Candepres hct

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Candepres HCT (Candesartan/HCT 1A Pharma)
32 mg + 12.5 mg, tablets
Candesartanum cilexetili + Hydrochlorothiazidum
Candepres HCT and Candesartan/HCT 1A Pharma are different trade names for the same medicinal product.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

1. What Candepres HCT is and what it is used for
2. What you need to know 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 Candepres HCT is and what it is used for

The name of the medicine is Candepres HCT. It is used in adult patients for the treatment of 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 reduces the tension in blood vessels and causes them to widen, which helps lower blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps the body eliminate water and salts (e.g., sodium) through urine, which helps lower blood pressure.

Your doctor may prescribe Candepres HCT if your blood pressure is not adequately controlled with either candesartan cilexetil alone or hydrochlorothiazide alone (monotherapy).

2. Important information before taking Candepres HCT

When not to use Candepres HCT

• if the patient has hypersensitivity to candesartan cilexetil or to hydrochlorothiazide, or to any of the other components of this medicine (listed in section 6);
• if the patient has hypersensitivity to sulfonamide medicines. In case of doubt, consult a doctor;
• if the patient has severe liver disease or biliary obstruction (impaired bile drainage from the gallbladder);
• if the patient has severe renal impairment;
• after the 3rd month of pregnancy (it is also advisable to avoid taking Candepres HCT during early pregnancy – see section below on pregnancy);
• if the patient has ever been diagnosed with gout;
• if the patient has persistently low potassium levels in the blood;
• if the patient has persistently high calcium levels in the blood;
• if the patient has diabetes or renal impairment and is taking a blood pressure-lowering medicine containing aliskiren.

If the patient is unsure whether any of the above apply, they should consult a doctor or pharmacist before taking Candepres HCT.

Warnings and precautions

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

• the patient has impaired heart, liver or kidney function;
• the patient has recently undergone a kidney transplant;
• the patient currently has or recently experienced severe vomiting or diarrhoea;
• the patient has been diagnosed with an adrenal gland disorder (such as Conn’s syndrome or primary hyperaldosteronism);
• the patient has diabetes;
• the patient has ever been diagnosed with systemic lupus erythematosus (SLE);
• the patient has low blood pressure;
• the patient has previously suffered a stroke;
• the patient has had a history of allergy or bronchial asthma;
• the patient has previously experienced breathing difficulties or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If severe shortness of breath or breathing difficulties occur after taking Candepres HCT, seek immediate medical help;
• the patient is taking any of the following medicines for high blood pressure:
  • ACE inhibitors (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney disease due to diabetes
  • aliskiren
• the patient has previously had skin cancer or develops an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially in high doses over a prolonged period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking Candepres HCT, protect the skin from sunlight and UV radiation;
• the patient experiences visual disturbances or eye pain. These may be symptoms of fluid accumulation in the uvea (excessive accumulation of fluid between the choroid and sclera) or increased intraocular pressure – these may occur from several hours to weeks after taking Candepres HCT, and if untreated, may lead to permanent vision loss. The risk of such disorders may be higher in patients who previously had hypersensitivity to penicillin or sulfonamides;
• the patient suspects or plans pregnancy. The use of Candepres HCT is not recommended during early pregnancy and must not be taken after the 3rd month of pregnancy, as it may cause severe harm to the unborn child (see section below on pregnancy).

The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also information in the section “When not to use Candepres HCT”.
If the patient has any of the above conditions, the doctor may recommend more frequent check-ups and certain tests.
If the patient is due to undergo surgery, they should inform the doctor or dentist about taking Candepres HCT, as its combination with certain anaesthetics may cause excessive lowering of blood pressure.

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Candepres HCT may increase skin sensitivity to sunlight.

Children and adolescents

Candepres HCT must 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 undergoing anti-doping testing, they should inform the doctor about taking Candepres HCT, as one of its active ingredients may cause a positive doping test result.

Candepres HCT and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Candepres HCT may affect the action of certain medicines, and other medicines may affect the action of Candepres HCT. If the patient is taking certain medicines, the doctor may need to perform periodic blood tests.

Especially inform about taking any of the following medicines, as the doctor may adjust the dose and/or recommend additional precautions:

• ACE inhibitors or aliskiren (see also information in sections “When not to use Candepres HCT” and “Warnings and precautions”);
• other blood pressure-lowering medicines, including beta-blockers, medicines containing aliskiren, diazoxide, and angiotensin-converting enzyme (ACE) inhibitors such as enalapril, captopril, lisinopril or ramipril;
• medicines regulating heart rhythm (antiarrhythmics), such as digoxin and beta-blockers;
• non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines used to treat pain and inflammation);
• acetylsalicylic acid (at doses above 3 g per day), a medicine used to treat pain and inflammation;
• potassium supplements or potassium-containing salt substitutes (medicines that increase blood potassium levels);
• heparin (a blood-thinning medicine);
• diuretics;
• lithium (a medicine used to treat psychiatric disorders);
• medicines whose effects may be influenced by blood potassium levels, such as certain antipsychotics;
• medicines used to lower cholesterol, such as colestipol or cholestyramine (resin-type medicines that reduce lipid levels);
• calcium supplements or vitamin D;
• anticholinergic medicines, such as atropine and biperiden;
• amantadine (a medicine used to treat Parkinson’s disease or severe viral infections);
• barbiturates (a group of sedative medicines also used to treat epilepsy);
• anticancer medicines;
• steroids, such as prednisolone;
• pituitary hormone (ACTH);
• antidiabetic medicines (oral tablets or insulin);
• laxatives;
• amphotericin (a medicine used to treat fungal infections);
• carbenoxolone (a medicine used to treat oesophageal or peptic ulcer disease);
• penicillin or cotrimoxazole, also known as trimethoprim with sulfamethoxazole (antibiotics);
• cyclosporine, a medicine used to prevent rejection of transplanted organs;
• other medicines that may enhance the antihypertensive effect, such as baclofen (a muscle relaxant), amifostine (used in cancer treatment), and certain antipsychotics.

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Candepres HCT with food, drink and alcohol

• Candepres HCT may be taken independently of meals.
• If the patient is taking Candepres HCT, they should consult their doctor before consuming alcohol. Alcohol may cause fainting or dizziness.

Pregnancy and breastfeeding

Pregnancy

If the patient suspects she is pregnant (or may have become pregnant), she must inform her doctor. The doctor will usually advise discontinuing Candepres HCT before conception or immediately after pregnancy is confirmed, and recommend an alternative medicine. Candepres HCT is not recommended during early pregnancy and must not be taken after the 3rd month of pregnancy, as it may severely harm the unborn child.

Breastfeeding

If the patient is breastfeeding or plans to breastfeed, she should inform her doctor. Candepres HCT is not recommended during breastfeeding. Therefore, for women who wish to breastfeed (especially newborns or preterm infants), the doctor may recommend alternative treatment.

Driving and operating machinery

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

Candepres HCT contains monohydrate lactose

If the patient has been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

Candepres HCT contains sodium

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

3. How to take Candepres HCT

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist. 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.
Try to take the medicine at the same time each day. This will make it easier to remember to take your medicine.
Candepres HCT is available in the strengths (32 mg + 12.5 mg) and (32 mg + 25 mg).
Taking more Candepres HCT than recommended
If you take more Candepres HCT than recommended, contact your 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 treatment with Candepres HCT, blood pressure may rise again.
Therefore, do not stop taking this medicine without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
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4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
It is important that the patient is aware of the possibility of these effects occurring. Some of them may be
caused by candesartan cilexetil, and some by hydrochlorothiazide.
If any of the following allergic reactions occur, stop taking Candepres HCT immediately and seek
medical help:

• 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 skin rashes).

The medicine should also be stopped immediately and medical help sought if the patient develops
acute respiratory failure (symptoms include severe shortness of breath, fever, weakness and confusion).
This adverse effect is very rare (may occur in fewer than 1 in 10,000 people).
Candepres HCT may cause a reduction in white blood cell count. This could lead to decreased resistance
to infection and the occurrence of fatigue, infection or fever. In such a case, contact your doctor.
Your doctor may recommend blood tests to check whether Candepres HCT has caused changes in blood
composition (agranulocytosis).
Other possible adverse effects:
Common (may occur in fewer than 1 in 10 people)

• Changes in blood test results:
  • decreased sodium levels in the blood. If this is significant, the patient may experience weakness, lack of energy or muscle cramps.
  • increased or decreased potassium levels in the blood, especially in patients with impaired kidney function or heart failure. If these disturbances are significant, the patient may experience fatigue, weakness, irregular heartbeat or tingling.
  • increased levels of cholesterol, glucose or uric acid in the blood.
• Presence of glucose in the urine.
• Dizziness/spinning sensation or weakness.
• Headache.
• Respiratory tract infection.

Uncommon (may occur in fewer than 1 in 100 people)

• Low blood pressure, which may cause faintness or dizziness.
• Loss of appetite, diarrhoea, constipation, stomach irritation.
• Skin rash, urticaria, photosensitivity rash.

Rare (may occur in fewer than 1 in 1,000 people)

• Jaundice (yellowing of the skin or whites of the eyes). In such a case, contact your doctor immediately.
• Effects on kidney function, especially in patients with impaired kidney function or heart failure.
• Sleep disorders, depression, restlessness.
• Tingling or pricking sensation in the hands or feet.
• Temporary blurred vision.
• Heart rhythm disturbances.
• Breathing difficulties (including pneumonia, presence of fluid in the lungs).
• High temperature (fever).
• Pancreatitis, causing moderate or severe abdominal pain.

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• Muscle cramps.
• Damage to blood vessels causing red or purple spots on the skin.
• Decreased number of red blood cells, white blood cells or platelets, with possible occurrence of fatigue, infection, fever or easy bruising.
• Severe, rapidly developing rash with blistering or peeling of the skin, and possible formation of blisters in the mouth.

Very rare (may occur in fewer 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. Fatigue, yellowing of the skin and whites of the eyes, and flu-like symptoms may occur.
• Cough.
• Nausea.

Frequency not known (cannot be estimated from available data)

• Sudden onset of myopia.
• Visual impairment or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular membrane surrounding the eye – excessive fluid accumulation between choroid and sclera – or acute angle-closure glaucoma).
• Systemic and cutaneous lupus erythematosus (an allergic disorder causing fever, joint pain, rash, e.g. with redness, blistering, skin peeling and nodule formation).
• Malignant skin and lip tumours (non-melanoma skin cancers).

Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your
doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department for Monitoring
Adverse Drug Reactions 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 adverse effects, additional information on the safety of the medicine’s use can be
collected.

5. How to store Candepres HCT

This medicine should be stored out of the 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 stated month.
Translation of some entries found on the blister:
Ch.-B.:/Verwendbar bis: siehe Prägung – batch number/expiry date – see embossing.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

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What Candepres HCT contains

• The active substances in this 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), sodium croscarmellose and magnesium stearate.

What Candepres HCT looks like and contents of the pack
Light brown, speckled, elongated, biconvex tablet with the imprint '32' on one side and a break line on both sides.
The break line is only intended to facilitate tablet fragmentation for easier swallowing and does not allow division into equal doses.
Al/Al blisters with a moisture-absorbing agent, packed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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., Domaniewska 50 C, 02-672 Warsaw, Poland
Parallel importer:
Delfarma Sp. z o.o., Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Austrian marketing authorisation number in the country of export: 1-31805
Parallel import authorisation number: 4/23
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