Candesartan Zentiva

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Candesartan Zentiva 8 mg tablets, 16 mg tablets, 32 mg tablets

EQUIVALENT MEDICINE
Please read this leaflet carefully before you start taking this medicine, as 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 substance is candesartan cilexetil.
This medicine belongs to a group of medicines known as angiotensin II receptor antagonists.
It works by relaxing and widening blood vessels. This helps lower blood pressure. It also helps the heart pump blood to all parts of the body.

Candesartan Zentiva is used to:

• treat high blood pressure (hypertension) in adults and in children and adolescents aged 6 to < 18 years;
• treat 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 (MRAs) cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. What you should know before taking Candesartan Zentiva

Do not take Candesartan Zentiva

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

If you are unsure whether 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 have heart, liver or kidney problems or are on dialysis;
• if you have recently undergone 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 known as primary hyperaldosteronism);
• if you have low blood pressure;
• if you have had a stroke in the past;
• you must inform your doctor if you think you may be (or may become) pregnant. Candesartan Zentiva is not recommended during early pregnancy and must not be taken after the third month of pregnancy as it may cause serious harm to the unborn baby when 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" (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes;
• aliskiren.
  • if you are taking an ACE-inhibitor together with a medicine belonging to a class of medicines known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see “Other medicines and Candesartan Zentiva”). Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals. See also information under the heading "Do not take Candesartan Zentiva". Your doctor may wish to examine you more frequently and carry out 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 anaesthetics, may 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 must 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 may affect how other medicines work, and some medicines may affect Candesartan Zentiva. If you are taking certain medicines, your doctor may need to perform periodic blood tests.
In particular, inform your doctor if you are taking any of the following medicines:

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

Your doctor may consider it necessary to adjust your dose and/or take other precautions:

• if you are taking an ACE-inhibitor or aliskiren (see also information 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 (MRAs) (e.g. spironolactone, eplerenone).

Candesartan Zentiva with food, drinks and alcohol
If you have been 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 may be (or may become) pregnant. Your doctor will normally advise you to stop taking Candesartan Zentiva before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Candesartan Zentiva is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if used beyond the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or about to start breast-feeding. Candesartan Zentiva is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is a 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 or operate tools or machinery.
Candesartan Zentiva contains lactose monohydrate and sodium
Candesartan Zentiva contains lactose monohydrate, a type of sugar. If your doctor has informed you that you have an intolerance to certain 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 exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist. It is important that you take Candesartan Zentiva every day.
You may 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 remember to take it.

High blood pressure

• The recommended dose of Candesartan Zentiva is 8 mg once daily. Your doctor may increase the dose to 16 mg once daily and subsequently up to 32 mg once daily, depending on your blood pressure response.
• Your doctor may prescribe a lower starting dose for some patients – for example, those with liver or kidney problems, or those who have recently lost body fluids (e.g. due to vomiting, diarrhoea, or diuretic use).
• In some patients of black origin, response to this type of medicine may be reduced when used as monotherapy; therefore, these patients may require higher doses.

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

Heart failure in adults:
The recommended starting dose is 4 mg once daily. Your doctor may double the dose at intervals of at least 2 weeks, up to a maximum of 32 mg once daily. Candesartan Zentiva may be taken together with other medicines for heart failure, and your doctor will decide which treatment is appropriate for you.

If you take more Candesartan Zentiva than you should
If you take more Candesartan Zentiva than prescribed, 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 the 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 rise again. Therefore, do not stop taking Candesartan Zentiva without first talking to your doctor.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is important that you are aware of what these side effects might be.
Stop taking Candesartan Zentiva and seek immediate medical help if you experience 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 swallowing;
• severe itching of the skin (with raised, itchy bumps).

Candesartan Zentiva may cause a reduction in the number of white blood cells. Your resistance to infections may decrease, and you may notice fatigue, infection or fever. If this occurs, contact your doctor. Your doctor may occasionally perform blood tests to monitor whether Candesartan Zentiva has affected your blood levels (agranulocytosis).

Other possible side effects include:

Common (may affect up to 1 in 10 people)

• Dizziness/vertigo
• Headache
• Respiratory tract infection
• Low blood pressure, which may cause weakness or dizziness
• Changes in blood test results:
  increased levels of potassium in the blood, especially if you already have kidney problems or heart failure. If potassium levels are significantly elevated, you may experience fatigue, weakness, irregular heartbeat, or tingling sensations
• Effects on kidney function, particularly 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
• Reduction in red or white blood cells. You may experience fatigue 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 whites of the eyes, and flu-like symptoms
• Nausea
• Cough
• Changes in blood test results: reduced levels of sodium in the blood. If the reduction is severe, it may cause weakness, loss of energy, or muscle cramps.

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

• Diarrhoea

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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the packaging and blister. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.

Do not dispose of medicines via wastewater 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 substance 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 components are: monohydrate lactose, maize starch, hydroxypropylcellulose,
sodium croscarmellose, magnesium stearate and triethyl citrate.

Description of the appearance of Candesartan Zentiva and pack contents
Candesartan Zentiva 8 mg tablets are biconvex, white in colour, with a score line on one side and marked "C8" on the same side, approximately 8 mm in diameter.
Candesartan Zentiva 16 mg tablets are biconvex, white in colour, with a score line on one side and marked "C16" on the same side, approximately 8 mm in diameter.
Candesartan Zentiva 32 mg tablets are biconvex, white in colour, with a score line on one side and marked "C32" on the same side, approximately 10.5 mm in diameter.
The tablet can be divided into two equal doses.
Pack sizes: 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

Manufacturers:
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 European Economic Area countries under the following names: