Candepres Hct

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Candepres HCT (Candesartan/HCT 1A Pharma)

32 mg + 12.5 mg, tablets

Candesartan cilexetil + Hydrochlorothiazide
Candepres HCT and Candesartan/HCT 1A Pharma are different trade names for the same medicine.

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

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given 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, pharmacist, or nurse. 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 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 a decrease in blood vessel tension and their dilation, which helps to lower blood pressure.
• Hydrochlorothiazide belongs to a group of diuretic medicines. It helps to remove water and salts (such as sodium) from the body with urine, which helps to lower blood pressure.

The doctor may recommend taking 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 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, the doctor should be consulted;
• if the patient has severe liver diseaseor bile duct narrowing(difficulty in draining bile from the gallbladder);
• if the patient has severe kidney problems;

Page 1 of 7

• 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 their 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 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;
• in the past, the patient has had breathing or 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 for high blood pressure:
• ACE inhibitor(such as enalapril, lisinopril, ramipril), especially if the patient has diabetic kidney disease
• aliskiren
• in the past, the patient has had skin canceror 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). During treatment with Candepres HCT, the patient should protect their skin from sunlight and UV radiation;
• the patient has experienced 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 such 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 can harm the fetus (see below 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" and "Warnings and precautions". If the patient has any of the above conditions, the doctor may order more frequent check-ups and tests. If the patient is to undergo surgery, they should inform their doctor or dentist about taking Candepres HCT, as its combination with certain medicines used during general anesthesia may cause excessive lowering of blood pressure. Page 2 of 7

Children and adolescents

Candepres HCT should not be taken by 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 of the medicine and/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-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);
• acetylsalicylic acid (in a dose greater than 3 g per day), a medicine used to treat pain and inflammation;
• potassium supplements or potassium-sparing diuretics (medicines that increase the amount of potassium in the blood);
• heparin (a blood-thinning medicine);
• 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 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.

Page 3 of 7

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 (or may have become pregnant), she must inform her 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 can 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 their baby (especially a newborn or premature baby).

Driving and using machines

Some patients taking Candepres HCT may feel tired or dizzy. In such cases, they should not drive vehicles, use any tools, or operate any 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 doctor or pharmacist should be consulted. 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. The patient should try to take the medicine at the same time every day. This makes it easier to remember to take the medicine. Candepres HCT is available in a dose of (32 mg + 12.5 mg) and (32 mg + 25 mg).

Taking a higher dose of Candepres HCT than recommended

If the patient has taken 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. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist. Page 4 of 7

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 are possible. 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 immediately and seek medical help:

• 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 itching of the skin (with raised bumps on the skin).

The patient should also stop taking the medicine immediately and seek medical help if they experienceacute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion). This side effect is very rare (it 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 the patient may experience fatigue, infection, or fever. In such cases, the patient should contact 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 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 fainting or dizziness.
• Lack of appetite, diarrhea, constipation, stomach upset.
• Skin rash, hives, sun-related 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.
• Numbness or tingling in the hands or feet.
• Temporary blurred vision.
• Heart rhythm disorders.
• Breathing difficulties (including pneumonia or fluid accumulation in the lungs).
• High temperature (fever).
• Pancreatitis, which causes moderate or severe abdominal pain.

Page 5 of 7

• Muscle cramps.
• Vascular 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. 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 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).
• Malignant skin tumors and lip tumors (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, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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 packaging. The expiry date refers to the last day of the month stated.

Translation of some entries on the blister pack:

Ch.-B.:/Verwendbar bis: see imprint – batch number/expiry date – see embossing. 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

Page 6 of 7

What Candepres HCT contains

• Active substancesof the medicine are 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 (E 172), red iron oxide (E 172), black iron oxide (E 172), corn starch, povidone K 30, carrageenan (E 407), croscarmellose sodium, and magnesium stearate.

What Candepres HCT looks like and contents of the pack

Light brown, speckled, oblong, biconvex tablet with the symbol '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 blisters with a desiccant, in a cardboard box. For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Austria, the country of export:

1A Pharma GmbH, Jakov-Lind-Straße 5, Top 3.05, 1020 Vienna, Austria

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź Austrian marketing authorization number, in the country of export: 1-31805

Parallel import authorization number: 4/23 Date of leaflet approval: 11.01.2023

[Information about the trademark]
Page 7 of 7