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

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. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you experience any side effects, including those not listed in this leaflet, tell your 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 pack 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 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. Your doctor may prescribe Candepres HCT if your 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 you are allergic to candesartan cilexetil, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6); if you are allergic to sulfonamide medicines. If in doubt, consult your doctor; if you have severe liver disease or narrowing of the bile duct (obstruction of the bile duct); if you have severe kidney problems; if you are more than 3 months pregnant (it is also better to avoid taking Candepres HCT in early pregnancy - see the section on pregnancy below); if you have ever had gout; if you have low potassium levels in your blood; if you have high calcium levels in your blood; if you have diabetes or kidney problems and are taking aliskiren (see also the information in the sections "When not to take Candepres HCT" and "Warnings and precautions"). If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking Candepres HCT.

Warnings and precautions

Before taking Candepres HCT, discuss with your doctor or pharmacist if:

you have heart, liver, or kidney problems, you have recently had a kidney transplant, you are currently experiencing or have recently experienced severe vomiting or diarrhea, you have been diagnosed with adrenal gland disease (a condition called Conn's syndrome or primary hyperaldosteronism), you have diabetes, you have been diagnosed with a condition called systemic lupus erythematosus (SLE), you have low blood pressure, you have had a stroke, you have had an allergy or asthma, you have had breathing problems or lung problems (including pneumonia or fluid build-up in the lungs) after taking hydrochlorothiazide. If you experience severe shortness of breath or difficulty breathing after taking Candepres HCT, seek medical help immediately. you are taking any of the following medicines for high blood pressure: ACE inhibitors (such as enalapril, lisinopril, ramipril), especially if you have diabetic kidney disease; aliskiren, if you have had skin cancer or if an unexpected skin change occurs 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, protect your skin from sunlight and UV radiation; you have 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; you are pregnant or think you may be pregnant (or may have 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 baby (see also the section on pregnancy below).

• ACE inhibitor or aliskiren (see also the information in the sections "When not to take Candepres HCT" and "Warnings and precautions"); other medicines that lower blood pressure, 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 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 type of sedative, also used to treat epilepsy); medicines used to treat cancer; steroids, such as prednisolone; adrenocorticotropic hormone (ACTH); antidiabetic medicines (oral or insulin); 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.

Your doctor may ask you to have regular checks of your kidney function, blood pressure, and electrolyte levels (such as potassium). See also the information in the section "When not to take Candepres HCT". If you have any of the conditions listed, your doctor may ask you to have more frequent check-ups and tests. If you are going to have surgery, tell your doctor or dentist that you are taking Candepres HCT, as it may interact with some anaesthetics. Candepres HCT may increase your skin's sensitivity 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 you are an athlete and are going to undergo a doping test, inform your doctor that you are taking Candepres HCT, as one of its active substances may cause a positive test result.

Candepres HCT and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.

Candepres HCT may affect the way some medicines work, and some medicines may affect the way Candepres HCT works. If you are taking certain medicines, your doctor may need to monitor your blood from time to time. In particular, tell your doctor if you are taking any of the following medicines, as your doctor may need to change your dose or recommend other precautions: ACE inhibitors or aliskiren (see also the information in the sections "When not to take Candepres HCT" and "Warnings and precautions"); other medicines that lower blood pressure, 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 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 type of sedative, also used to treat epilepsy); medicines used to treat cancer; steroids, such as prednisolone; adrenocorticotropic hormone (ACTH); antidiabetic medicines (oral or insulin); 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.

Candepres HCT with food, drink, and alcohol

Candepres HCT can be taken with or without food. If you are taking Candepres HCT, consult your doctor before consuming alcohol. Alcohol may cause dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or think you may be pregnant (or may have become pregnant), tell your doctor.

Your doctor will usually advise you to stop taking Candepres HCT before you become pregnant or as soon as you find out you are pregnant, and will recommend that you take 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 baby. Breastfeeding If you are breastfeeding or plan to breastfeed, tell your doctor. Candepres HCT is not recommended during breastfeeding, so your doctor may recommend a different treatment if you want to breastfeed your baby (especially a newborn or premature baby).

Driving and using machines

Some patients taking Candepres HCT may feel tired or dizzy. If this happens, do not drive, use tools, or operate machinery.

Candepres HCT contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Candepres HCT contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take Candepres HCT

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. It is important to take Candepres HCT every day. The recommended dose of Candepres HCT is one tablet once daily. Swallow the tablet with water. Try to take your medicine at the same time each day. This will help you remember to take your medicine.

Taking more Candepres HCT than prescribed

If you take more Candepres HCT than you should, contact your doctor or pharmacist immediately.

Missing a dose of Candepres HCT

Do not take a double dose to make up for a forgotten dose. Take the next tablet at the normal time.

Stopping treatment with Candepres HCT

If you stop taking Candepres HCT, your blood pressure may increase again. Therefore, do not stop taking your medicine without consulting your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. It is important that you know what these side effects are, as some of them may be serious. Some of these side effects may be caused by candesartan cilexetil, while others may be caused by hydrochlorothiazide.

If you experience any of the following allergic reactions, stop taking the medicine 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). You should also stop taking the medicine and seek medical help immediately if you experience acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion). This side effect is very rare (may occur in less than 1 in 10,000 people). Candepres HCT may cause a decrease in white blood cell count. This may weaken your immune system and make you more likely to get infections, which may be serious. If you experience any of the following, contact your doctor: tiredness, infection, or fever. Your doctor may occasionally perform blood tests to check if Candepres HCT has affected your blood. Other possible side effects:

Common (may affect up to 1 in 10 people)

Changes in blood test results: decreased sodium levels in the blood. If this is severe, you may feel weak, tired, or experience muscle cramps; increased or decreased potassium levels in the blood, especially in patients with kidney problems or heart failure. If these changes are severe, you 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 dizzy or lightheaded. Headache. Respiratory tract infection.

Uncommon (may affect up to 1 in 100 people)

Low blood pressure, which may cause dizziness or fainting. Loss of appetite, diarrhea, constipation, stomach upset. Skin rash, itching, sun-related skin rash.

Rare (may affect up to 1 in 1,000 people)

Jaundice (yellowing of the skin or whites of the eyes). If this happens, contact your doctor immediately. Effects on kidney function, especially in patients with kidney problems or heart failure. Sleep disorders, depression, restlessness. Tingling or numbness in the hands or feet. Temporary blurred vision. Heart rhythm disorders. Breathing difficulties (including pneumonia or fluid build-up in the lungs). High temperature (fever). Pancreatitis, which causes moderate or severe stomach pain. Muscle cramps. Blood vessel damage, which causes red or purple spots on the skin. Decreased red or white blood cell count or platelet count, which may cause tiredness, infection, fever, or easy bruising. Severe, rapidly developing rash with blistering or peeling of the skin, and possibly blisters in the mouth.

Very rare (may affect up to 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. You may experience tiredness, 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). Generalized and skin lupus erythematosus (an allergic disorder that causes fever, joint pain, rash, e.g., with redness, blistering, peeling of the skin, and lump formation). Skin and lip cancer (non-melanoma skin cancer).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Candepres HCT

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Store in a cool, dry place, below 25°C. Store in the original package to protect from moisture. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Candepres HCT contains

Tablets 8 mg + 12.5 mg

• The active substances are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 8 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• The other ingredients are lactose monohydrate, corn starch, povidone K30, carrageenan, sodium croscarmellose, and magnesium stearate.

Tablets 16 mg + 12.5 mg

• The active substances are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• The other ingredients are lactose monohydrate, corn starch, 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 Orange, mottled, oval, biconvex tablets with a score line on both sides. The score line is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses. Blister packs with aluminium/aluminium foil and 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 Warsaw

For more information about this medicine, including its other names in the European Economic Area, contact:

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