Candepres Hct

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Candepres HCT(Candesartan cilexetil/Hydrochlorothiazide Sandoz)

16 mg + 12.5 mg, tablets

Candesartan cilexetil + Hydrochlorothiazide
Candepres HCT and Candesartan cilexetil/Hydrochlorothiazide Sandoz are different trade names
for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

You should keep this leaflet, so that you can read it again if necessary.
In case of any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may
harm another person, even if the symptoms of their illness are the same.
If the patient experiences any side effects, including any side effects 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 package and other information

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

The medicine is called Candepres HCT. It is used in adult patients 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
the 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.
The doctor may prescribe Candepres HCT if the blood pressure is not properly controlled when 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 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;
if the patient is pregnant for more than 3 months (it is also recommended to avoid taking Candepres HCT in early pregnancy - see below under pregnancy);
if the patient has ever had gout;
if the patient has persistently low potassium levels;
if the patient has persistently high calcium levels;
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 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;
in the past, the patient has experienced breathing problemsor lung problems(including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If, after taking Candepres HCT, the patient experiences severe shortness of breath or difficulty breathing, they should seek medical help immediately.
the patient is taking any of the following medicines used to treat high blood pressure:

• ACE inhibitor(e.g. 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 accumulation of fluid between the choroid and sclera) or increased pressure inside the eye - they may occur within a few hours to weeks after taking Candepres HCT, and if left untreated, may lead to permanent vision loss. The risk of developing such disorders may be higher in patients who have previously been allergic to penicillin or sulfonamides; the patient is pregnant or thinks she 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 below under 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 above conditions, 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 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 taking, have recently taken, or plan to take.

The patientshould especially tell their doctor or pharmacist if they are taking any of the following medicines, 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 medicines, including beta-blockers, aliskiren, 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);
acetylsalicylic acid (in a dose 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 type of sedative used to treat insomnia or epilepsy);
medicines used to treat cancer;
corticosteroids, such as prednisolone;
adrenocorticotropic hormone (ACTH);
oral hypoglycemic medicines or insulin;
laxatives;
amphotericin (a medicine used to treat fungal infections);
carbenoxolone (a medicine used to treat esophageal or peptic ulcer 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 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 is pregnant or thinks she may be pregnant, she must inform her doctor.

The doctorwill 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, she should inform her 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 using machines

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

Candepres HCT contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact 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 the medicine is considered "sodium-free".

3. How to take Candepres HCT

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. It is important to take Candepres HCT every day.
Candepres HCT is available in a dose of 8 mg + 12.5 mg and 16 mg + 12.5 mg.
The recommended dose of Candepres HCT is one tablet once a day.
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

In case of taking more Candepres HCT than recommended, the patient should immediately contact their doctor or pharmacist.

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 rise 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 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 medicine 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 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 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, 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, 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, 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, the patient should contact their doctor immediately.
Affecting kidney function, especially in patients with kidney problems or heart failure.
Sleep disorders, depression, restlessness.
Tingling or prickling sensation 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.
Damaged blood vessels, which cause 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. This may cause symptoms such as 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 accumulation of fluid 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).
Skin cancer and lip cancer (non-melanoma skin cancer).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell 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 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
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Candepres HCT

This 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 a temperature below 25°C. Store in the original package 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 package and other information

What Candepres HCT contains

• The active substances of the medicine are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• Other ingredients are: lactose monohydrate, corn starch, povidone K 30, carrageenan, sodium croscarmellose, magnesium stearate, red iron oxide (E 172), and yellow iron oxide (E 172).

What Candepres HCT looks like and what the package contains

Apricot-colored, speckled, 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.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Sandoz B.V.
Veluwezoom 22
1327 AH Almere
Netherlands

Manufacturer:

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava
Slovenia
LEK S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Netherlands marketing authorization number: RVG 102913
Parallel import authorization number: 100/24

Date of leaflet approval: 13.03.2024

[Information about the trademark]