Carzap hct

Package leaflet: Information for the patient

Carzap HCT, 8 mg + 12.5 mg, tablets
Carzap HCT, 16 mg + 12.5 mg, tablets
Candesartan cilexetil + Hydrochlorothiazide
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

The medicine is called Carzap HCT. It is used to treat high blood pressure (hypertension) in adult patients. The medicine 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 known as 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 a known 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),
• if the patient has diabetes or kidney impairment 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 to the patient, consult a
doctor or pharmacist before starting treatment with Carzap HCT.
Warnings and precautions
Before starting treatment with Carzap HCT, discuss the following with a doctor or pharmacist:

• if the patient has diabetes,
• if the patient has heart, liver or kidney problems,
• if the patient has recently received a kidney transplant,
• if the patient has had or is currently experiencing severe vomiting or diarrhoea,
• if the patient has a disease of the adrenal glands called Conn's syndrome (also known as primary hyperaldosteronism),
• if the patient has had skin cancer in the past or develops unexpected skin changes during treatment. Treatment with hydrochlorothiazide, especially at high doses and over a long period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking Carzap HCT, protect the skin from sunlight and UV radiation,
• if the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the uvea (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure – these may occur from a few 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 ever had allergies or asthma,
• if the patient has previously experienced 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. Carzap HCT is not recommended during early pregnancy and must not be used 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 used to treat high blood pressure:
• ACE inhibitors (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney problems 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 to the patient, the doctor may recommend more frequent
monitoring and tests.
If the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Carzap HCT,
discuss this with the doctor. The doctor will decide whether treatment should continue. Do not
discontinue Carzap HCT on your own.
If surgery is planned, inform the doctor or dentist about taking Carzap HCT, as concomitant use of
certain anaesthetics may cause excessive lowering of blood pressure.
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 or adolescents.
Carzap HCT and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any
medicines the patient plans to take. 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 a 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 (used 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 whose effects may be influenced 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 (sedative medicines, also used to treat epilepsy).
• 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 the antihypertensive effect, such as baclofen (a medicine that reduces skeletal muscle tone), amifostine (used in cancer treatment) and certain antipsychotics.

The doctor may recommend a 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, food, drink and alcohol
During treatment with Carzap HCT, consult a doctor before consuming alcohol.
Alcohol may cause feelings of weakness or dizziness.
Pregnancy, breastfeeding and fertility
Pregnancy
Inform the doctor if pregnancy is suspected (or planned). The doctor will usually recommend
discontinuing Carzap HCT before planning pregnancy or immediately after confirming pregnancy, and
will recommend using another medicine instead of Carzap HCT. 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 the doctor if breastfeeding or planning 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 infant is a newborn or premature.
Driving and operating machinery
While taking Carzap HCT, some patients may experience fatigue or dizziness. If these symptoms
occur, do not drive, use tools or operate machinery.
Carzap HCT contains lactose and sodium
Carzap HCT contains lactose, 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, meaning 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 in doubt,
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. Swallow the tablet 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 your tablet.
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 your usual time.
Stopping Carzap HCT
Stopping Carzap HCT may cause your 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
It is important for the patient to be aware of the possibility of adverse reactions occurring. Some of the
adverse reactions of Carzap HCT are caused by candesartan cilexetil, and others by
hydrochlorothiazide.
The use of Carzap HCT must be stopped immediately and medical help 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 itching of the skin (with raised lumps).

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

• Changes in blood test results:
  • Decreased sodium levels in the blood. If significantly reduced, weakness, lack of energy, or muscle cramps may occur.
  • 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, glucose, or uric acid in the blood.
• Presence of glucose in the urine.
• Dizziness/balance disorders or fatigue.
• Headache.
• Respiratory tract infection.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. May cause fainting or dizziness.
• Loss of appetite, diarrhoea, constipation, stomach irritation.
• Skin rash, urticaria, rash caused by photosensitivity. 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 a doctor immediately.
• Effects on kidney function, particularly in patients with impaired kidney function or heart failure.
• Sleep disorders, depression, anxiety.
• Tingling or pricking sensations in the arms or legs.
• Short-term blurred vision.
• Heart rhythm disturbances.
• Breathing difficulties (including pneumonia and 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.
• Decreased number of red blood cells, white blood cells, or platelets. The patient may feel fatigued, infections may occur, fever may develop, or bruising may appear easily.
• Severe, rapidly developing rash, with blisters or peeling of the skin 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.
• Angioedema of the intestine: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.
• Itching.
• Back pain, joint pain, and muscle pain.
• Liver function disorders, including hepatitis. The patient may feel fatigued, yellowing of the skin and whites of the eyes may occur, and flu-like symptoms may appear.
• Cough.
• Acute respiratory failure (symptoms include severe shortness of breath, fever, fatigue, 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 vascular membrane surrounding the eye (excessive fluid accumulation between choroid and sclera), acute myopia, or acute closed-angle 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 reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorisation holder or the representative of the marketing authorisation holder in Poland.
By reporting adverse reactions, more information can be gathered about the safety of using the medicine.

5. How to store Carzap HCT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and on the blister after EXP. The expiry date refers to the last day of the stated month.
This medicine does not require any special storage precautions.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will 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.
  Carzap HCT 8 mg + 12.5 mg: Each tablet contains 8 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
  Carzap HCT 16 mg + 12.5 mg: Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• Other ingredients: monohydrate lactose, corn starch, hydroxypropylcellulose (300 - 600 cps), sodium croscarmellose, magnesium stearate, and triethyl citrate.

What Carzap HCT looks like and contents of the pack
Carzap HCT 8 mg + 12.5 mg: Round, biconvex tablets, white or almost white, with an imprint "CH/8" and a break line on one side, approximately 8 mm in diameter.
Carzap HCT 16 mg + 12.5 mg: Round, biconvex tablets, white or almost white, with an imprint "CH/16" and a break line on one side, approximately 8 mm in diameter.
Pack sizes: 7, 14, 28, 30, 56, 70, 90, 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva k.s., U kabelovny 130, Dolni Měcholupy, 102 37 Prague 10, Czech Republic.

Manufacturer
Zentiva k.s., U kabelovny 130, Dolni Měcholupy, 102 37 Prague 10, Czech Republic.

This medicinal product is authorised in 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

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00