Candepres Hct

Package Leaflet: Information for the Patient

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

Candepres HCT (Candesartan/HCT 1A Pharma)

32 mg + 25 mg, tablets

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

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• 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 their symptoms are the same.
• If the patient experiences any side effects, including any 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 pack 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.

The 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 allergic to 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. If in doubt, the doctor should be consulted;
• if the patient has severe liver disease or biliary obstruction (difficulty in draining bile from the gallbladder);
• if the patient has severe kidney problems;

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• after the 3rd month of pregnancy (it is also recommended to avoid taking Candepres HCT in early pregnancy - see below for information on pregnancy);
• if the patient has ever had gout;
• if the patient has persistent low potassium levels in the blood;
• if the patient has persistent high calcium levels in the blood;
• if the patient has diabetes or kidney problems and is taking a blood pressure-lowering medicine that contains 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 treatment with Candepres HCT, the doctor or pharmacist should be consulted if:

• the patient has heart, liver, or kidney problems;
• the patient has recently had a kidney transplant;
• the patient is currently vomiting or has diarrhea;
• the patient has been diagnosed with adrenal gland disease (such as Conn's syndrome or primary hyperaldosteronism);
• the patient has diabetes;
• the patient has ever been diagnosed with a condition called systemic lupus erythematosus (SLE);
• the patient has low blood pressure;
• the patient has had a stroke;
• the patient has had an allergy or asthma;
• the patient has had breathing problems or lung problems (including pneumonia or fluid buildup 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, or ramipril), especially if the patient has diabetic kidney disease
• aliskiren
• the patient has had skin cancer or has had an unexpected skin change 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). While taking Candepres HCT, the patient should protect their skin from sunlight and UV radiation;
• the patient has had vision loss or eye pain. These may be symptoms of fluid buildup in the eye (excessive accumulation of fluid between the choroid and sclera) or increased pressure in the eye - they can occur within 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;
• the patient is pregnant or plans to become pregnant. Candepres HCT is not recommended during pregnancy and should not be taken after the 3rd month of pregnancy, as it may harm the baby (see below for information 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 these 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 anesthetics may cause excessive lowering of blood pressure. Page 2 of 7

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 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.Candepres HCT is not recommended during early pregnancy and should not be taken after the 3rd month of pregnancy, as it may harm the baby. 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 using machines

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

Candepres HCT contains lactose monohydrate

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 essentially "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 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. Candepres HCT is available in doses of (32 mg + 12.5 mg) and (32 mg + 25 mg).

Taking more than the recommended dose of Candepres HCT

If more than the recommended dose of Candepres HCT is taken, the doctor or pharmacist should be consulted immediately.

Missing a dose of Candepres HCT

A double dose should not be taken to make up for a missed dose. The next tablet should be taken at the normal 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 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, 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 and seek medical help immediately 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 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 composition (agranulocytosis). Other possible side effects: Common(may occur in less than 1 in 10 people)

• Changes in blood test results:
• low sodium levels in the blood. If this is severe, the patient may feel weak, tired, or have muscle cramps.
• high or low potassium levels in the blood, especially in patients with kidney problems or heart failure. If these disorders are severe, the patient may feel tired, weak, have irregular heartbeats, or feel numbness.
• high cholesterol, sugar, or uric acid levels in the blood.
• Presence of sugar in the urine.
• Feeling dizzy or lightheaded.
• 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-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 doctor should be consulted 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.
• Temporary blurred vision.
• Heart rhythm disturbances.
• Breathing difficulties (including pneumonia or fluid buildup in the lungs).
• High fever.
• Pancreatitis, which causes moderate or severe abdominal pain.

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• 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 or 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 buildup in 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).
• Malignant skin tumors and lip tumors (non-melanoma skin cancer).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 gathered on the safety of the medicine.

5. How to store Candepres HCT

This medicine should be stored out of sight and reach of children. The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

Translation of some inscriptions on the blister pack:

Ch.-B.:/Verwendbar bis: see embossing - 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 pack and other information

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What Candepres HCT contains

• The active substancesare candesartan cilexetil and hydrochlorothiazide. Each tablet contains 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.
• The other ingredients are:lactose monohydrate, iron oxide red (E 172), iron oxide black (E 172), titanium dioxide (E 171), corn starch, povidone K 30, carrageenan, sodium croscarmellose, and magnesium stearate.

What Candepres HCT looks like and contents of the pack

Red-brown, 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 blisters with a desiccant, in a cardboard box. For more detailed information, the patient should contact the marketing authorization holder or the 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: 1-31806

Parallel import authorization number: 5/23 Date of approval of the leaflet: 11.01.2023

[Information about the trademark] Page 7 of 7