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 + 25 mg, tablets
Candesartanum cilexetili + Hydrochlorothiazidum
Candepres HCT and Candesartan/HCT 1A Pharma are different trade names for the same medicine.
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, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Candepres HCT is and what it is 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 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
arterial 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 vascular tone and causes blood vessels 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 the urine, which helps lower blood pressure.

Your doctor may recommend using Candepres HCT if your blood pressure is not adequately
controlled with 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-type drugs. If in 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;

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• after the 3rd month of pregnancy (it is also better to avoid using Candepres HCT in early pregnancy – see section below on pregnancy);
• if the patient has ever had 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 a doctor or pharmacist if:

• the patient has cardiac, hepatic or renal dysfunction;
• the patient has recently undergone kidney transplantation;
• the patient is currently experiencing or has recently had severe vomiting or has diarrhea;
• the patient has been diagnosed with an adrenal disorder (called 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 had a stroke;
• the patient has previously had allergy or bronchial asthma;
• in the past, after taking hydrochlorothiazide, the patient experienced breathing problems or lung problems (including pneumonia or fluid accumulation in the lungs). If the patient develops severe shortness of breath or difficulty breathing after taking Candepres HCT, immediate medical help must be sought.
• the patient is taking any of the following medicines used to treat 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 if unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, especially at high doses over a prolonged period, may increase the risk of certain types of skin and lip cancers (non-melanoma skin cancer). While taking Candepres HCT, the skin should be protected from sunlight and UV radiation;
• the patient experiences visual disturbances or eye pain. These may be symptoms of fluid accumulation in the uvea (the vascular layer surrounding the eye) or increased intraocular pressure – they may occur from a few 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 to become pregnant. Use of Candepres HCT is not recommended in early pregnancy and must not be used after the 3rd month of pregnancy, as it may severely harm 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 conditions listed above, the doctor may recommend more frequent check-ups and certain tests.
If the patient is to undergo surgery, they should inform the doctor or dentist about taking Candepres HCT, as combining it with certain anesthetics 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 substances may cause a positive test result.
Candepres HCT and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient 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 antihypertensive medicines, including beta-blockers, medicines containing aliskiren, diazoxide, and angiotensin-converting enzyme (ACE) inhibitors such as enalapril, captopril, lisinopril or ramipril;
• antiarrhythmic medicines (drugs regulating heart rhythm), 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 increasing potassium levels in blood);
• 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;
• cholesterol-lowering medicines, such as colestipol or cholestyramine (resin-type medicines reducing lipid levels);
• calcium or vitamin D supplements;
• 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 or insulin);
• laxatives;
• amphotericin (a medicine used to treat fungal infections);
• carbenoxolone (a medicine used to treat esophageal or peptic ulcer disease);
• penicillin or co-trimoxazole, 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 can 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 might be pregnant), she must inform her doctor. The doctor will usually advise discontinuing Candepres HCT before pregnancy or immediately after pregnancy is confirmed and recommend an alternative medicine. Use of Candepres HCT is not recommended in early pregnancy and must not be used after the 3rd month of pregnancy, as it may severely harm the unborn child.
Breastfeeding
If the patient is breastfeeding or planning 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, driving, using tools, or operating machinery should be avoided.
Candepres HCT contains lactose monohydrate
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 use Candepres HCT

This medicine should always be taken as directed by the physician. In case of doubts, contact the
physician or pharmacist. It is important to take Candepres HCT every
day. The recommended dose of Candepres HCT is one tablet daily.
The tablet should be swallowed with water.
Try to take the medicine at the same time each day. This makes it easier to remember to take the 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 more Candepres HCT has been taken than recommended, contact a physician 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 discontinue use of the medicine without consulting the physician.
If you have any further questions about the use of this medicine, consult your
physician 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 allergic reactions listed below 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 skin itching (with raised skin rashes).

You should also stop taking the medicine immediately and seek medical help if the patient
experiences 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 the number of white blood cells. This may lead to weakened
immunity against infections, as well as 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 concentration in the blood. If this is significant, the patient may experience weakness, lack of energy or muscle cramps.
  • increased or decreased potassium concentration in the blood, especially in patients with impaired kidney function or heart failure. If these disorders are significant, the patient may experience fatigue, weakness, irregular heartbeat or tingling.
  • increased concentration 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 fainting 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 prickling in the hands or feet.
• Temporary blurred vision.
• Heart rhythm disorders.
• Breathing difficulties (including pneumonia, fluid in the lungs).
• High temperature (fever).
• Pancreatitis, which causes 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, possibly leading to fatigue, 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 occur in fewer than 1 in 10,000 people)

• Swelling of the face, lips, tongue and (or) throat.
• Itching.
• Back pain, joint and muscle pain.
• Liver function abnormalities, 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 uvea surrounding the eye – excessive fluid buildup between the choroid and sclera – or acute angle-closure glaucoma).
• Systemic and cutaneous lupus erythematosus (an allergic disorder causing fever, joint pain, rash, e.g. 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, tell your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of 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, more information on the safety of this medicine 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: see imprint – batch number/expiry date – see imprint.
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 in use. This will help protect the environment.

6. Contents of the pack and other information

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What Candepres HCT contains

• The active substances are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.
• The other ingredients are: monohydrate lactose, 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
Reddish-brown, mottled, elongated, biconvex tablet with the imprint 'H 32' on one side and a break line on both sides.
The break line on the tablet is intended only to facilitate crushing for easier swallowing and does not allow division into equal doses.
Al/Al blisters with a desiccant, in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Austria, 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, Poland
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Austrian marketing authorization number, country of export: 1-31806
Parallel import authorization number: 5/23
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