Casaro

Leaflet accompanying 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your 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 pack 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 the 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 you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking Casaro.

Warnings and precautions

Before starting to take Casaro, discuss it with your doctor or pharmacist:

• you should inform your doctor if you are (or might become) 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 section "Pregnancy and breastfeeding"),
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• aliskiren,

If any of the above conditions apply to you, your doctor may recommend more frequent checks and blood tests.
If you experience stomach pain, nausea, vomiting, or diarrhea after taking Casaro, discuss it with your doctor. The doctor will decide on further treatment. Do not stop taking Casaro on your own.
Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
If you are planning surgery, inform your doctor or dentist that you are taking Casaro. This is because Casaro, in combination with certain anesthetics, may cause excessive lowering of blood pressure.

Children and adolescents

The use of Casaro has been studied in children. For further information, talk to your 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

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Casaro may affect the action of some other medicines, and some medicines may affect the action of Casaro.
If you are taking certain medicines, your doctor may periodically recommend blood tests.
In particular, inform your doctor if you are taking any of the following medicines, as your doctor may recommend a change in dose 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 (pain-relieving and anti-inflammatory medicines),
• acetylsalicylic acid (if taken in a dose greater than 3 g per day) (pain-relieving and anti-inflammatory medicine),
• potassium supplements, potassium-containing salt substitutes (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),

Casaro with food, drink, and alcohol

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

Pregnancy and breastfeeding

Pregnancy
If you are pregnant or think you may be pregnant, inform your doctor. Your doctor will usually advise you to stop taking Casaro before becoming pregnant or as soon as possible after finding out you are pregnant 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
Inform your 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, do not drive, use tools, or operate machines.

Casaro contains lactose

If you have been diagnosed with intolerance to some sugars, contact your doctor before taking Casaro.

Casaro 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

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.
It is important to take Casaro every day. Take one tablet each day at the same time. This will help you remember to take your medicine.
Casaro can be taken with or without food.
Swallow the tablet with water. The tablet can be divided into equal doses.
High blood pressure
The recommended dose of Casaro is 8 mg once daily. Your doctor may increase the dose to 16 mg once daily, and then to 32 mg once daily, depending on your 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 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 daily.
Patients with 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 daily.
Patients with body weight ≥ 50 kg: In some patients with insufficient blood pressure control, the doctor may increase the dose of Casaro to 8 mg once daily and then to 16 mg once daily.
Heart failure
The recommended initial dose of Casaro is 4 mg once daily. The doctor may increase the dose by doubling it, at intervals of at least 2 weeks, to 32 mg once daily. 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.

Overdose of Casaro

If you have taken more Casaro than prescribed by your doctor, contact your doctor or pharmacist immediately.

Missed dose of Casaro

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

Stopping treatment with Casaro

If you stop taking Casaro, your blood pressure may increase again.
Therefore, do not stop taking Casaro without consulting your doctor first.
If you have any further questions about taking Casaro, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Casaro and seek medical help immediately if you 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 be a sign of reduced immunity to infections, and you may experience tiredness, infection, and fever. If you experience such symptoms, contact your doctor. Your doctor may periodically recommend blood tests to check if Casaro is causing any blood disorders (agranulocytosis).
Other possible side effects include:

• Frequent(may affect up to 1 in 10 people)
• dizziness/spinning sensation
• 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 you have kidney problems or heart failure. If potassium levels become very high, you may experience tiredness, weakness, irregular heartbeat, or tingling sensations.
• effects 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
• decreased number of red or white blood cells. You may feel tired, get infections, or have a fever.
• skin rash, hives
• itching
• back pain, joint or muscle pain
• changes in liver function, including hepatitis (jaundice). You may feel tired, 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:
• decreased sodium levels in the blood. If this is a significant decrease, you 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 seen in adult patients, but they occur more frequently. Sore throat is a very common side effect in children but not reported in adults, and runny nose, fever, and rapid heartbeat are common in children but not reported in adults.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Casaro

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Casaro contains

• The active substance 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, red iron oxide (E 172), hydroxypropyl cellulose, disodium edetate, microcrystalline cellulose, dried.

What Casaro looks like and contents of the pack

Casaro, 8 mg:
Pink to reddish-brown with a whitish 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.
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.
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.
Výrobní závod 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