders;
• pancreatitis, which may cause severe abdominal and back pain, accompanied by a very poor general condition.

Candesartan may cause a reduction in the number of white blood cells. The patient's resistance to infections
may be weakened and fatigue, infection or fever may occur. In such a case, contact your doctor.
Your doctor may order periodic blood tests to check whether Candezek Combi
is affecting your blood composition in any way (agranulocytosis).
Other possible adverse effects
Since Candezek Combi contains two active substances, the reported adverse effects
are associated with both amlodipine and candesartan.
Adverse effects associated with amlodipine
The following adverse effects have been reported. If any of the effects listed below cause problems or persist for longer than one week, contact your doctor.
Very common (may occur in more than 1 in 10 people)

• ankle swelling

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

• headache, dizziness, drowsiness (especially at the beginning of treatment);
• palpitations (awareness of heartbeat), facial flushing;
• abdominal pain, nausea;
• changes in bowel rhythm, diarrhoea, constipation, indigestion;
• fatigue, weakness;
• visual disturbances, double vision;
• muscle cramps.

Uncommon (may occur in up to 1 in 100 people)

• mood swings, anxiety, depression, insomnia;
• tremor, taste disturbances, loss of consciousness;
• tingling in the limbs, loss of pain sensation;
• ringing in the ears;
• low blood pressure;
• sneezing and/or nasal discharge due to inflammation of the nasal mucosa (rhinitis);
• cough;
• dry mouth, vomiting;
• hair loss, excessive sweating, skin itching, red spots on the skin, skin discoloration;
• urinary disorders, increased need to urinate at night, increased frequency of urination;
• inability to achieve erection; discomfort or enlargement of the breasts in men;
• pain, malaise;
• joint or muscle pain, back pain;
• increase or decrease in body weight.

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

• feeling confused.

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

• decrease in the number of white blood cells, decrease in the number of platelets, which may lead to unusual bruising or easier bleeding;
• high blood sugar levels (hyperglycaemia);
• nerve disorders, which may cause weakness, tingling sensations;
• gum swelling;
• abdominal bloating (dyspepsia);
• liver function abnormalities, inflammatory liver disease (hepatitis), yellowing of the skin (jaundice), increased liver enzyme activity, which may affect certain laboratory test results;
• increased muscle tension;
• inflammation of blood vessels, often accompanied by skin rash;
• light sensitivity;
• disorders involving muscle stiffness, tremor and/or movement disorders.

Frequency not known

• tremor, muscle rigidity, mask-like facial expression, slowed movements and shuffling gait, toxic epidermal necrolysis.

Adverse effects associated with candesartan
Common (may occur in up to 1 in 10 people)

• dizziness (feeling of spinning);
• headache;
• respiratory tract infection;
• low blood pressure – this may cause fainting or dizziness;
• changes in blood laboratory test results: increased potassium levels in the blood, especially in patients with existing kidney disorders or heart failure – if the increase is significant, the patient may experience fatigue, weakness, irregular heartbeat or tingling;
• effect on kidney function, particularly in patients with pre-existing kidney disorders or heart failure. In very rare cases, kidney failure may occur.

Very rare (may occur in 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 – fatigue, infection or fever may occur;
• skin rash, nodular rash (urticaria);
• itching;
• back pain, joint and muscle pain;
• changes in liver function, including inflammatory liver disease (hepatitis). Fatigue, yellowing of the skin and whites of the eyes, and flu-like symptoms may occur;
• cough;
• nausea;
• changes in blood laboratory test results;
• decreased sodium levels in the blood. If the decrease is significant, weakness, lack of energy or painful muscle cramps may occur;
• intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Frequency not known (frequency cannot be determined from available data)

• diarrhoea

Reporting of adverse effects
If any adverse effects occur, including any adverse effects
not listed in this leaflet, tell your 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
Tel.: + 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 authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Candezek Combi

Store below 30°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton/blister after: EXP.
The expiry date refers to the last day of the stated 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 help protect the environment.

6. Contents of the packaging and other information

What Candezek Combi contains
The active substances in 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: monohydrate lactose, corn starch, calcium carmellose, macrogol 8000,
hydroxypropylcellulose/type EXF (250–800 cP (for 10% solution)), hydroxypropylcellulose/type LF (65–
175 cP (for 5% solution)), magnesium stearate.
Capsule shell (8 mg + 5 mg, 8 mg + 10 mg): quinoline yellow (E104), iron oxide yellow (E172), titanium
dioxide (E171), gelatin.
Capsule shell (16 mg + 5 mg): quinoline yellow (E104), titanium dioxide (E171), gelatin.
Capsule shell (16 mg + 10 mg): titanium dioxide (E171), gelatin.
Printing ink (8 mg + 10 mg, 16 mg + 5 mg): shellac (E904), iron oxide black (E172), propylene glycol,
concentrated ammonium hydroxide, 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 printed with "CAN 8" in black, yellow cap printed with "AML 10" in black, filled with white or almost white granules.
Candezek Combi 16 mg + 5 mg, hard capsules: hard gelatin capsules, size 1, white opaque body printed with "CAN 16" in black, light yellow cap printed with "AML 5" in black, 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Importer
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice
Poland

This medicinal product is authorised in the member states of the European Economic Area under the following names:
Poland: Candezek Combi
Bulgaria: Candezek Combi
Repido AM