Candepres hct

Package leaflet: Information for the patient

Caution! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Candepres HCT (Candesartancilexetil/Hydrochloorthiazide Sandoz 16/12.5 mg)
16 mg + 12.5 mg, tablets
Candesartanum cilexetili + Hydrochlorothiazidum
Candepres HCT and Candesartancilexetil/Hydrochloorthiazide Sandoz 16/12.5 mg are different
brand 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 to be able to read it again if needed.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same as yours.
• 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 package and other information

1. What Candepres HCT is and what it is used for

This medicine is called 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 blood vessel tension and causes blood vessels to widen, helping to 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 candesartan cilexetil alone or hydrochlorothiazide alone
(monotherapy).

2. Important information before taking Candepres HCT

When NOT TO USE Candepres HCT

• if the patient is allergic to candesartan cilexetil, hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to sulfonamide medicines. 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 kidney impairment;
• if the patient is more than 3 months pregnant (it is also advisable to avoid using Candepres HCT in early pregnancy – see section on pregnancy below);
• 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 kidney 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 heart, liver, or kidney function disorders;
• the patient has recently undergone a kidney transplant;
• the patient is currently experiencing or has recently experienced severe vomiting or diarrhea;
• the patient has been diagnosed with an adrenal gland 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 had allergies or bronchial asthma in the past;
• the patient has previously experienced breathing problems or lung issues (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or breathing difficulties 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 long 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 vision disturbances or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive accumulation of fluid between the choroid and sclera) or increased intraocular pressure – these 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 an allergy to penicillin or sulfonamides;
• the patient suspects she is pregnant (or may have become pregnant). Use of 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 (see section on pregnancy below).

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.

Candepres HCT may increase skin sensitivity to sunlight.

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

Candepres HCT and other medicines

Tell your 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 the doctor if the patient is 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 (in doses exceeding 3 g daily), a medicine used to treat pain and inflammation;
• potassium supplements or potassium-containing salt substitutes (medicines increasing blood potassium levels);
• heparin (an anticoagulant);
• 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 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 type of sedative used also in epilepsy treatment);
• medicines used to treat cancer;
• 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 disease or peptic ulcer);
• penicillin or cotrimoxazole, also known as trimethoprim with sulfamethoxazole (antibiotics);
• cyclosporine, a medicine used to prevent organ transplant rejection;
• other medicines that may enhance antihypertensive effects, such as baclofen (a muscle relaxant), amifostine (used in cancer treatment), and certain antipsychotics.

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 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 will 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 planning to breastfeed, she should inform her doctor. Candepres HCT is not recommended during breastfeeding; therefore, the doctor may recommend alternative treatment for patients who wish to breastfeed (especially newborns or premature infants).

Driving and operating machinery

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

Candepres HCT contains lactose monohydrate

If the patient has been diagnosed with intolerance to certain 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, meaning it is considered "sodium-free".

3. How to use Candepres HCT

This medicine should always be taken as prescribed by the doctor. If in doubt, consult a
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 makes it easier to remember to
take the medicine.
Taking more than the recommended dose of Candepres HCT
If more Candepres HCT has been taken than prescribed, contact a 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 discontinue use of this medicine without consulting a doctor.
If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse effects

Like any medicine, 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 the medicine 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).

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 decrease in the number of white blood cells. This may weaken the patient's
resistance to infection, with possible occurrence of fatigue, infection or fever. In such a case, contact a
doctor. The doctor may occasionally perform a blood test to check whether Candepres HCT has caused
any blood changes (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 feel weak, lack energy or experience 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 feel 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 fainting or dizziness.
• Loss of appetite, diarrhoea, constipation, stomach irritation.
• Skin rash, urticaria, rash due to photosensitivity.

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 a doctor immediately.
• Effects on kidney function, especially in patients with impaired kidney function or heart failure.
• Sleep disorders, depression, restlessness.
• Tingling or pricking sensations in the hands or feet.
• Short-term 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.
• 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, including possible blistering 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.
• 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 uvea surrounding the eye – excessive fluid accumulation 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. 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 a doctor,
pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse
Drug Reactions, 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 can be collected.

5. How to store Candepres HCT

This medicine should be stored in a place inaccessible and out of sight 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.
Store below 25°C. Keep 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

What Candepres HCT contains

• 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, maize starch, povidone K 30, carrageenan (E 407), sodium croscarmellose, magnesium stearate, iron oxide red (E 172) and iron oxide yellow (E 172).

What Candepres HCT looks like and contents of the pack
Pinkish, speckled, oval, biconvex tablets with a division line on both sides.
The division line on the tablet is only intended to facilitate breaking for ease of swallowing and does not ensure equal dose division.
Al/Al blisters with a desiccant, in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in the Netherlands, country of export:
Sandoz B.V.
Hospitaaldreef 29
1315 RC Almere
The Netherlands
Manufacturer:
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia
LEK S.A., Domaniewska 50 C, 02-672 Warsaw, Poland
Salutas Pharma GmbH, Otto-von Guericke Allee 1, 39179 Barleben, Germany
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
Marketing Authorisation number in the Netherlands, country of export: RVG 102913
Parallel Import Authorisation number: 84/21