Candepres hct

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Candepres HCT (Candesartan cilexetil/Hydrochlorothiazide Sandoz)
16 mg + 12.5 mg, tablets
Candesartanum cilexetili + Hydrochlorothiazidum
Candepres HCT and Candesartan cilexetil/Hydrochlorothiazide Sandoz are different trade names
of the same medicine.
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific person. 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, please inform your doctor or pharmacist.
See section 4.
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

This medicine is called Candepres HCT. It is used in adult patients for the treatment of high
arterial 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 vessel dilation, 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 candesartan cilexetil alone or hydrochlorothiazide alone (monotherapy).

2. Information before taking Candepres HCT

When NOT TO USE Candepres HCT
if the patient has hypersensitivity to candesartan cilexetil, hydrochlorothiazide, or to any of
the other components of this medicine (listed in section 6);
if the patient has hypersensitivity to medicines of the sulfonamide group. If in doubt, consult a
physician;
if the patient has severe liver disease or biliary obstruction (impaired bile drainage from the gallbladder);
if the patient has severe renal impairment;
if the patient is more than 3 months pregnant (it is also advisable to avoid taking Candepres HCT in early pregnancy – see section on pregnancy below);
if the patient has ever been diagnosed with gout;
if the patient has persistently low blood potassium levels;
if the patient has persistently high blood calcium levels;
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 conditions apply, they should consult a doctor or pharmacist before taking Candepres HCT.

Warnings and precautions
Before starting treatment with Candepres HCT, consult a doctor or pharmacist if:
the patient has heart, liver, or kidney dysfunction;
the patient has recently undergone kidney transplantation;
the patient is currently experiencing or has recently experienced severe vomiting or diarrhea;
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 had a stroke;
the patient has previously had allergies or bronchial asthma;
the patient has previously experienced breathing problems or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or difficulty breathing after taking Candepres HCT, seek immediate medical attention.
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.

if the patient has previously had skin cancer or develops an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially at 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, the patient should protect their skin from sunlight and UV radiation;
if the patient experiences visual disturbances or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (excessive fluid accumulation 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;
if the patient suspects she is pregnant (or may have 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 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 listed conditions, the doctor may recommend more frequent check-ups and certain tests.
If the patient is scheduled for 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 undergoing 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 they plan to use. 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 (at doses above 3 g daily), 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;
cholesterol-lowering medicines, such as colestipol or cholestyramine (resin-type medicines that reduce 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 type of sedative medicine, also used 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 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.

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 the patient to discontinue Candepres HCT before becoming pregnant or immediately after pregnancy is confirmed, and will 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 plans to breastfeed, she should inform her doctor. Candepres HCT is not recommended during breastfeeding. Therefore, for patients who wish to breastfeed (especially newborns or premature infants), the doctor may recommend alternative treatment.

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

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 prescribed by the doctor. In case of any doubts, consult
your doctor or pharmacist. It is important to take Candepres HCT every day.
Candepres HCT is available in doses of 8 mg + 12.5 mg and 16 mg + 12.5 mg.
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 a higher than recommended dose of Candepres HCT
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 discontinue the use of this medicine without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
It is important for the patient to be aware of the possibility that these effects may occur. Some of them may be
caused by candesartan cilexetil, and some by hydrochlorothiazide.
If any of the following allergic adverse reactions occur, the medicine must be discontinued immediately and
medical help sought 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 in swallowing;
intense skin itching (with raised skin lesions).
The medicine should also be discontinued 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 immunity to infection, with possible symptoms 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 changes in the blood (agranulocytosis).
Other possible adverse effects:
Common (may occur in fewer than 1 in 10 people)
Changes in blood test results:
Reduced 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 disturbances 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 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, fluid in the lungs).
High temperature (fever).
Pancreatitis, causing moderate or severe abdominal pain.
Muscle cramps.
Damage to blood vessels, resulting in red or purple spots on the skin.
Decreased number of red blood cells, white blood cells or platelets, with possible symptoms of fatigue, infection, fever or easy bruising.
Severe, rapidly developing rash with blistering or skin peeling, and possible development 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 and muscle pain.
Changes in liver function, including hepatitis. Possible symptoms include fatigue, yellowing of the skin and whites of the eyes, and flu-like symptoms.
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 layer 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. 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 symptoms not listed
in this leaflet, inform a doctor or pharmacist. 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
Reporting adverse effects helps to gather more information on the safety of the medicine.

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 cardboard box and
blister pack following EXP. 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 required. Such measures 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.
• Other ingredients are: lactose monohydrate, maize starch, povidone K 30, carrageenan, 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
Peach-coloured, 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.
Aluminium/Aluminium foil blisters with a desiccant, in a cardboard box containing 28, 30, 56 or 60 tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in the Netherlands, the country of export:
Sandoz B.V.
Veluwezoom 22
1327 AH 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.
ul. Domaniewska 50 C
02-672 Warsaw
Poland
Salutas Pharma GmbH
Otto-von Guericke Allee 1
39179 Barleben
Germany
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
Marketing Authorisation number in the Netherlands, the country of export: RVG 102913
Parallel import licence number: 100/24