Candepres Hct

Leaflet accompanying the packaging: patient information

Candepres HCT, 8 mg + 12.5 mg, tablets

Candepres HCT, 16 mg + 12.5 mg, tablets

Candesartan cilexetil + Hydrochlorothiazide

It is essential to carefully read the contents of the leaflet before taking the medication, as it contains important information for the patient.

Keep this leaflet, so you can read it again if necessary.
In case of any doubts, consult a doctor or pharmacist.
This medication has been prescribed to a specific person. Do not pass it on to others. The medication 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 inform 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 medication is called Candepres HCT. It is used in adults to treat high blood pressure (hypertension). The medication contains two active substances: candesartan cilexetil and hydrochlorothiazide, which together lower blood pressure.
Candesartan cilexetil belongs to a group of medications called angiotensin II receptor antagonists.
It causes a decrease in blood vessel tension and their dilation, which helps to lower blood pressure.
Hydrochlorothiazide belongs to a group of diuretic medications. It helps to remove water and salts (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 properly controlled while taking only candesartan cilexetil or only hydrochlorothiazide (monotherapy).

2. Important information before taking Candepres HCT

When NOT to take Candepres HCT

if the patient is allergicto candesartan cilexetil, hydrochlorothiazide, or any of the other ingredients of this medication (listed in section 6);
if the patient is allergic to sulfonamide medications. In case of doubts, 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;
if the patient is pregnant for more than 3 months(it is also recommended to avoid taking Candepres HCT in early pregnancy - see below for information on pregnancy);
if the patient has ever been diagnosed with gout;
if the patient has low potassium levelsin the blood;
if the patient has high calcium levelsin the blood;
if the patient has diabetesor kidney problemsand is taking a blood pressure-lowering medication 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 to take 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 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 in the past. 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 medications used to treat high blood pressure:

• ACE inhibitor(such as enalapril, lisinopril, or 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 eye pressure - 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 these disorders may be higher in patients who have previously been allergic to penicillin or sulfonamides; if the patient is pregnant or thinks they may be 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 order regular checks of kidney function, blood pressure, and electrolyte levels (such as potassium) in the patient's blood. See also the information in the section "When not to take Candepres HCT" and "Warnings and precautions".
If the patient has any of the mentioned disorders, the doctor may order more frequent check-ups and perform certain tests.
If the patient is to undergo surgery, they should inform their doctor or dentist about taking Candepres HCT, as its combination with certain medications 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 a 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 medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.

Candepres HCT may affect the way some medications work, and other medications may affect the way Candepres HCT works. If the patient is taking certain medications, the doctor may need to perform blood tests from time to time.
Particularly, the patient should mention if they are taking any of the following medications, as the doctor may need to change the dose or recommend other precautions:
ACE inhibitor or aliskiren (see also the information in the section "When not to take Candepres HCT" and "Warnings and precautions");
other blood pressure-lowering medications, including beta-adrenergic blockers, medications containing aliskiren, diazoxide, and ACE inhibitors, such as enalapril, captopril, lisinopril, or ramipril;
medications that regulate heart rhythm (anti-arrhythmic medications), such as digoxin and beta-adrenergic blockers;
non-steroidal anti-inflammatory medications (NSAIDs), such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medications used to treat pain and inflammation);
acetylsalicylic acid (in doses greater than 3 g per day), a medication used to treat pain and inflammation;
potassium supplements or salt substitutes containing potassium (medications that increase potassium levels in the blood);
heparin (a blood thinner);
diuretic medications;
lithium (a medication used to treat mental disorders);
medications whose effects may be influenced by potassium levels in the blood, such as certain antipsychotic medications;
medications used to lower cholesterol levels, such as colestyramine or colestipol (resins that lower fat levels);
calcium or vitamin D supplements;
anticholinergic medications, such as atropine and bipiperiden;
amantadine (a medication used to treat Parkinson's disease or severe viral infections);
barbiturates (a type of sedative medication also used to treat epilepsy);
medications used to treat cancer;
corticosteroids, such as prednisolone;
adrenocorticotropic hormone (ACTH);
oral hypoglycemic medications or insulin;
laxatives;
amphotericin (a medication used to treat fungal infections);
carbenoxolone (a medication used to treat esophageal or ulcer disease);
penicillin or cotrimoxazole, also known as trimethoprim with sulfamethoxazole (antibiotics);
cyclosporine, a medication used to prevent organ rejection;
other medications that may enhance the blood pressure-lowering effect, such as baclofen (a medication that reduces muscle tension), amifostine (used in cancer treatment), and certain antipsychotic medications.

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 thinks they may be 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 medication 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 (especially newborns or premature babies).

Driving and operating machinery

Some patients may feel tired or dizzy when taking Candepres HCT. In such cases, they should not drive vehicles, use any tools, or operate any machinery.

Candepres HCT contains lactose

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

Candepres HCT contains sodium

The medication 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 medication should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist. It is essential to take Candepres HCT every day.
The recommended dose of Candepres HCT is one tablet per day.
The tablet should be swallowed with water.
Try to take the medication at the same time every day. This way, it will be easier to remember to take the medication.

Taking a higher dose of Candepres HCT than recommended

In case of taking more Candepres HCT than recommended, contact a doctor or pharmacist immediately.

Missing a dose of Candepres HCT

Do not take a double dose to make up for a missed dose. 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, do not stop taking the medication without consulting a doctor.
In case of any further doubts about taking this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Candepres HCT can cause side effects, although not everyone will experience them.
It is essential for the patient to know about the possibility of these side effects. Some of them may be caused by candesartan cilexetil, and some by hydrochlorothiazide.

In case of any of the following allergic reactions, the patient should stop taking the medication and seek medical help immediately:

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 raised skin lesions).
The patient should also stop taking the medication 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 may lead to a weakened immune system, with possible symptoms such as fatigue, infection, or fever.
In such cases, the patient should contact their doctor. The doctor may occasionally perform a blood test to check if Candepres HCT has caused any changes in the blood (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 feel weak, lack energy, or experience 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 feel tired, weak, or experience 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, skin rash due to increased sensitivity to sunlight.

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.
Tingling or prickling sensation in the hands or feet.
Temporary blurred vision.
Heart rhythm disturbances.
Breathing difficulties (including pneumonia or fluid accumulation in the lungs).
High fever.
Pancreatitis, which causes moderate or severe abdominal pain.
Muscle cramps.
Blood vessel damage, which causes the appearance of red or purple spots on the skin.
Decreased number of red or white blood cells or platelets, with possible symptoms such as 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., 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 inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Urzędzie Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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 medication.

5. How to store Candepres HCT

This medication should be stored out of sight and reach of children.
Do not use this medication after the expiration date stated on the carton and blister pack after EXP. The expiration date refers to the last day of the specified month.
Store in a temperature below 25°C. Store in the original packaging to protect from moisture.
Medications should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the packaging and other information

What Candepres HCT contains

Tablets 8 mg + 12.5 mg

• The active substances of the medication are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 8 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• Other ingredients are: lactose monohydrate, cornstarch, povidone K30, carrageenan, sodium croscarmellose, and magnesium stearate.

Tablets 16 mg + 12.5 mg

• The active substances of the medication are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• Other ingredients are: lactose monohydrate, cornstarch, povidone K30, carrageenan, sodium croscarmellose, magnesium stearate, red iron oxide (E172), and yellow iron oxide (E172).

What Candepres HCT looks like and contents of the pack

Tablets 8 mg + 12.5 mg
White, oval, biconvex tablets with a score line on both sides.
Tablets 16 mg + 12.5 mg
Peach-colored, mottled, oval, biconvex tablets with a score line on both sides.
The score line on the tablet is only to facilitate breaking and not to divide into equal doses.
Aluminum/Aluminum foil blisters with a desiccant, in a carton, containing 28, 30, 56, or 60 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.
ul. Domaniewska 50 C
02-672 Warszawa

To obtain more detailed information about the medication and its names in the Member States of the European Economic Area, please contact:

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