Carzap hct

Patient Information Leaflet

Carzap HCT, 32 mg + 12.5 mg, tablets
Carzap HCT, 32 mg + 25 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 a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Carzap HCT is and what it is used for
2. What you need to know 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 substances help 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 lower blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics (water tablets). It helps the body get rid of excess water and salts, such as sodium, through the urine. This also 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 is allergic 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,
• if the patient is in the 3rd month of pregnancy or later (Carzap HCT should also be avoided in early pregnancy – see section on pregnancy),
• if the patient has severe kidney function disorders,
• if the patient has severe liver disease or biliary obstruction or biliary tract narrowing (impaired bile flow from the gallbladder),
• 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 Carzap HCT.
Warnings and precautions
Before starting Carzap HCT, discuss with a doctor or pharmacist if:

• the patient has diabetes,
• the patient has heart, liver, or kidney disorders,
• the patient has recently received a kidney transplant,
• the patient has had or currently has severe vomiting or diarrhea,
• the patient has a disease of the adrenal glands called Conn's syndrome (also known as primary hyperaldosteronism),
• the patient has previously had skin cancer or develops an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially in high doses over a long period, may increase the risk of certain types of non-melanoma skin cancer, including skin and lip cancer. During treatment with Carzap HCT, protect the skin from sunlight and UV radiation,
• the patient has ever had systemic lupus erythematosus (SLE),
• the patient has low blood pressure,
• the patient has ever had a stroke,
• the patient has ever had allergies or asthma,
• the patient suspects (or plans) she may be pregnant. Use of Carzap HCT is not recommended in early pregnancy and must be avoided after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section on pregnancy),
• 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 problems related to diabetes,
  • aliskiren.
• the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (ciliary body effusion) or increased intraocular pressure. These may occur from a few hours to weeks after taking Carzap HCT and may lead to permanent vision loss if untreated. Patients who previously had an allergic reaction to penicillin or sulfonamides may be at higher risk of developing this condition.
• 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 breathing difficulties after taking Carzap HCT, seek immediate medical help.

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 check-ups and tests.
If the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Carzap HCT, discuss this with the doctor. The doctor will decide on further treatment. Do not stop taking Carzap HCT without medical advice.
If surgery is planned, inform the doctor or dentist about taking Carzap HCT, as concomitant use of certain anesthetics may cause excessive drop in 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 about all medicines currently used, recently used, or planned to be used.
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.
Especially 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 (painkillers and anti-inflammatory medicines),
• acetylsalicylic acid (at doses above 3 g per day) (painkiller and anti-inflammatory medicine),
• potassium supplements or potassium-containing salt substitutes (medicines that increase blood potassium levels),
• calcium or vitamin D,
• cholesterol-lowering medicines such as colestipol or cholestyramine,
• medicines used to treat diabetes (tablets or insulin),
• medicines controlling 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,
• laxatives,
• penicillin or co-trimoxazole (also known as trimethoprim/sulfamethoxazole) (antibiotics),
• amphotericin (used to treat fungal infections),
• lithium salts (a medicine used in psychiatric disorders),
• corticosteroid medicines, such as prednisolone,
• pituitary hormones (ACTH),
• medicines used in cancer treatment,
• amantadine (used in Parkinson's disease or severe viral infections),
• barbiturates (sedatives, also used in epilepsy treatment),
• carbenoxolone (used in esophageal 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, food, drink, and alcohol
Consult a doctor before consuming alcohol while taking Carzap HCT.
Alcohol may cause feelings of weakness or dizziness.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine.
Pregnancy
Inform the doctor if the patient thinks she is pregnant (or might become pregnant).
The doctor will usually advise stopping Carzap HCT before planning pregnancy or immediately after pregnancy is confirmed, 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 the doctor if the patient is breastfeeding or intends 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
While taking Carzap HCT, some patients may experience fatigue or dizziness. If such symptoms occur, do not drive, use tools, or operate machinery.

3. How to use Carzap HCT

This medicine should always be taken exactly as your doctor has told you. If you are unsure, 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 with food or independently of meals.
Try to take the tablet at the same time each day. This will help you remember to take your tablet.
Carzap HCT, 32 mg + 12.5 mg:
The score line on the tablet is only intended to facilitate breaking the tablet for easier swallowing.
Carzap HCT, 32 mg + 25 mg:
The tablet may be divided into equal doses.
Taking more Carzap HCT than prescribed
If you take more Carzap HCT than prescribed, 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 your blood pressure to rise again. Therefore, do not discontinue treatment with 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 that the patient is 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.
Treatment with Carzap HCT should be stopped immediately and medical help sought without delay
if the patient experiences any of the following allergic reactions:

• 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:
  • Decreased sodium levels in the blood. If significantly reduced, weakness, lack of energy or painful 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 and (or) impaired balance or weakness.
• Headaches.
• Respiratory tract infections.

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, photosensitivity rash.

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 disorders, depression, anxiety.
• Tingling or pricking sensations in the arms or legs.
• Short-term 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.
• Painful 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 feel fatigued, infections may occur, fever may develop or bruising may appear easily.
• 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.
• Angioedema of the intestine: intestinal swelling 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 breathlessness, 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 the 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 adverse effects not listed in this leaflet, inform your doctor,
pharmacist or nurse. Adverse effects can be reported directly to the Department for Monitoring of
Adverse Drug Reactions, 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 effects can also be reported to the marketing authorisation holder or the representative of
the marketing authorisation holder in Poland.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Carzap HCT

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack. The expiry date refers to the last day of the stated month.
No special requirements for storage conditions of the medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the packaging and other information

What Carzap HCT contains
The active substances in this medicine are candesartan cilexetil and hydrochlorothiazide.
Carzap HCT 32 mg + 12.5 mg: Each tablet contains 32 mg of candesartan cilexetil and 12.5 mg of
hydrochlorothiazide.
Other ingredients are: mannitol, maize starch, copovidone, glycerol, magnesium stearate, and yellow iron oxide (E172).
Carzap HCT 32 mg + 25 mg: Each tablet contains 32 mg of candesartan cilexetil and 25 mg of
hydrochlorothiazide.
Other ingredients are: mannitol, maize starch, copovidone, glycerol, magnesium stearate, yellow iron oxide (E172), and red iron oxide (E172).

What Carzap HCT looks like and contents of the pack
Carzap HCT 32 mg + 12.5 mg: Oval, biconvex (~12 x 6 mm), uncoated yellow tablets with a score line on one side.
Pack size: 28 tablets in blister packs.
Carzap HCT 32 mg + 25 mg: Oval, biconvex (~12 x 6 mm), uncoated peach-coloured tablets with a score line on one side, imprinted with the letters "C" and "H".
Pack size: 28 tablets in blister packs.

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

Manufacturer/Importer
Delorbis Pharmaceuticals Ltd.
17, Athinon Street, Ergates Industrial Area
2643 Nicosia
Cyprus
HBM Pharma s.r.o.
Sklabinská 30
036 80 Martin
Slovakia
S.C. Zentiva S.A.
50 Theodor Pallady Blvd., District 3
03226 Bucharest
Romania
Winthrop Arzneimittel GmbH
Brüningstraße 50
65926 Frankfurt am Main
Germany

This medicine is authorised for marketing in the European Economic Area under the following names:
Portugal: Candesartan + Hidroclorotiazida Zentiva
Czech Republic: CARZAP HCT
Germany: Candesartan Zentiva comp
Italy: Candesartan e Idrochlorotiazide Zentiva Italia
Poland: CARZAP HCT

For more detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00