Casaro

Leaflet attached to the packaging: patient information

Casaro, 8 mg, tablets

Casaro, 16 mg, tablets

Casaro, 32 mg, tablets

Candesartan cilexetil

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.
• If you have any doubts, consult your 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 side effects 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 and what is it used for
• 2. Important information before taking Casaro
• 3. How to take Casaro
• 4. Possible side effects
• 5. How to store Casaro
• 6. Contents of the packaging and other information

1. What is Casaro and what is it used for

The active substance of the medicine is candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor antagonists. It works by relaxing and widening blood vessels. This helps to lower blood pressure. It also makes it easier for the heart to pump blood to all parts of the body.
Casaro can be used:

• to treat high blood pressure (hypertension) in adult patients and in children and adolescents from 6 to 18 years of age,
• to treat adult patients with heart failure, with reduced heart muscle function, if angiotensin-converting enzyme inhibitors (ACE inhibitors) cannot be used or as an addition to ACE inhibitor therapy, if symptoms of heart failure persist despite treatment, and mineralocorticoid receptor antagonists (MRAs) cannot be used (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. Important information before taking Casaro

When not to take Casaro

• if the patient is allergic to candesartan cilexetil or any of the other ingredients of this medicine (listed in section 6),
• if the patient is pregnant for more than 3 months (it is also better not to take Casaro in early pregnancy - see the section "Pregnancy and breastfeeding"),
• if the patient has severe liver disease or bile duct obstruction (disorder of bile flow from the gallbladder),
• if the patient is a child under 1 year of age,
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

In case of doubt as to whether any of the above situations apply to the patient, they should consult their doctor or pharmacist before taking Casaro.

Warnings and precautions

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

• if the patient has heart, liver, or kidney problems, or is undergoing dialysis,
• if the patient has recently had a kidney transplant,
• if the patient has vomiting or has recently had severe vomiting, or has diarrhea,
• if the patient has a disease of the adrenal glands called Conn's syndrome (primary hyperaldosteronism),
• if the patient has low blood pressure,
• if the patient has ever had a stroke,
• the patient should inform their doctor if they are (or may be) pregnant. It is not recommended to take Casaro in early pregnancy and it should not be taken after 3 months of pregnancy, as it may seriously harm the baby (see the section "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 is taking an ACE inhibitor at the same time as a medicine belonging to a group of medicines called mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see "Casaro and other medicines").

If any of the above conditions apply to the patient, the doctor may recommend more frequent checks and blood tests.
If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Casaro, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Casaro on their own.
The doctor may recommend regular checks of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
If the patient is planning to have surgery, they should inform their doctor or dentist that they are taking Casaro. This is because Casaro, in combination with certain anesthetics, may cause a significant drop in blood pressure.

Children and adolescents

The use of Casaro has been studied in children. For further information, the patient should talk to their doctor. Casaro should not be given to children under 1 year of age due to the potential risk to kidney development.

Casaro and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Casaro may affect the action of some other medicines, and some medicines may affect the action of Casaro.
If the patient is taking certain medicines, the doctor may periodically recommend blood tests.
In particular, the patient should inform their doctor if they are taking any of the following medicines, as the doctor may recommend a dose change and/or other precautions:

• other blood pressure-lowering medicines, including beta-blockers, 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 (medicines that relieve pain and inflammation),
• acetylsalicylic acid (if taken in a dose greater than 3 g per day) (a medicine that relieves pain and inflammation),
• potassium supplements, salt substitutes containing potassium (medicines that increase potassium levels in the blood),
• heparin (a medicine that reduces blood clotting),
• cotrimoxazole (an antibiotic), also known as trimethoprim with sulfamethoxazole,
• diuretics,
• lithium (a medicine used to treat mental disorders),
• if the patient is taking an ACE inhibitor or aliskiren (see also the subsections "When not to take Casaro" and "Warnings and precautions"),
• if the patient is taking an ACE inhibitor at the same time as certain medicines used to treat heart failure, called mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone).

Casaro with food, drink, and alcohol

Casaro can be taken with or without food.
Before planned alcohol consumption while taking Casaro, the patient should consult their doctor. Alcohol may cause dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy
If the patient suspects they are (or may be) pregnant, they must inform their doctor. The doctor will usually advise stopping Casaro before becoming pregnant or as soon as possible after finding out about the pregnancy and recommend taking another medicine instead.
Taking Casaro in early pregnancy is not recommended, and it should not be taken after 3 months of pregnancy, as it may seriously harm the baby.
Breastfeeding
The patient should inform their doctor about breastfeeding or planning to breastfeed. Taking Casaro is not recommended during breastfeeding. For patients planning to breastfeed, especially newborns or premature babies, the doctor may choose another suitable medicine.

Driving and using machines

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

Casaro contains lactose

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

Casaro contains sodium

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

3. How to take Casaro

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 every day. The patient should take one tablet every day at the same time. This will help them remember to take the medicine.
Casaro can be taken with or without food.
The tablet should be swallowed with water. The tablet can be divided into equal doses.
High blood pressure
The recommended dose of Casaro is 8 mg once a day. The doctor may increase the dose to 16 mg once a day, and then to 32 mg once a day, depending on the patient's blood pressure response to treatment.
Some patients, e.g., those with liver or kidney problems, or patients who have recently lost a lot of fluid (due to vomiting or diarrhea, or taking diuretics), may be prescribed a lower initial dose by their doctor.
In some black patients, the response to this type of medicine may be reduced when it is given as the only treatment (monotherapy), and such patients may need a higher dose.

Use in children and adolescents

Children from 6 to 18 years of age:
The recommended initial dose is 4 mg once a day.
Patients with a body weight <50 kg: in some patients with insufficient blood pressure control, the doctor may increase dose of casaro to a maximum 8 mg once day.
Patients with a body weight ≥ 50 kg: In some patients with insufficient blood pressure control, the doctor may increase the dose of Casaro to 8 mg once a day and then to 16 mg once a day.
Heart failure
The recommended initial dose of Casaro is 4 mg once a day. The doctor may increase the dose by doubling it, at intervals of at least 2 weeks, to 32 mg once a day. Casaro can be taken with other medicines used to treat heart failure, and the doctor will decide which therapy is most suitable for the patient.

Taking a higher dose of Casaro than recommended

In case of taking a higher dose of Casaro than prescribed by the doctor, the patient should immediately contact their doctor or pharmacist.

Missing a dose of Casaro

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

If the patient stops taking Casaro, their blood pressure may increase again.
Therefore, the patient should not stop taking Casaro 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 can cause side effects, although not everybody gets them.

The patient should stop taking Casaro 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 of the face, lips, tongue, and/or throat, which may cause difficulty swallowing,
• severe itching of the skin (with raised bumps).

Casaro may cause a decrease in the number of white blood cells. This can lead to reduced immunity to infections, so the patient may experience fatigue, infection, and fever. If such symptoms occur, the patient should contact their doctor. The doctor may periodically recommend blood tests to check if Casaro is causing any blood disorders (agranulocytosis).
Other possible side effects include:
Common(may affect up to 1 in 10 people)

• dizziness/feeling of spinning
• headache
• respiratory tract infection
• low blood pressure - this may cause fainting or dizziness
• changes in blood test results:
• increased potassium levels in the blood, especially if the patient has kidney problems or heart failure. In case of significant increases in potassium levels, the patient may experience fatigue, weakness, irregular heartbeat, or tingling.
• effect on kidney function, especially in cases of existing kidney problems or heart failure. In very rare cases, kidney failure may occur.

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

• swelling of the face, lips, tongue, and/or throat
• decrease in the number of red or white blood cells. The patient may feel tired, get infections, or have a fever.
• skin rash, bumpy rash (hives)
• itching
• back pain, joint and muscle pain
• changes in liver function, including liver inflammation (jaundice). The patient may notice fatigue, yellowing of the skin and whites of the eyes, and flu-like symptoms.
• intestinal angioedema: swelling in the intestine with symptoms such as stomach pain, nausea, vomiting, and diarrhea
• nausea
• cough
• changes in blood test results:
• decrease in sodium levels in the blood. If this is a significant decrease, the patient may experience weakness, lack of energy, or muscle cramps.

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

• diarrhea.

Additional side effects in children and adolescents

Side effects in children treated for high blood pressure seem to be similar to those observed in adult patients, but they occur more frequently. Sore throat is a very common side effect in children, but it is not reported in adults, and runny nose, fever, and rapid heartbeat are common in children, but not reported in adults.

Reporting side effects

If the patient experiences any side effects, including any side effects 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 gathered on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Casaro

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.
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 packaging and other information

What Casaro contains

• The active substance of the medicine is candesartan cilexetil. Each tablet contains 8 mg, 16 mg, or 32 mg of candesartan cilexetil.
• The other ingredients are: lactose monohydrate, cornstarch, hypromellose 2910, calcium stearate, iron oxide red (E 172), hydroxypropyl cellulose, disodium edetate, microcrystalline cellulose, dried.

What Casaro looks like and what the pack contains

Casaro, 8 mg:
Pink to reddish-brown with a white mottled appearance, round, biconvex, uncoated tablets (with a diameter of 8.00 mm ± 0.20 mm) with a dividing line on one side and smooth on the other side.
Casaro, 16 mg:
Light pink to pale red, round, biconvex, uncoated tablets (with a diameter of 7.14 mm ± 0.20 mm) with a dividing line on one side and smooth on the other side.
Casaro, 32 mg:
Light pink to pale red, round, biconvex, uncoated tablets (with a diameter of 9.52 mm ± 0.20 mm) with a dividing line on both sides.
The tablet can be divided into equal doses.
The tablets are provided in blisters of OPA/Aluminum/PVC/Aluminum or PVC/PVDC/Aluminum, in a cardboard box.
Pack sizes: 7, 14, 28, 30, 56, 70, 90, and 98 tablets.
Not all pack 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.
Manufacturing plant Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Pharmazet Group s.r.o.
Třtinová 260/1
Čakovice
196 00 Prague 9
Czech Republic

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

Slovakia:
Casaro 8 mg
Casaro 16 mg
Casaro 32 mg
Czech Republic:
Casaro
Poland:
Casaro
Romania:
Candesartan Gemax Pharma 8 mg tablets
Candesartan Gemax Pharma 16 mg tablets
Candesartan Gemax Pharma 32 mg tablets

Date of last revision of the leaflet: 02/2025