Candepres Hct

Leaflet attached to the packaging: patient information

Candepres HCT, 32 mg + 12.5 mg, tablets

Candepres HCT, 32 mg + 25 mg, tablets

Candesartan cilexetil + Hydrochlorothiazide

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.
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.

Table of contents of the leaflet:

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

1. What is Candepres HCT and what is it used for

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 blood vessels to relax and widen, which helps to lower blood pressure.
Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps to remove excess water and salt (such as sodium) from the body in the urine, which helps to lower blood pressure.
A doctor may prescribe Candepres HCT if blood pressure is not adequately controlled with candesartan cilexetil or hydrochlorothiazide alone (monotherapy).

2. Important information before taking Candepres HCT

When not to take Candepres HCT

if the patient is allergicto candesartan cilexetil or hydrochlorothiazide or 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 obstruction(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 section on pregnancy);
if the patient has ever had 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 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.

Warnings and precautions

Before starting treatment with Candepres HCT, the patient should discuss it with their doctor or pharmacist if:

the patient has heart, liver, or kidney problems;
the patient has recently undergone a kidney transplant;
the patient is currently experiencing or has recently experienced 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 experienced 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:

• ACE inhibitor(such as enalapril, lisinopril, ramipril), especially if the patient has diabetic kidney disease
• aliskirenif the patient has had malignant skin cancerin the past or if an unexpected skin changeoccurs during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). When taking Candepres HCT, the patient should protect their skin from sunlight and UV radiation; if the patient experiences vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure inside the eye - they can occur within a few hours to weeks after taking Candepres HCT and, if left untreated, can lead to permanent vision loss. The risk of developing these disorders may be higher in patients who have previously been allergic to penicillin or sulfonamides; the patient is pregnant or plans to become pregnant.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 (see also the section on pregnancy).

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 recommend more frequent check-ups and 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.

Children and adolescents

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 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.

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, the patient should mention if they are taking any of the following medicines, as their 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, diazoxide, and ACE inhibitorssuch 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);
diuretics;
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 (resins 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);
cyclosporin, 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 with food, drink, and alcohol

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 and breastfeeding

Pregnancy

If the patient suspects that they are pregnant (or may have become pregnant), they must inform

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 a different 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 the doctor may recommend a different treatment for patients who want to breastfeed their baby (especially newborns or premature babies).

Driving and using machines

Some patients taking Candepres HCT may experience drowsiness or dizziness. In such cases, they should not drive vehicles, operate any tools, or use any machines.

Candepres HCT contains lactose

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

Candepres HCT contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free).

3. How to take Candepres HCT

This medicine should always be taken as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist. It is important to take Candepres HCT every day.
The recommended dose of Candepres HCT is one tablet once daily.
The tablet should be swallowed with water.
The patient should try to take the medicine at the same time every day. This makes it easier to remember to take the medicine.

Taking a higher dose of Candepres HCT than recommended

If the patient takes more Candepres HCT than recommended, they should contact their doctor or pharmacist immediately.

Missing a dose of Candepres HCT

The patient should not take a double dose to make up for a missed dose. They should take the next tablet at the usual time.

Stopping treatment with Candepres HCT

If the patient stops taking Candepres HCT, their blood pressure may increase again.
Therefore, the patient should not stop taking the medicine without consulting their doctor.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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 can occur. Some of them may be caused by candesartan cilexetil, and some by hydrochlorothiazide.

If the patient experiences any of the following allergic reactions, they should stop taking Candepres HCT and seek medical help immediately:

difficulty breathing with swelling of the face, lips, tongue, and/or throat, with or without hives;
swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing;
severe itching of the skin (with hives).
The patient should also stop taking the medicine and seek medical help immediately if they experience
acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).
This side effect is very rare (may occur less frequently than in 1 in 10,000 people).
Candepres HCT may cause a decrease in the number of white blood cells. This can lead to a weakened immune system and an increased risk of infection, as well as fatigue, infection, or fever. In such cases, the patient should consult their doctor. The doctor may recommend blood tests to check if Candepres HCT has caused changes in the blood count (agranulocytosis).
Other possible side effects:
Common(may occur in less than 1 in 10 people)
Changes in blood test results:

• decreased sodium levels in the blood. If this is significant, the patient may experience weakness, lack of energy, or muscle cramps.
• increased or decreased potassium levels in the blood, especially in patients with kidney problems or heart failure. If these disorders are significant, the patient may experience fatigue, weakness, irregular heartbeat, or tingling.
• increased cholesterol, sugar, or uric acid levels in the blood. Presence of sugar in the urine. Feeling of dizziness or weakness. Headache. Respiratory tract infection.

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, photosensitivity reaction.
Rare(may occur in less than 1 in 1,000 people)
Jaundice (yellowing of the skin or whites of the eyes). In such cases, the patient should contact their doctor immediately.
Affecting kidney function, especially in patients with kidney problems or heart failure.
Sleep disturbances, depression, restlessness.
Numbness or tingling in the hands or feet.
Transient blurred vision.
Heart rhythm disturbances.
Breathing difficulties (including pneumonia or fluid accumulation in the lungs).
High temperature (fever).
Pancreatitis, which causes moderate or severe abdominal pain.
Muscle cramps.
Vascular damage, which causes red or purple spots on the skin.
Decreased number of red or white blood cells or platelets, which may cause 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. This may cause fatigue, yellowing of the skin and whites of the eyes, and flu-like symptoms.
Cough.
Nausea.
Frequency not known(cannot be estimated from the 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., with redness, blistering, peeling of the skin, and lump formation).
Malignment skin tumors and lip tumors (non-melanoma skin cancer).

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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.

5. How to store Candepres HCT

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 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Candepres HCT contains

Tablets 32 mg + 12.5 mg

• Active substancesare candesartan cilexetil and hydrochlorothiazide. Each tablet contains 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• Other ingredients are: lactose monohydrate, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), cornstarch, povidone K30, carrageenan, sodium croscarmellose, and magnesium stearate.

Tablets 32 mg + 25 mg

• Active substancesare candesartan cilexetil and hydrochlorothiazide. Each tablet contains 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.
• Other ingredients are: lactose monohydrate, red iron oxide (E172), black iron oxide (E172), titanium dioxide (E171), cornstarch, povidone K30, carrageenan, sodium croscarmellose, and magnesium stearate.

What Candepres HCT looks like and contents of the pack

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 carton.
Packaging contains 28, 30, 56, 60, or 90 tablets.

Marketing authorization holder and manufacturer

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.
Domaniewska 50 C
02-672 Warsaw

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, the patient should contact:

Sandoz Polska Sp. z o.o.
Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:02/2022
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