Candesartan HCS

PACKAGE LEAFLET

Package leaflet: information for the user

Candesartan HCS 4 mg tablets, 8 mg tablets, 16 mg tablets, 32 mg tablets

candesartan cilexetil
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it may contain 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 others, even if their symptoms are the same as yours, as it could 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 HCS is and what it is used for
2. What you need to know before taking Candesartan HCS
3. How to take Candesartan HCS
4. Possible side effects
5. How to store Candesartan HCS
6. Contents of the pack and other information

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

The name of the medicine is Candesartan HCS. The active substance is candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor antagonists. It works by causing relaxation and dilation of blood vessels. This helps to reduce blood pressure. It also allows the heart to pump blood more easily throughout the body.

This medicine is used for:

• treating high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to under 18 years,
• Candesartan HCS may be used to 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 need to know before taking Candesartan HCS

Do not take Candesartan HCS if

• you are allergic (hypersensitive) to candesartan cilexetil or to any of the excipients of this medicine (listed in section 6),
• you are more than three months pregnant (it is best to avoid Candesartan HCS even in the early stages of pregnancy – see section Pregnancy),
• 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 HCS.

Warnings and precautions

Talk to your doctor or pharmacist before taking Candesartan HCS:

• if you have heart, liver or kidney problems or are on dialysis.
• if you have recently had a kidney transplant.
• if you are vomiting, have recently had severe vomiting, or have diarrhoea.
• if you have a disease of the adrenal gland known as Conn's syndrome (also called primary hyperaldosteronism).
• if you have low blood pressure.
• if you have ever had a stroke.
• inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Candesartan HCS 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 taken during this period (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 HCS").

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.

See also the information under the heading "Do not take Candesartan HCS".

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Candesartan HCS. Your doctor will decide whether to continue treatment. Do not stop taking Candesartan HCS on your own.

Your doctor may need to examine you more frequently and carry out tests if you have any of these conditions.

If you are about to undergo surgery, tell your doctor or dentist that you are taking Candesartan HCS. This is because Candesartan HCS, when combined with certain anaesthetics, may cause a drop in blood pressure.

Children and adolescents

Candesartan HCS has been studied in children. For further information, speak with your doctor.

Candesartan HCS must not be given to children under 1 year of age due to potential risks to kidney development.

Other medicines and Candesartan HCS

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Candesartan HCS may affect how other medicines work, and some medicines may affect Candesartan HCS. If you are taking certain medicines, your doctor may need to carry out blood tests from time to time.

In particular, tell your doctor if you are taking any of the following medicines:

• other medicines that help 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, or diclofenac, celecoxib or etoricoxib (medicines used to relieve pain and inflammation),
• acetylsalicylic acid (if you are 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, also known as trimethoprim/sulfamethoxazole (an antibiotic),
• tablets that help you pass urine (diuretics),
• lithium (a medicine used for mental health conditions).

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

• if you are taking an ACE inhibitor or aliskiren (see also information under "Do not take Candesartan HCS" 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 HCS with food and drink and alcohol

• You may take Candesartan HCS with or without food.
• When Candesartan HCS is prescribed for you, talk to your doctor before drinking alcohol. Alcohol may make you feel weak or dizzy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Candesartan HCS before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Candesartan HCS. Candesartan HCS 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 taken beyond the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Candesartan HCS is not recommended for women who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines

Some people may feel tired or dizzy while taking Candesartan HCS. If this happens to you, do not drive or operate tools or machinery.

Candesartan HCS contains lactose and sodium

If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg), i.e. essentially "sodium-free".

3. How to take Candesartan HCS

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. It is important to continue taking Candesartan HCS every day.
Candesartan HCS can be taken 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 HCS is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily and further up to 32 mg once daily, depending on your blood pressure response.
• In some patients, such as those with liver problems, kidney problems, or who have recently lost fluids (e.g. due to vomiting, diarrhoea, or taking tablets that increase urine production), your doctor may prescribe a lower starting dose.
• Some black patients may have a reduced response to this medicine when used as monotherapy and may require a higher dose.

Use in children and adolescents with high blood pressure
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, the 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, the doctor may decide to increase the dose to 8 mg once daily and further to 16 mg once daily.

Heart failure
The recommended starting dose of Candesartan HCS is 4 mg once daily. Your doctor may increase this dose by doubling it at intervals of at least 2 weeks, up to 32 mg once daily. Candesartan HCS may be taken together with other medicines for heart failure, and your doctor will decide which treatment is most suitable for you.

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

If you forget to take Candesartan HCS
Do not take a double dose to make up for the forgotten tablet. Take only the next dose as usual.

If you stop taking Candesartan HCS
If you stop treatment with Candesartan HCS, your blood pressure may rise again. Therefore, do not stop treatment with Candesartan HCS without first discussing it with your doctor.

If you have any doubts about how to use this medicine, consult 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 might be.
Stop taking Candesartan HCS 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, blister-like rashes)

Candesartan HCS may cause a reduction in the number of white blood cells in the blood. 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 check whether Candesartan HCS has affected your blood (agranulocytosis).

Other possible side effects include:
Common (may affect up to 1 in 100 people)

• Dizziness/vertigo
• Headache
• Respiratory infection
• Low blood pressure. This may make you feel weak or dizzy
• Changes in blood test results: increased potassium levels in the blood, especially if you already have kidney problems or heart failure. If this is severe, you may also notice 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
• Reduction in red or white blood cells. You may notice fatigue, 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
• Intestinal angioedema: intestinal swelling presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea
• Cough
• Nausea
• Changes in blood test results: reduced sodium levels in the blood. If this is severe, you may also notice weakness, lack of energy or muscle cramps

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 HCS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp.
The expiry date refers to the last day of that month.
Do not store above 30 °C.
Do not dispose of any medicine 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 HCS contains

• The active substance is candesartan cilexetil. Each tablet contains 4 mg, 8 mg, 16 mg or 32 mg of candesartan cilexetil.
• The excipients are monohydrate lactose, corn starch, dibutyl sebacate, sodium lauryl sulfate, hydroxypropylcellulose, calcium carmellose, magnesium stearate and red iron oxide (E172) – only for the 8 mg, 16 mg and 32 mg tablets. See section 2 “Candesartan HCS contains lactose and sodium”.

Description of the appearance of Candesartan HCS and contents of the pack
Candesartan HCS 4 mg: white, round, biconvex tablets, with a score line on one side and the number "4" engraved on it.
Candesartan HCS 8 mg: pink, round, biconvex tablets, with a score line on one side and the number "8" engraved on it.
Candesartan HCS 16 mg: slightly pink, round, biconvex tablets, with a score line on one side. One side is engraved with the number "1", the other side with the number "6".
Candesartan HCS 32 mg: slightly pink, round, biconvex tablets, with a score line on one side. One side is engraved with the number "3", the other side with the number "2".
The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and does not indicate division into equal doses.
Packs of 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98 and 100 tablets in blisters are available.
Not all pack sizes may be marketed.

Marketing Authorization Holder
HCS BV, H Kennisstraat 53, B 2650 Edegem, Belgium

Responsible producer for batch release
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Local representative in Italy
KRKA Farmaceutici Milano S.r.l. - Italy