Casaro hct

Package leaflet: Information for the patient

Casaro HCT, 16 mg + 12.5 mg, tablets
Casaro HCT, 32 mg + 12.5 mg, tablets
Candesartan cilexetil + Hydrochlorothiazide
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Casaro HCT is and what it is used for
2. What you need to know 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 Casaro HCT is and what it is used for

Casaro HCT is a medicine used to treat high blood pressure (hypertension) in adult patients. It contains two active substances: candesartan cilexetil and hydrochlorothiazide. Together, they work to lower the patient's blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It works by relaxing and widening blood vessels. This helps lower blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics (water tablets). It helps the body get rid of water and salts, such as sodium, through the urine. This helps reduce blood pressure.

Your doctor may prescribe Casaro HCT if your blood pressure cannot be adequately controlled with either candesartan cilexetil or hydrochlorothiazide alone.

2. Important information before using Casaro HCT

When not to use Casaro HCT

• if the patient is allergic to candesartan cilexetil or hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to sulphonamide medicines. If in doubt, consult a doctor,
• if the patient is more than 3 months pregnant (Casaro HCT should also be avoided in early pregnancy - see section "Pregnancy and breastfeeding"),
• if the patient has severe kidney disease,
• if the patient has severe liver disease or biliary obstruction (impaired bile flow from the gallbladder),
• if the patient has persistently low blood potassium levels,
• if the patient has persistently high blood calcium levels,
• if the patient has ever had gout,
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

If in doubt whether any of the above points apply to the patient, consult a doctor or pharmacist before using Casaro HCT.

Warnings and precautions

Before starting Casaro HCT, discuss with your doctor or pharmacist:

• if the patient has diabetes,
• in patients with heart, liver or kidney disease,
• if the patient has recently undergone a kidney transplant,
• if the patient is currently or has recently experienced vomiting or diarrhoea,
• if the patient has a condition of the adrenal glands 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,
• inform the doctor if the patient is (or may become) pregnant. Use of Casaro HCT is not recommended during early pregnancy and must not be used after 3 months of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy and breastfeeding").
• if the patient is taking any of the following medicines used to treat high blood pressure:
• ACE inhibitors (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes
• aliskiren
• if the patient has previously had skin cancer or if any new skin changes occur during treatment. Treatment with hydrochlorothiazide, especially at high doses over a long period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. When taking Casaro HCT, protect the skin from sunlight and UV radiation.
• if the patient experiences worsening vision or eye pain. These may be symptoms of fluid accumulation in the uvea (excessive fluid buildup between the choroid and sclera) or increased intraocular pressure, which may occur within hours or weeks of taking Casaro HCT. This may lead to permanent vision loss if untreated. Patients who previously had an allergy to penicillin or sulphonamides may be at higher risk of developing these symptoms.
• if the patient has previously experienced breathing problems or lung problems (including pneumonia or fluid in the lungs) after taking hydrochlorothiazide. If severe shortness of breath or breathing difficulties occur after taking Casaro HCT, seek immediate medical help.

The doctor may recommend frequent monitoring and additional tests if the patient has any of the above conditions.

If the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Casaro HCT, discuss this with the doctor. The doctor will decide on further treatment. Do not make decisions independently about stopping Casaro HCT.

The doctor may monitor kidney function, blood pressure and blood electrolyte levels (e.g. potassium) at regular intervals.

See also information under the heading "When not to use Casaro HCT".

Before any surgical procedure, inform the doctor or dentist about taking Casaro HCT, as this medicine combined with certain anaesthetics may cause a sudden drop in blood pressure.

Casaro HCT may increase 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 and other medicines

Tell your doctor about all medicines currently taken or recently taken, including those obtained 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, the doctor may recommend periodic blood tests.

In particular, inform the doctor if the patient is taking any of the following medicines:

• other medicines that lower blood pressure, including beta-blockers, medicines containing aliskiren, diazoxide and ACE inhibitors such as enalapril, captopril, lisinopril or ramipril,
• non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines that relieve pain and reduce inflammation),
• acetylsalicylic acid (if the patient is taking more than 3 g per day) (a medicine that relieves pain and reduces inflammation),
• potassium supplements or potassium-containing salt substitutes (medicines that increase blood potassium levels),
• calcium supplements or vitamin D,
• cholesterol-lowering medicines such as colestipol or cholestyramine,
• medicines used for diabetes (oral medicines or insulin),
• medicines controlling heart rhythm (antiarrhythmics), such as digoxin or beta-blockers,
• medicines whose effects depend on blood potassium levels, such as certain antipsychotics,
• heparin (a blood-thinning medicine),
• diuretics (water tablets),
• laxatives,
• penicillin or cotrimoxazole also known as trimethoprim/sulfamethoxazole (antibiotics),
• amphotericin (a medicine used to treat fungal infections),
• lithium (a medicine used to treat psychiatric disorders),
• steroids, such as prednisolone,
• pituitary hormones (ACTH),
• medicines used in cancer treatment,
• amantadine (used in the treatment of Parkinson's disease or severe viral infections),
• barbiturates (sedatives, also used in epilepsy treatment),
• carbenoxolone (a medicine used in oesophageal disorders or oral ulcers),
• anticholinergic medicines, such as atropine and biperiden,
• cyclosporine (a medicine used after organ transplantation to prevent rejection),
• other medicines that may enhance antihypertensive effects, such as baclofen (a medicine reducing skeletal muscle tone), amifostine (used in cancer treatment) and certain antipsychotics,
• if the patient is taking an ACE inhibitor or aliskiren (see also information under the headings "When not to use Casaro HCT" and "Warnings and precautions").

Casaro HCT with food, drink and alcohol

Casaro HCT may be taken with or without food.

During treatment with Casaro HCT, consult your doctor before consuming alcohol. Alcohol may cause feelings of weakness or dizziness.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you suspect you are (or may become) pregnant. Your doctor will usually recommend stopping Casaro HCT before planned pregnancy or immediately after confirming pregnancy and will advise taking an alternative medicine.

Use of Casaro HCT is not recommended during early pregnancy and must not be used after 3 months of pregnancy, as it may seriously harm the unborn child.

Breastfeeding

Inform your doctor if you are breastfeeding or intend to breastfeed. Use of Casaro HCT is not recommended during breastfeeding, especially when breastfeeding a newborn or premature infant, and your doctor may recommend an alternative medicine.

Driving and using machines

While taking Casaro HCT, some patients may experience fatigue or dizziness. If these symptoms occur, do not drive, operate machinery or use tools.

Casaro HCT contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

Casaro HCT contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Casaro HCT

This medicine should always be used exactly as your doctor has told you. If you are unsure, you should
consult your doctor or pharmacist.
It is important to take Casaro HCT every day. Try to take the tablets
at the same time each day. This will help you remember to take your medicine.
The recommended dose of Casaro HCT is one tablet once daily.
Casaro HCT may be taken with or without food. Swallow the tablet with water.
The tablet may be divided into equal doses.
Taking more Casaro HCT than recommended
If you take more Casaro HCT than recommended, contact your doctor or pharmacist immediately
for advice.
Missing a dose of Casaro HCT
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping Casaro HCT
If you stop taking Casaro HCT, your blood pressure may rise again. Therefore, do not stop taking Casaro HCT
without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Casaro HCT may cause adverse reactions, although not everyone experiences them.
It is important that the patient is informed about which adverse reactions may occur. Adverse
reactions are usually mild in nature and resolve quickly. Some of the adverse reactions of Casaro HCT are caused by candesartan cilexetil, while others are caused by hydrochlorothiazide.
The treatment with Casaro HCT must be stopped immediately and medical help should be sought
if the patient experiences any of the following allergic reactions:

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

Casaro HCT may cause a reduction in the number of white blood cells. Immunity to infections may be reduced, therefore the patient may experience fatigue, infection or fever. If such symptoms occur, contact a doctor. The doctor may recommend periodic blood tests to check whether Casaro HCT has affected blood composition (agranulocytosis).
Other possible adverse reactions include:
Common (may affect up to 1 in 10 patients):

• dizziness/vertigo or weakness
• headache
• respiratory tract infections
• changes in blood test results:
• decreased sodium levels in blood. If significantly reduced, weakness, lack of energy or muscle cramps may occur.
• increased or decreased potassium levels in blood, especially in patients with kidney disorders or heart failure. If significantly reduced, fatigue, weakness, irregular heartbeat or tingling may occur.
• increased levels of cholesterol, glucose or uric acid in blood
• glucose in urine.

Uncommon (may affect up to 1 in 100 patients):

• low blood pressure. This may cause fainting or dizziness.
• loss of appetite, diarrhoea, constipation, stomach irritation
• skin rash, hives (urticaria), rash due to photosensitivity.

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

• jaundice (yellowing of the skin or whites of the eyes). If such symptoms occur, contact a doctor immediately.
• kidney function disorders, particularly in patients with prior kidney disorders or heart failure
• difficulty in falling asleep, depression, anxiety
• tingling or prickling sensations in hands and feet
• transient blurred vision
• heart rhythm disturbances
• breathing difficulties (including pneumonia and pulmonary edema)
• high temperature (fever)
• pancreatitis. Causes moderate to severe pain in the upper abdomen.
• muscle cramps
• damage to blood vessels causing red or purple spots on the skin
• decreased number of white or red blood cells, or platelets. The patient may feel fatigued, infections, fever or easy bruising may occur.
• severe, rapidly developing rash with blisters, skin peeling and possible development of 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 function disorders, including hepatitis. The patient may feel fatigued, yellowing of the skin and eyes may occur, as well as flu-like symptoms.
• angioedema of the intestine: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting and diarrhoea
• cough
• nausea
• acute respiratory failure (symptoms: severe shortness of breath, fever, weakness and confusion).

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

• skin and lip cancers (non-melanoma skin cancers)
• sudden onset of myopia
• worsening of vision or eye pain due to high pressure (possible symptoms of fluid accumulation in the uvea (excessive fluid buildup between choroid and sclera) or acute angle-closure glaucoma)
• systemic and cutaneous lupus erythematosus (an allergic condition causing fever, joint pain, skin rashes which may include redness, blisters, peeling and nodules). Reporting of adverse reactions If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 reactions, more information on the safety of the medicine can be collected.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Casaro HCT

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 stated on the carton or blister after:
EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Casaro HCT contains

• The active substances in this medicine are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 16 mg or 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• Other ingredients are:
  Casaro HCT, 16 mg + 12.5 mg: monohydrate lactose, corn starch, hypromellose 2910, calcium stearate, red iron oxide (E 172), yellow iron oxide (E 172), hydroxypropylcellulose, disodium edetate, microcrystalline cellulose, dried.
  Casaro HCT, 32 mg + 12.5 mg: monohydrate lactose, corn starch, calcium stearate, yellow iron oxide (E 172), hydroxypropylcellulose, disodium edetate, calcium carmellose, ethylcellulose, 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 uncoated tablets with bevelled edges (approximately 9.5 mm in length and 4.5 mm in width), with a division line on both sides.
Casaro HCT, 32 mg + 12.5 mg:
Light yellow to yellow, oval, biconvex uncoated tablets with bevelled edges (approximately 11.0 mm in length and 6.5 mm in width), with a division line on both sides.
The tablet can be divided into equal doses.
The tablets are supplied in blisters made of OPA/Aluminum/PVC/Aluminum or PVC/PVDC/Aluminum, packed 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

Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

This medicine is authorized in the European Economic Area countries 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