CANDESARTAN 4 mg Tablet

Зміст інструкції

1. Candesartan HCS 4 mg tablets, 8 mg tablets, 16 mg tablets, 32 mg tablets
   1. What Candesartan HCS is and what it is used for
   2. What you need to know before taking Candesartan HCS
2. Candesartan HCS has been studied in children. For more information, talk to your
3. Candesartan HCS. Candesartan HCS is not recommended during the early stages of pregnancy, and
   1. How to take Candesartan HCS
   2. Possible side effects
   3. How to store Candesartan HCS
   4. Package contents and other information

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

Candesartan cilexetil
Generic 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 you get any side effects, even those not listed in this leaflet, tell 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 you take 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 ingredient is candesartan cilexetil.
It belongs to a group of medicines called angiotensin II receptor antagonists.
It works by causing the relaxation and widening of blood vessels. This helps to reduce
blood pressure. It also ensures that the heart pumps 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 from 6 up to under 18 years,
• Candesartan HCS can 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 (MRA) 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 any of the other ingredients of this medicine (listed in section 6),
• you are pregnant for more than three months (it is best to avoid Candesartan HCS even in the early stages of pregnancy - see section Pregnancy),
• you have a severe liver disease or obstruction of the bile ducts (a problem with drainage of bile from the gallbladder),
• the patient is a child under 1 year of age
• 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 HCS.

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

• if you have problems with your heart, liver or kidneys 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.
• tell your doctor if you think you might be pregnant (or if there is a possibility of becoming pregnant). Candesartan HCS is not recommended in early pregnancy, and must not be taken if you are pregnant for more than three months, as it may cause serious harm to the 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), especially if you have 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 to treat heart failure (see "Other medicines and Candesartan HCS").

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 HCS".
Your doctor may need to see you more often and carry out tests if you develop any of
these conditions.
If you are going to have an operation, tell your doctor or dentist that you are taking Candesartan
HCS. This is because Candesartan HCS, when combined with certain anaesthetics, can
cause a drop in blood pressure.

Children and adolescents

Candesartan HCS has been studied in children. For more information, talk to your

doctor. Candesartan HCS should not be given to children under 1 year of age due to potential risks in 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 can affect the mechanism of action of other medicines, and some medicines
may have an effect on Candesartan HCS. If you are taking certain medicines, your
doctor may need to perform 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 to relieve pain and inflammation)
• acetylsalicylic acid (if you are taking more than 3 g per day) (medicine to relieve pain and inflammation)
• potassium supplements or salt substitutes containing potassium (medicines that increase the level of potassium in the blood)
• heparin (a medicine to thin the blood)
• tablets that help you urinate (diuretics)
• lithium (a medicine for mental health problems).

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

• If you are taking an ACE-inhibitor or aliskiren (see also the section "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 (MRA) (for example spironolactone, eplerenone).

Candesartan HCS with food and drink and alcohol

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

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to
become pregnant, ask your doctor or pharmacist for advice before taking this
medicine.
Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant). Usually your doctor will advise you to stop taking
Candesartan HCS before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of

Candesartan HCS. Candesartan HCS is not recommended during the early stages of pregnancy, and

must not be taken if you are more than three months pregnant, as it may cause
serious harm to the baby if taken after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or are planning to start breast-feeding. Candesartan HCS is
not recommended for women who are breast-feeding and your doctor may choose an alternative
treatment for you if you wish to breast-feed, especially if your baby is newborn or was born
prematurely.

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

Candesartan HCS contains lactose
If you have been diagnosed with intolerance to some sugars, contact your doctor before
taking this medicine.

3. How to take Candesartan HCS

Always take this medicine exactly as your doctor or
pharmacist has told you. If you have doubts, ask your doctor or pharmacist. It is important to continue to
take 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 to remember to
take it.

High blood pressure

• The recommended dose of Candesartan HCS is 8 mg once a day. Your doctor may increase this dose to 16 mg once a day and further to 32 mg once a day depending on your blood pressure response.
• In some patients, such as those with liver problems, kidney problems or who have recently lost fluids due to for example: vomiting, diarrhea or taking tablets that help you to urinate, your doctor may prescribe a lower starting dose.
• Some patients of Black race may respond to this medicine in a reduced manner, when it is given as a single treatment, and may need a higher dose.

Use in children and adolescents with high blood pressure
Children from 6 to 18 years of age
The recommended starting 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 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 the dose should be increased to 8
mg once a day and to 16 mg once a day.

Heart failure
The recommended initial dose of Candesartan HCS is 4 mg once a day. Your doctor
may increase this dose by doubling the dose at intervals of at least 2 weeks
up to 32 mg once a day. Candesartan HCS can be taken together with other
medicines for heart failure and your doctor will decide which is the most suitable treatment
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 a missed tablet. Just take
the next dose as usual.

If you stop taking Candesartan HCS
If you stop taking Candesartan HCS, your blood pressure may
increase again. Therefore do not stop taking Candesartan HCS 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 HCS 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 may cause difficulty in swallowing
• severe itching of the skin (with raised blisters).

Candesartan HCS can cause a decrease 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 happens, contact your doctor. Your doctor may occasionally perform blood tests to check if
Candesartan HCS has had any effects on your blood (agranulocytosis).
Other possible side effects include:

Common (may affect up to 1 in 10 people)

• Feeling dizzy/lightheaded.
• Headache.
• Respiratory infection.
• Low blood pressure. This may make you feel weak or dizzy.
• Changes in blood test results: an increased amount of potassium 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 the function of your kidneys, 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 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.
• Cough.
• Nausea.
• Changes in blood test results: a reduced amount of sodium 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):

• Diarrhea.

In children treated for high blood pressure, side effects appear to be similar to those
observed in adults, but occur more often. 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 HCS

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 after
Exp.
The expiry date refers to the last day of that month.
Do not store at a temperature above 30 °C.
Do not dispose of any medicine in wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. Package contents and other information

What Candesartan HCS contains

• The active ingredient is candesartan cilexetil. Each tablet contains 4 mg, 8 mg, 16 mg or 32 mg of candesartan cilexetil.
• The excipients are lactose monohydrate, corn starch, dibutyl sebacate, sodium lauryl sulfate, hydroxypropylcellulose, calcium carmellose, magnesium stearate and red iron oxide (E172) - only for 8 mg, 16 mg and 32 mg tablets.

Description of the appearance of Candesartan HCS and package contents
4 mg: white, round, biconvex tablets, with a score line on one side.
8 mg: white-pink coloured, round, biconvex tablets, with a score line on one
side.
16 mg: light pink, round, biconvex tablets, with a score line on one side.
32 mg: light pink, round, biconvex tablets, with a score line on one side.
The score line on the tablet is to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.
Packs of 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100 are available in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
HCS bvba, H Kennisstraat 53, B 2650 Edegem, Belgium
P roducing manufacturer responsible 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 for Italy
KRKA Farmaceutici Milano S.r.l. Viale Achille Papa 30, 20149 Milano, Italy