Carzap hct

Patient Information Leaflet

Caution: Keep this leaflet. Information on the immediate packaging in a foreign language.
Carzap HCT, 16 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, 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 individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of Contents:

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

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

This medicine is called Carzap HCT. It is used to treat high blood pressure (hypertension) in adult patients. Carzap HCT contains two active substances: candesartan cilexetil and hydrochlorothiazide. Both of these substances lower blood pressure.

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

Your doctor may prescribe Carzap HCT if your blood pressure is not adequately controlled with either candesartan cilexetil or hydrochlorothiazide alone.

2. Important information before using Carzap HCT

When not to use Carzap HCT

• if the patient has a known allergy to candesartan cilexetil or hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6),
• if the patient has an allergy to sulfonamide derivatives – in case of doubt, consult a doctor,
• after the 3rd month of pregnancy (Carzap HCT should also be avoided during early pregnancy – see section on pregnancy),
• if the patient has severe kidney function impairment,
• if the patient has severe liver disease or biliary obstruction (impaired bile flow from the gallbladder),

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• if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren,
• 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 in doubt whether any of the above situations apply, consult a
doctor or pharmacist before starting treatment with Carzap HCT.
Warnings and precautions
Before starting treatment with Carzap HCT, discuss the following with your doctor or pharmacist:

• if the patient has diabetes,
• if the patient has heart, liver or kidney disorders,
• if the patient has recently received a kidney transplant,
• if the patient has had or recently experienced severe vomiting or diarrhoea,
• if the patient has an adrenal gland disorder called Conn's syndrome (also known as primary hyperaldosteronism),
• if the patient has had or currently has skin cancer or develops an unexpected skin lesion. 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. During treatment with Carzap HCT, protect the skin from sunlight and UV radiation,
• if the patient experiences visual disturbances 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 – these may occur from several hours to weeks after taking Carzap HCT. This may lead to permanent vision loss if not treated. Patients who previously had an allergic reaction to penicillin or sulfonamides may be at higher risk of developing this condition,
• if the patient has or has ever had systemic lupus erythematosus (SLE),
• if the patient has low blood pressure,
• if the patient has ever had a stroke,
• if the patient has or has ever had allergies or asthma,
• if the patient has had or currently has breathing 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 Carzap HCT, seek immediate medical help,
• if the patient suspects (or plans) pregnancy. Use of Carzap HCT is not recommended during early pregnancy and must be avoided after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section on pregnancy),
• if 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 impairment related to diabetes,
• aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure and blood electrolyte levels (e.g. potassium).
See also the section “When not to use Carzap HCT”.
If any of the above conditions apply, the doctor may recommend more frequent monitoring and tests.
If surgery is planned, inform the doctor or dentist about the use of Carzap HCT, as concomitant administration of certain anaesthetics may cause excessive drop in blood pressure.
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Carzap HCT may increase skin sensitivity to sunlight.
Children and adolescents
There is no experience with the use of Carzap HCT in children and adolescents (under 18 years of age). Therefore, Carzap HCT should not be given to children and adolescents.
Carzap HCT with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use. Carzap HCT may affect the action of certain other medicines, and other medicines may affect the action of Carzap HCT. If the patient is taking other medicines, the doctor may recommend periodic blood tests.
In particular, inform the doctor if the patient is taking any of the following medicines, as the doctor may recommend dose adjustment and/or additional precautions:

• Other medicines used to lower blood pressure, including beta-blockers, 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 (at doses above 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 or vitamin D supplements.
• Cholesterol-lowering medicines such as colestipol or cholestyramine.
• Medicines used to treat diabetes (tablets or insulin).
• Medicines affecting heart rhythm (antiarrhythmics), such as digoxin and beta-blockers.
• Medicines affected by blood potassium levels, such as certain antipsychotics.
• Heparin (a blood-thinning medicine).
• Diuretics (water pills).
• Laxatives.
• Penicillin or cotrimoxazole (also known as trimethoprim/sulfamethoxazole) (antibiotics).
• Amphotericin (used to treat fungal infections).
• Lithium (a medicine used in psychiatric disorders).
• Steroid medicines, such as prednisolone.
• Pituitary hormones (ACTH).
• Medicines used in cancer treatment.
• Amantadine (used to treat Parkinson's disease or severe viral infections).
• Barbiturates (sedatives, also used in epilepsy treatment).
• Carbenoxolone (used to treat 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 muscle relaxant), amifostine (used in cancer treatment) and certain antipsychotics.

The doctor may recommend dose adjustment and/or additional precautions:

• If the patient is taking an ACE inhibitor or aliskiren (see also sections “When not to use Carzap HCT” and “Warnings and precautions”).

Carzap HCT with food, drink and alcohol
Consult your doctor before consuming alcohol while taking Carzap HCT.
Alcohol may cause feelings of weakness or dizziness.
Pregnancy, breastfeeding and fertility
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Pregnancy
Inform your doctor if you suspect (or are planning) pregnancy. The doctor will usually advise stopping Carzap HCT before planned pregnancy or immediately after confirmed pregnancy and will recommend an alternative medicine. Carzap HCT is not recommended during pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Carzap HCT is not recommended during breastfeeding. The doctor may recommend an alternative medicine if the patient wishes to breastfeed, especially if the baby is a newborn or premature.
Driving and operating machinery
Some patients may experience fatigue or dizziness while taking Carzap HCT. If these symptoms occur, do not drive, use tools or operate machinery.
Carzap HCT contains lactose monohydrate and sodium
Carzap HCT contains lactose monohydrate, a type of sugar. If the patient has been diagnosed with an intolerance to certain sugars, consult a doctor before using this medicine.
The medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to use Carzap HCT

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist. It is important to take Carzap HCT
every day. The recommended dose of Carzap HCT is one tablet once daily. The tablet should be swallowed
with water. Carzap HCT may be taken during a meal or independently of meals.
Try to take the tablet at the same time each day. This will help you remember to take it.
The tablet may be divided into equal doses.
Taking more Carzap HCT than recommended
If you take more Carzap HCT than recommended, contact your doctor or pharmacist immediately
for advice.
If you miss a dose of Carzap HCT
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping Carzap HCT
Stopping treatment with Carzap HCT may cause blood pressure to rise again. Therefore, do not stop taking
Carzap 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 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 of adverse effects occurring. Some of the
adverse effects of Carzap HCT are caused by candesartan cilexetil, and others by
hydrochlorothiazide.
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You must stop taking Carzap HCT immediately and seek medical help
if any of the following allergic reactions occur:

• difficulty 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 lumps).

Carzap HCT may cause a reduction in the number of white blood cells. Resistance to infections
may be weakened, and fatigue, infection or fever may occur. If such symptoms occur, contact your doctor.
Your doctor may recommend periodic blood tests to check whether Carzap HCT is affecting blood composition (agranulocytosis).
Other possible adverse effects include:
Common (may affect up to 1 in 10 people)

• Changes in blood test results:
• Reduced sodium levels in the blood. If significantly reduced, this may cause weakness, lack of energy, or muscle cramps.
• Increased or decreased potassium levels in the blood, particularly in patients with impaired kidney function or heart failure. If significantly reduced or increased, fatigue, weakness, heart rhythm disturbances, or tingling sensations may occur.
• Increased levels of cholesterol, blood sugar, or uric acid in the blood.
• Presence of sugar in the urine.
• Dizziness/balance disturbances or weakness.
• Headache.
• Respiratory tract infection.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This may cause fainting or dizziness.
• Loss of appetite, diarrhoea, constipation, stomach irritation.
• Skin rash, urticaria, rash caused by hypersensitivity to sunlight.

Rare (may affect up to 1 in 1,000 people)

• Jaundice (yellowing of the skin or whites of the eyes). In such a case, contact your doctor immediately.
• Effects on kidney function, particularly in patients with impaired kidney function or heart failure.
• Sleep disturbances, depression, anxiety.
• Tingling or pricking sensations in the arms or legs.
• Temporary blurred vision.
• Heart rhythm disturbances.
• Breathing difficulties (including pneumonia and presence of fluid in the lungs).
• High body temperature (fever).
• Pancreatitis, causing moderate or severe abdominal pain.
• Muscle cramps.
• Damage to blood vessels, causing red or purple spots on the skin.
• Reduction in the number of red blood cells, white blood cells, or platelets. The patient may experience fatigue, infection, fever, or easy bruising.
• Severe, rapidly developing rash, with blisters or skin peeling and possible blisters in the mouth.

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

• Swelling of the face, lips, tongue and (or) throat.
• Itching.
• Back pain, joint pain, and muscle pain.

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• Liver function disorders, including hepatitis. The patient may experience fatigue, yellowing of the skin and whites of the eyes, and flu-like symptoms.
• Cough.
• Acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).
• Nausea.

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

• Sudden onset of myopia.
• Malignant skin and lip tumours (non-melanoma skin cancers).
• Visual impairment or eye pain due to increased pressure (possible symptoms of fluid accumulation in the uvea surrounding the eye (excessive fluid accumulation between choroid and sclera), acute myopia, or acute angle-closure glaucoma).
• Systemic and cutaneous lupus erythematosus (an autoimmune disorder causing fever, joint pain, skin rash with redness, blistering, skin peeling, and nodule formation).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 181 C, 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 provide more information on the safety of the medicine.

5. How to store Carzap HCT

No special storage conditions are required for this medicinal product.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
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 Carzap HCT contains

• The active substances in this medicine are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• Other ingredients: monohydrate lactose, corn starch, hydroxypropylcellulose (E 463), sodium croscarmellose (E 468), magnesium stearate (E 572), and triethyl citrate (E 1505).

What Carzap HCT looks like and contents of the pack
Round, biconvex tablets, white or almost white, with an imprint "CH/16" and a score line on one side, approximately 8 mm in diameter. The tablet can be divided into equal doses.
Pack sizes: 14, 28, 56, 98 tablets.
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For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in the Czech Republic, the country of export:
Zentiva, k. s., U Kabelovny 130, 102 37, Prague 10, Czech Republic
Manufacturer:
Zentiva, k. s., U Kabelovny 130, 102 37, Prague 10, Czech Republic
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in the Czech Republic, the country of export: 58/772/11-C
Parallel Import Authorisation number: 361/19
This medicinal product is authorised for sale in the Member States of the European Economic Area under the following names:
Bulgaria КАРЗАП H
Czech Republic, Slovakia, Poland CARZAP HCT
Estonia, Latvia, Lithuania Carzan HCT
Portugal Candesartan + Hidroclorotiazida Zentiva
Romania CANZENO HCT
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