Candesartan cilexetil + Hydrochlorothiazide
Keep this leaflet, so you can read it again if you need to.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed to a specific person. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
The name of the medicine is Candepres HCT. It is used in adults to treat high blood pressure (hypertension). The medicine contains two active substances: candesartan cilexetil and hydrochlorothiazide, which together lower blood pressure.
Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It causes a decrease in blood vessel tension and their expansion, which helps to lower blood pressure.
Hydrochlorothiazide belongs to a group of diuretic medicines. It helps to remove water and salt (such as sodium) from the body with urine, which helps to lower blood pressure.
A doctor may prescribe Candepres HCT if blood pressure is not properly controlled while taking only candesartan cilexetil or only hydrochlorothiazide (monotherapy).
if the patient is allergicto candesartan cilexetil or hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6);
if the patient is allergic to sulfonamide medicines. In case of doubt, consult a doctor;
if the patient has severe liver diseaseor bile duct narrowing(difficulty in draining bile from the gallbladder);
if the patient has severe kidney problems;
after the 3rd month of pregnancy(it is also recommended to avoid taking Candepres HCT in early pregnancy - see below the section on pregnancy);
if the patient has ever been diagnosed with gout;
if the patient has persistent low potassium levelsin the blood;
if the patient has persistent high calcium levelsin the blood;
if the patient has diabetesor has kidney problemsand is taking a blood pressure-lowering medicine containing aliskiren.
If the patient is unsure whether any of the above applies to them, they should consult a doctor or pharmacist before taking Candepres HCT.
the patient has heart, liver, or kidney problems;
the patient has recently undergone a kidney transplant;
the patient currently has or has recently had severe vomitingor has diarrhea;
the patient has been diagnosed with adrenal gland disease(called Conn's syndrome or primary hyperaldosteronism);
the patient has diabetes;
the patient has been diagnosed with a disease called systemic lupus erythematosus(SLE);
the patient has low blood pressure;
the patient has had a strokein the past;
the patient has had an allergyor asthmain the past;
the patient has had breathing problemsor lung problems(including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient experiences severe shortness of breath or difficulty breathing after taking Candepres HCT, they should seek medical help immediately.
the patient is taking any of the following medicines used to treat high blood pressure:
The doctor may recommend regular checks of kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood. See also the information in the section "When not to take Candepres HCT".
If the patient has any of the above conditions, the doctor may prescribe more frequent check-ups and perform certain tests.
If the patient is to undergo surgery, they should inform their doctor or dentist that they are taking Candepres HCT, as its combination with certain medicines used during general anesthesia may cause excessive lowering of blood pressure.
Candepres HCT may increase the sensitivity of the skin to sunlight.
Candepres HCT should not be used in children and adolescents (under 18 years of age) due to lack of experience in this age group.
If the patient is an athlete and is to undergo a doping test, they should inform their doctor about taking Candepres HCT, as one of its active substances may cause a positive test result.
Candepres HCT may affect the way some medicines work, and other medicines may affect the way Candepres HCT works. If the patient is taking certain medicines, their doctor may need to perform blood tests from time to time.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as your doctor may need to change the dose or recommend other precautions:
ACE inhibitoror aliskiren(see also the information in the section "When not to take Candepres HCT" and "Warnings and precautions");
other blood pressure-lowering medicines, including beta-blockers, aliskiren-containing medicines, diazoxide, and ACE inhibitors, such as enalapril, captopril, lisinopril, or ramipril;
medicines that regulate heart rhythm (anti-arrhythmic medicines), such as digoxin and beta-blockers;
non-steroidal anti-inflammatory medicines (NSAIDs), such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines used to treat pain and inflammation);
aspirin (in doses greater than 3 g per day), a medicine used to treat pain and inflammation;
potassium supplements or salt substitutes containing potassium (medicines that increase potassium levels in the blood);
heparin (a blood thinner);
diuretic medicines;
lithium (a medicine used to treat mental disorders);
medicines whose effects may be influenced by potassium levels in the blood, such as certain antipsychotic medicines;
medicines used to lower cholesterol levels, such as colestyramine or colestipol (resin medicines that lower fat levels);
calcium or vitamin D supplements;
anticholinergic medicines, such as atropine and bipiperidine;
amantadine (a medicine used to treat Parkinson's disease or severe viral infections);
barbiturates (a group of sedative medicines, also used to treat epilepsy);
medicines used to treat cancer;
corticosteroids, such as prednisolone;
adrenocorticotropic hormone (ACTH);
antidiabetic medicines (in tablet or insulin form);
laxatives;
amphotericin (a medicine used to treat fungal infections);
carbenoxolone (a medicine used to treat esophageal or stomach disease);
penicillin or cotrimoxazole, also known as trimethoprim with sulfamethoxazole (antibiotics);
cyclosporine, a medicine used to prevent organ rejection;
other medicines that may enhance the blood pressure-lowering effect, such as baclofen (a muscle relaxant), amifostine (used to treat cancer), and certain antipsychotic medicines.
Candepres HCT can be taken with or without food.
If the patient is taking Candepres HCT, they should consult their doctor before consuming alcohol. Alcohol may cause dizziness or fainting.
Pregnancy
their doctor.The doctor will usually advise the patient to stop taking Candepres HCT before becoming pregnant or as soon as pregnancy is confirmed and recommend taking another medicine instead. It is not recommended to take Candepres HCT in early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may harm the fetus.
Breastfeeding
If the patient is breastfeeding or plans to breastfeed, they should inform their doctor. Candepres HCT is not recommended during breastfeeding, so doctors may recommend alternative treatment for patients who want to breastfeed (especially newborns or premature babies).
Some patients taking Candepres HCT may experience drowsiness or dizziness. In such cases, they should not drive vehicles, use any tools, or operate any machines.
If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".
This medicine should always be taken as directed by the doctor. In case of doubt, consult a doctor or pharmacist. It is important to take Candepres HCT every day.
The recommended dose of Candepres HCT is one tablet once a day.
The tablet should be swallowed with water.
Try to take the medicine at the same time every day. This makes it easier to remember to take the medicine.
In case of taking a larger amount of Candepres HCT than recommended, contact a doctor or pharmacist immediately.
Do not take a double dose to make up for a missed dose. Take the next tablet at the usual time.
If the patient stops taking Candepres HCT, their blood pressure may rise again.
Therefore, do not stop taking the medicine without consulting a doctor.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.
Like all medicines, Candepres HCT can cause side effects, although not everybody gets them.
It is important for the patient to know that these side effects are possible. Some of them may be caused by candesartan cilexetil, and some by hydrochlorothiazide.
difficulty breathing with swelling of the face, lips, tongue, and (or) throat, with or without such swelling;
swelling of the face, lips, tongue, and (or) throat, which may cause difficulty swallowing;
severe skin itching (with hives).
Also, stop the medicine and seek medical help immediately if the patient experiences
acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).
This side effect is very rare (may occur less often than in 1 in 10,000 people).
Candepres HCT may cause a decrease in the number of white blood cells. This may lead to a weakened immune system and an increased risk of infection, as well as fatigue, infection, or fever. In such cases, consult a doctor. The doctor may recommend blood tests to check if Candepres HCT has caused changes in blood composition (agranulocytosis).
Other possible side effects:
Common(may occur in less than 1 in 10 people)
Changes in blood test results:
Uncommon(may occur in less than 1 in 100 people)
Low blood pressure, which may cause dizziness or fainting.
Lack of appetite, diarrhea, constipation, stomach upset.
Skin rash, hives, sun-induced skin rash.
Rare(may occur in less than 1 in 1,000 people)
Jaundice (yellowing of the skin or whites of the eyes). In such cases, consult a doctor immediately.
Affecting kidney function, especially in patients with kidney problems or heart failure.
Sleep disorders, depression, restlessness.
Tingling or numbness in the hands or feet.
Temporary blurred vision.
Heart rhythm disorders.
Breathing difficulties (including pneumonia or fluid accumulation in the lungs).
High fever (fever).
Pancreatitis, which causes moderate or severe abdominal pain.
Muscle cramps.
Blood vessel damage, which causes red or purple spots on the skin.
Decreased number of red or white blood cells or platelets, with possible fatigue, infection, fever, or easy bruising.
Severe, rapidly developing rash with blistering or peeling of the skin, as well as possible blistering in the mouth.
Very rare(may occur in less than 1 in 10,000 people)
Swelling of the face, lips, tongue, and (or) throat.
Itching.
Back pain, joint pain, and muscle pain.
Changes in liver function, including hepatitis. Possible symptoms include fatigue, yellowing of the skin and whites of the eyes, and flu-like symptoms.
Cough.
Nausea.
Frequency not known(cannot be estimated from available data)
Sudden short-sightedness.
Vision loss or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma).
Systemic lupus erythematosus (an allergic disorder that causes fever, joint pain, rash, e.g., redness, blistering, peeling of the skin, and lump formation).
Malignant skin tumors and lip tumors (non-melanoma skin cancer).
If side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
Store in the original packaging to protect from 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.
Tablets 32 mg + 12.5 mg
Tablets 32 mg + 25 mg
Tablets 32 mg + 12.5 mg
Light brown, speckled, oblong, biconvex tablet with the symbol ‘32’ embossed on one side and a score line on both sides.
Tablets 32 mg + 25 mg
Brown-red, speckled, oblong, biconvex tablet with the symbol ‘H 32’ embossed on one side and a score line on both sides.
The score line on the tablet is only to facilitate breaking and does not allow for division into equal doses.
Aluminum/Aluminum blister pack with a desiccant, in a cardboard box.
Pack sizes: 28, 30, 56, 60, or 90 tablets.
Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Salutas Pharma GmbH
Otto-von-Guericke Allee 1,
39179 Barleben, Germany
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:02/2022
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