Casaro Hct

Leaflet accompanying the packaging, patient information

Casaro HCT, 16 mg + 12.5 mg, tablets

Casaro HCT, 32 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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Casaro HCT and what is it used for
• 2. Important information before taking Casaro HCT
• 3. How to take Casaro HCT
• 4. Possible side effects
• 5. How to store Casaro HCT
• 6. Contents of the pack and other information

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

Casaro HCT is used to treat high blood pressure (hypertension) in adult patients. It contains two active substances: candesartan cilexetil and hydrochlorothiazide. Their combined effect reduces the patient's blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. Its action is to relax and dilate blood vessels. This helps to lower blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics (water pills). It helps the body get rid of water and salts, such as sodium, in the urine. This helps to lower blood pressure.

The doctor may prescribe Casaro HCT if the patient's blood pressure cannot be reduced by taking candesartan cilexetil or hydrochlorothiazide alone.

2. Important information before taking Casaro HCT

When not to take Casaro HCT

• if the patient is allergic to candesartan cilexetil or hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to sulphonamide medicines. In case of doubt, consult a doctor,
• if the patient is pregnant for more than 3 months (it is also recommended to avoid taking Casaro HCT in early pregnancy - see "Pregnancy and breastfeeding"),
• if the patient has severe kidney disease,
• if the patient has severe liver disease or biliary obstruction (disorders of bile flow from the gallbladder),
• 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 ever been diagnosed with gout,
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

In case of doubt whether any of the above points apply to the patient, they should consult a doctor or pharmacist before taking Casaro HCT.

Warnings and precautions

Before starting to take Casaro HCT, the patient should discuss it with their doctor or pharmacist:

• if the patient has diabetes,
• in patients with heart, liver, or kidney disease,
• if the patient has recently had a kidney transplant,
• if the patient is currently vomiting or has recently vomited or has diarrhea,
• if the patient has a condition called Conn's syndrome (also known as primary hyperaldosteronism),
• if the patient has ever been diagnosed with an autoimmune disease called systemic lupus erythematosus (SLE),
• if the patient has low blood pressure,
• if the patient has ever had a stroke,
• if the patient has ever had an allergy or asthma,
• the patient should inform their doctor if they are (or may become) pregnant. Casaro HCT should not be taken in early pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the baby (see "Pregnancy and breastfeeding").
• if the patient is taking any of the following medicines for high blood pressure:
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes
• aliskiren
• if the patient has ever 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). During treatment with Casaro HCT, the patient should protect their skin from sunlight and UV radiation.
• if the patient experiences vision problems or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (excessive accumulation of fluid between the choroid and sclera) or increased eye pressure and may occur within a few hours or weeks of taking Casaro HCT. This can lead to permanent vision loss if left untreated. If the patient has previously been allergic to penicillin or sulphonamides, they may be more likely to develop these symptoms.
• if the patient has experienced breathing problems or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If the patient experiences severe shortness of breath or difficulty breathing after taking Casaro HCT, they should seek medical help immediately.

The doctor may recommend regular check-ups and additional tests if the patient has any of the above conditions.
If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Casaro HCT, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Casaro HCT on their own.
The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.
See also the information under the heading "When not to take Casaro HCT".
Before any surgical procedure, the patient should inform their doctor or dentist that they are taking Casaro HCT, as the medicine may cause a sudden drop in blood pressure when combined with certain anesthetics.
Casaro HCT may increase the patient's skin sensitivity to sunlight.

Children and adolescents

There is no experience with the use of Casaro HCT in children (under 18 years of age).
Therefore, Casaro HCT should not be given to this age group.

Casaro HCT with other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, including those available without a prescription.
Casaro HCT may affect the action of other medicines, and other medicines may affect the action of Casaro HCT. If the patient is taking certain medicines, their doctor may recommend regular blood tests.
In particular, the patient should inform their doctor if they are taking any of the following medicines:

• other blood pressure-lowering medicines, including beta-blockers, aliskiren, diazoxide, and ACE inhibitors, such as enalapril, captopril, lisinopril, or ramipril,
• non-steroidal anti-inflammatory medicines (NSAIDs), such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (pain-relieving and anti-inflammatory medicines),
• acetylsalicylic acid (if the patient takes more than 3 g per day) (pain-relieving and anti-inflammatory medicine),
• potassium supplements or salt substitutes containing potassium (medicines that increase potassium levels in the blood),
• calcium supplements or vitamin D,
• cholesterol-lowering medicines, such as colestyramine or colestipol,
• medicines for diabetes (oral or insulin),
• medicines that control heart rhythm (anti-arrhythmic medicines), such as digoxin or beta-blockers,
• medicines whose action is affected by potassium levels in the blood, such as certain antipsychotic medicines,
• heparin (blood thinner),
• diuretics (water pills),
• laxatives,
• penicillin or cotrimoxazole (also known as trimethoprim/sulfamethoxazole) (antibiotics),
• amphotericin (medicine used to treat fungal infections),
• lithium (medicine used to treat mental disorders),
• corticosteroids, such as prednisolone,
• pituitary hormones (ACTH),
• medicines used to treat cancer,
• amantadine (used to treat Parkinson's disease or severe viral infections),
• barbiturates (sedatives, also used to treat epilepsy),
• carbenoxolone (medicine used to treat esophageal or mouth ulcers),
• anticholinergic medicines, such as atropine and bipiperidine,
• cyclosporin (medicine used after organ transplantation to prevent rejection),
• other medicines that may enhance the blood pressure-lowering effect, such as baclofen (muscle relaxant), amifostine (used to treat cancer), and certain antipsychotic medicines,
• if the patient is taking an ACE inhibitor or aliskiren (see also the information under the heading "When not to take Casaro HCT" and "Warnings and precautions").

Casaro HCT with food, drink, and alcohol

Casaro HCT can be taken with or without food.
The patient should consult their doctor before consuming alcohol while taking Casaro HCT. Alcohol may cause dizziness or weakness.

Pregnancy and breastfeeding

Pregnancy
The patient should inform their doctor if they suspect they are (or may become) pregnant. The doctor will usually recommend stopping Casaro HCT before planned pregnancy or as soon as pregnancy is confirmed and prescribe a different medicine instead of Casaro HCT.
Casaro HCT should not be taken in early pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the baby.
Breastfeeding
The patient should inform their doctor if they are breastfeeding or plan to breastfeed. Casaro HCT should not be taken during breastfeeding, especially in the case of breastfeeding a newborn or premature baby, and the doctor may recommend a different medicine.

Driving and using machines

While taking Casaro HCT, some patients may feel tired or dizzy. If such symptoms occur, the patient should not drive vehicles, operate machinery, or use tools.

Casaro HCT contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking Casaro HCT.

Casaro HCT contains sodium

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

3. How to take Casaro HCT

This medicine should always be taken as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
It is important to take Casaro HCT every day. The patient should try to take the tablets at the same time every day. This will help them remember to take the medicine.
The recommended dose of Casaro HCT is one tablet once a day.
Casaro HCT can be taken with or without food. The tablet should be swallowed with water.
The tablet can be divided into equal doses.

Taking a higher dose of Casaro HCT than recommended

If a higher dose of Casaro HCT than recommended is taken, the patient should immediately consult their doctor or pharmacist for advice.

Missing a dose of Casaro HCT

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the usual time.

Stopping treatment with Casaro HCT

If treatment with Casaro HCT is stopped, blood pressure may rise again. Therefore, the patient should not stop taking Casaro HCT without consulting their doctor first.
In case of any further doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Casaro HCT can cause side effects, although not everybody gets them.
It is important that the patient is informed about the possible side effects that may occur. Side effects are usually mild and disappear quickly. Some of the side effects of Casaro HCT are caused by candesartan cilexetil, while others are caused by hydrochlorothiazide.

The patient should stop taking Casaro HCT and seek medical help immediately if they experience any of the following allergic reactions:

• difficulty breathing, with swelling of the face, lips, tongue, and/or throat, with or without swelling,
• swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing,
• severe itching of the skin (with raised patches).

Casaro HCT may cause a decrease in the number of white blood cells. The patient's resistance to infection may be reduced, so they may experience fatigue, infection, or fever. If such symptoms occur, the patient should consult their doctor. The doctor may recommend regular blood tests to check if Casaro HCT has affected the blood composition (agranulocytosis).
Other possible side effects include:

• Frequent(may affect up to 1 in 10 patients):
• dizziness/spinning sensation or weakness
• headache
• respiratory tract infections
• changes in blood test results:
• decreased sodium levels in the blood. In case of significant decrease, weakness, lack of energy, or muscle cramps may occur.
• increased or decreased potassium levels in the blood, especially in patients with kidney problems or heart failure. In case of significant decrease, fatigue, weakness, irregular heartbeat, or tingling may occur.
• increased cholesterol, sugar, or uric acid levels in the blood
• sugar in the urine.

Less frequent(may affect up to 1 in 100 patients):

• low blood pressure. This may cause fainting or dizziness.
• loss of appetite, diarrhea, constipation, stomach upset
• skin rash, patchy rash (hives), sun-related skin rash.

Rare(may affect up to 1 in 1,000 patients):

• jaundice (yellowing of the skin or whites of the eyes). If such symptoms occur, the patient should immediately consult their doctor.
• kidney problems, especially in patients with pre-existing kidney problems or heart failure
• difficulty sleeping, depression, anxiety
• tingling or prickling sensation in the hands and feet
• temporary blurred vision
• heart rhythm disturbances
• breathing difficulties (including pneumonia and fluid in the lungs)
• high temperature (fever)
• pancreatitis. This causes moderate to severe stomach pain.
• muscle cramps
• blood vessel damage causing red or purple spots on the skin
• reduced number of white blood cells, red blood cells, or platelets. The patient may feel tired, may experience infection, fever, or easy bruising.
• severe, rapidly developing rash with blisters and peeling of the skin, and possible blisters in the mouth.

Very rare(may affect up to 1 in 10,000 patients):

• swelling of the face, lips, tongue, and/or throat
• itching
• back pain, joint pain, and muscle pain
• liver problems, including liver inflammation. The patient may feel tired, may experience yellowing of the skin and eyes, and flu-like symptoms.
• gastrointestinal angioedema: swelling in the intestine with symptoms such as stomach pain, nausea, vomiting, and diarrhea
• cough
• nausea
• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).

Frequency not known(frequency cannot be estimated from the available data):

• skin and lip cancer (non-melanoma skin cancer)
• sudden short-sightedness
• worsening of vision or eye pain due to high pressure (possible symptoms of fluid accumulation in the vascular layer of the eye (excessive accumulation of fluid between the choroid and sclera) or acute angle-closure glaucoma)
• systemic lupus erythematosus and cutaneous lupus (an allergic condition that causes fever, joint pain, skin rash, which may include redness, blisters, peeling, and lumps).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 side effects, more information can be collected on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Casaro HCT

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton or blister after: EXP. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Casaro HCT contains

• The active substances of Casaro HCT are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 16 mg or 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: Casaro HCT, 16 mg + 12.5 mg:lactose monohydrate, cornstarch, hypromellose 2910, calcium stearate, red iron oxide (E 172), yellow iron oxide (E 172), hydroxypropyl cellulose, disodium edetate, microcrystalline cellulose, dried. Casaro HCT, 32 mg + 12.5 mg:lactose monohydrate, cornstarch, calcium stearate, yellow iron oxide (E 172), hydroxypropyl cellulose, disodium edetate, calcium carmellose, ethyl cellulose, microcrystalline cellulose, dried.

What Casaro HCT looks like and contents of the pack

Casaro HCT, 16 mg + 12.5 mg:
Peach to light orange, oval, biconvex tablets with a score line on both sides (length approximately 9.5 mm and width approximately 4.5 mm).
Casaro HCT, 32 mg + 12.5 mg:
Light yellow to yellow, oval, biconvex tablets with a score line on both sides (length approximately 11.0 mm and width approximately 6.5 mm).
The tablet can be divided into equal doses.
The tablets are provided in blisters of OPA/Aluminum/PVC/Aluminium or PVC/PVDC/Aluminium, in a cardboard box.
Package sizes: 7, 14, 28, 30, 56, 70, 90, and 98 tablets.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer/Importer:

Medis International a.s.
Výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Slovakia:
Casaro HCT 16 mg/12.5 mg
Casaro HCT 32 mg/12.5 mg
Czech Republic: Casaro HCT
Poland:
Casaro HCT

Date of last revision of the leaflet: 02/2025