CANDESARTAN 8 mg Tabletka Powlekana

Treść ulotki

1. Candesartan Zentiva 8 mg tablets
   1. What Candesartan Zentiva is and what it is used for
   2. What you need to know before taking Candesartan Zentiva
   3. How to take Candesartan Zentiva
   4. Possible side effects
   5. How to store Candesartan Zentiva
   6. Package contents and other information

Candesartan Zentiva 8 mg tablets

Candesartan Zentiva 16 mg tablets
Candesartan Zentiva 32 mg tablets
EQUIVALENT MEDICINE

Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Candesartan Zentiva is and what it is used for
• 2. What you need to know before you take Candesartan Zentiva
• 3. How to take Candesartan Zentiva
• 4. Possible side effects
• 5. How to store Candesartan Zentiva
• 6. Contents of the pack and other information

1. What Candesartan Zentiva is and what it is used for

The name of the medicine is Candesartan Zentiva. The active ingredient is candesartan cilexetil.
This medicine belongs to a group of medicines called angiotensin II receptor antagonists.
It works by relaxing and widening blood vessels. This helps to reduce
blood pressure. It also helps the heart to pump blood to all parts of the body.

Candesartan Zentiva is used for:

• treating high blood pressure (hypertension) in adult patients and in children and adolescents aged between 6 and < 18 years;
• treating heart failure in adult patients with reduced heart muscle function when angiotensin-converting enzyme (ACE) inhibitors cannot be used or in addition to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRA) cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. What you need to know before taking Candesartan Zentiva

Do not take Candesartan Zentiva

• if you are allergic to candesartan cilexetil or any of the other ingredients of this medicine (listed in section 6);
• if you are more than 3 months pregnant (it is best to avoid using Candesartan Zentiva even at the beginning of pregnancy - see section “Pregnancy”);
• if you suffer from a severe liver disease or an obstruction of the bile ducts (a problem with the drainage of bile from the gallbladder);
• if the patient is a child under 1 year of age;
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

If you are not sure if any of these conditions apply to you, consult your doctor or pharmacist before taking Candesartan Zentiva.

Warnings and precautions
Talk to your doctor or pharmacist before taking Candesartan Zentiva:

• if you suffer from heart, liver or kidney problems or are undergoing dialysis;
• if you have recently had a kidney transplant;
• if you are vomiting, have recently vomited or have diarrhoea;
• if you have a disease of the adrenal gland called Conn's syndrome (also called primary hyperaldosteronism);
• if you suffer from low blood pressure;
• if you have had a stroke in the past;
• you must inform your doctor if you think you are (or may become) pregnant. Candesartan Zentiva is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant as it may cause serious harm to the baby if used at this stage (see section “Pregnancy”);
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE-inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes;
• aliskiren.
• if you are taking an ACE-inhibitor together with a medicine that belongs to the class of medicines known as mineralocorticoid receptor antagonists (MRA). These medicines are used for the treatment of heart failure (see “Other medicines and Candesartan Zentiva”). Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also what is stated under "Do not take Candesartan Zentiva”. Your doctor may want to visit you more often and have you undergo tests if you have any of these conditions.

If you are about to undergo surgery, inform your doctor or dentist that you are taking Candesartan Zentiva. This is because Candesartan Zentiva, when combined with certain anesthetics, can cause an excessive drop in blood pressure.

Children and adolescents
Candesartan cilexetil has been studied in children. For further information, consult your doctor. Candesartan Zentiva should not be given to children under 1 year of age due to the potential risk to developing kidneys.

Other medicines and Candesartan Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Candesartan Zentiva can affect the mechanism of action of other medicines, and some medicines can have an effect on Candesartan Zentiva. If you are taking certain medicines, your doctor may need to have you undergo blood tests periodically.
In particular, tell your doctor if you are taking any of the following medicines:

• other medicines that help to lower blood pressure, including beta-blockers, diazoxide;
• non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines for relieving pain and inflammation);
• acetylsalicylic acid (if you take more than 3 g every day) (a medicine for relieving pain and inflammation);
• potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in the blood);
• heparin (a medicine for thinning the blood);
• co-trimoxazole (an antibiotic) also known as trimethoprim/sulfamethoxazole;
• water tablets (diuretics);
• lithium (a medicine for mental health problems).

Your doctor may need to adjust the dose and/or take other precautions:

• if you are taking an ACE-inhibitor or aliskiren (see also what is stated under: "Do not take Candesartan Zentiva" and "Warnings and precautions“);
• if you are being treated with an ACE-inhibitor together with other medicines used for heart failure, known as mineralocorticoid receptor antagonists (MRA) (for example spironolactone, eplerenone).

Candesartan Zentiva with food, drinks and alcohol
If you are prescribed Candesartan Zentiva, consult your doctor before drinking alcohol.
Alcohol may cause weakness or dizziness.

Pregnancy, breastfeeding and fertility
Pregnancy
You must inform your doctor if you think you are (or may become )pregnant. As a rule, your doctor will advise you to stop using Candesartan Zentiva before starting a pregnancy or as soon as you know you are pregnant and will advise you to take another medicine instead of Candesartan Zentiva. Candesartan Zentiva is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant as it may cause serious harm to the baby if used after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Candesartan Zentiva is not recommended for mothers who are breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or was born prematurely.

Driving and using machines
Some people may feel tired or dizzy when taking Candesartan Zentiva. If this happens to you, do not drive vehicles or use tools or machinery.

Candesartan Zentiva contains lactose monohydrate and sodium
Candesartan Zentiva contains lactose monohydrate, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Candesartan Zentiva

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist. It is important that you take Candesartan Zentiva every day.
You can take Candesartan Zentiva with or without food.
Swallow the tablet with a glass of water.
Try to take the tablet at the same time each day. This will help you to remember to take the tablet.

High blood pressure

• The recommended dose of Candesartan Zentiva is 8 mg once a day. Your doctor may increase the dose to 16 mg once a day and subsequently up to 32 mg once a day based on the response of the blood pressure.
• Some patients - for example, those suffering from liver or kidney problems or who have recently lost body fluids, e.g. due to vomiting or diarrhea or following the use of diuretics - the doctor may prescribe a lower initial dose.
• Some patients of Black skin may experience a reduced response to this type of medicine when taken as a single treatment, therefore these patients may require a higher dose.

Use in children and adolescents with hypertension
Children aged between 6 and < 18 years:
The recommended initial dose is 4 mg once a day.
For patients weighing <50 kg: In some patients whose blood pressure is not adequately controlled, the doctor may decide that the dose should be increased up to a maximum of 8 mg once a day.
For patients weighing ≥ 50 kg: In some patients whose blood pressure is not adequately controlled, the doctor may decide that the dose should be increased to 8 mg once a day and to 16 mg once a day.

Heart failure in adults:
The recommended initial dose is 4 mg once a day. The doctor may increase the dose by doubling it at intervals of at least 2 weeks up to a dose of 32 mg once a day. Candesartan Zentiva can be taken together with other medicines for heart failure and the doctor will decide which treatment is suitable for you.

If you take more Candesartan Zentiva than you should
If you take more Candesartan Zentiva than prescribed by your doctor, contact your doctor or pharmacist immediately for advice.

If you forget to take Candesartan Zentiva
Do not take a double dose to make up for a missed tablet. Simply take the next dose as usual.

If you stop taking Candesartan Zentiva
If you stop taking Candesartan Zentiva, your blood pressure may increase again. Therefore, do not stop taking Candesartan Zentiva without first talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
It is important that you are aware of what these side effects may be.

Stop taking Candesartan Zentiva and seek immediate medical help if you
experience 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 can cause difficulty in swallowing;
• intense itching of the skin (with raised blisters).

Candesartan Zentiva can cause a decrease in the number of white blood cells. Your
resistance to infections may decrease and you may notice fatigue, infection or fever. If
this happens, contact your doctor. Your doctor may occasionally perform blood tests to check if Candesartan Zentiva has had any effect on blood levels
(agranulocytosis).
Other possible side effects include:

Common (may affect up to 1 in 10 people)

• Dizziness
• Headache
• Respiratory tract infection
• Low blood pressure, which may cause weakness or dizziness
• Changes in blood test results:

an increased amount of potassium in the blood, especially if you already have kidney problems
or heart failure. If the increase in potassium is high, you may experience
fatigue, weakness, irregular heartbeat or tingling

• Effects on kidney function, especially if you already have 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
• A decrease in red blood cells or white blood cells. You may feel tired or develop an infection or fever
• Skin rash, rash with swelling (urticaria)
• Itching
• Back pain, joint and muscle pain
• Changes in liver function, including inflammation of the liver (hepatitis). You may notice fatigue, yellowing of the skin and the whites of the eyes, and flu-like symptoms
• Nausea
• Cough
• Changes in blood test results: a reduced amount of sodium in the blood. If the reduction is severe, it can lead to weakness, loss of energy or muscle cramps.

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

• Diarrhea In children treated for high blood pressure, side effects appear to be similar to those observed in adults, but occur more frequently. Sore throat is a very common side effect in children, but not reported in adults, and runny nose, fever and increased heart rate are common in children, but not reported in adults.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Candesartan Zentiva

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the packaging and blister. The expiry date refers to the last day of that month.
• The medicine does not require special storage conditions.

Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Candesartan Zentiva contains
The active ingredient is candesartan cilexetil.

Candesartan Zentiva 8 mg tablets
Each tablet contains 8 mg of candesartan cilexetil.

Candesartan Zentiva 16 mg tablets
Each tablet contains 16 mg of candesartan cilexetil.

Candesartan Zentiva 32 mg tablets
Each tablet contains 32 mg of candesartan cilexetil.
The other ingredients are: lactose monohydrate, corn starch, hydroxypropylcellulose,
sodium croscarmellose, magnesium stearate and triethyl citrate.

Description of the appearance of Candesartan Zentiva and package contents
Candesartan Zentiva 8 mg tablets are biconvex, white in color with a score line on one side and C8 imprinted on the same side, approximate diameter of 8 mm.
Candesartan Zentiva 16 mg tablets are biconvex, white in color with a score line on one side and C16 imprinted on the same side, approximate diameter of 8 mm.
Candesartan Zentiva 32 mg tablets are biconvex, white in color with a score line on one side and C32 imprinted on the same side, approximate diameter of 10.5 mm.
The tablet can be divided into two equal doses.
Packs: 7, 14, 28, 30, 56, 70, 90 and 98 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Zentiva Italia S.r.l.
Viale L. Bodio, 37/b
20158 Milan - Italy

Manufacturer:
Siegfried Malta Ltd
HHF070 Hal Far Industrial Estate
P.O. box 14
Hal Far BBG 07 - Malta
Sanofi S.P.A.
Viale Europa, 11
21040 Origgio (MI) – Italy
Zentiva k.s.
U Kabelovny 130
Prague 10 – Dolni Mecholupy 102 37
Czech Republic

This medicinal product is authorised in the Member States of the European Economic
Area with the following denominations: