CANDESARTAN 4 mg Tabletki Powlekane

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1. Candesartan EG STADA 4 mg tablets, 8 mg tablets, 16 mg tablets, 32 mg tablets
   1. What Candesartan EG STADA is and what it is used for
   2. What you need to know before taking Candesartan EG STADA
   3. How to take Candesartan EG STADA
   4. Possible side effects
   5. How to store Candesartan EG STADA
   6. Package contents and other information

Candesartan EG STADA 4 mg tablets, 8 mg tablets, 16 mg tablets, 32 mg tablets

Generic medicine

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

1. What Candesartan EG STADA is and what it is used for

The name of the medicine is Candesartan EG STADA. The active substance is candesartan cilexetil. It belongs to a
group of medicines called angiotensin II receptor antagonists. It works by causing the
relaxation and dilation of blood vessels. This helps to reduce blood pressure. Furthermore, it ensures that the
heart pumps blood more easily throughout the body.
Candesartan EG STADA can be used for:

• treating high blood pressure (hypertension) in adult patients and in children and adolescents aged from 6 to 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 MRA are medicines used to treat heart failure).

2. What you need to know before taking Candesartan EG STADA

Do not take Candesartan EG STADA:

• if you are allergic to candesartan cilexetil or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant for more than three months (it is best to avoid Candesartan EG STADA even in the early stages of pregnancy - see section Pregnancy);
• if you have a severe liver disease or 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, talk to your doctor or pharmacist before taking
Candesartan EG STADA.

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

• 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;
• tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Candesartan EG STADA is not recommended in early 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 during this period (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 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 (MRAs). These medicines are used to treat heart failure (see “Other medicines and Candesartan EG STADA”).

Talk to your doctor if, after taking Candesartan EG STADA, you experience abdominal pain, nausea,
vomiting or diarrhoea. The doctor will decide on the continuation of treatment. Do not stop
taking Candesartan EG STADA on your own.
The doctor may check your kidney function, blood pressure and the amount of electrolytes (such as
potassium) in your blood at regular intervals.
See also what is stated in the section "Do not take Candesartan EG STADA”.
The doctor may need to visit you more often and perform tests if you experience any of these conditions.
If you are about to have an operation, tell your doctor or dentist that you are taking Candesartan EG STADA.
This is because Candesartan EG STADA, when combined with some anaesthetics, can cause a drop
in blood pressure.

Children and adolescents
Candesartan EG STADA has been studied in children. For more information, talk to your doctor.
Candesartan EG STADA should not be given to children under 1 year of age due to the potential risk
to developing kidneys.

Other medicines and Candesartan EG STADA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Candesartan EG STADA can affect the mechanism of action of other medicines, and some medicines
can have an effect on Candesartan EG STADA. 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 as your doctor may
need to adjust the dose and/or take other precautions:

• 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, diclofenac, celecoxib, or etoricoxib (medicines for relieving pain and inflammation-like conditions);
• acetylsalicylic acid (if you are taking more than 3 g per day) (medicine for relieving pain and inflammation-like conditions);
• potassium supplements or salt substitutes containing potassium (medicines that increase the level of potassium in the blood);
• heparin (a medicine for thinning the blood);
• co-trimoxazole (an antibiotic) also known as trimethoprim/sulfamethoxazole;
• tablets that help you urinate (diuretics);
• lithium (a medicine for mental health problems);
• if you are taking an ACE inhibitor or aliskiren (see also what is stated in the section: "Do not take Candesartan EG STADA" 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) (for example spironolactone, eplerenone).

Candesartan EG STADA with food, drinks and alcohol

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

Pregnancy and breastfeeding
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 EG STADA
before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Candesartan EG STADA. Candesartan EG STADA
is not recommended in early 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.
Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Candesartan EG STADA 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 newborn or premature.

Driving and using machines
Some people may feel tired or dizzy when taking Candesartan EG STADA.
If this happens, do not drive or use tools or machines.

Candesartan EG STADA contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this
medicine.

3. How to take Candesartan EG STADA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist. It is important to continue taking Candesartan EG STADA every
day. Candesartan EG STADA can be taken with or without food.
Swallow the tablet with water.
Try to take the tablet at the same time each day. This will help you to remember to take it.
The 4 mg, 8 mg, 16 mg and 32 mg tablets can be divided into equal doses.
High blood pressure:

• The recommended dose of Candesartan EG STADA is 8 mg once a day. Your doctor may increase this dose up to 16 mg once a day and further up to 32 mg once a day depending on the 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 to urinate, the doctor may prescribe a lower starting dose.
• Some patients belonging to the black population may respond to this medicine in a reduced manner, when administered as single treatment, and may need a higher dose.

Use in children and adolescents
Children and adolescents from 6 to 18 years of age:
The recommended starting dose is 4 mg once a day.
For patients weighing less than 50 kg: in some patients whose blood pressure is not adequately
controlled, the doctor may decide whether the dose should be increased up to a maximum of 8 mg once a
day.
For patients weighing 50 kg or more: in some patients whose blood pressure is not
adequately controlled, the doctor may decide whether the dose should be increased to 8 mg once a
day and to 16 mg once a day.
Heart failure in adults:

• The recommended starting dose of Candesartan EG STADA is 4 mg once a day. The doctor may increase this dosage by doubling the dose at intervals of at least 2 weeks up to 32 mg once a day. Candesartan EG STADA can be taken together with other medicines for heart failure, and the doctor will decide what is the most suitable treatment for you.

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

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

If you stop taking Candesartan EG STADA
If you stop taking Candesartan EG STADA, your blood pressure may increase
again. Therefore do not stop taking Candesartan EG STADA 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 know what these side effects might be.

Stop taking Candesartan EG STADA and seek immediate medical attention 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 blisters).

Candesartan EG STADA 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 EG STADA has had any effects on your blood (agranulocytosis).
Other possible side effects include:

Common: may affect up to 1 in 10 people

• dizziness/feeling faint;
• headache;
• respiratory infection;
• low blood pressure. This can make you feel unwell or dizzy;
• changes in blood test results:
• 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 a tingling/burning sensation somewhere in your body;
• 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;
• reduction in red blood cells or white blood cells. You may notice fatigue, infection or fever;
• skin rash, hives;
• itching sensation;
• back pain, joint and muscle pain;
• changes in liver function, including inflammation of the liver (hepatitis). You may notice fatigue, yellowing of the skin or whites of the eyes, or flu-like symptoms;
• nausea;
• changes in blood test results:
• reduced amount of sodium in the blood. If this is severe, you may also notice weakness, lack of energy or muscle cramps;
• cough;
• intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting and diarrhea.

Not known (frequency cannot be estimated from available data)

• diarrhea.

Additional side effects in children
In children treated for high blood pressure, side effects appear to be similar to
those observed in adults, but occur more frequently. Sore throat in children is a very common side effect 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 EG STADA

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 on the blister after Exp.
The expiry date refers to the last day of that month.
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.
This medicine does not require any particular storage conditions.

6. Package contents and other information

What Candesartan EG STADA contains
The active ingredient is candesartan cilexetil.
Candesartan EG Stada 4 mg tablets contains 4 mg of candesartan cilexetil.
Candesartan EG Stada 8 mg tablets contains 8 mg of candesartan cilexetil.
Candesartan EG Stada 16 mg tablets contains 16 mg of candesartan cilexetil.
Candesartan EG Stada 32 mg tablets contains 32 mg of candesartan cilexetil.
The other ingredients are:
Lactose monohydrate, corn starch, hydroxypropylcellulose, calcium carmellose, macrogol 8000, magnesium
stearate. The 8 mg, 16 mg and 32 mg tablets also contain red iron oxide (E172).

Description of the appearance of Candesartan EG STADA and package contents
Candesartan EG STADA 4 mg: round tablet of 7 mm in white-whitish color with a breaking line on one side and "4" on the other side.
Candesartan EG STADA 8 mg: round tablet of 6.4 mm in pink color (non-uniform with possible small dark or white spots) with a breaking line on one side and "8" on the other side.
Candesartan EG STADA 16 mg: round tablet of 7 mm in pink color (non-uniform with possible small dark or white spots) with a breaking line on one side and "16" on the other side.
Candesartan EG STADA 32 mg: round tablet of 9.5 mm in pink color (non-uniform with possible small dark or white spots) with a breaking line on one side and "32" on the other side.
The tablets are available in:

Packs of 4 mg:
Blisters: 10, 14, 28, 30, 50, 56, 90, 98, 100 tablets.

Packs of 8 mg:
Blisters: 10, 14, 28, 30, 50, 56, 90, 98, 100 tablets.

Packs of 16 mg:
Blisters: 10, 14, 28, 30, 50, 56, 90, 98, 100 tablets.

Packs of 32 mg:
Blisters: 10, 14, 28, 30, 50, 56, 90, 98, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., via Pavia 6, 20136 Milan

Manufacturers
Laboratorios Liconsa S.A., Avda. Miralcampo, Nº7, Pol. Ind. Miralcampo Azuqueca de Henares
(Guadalajara) 19200 - Spain
STADA Arzneimittel AG, Stadastrasse 2-18 Bad Vilbel 61118 – Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
DE Candesartan AL 2 mg/4 mg/8 mg/16 mg/32 mg Tablets
DK Candesartan STADA Arzneimittel AG
IT Candesartan EG STADA