Candesartan Eg Stada

Package leaflet: Information for the patient

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

Equivalent medicine
Please read all of this leaflet carefully before you start 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 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 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. 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 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.

Candesartan EG STADA can be used to:

• treat high blood pressure (hypertension) in adult patients 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 (MRA) cannot be used (ACE inhibitors and MRAs 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 more than three months pregnant (it is better to avoid Candesartan EG STADA even in the early stages of 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, 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;
• inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Candesartan EG STADA is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, 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 EG STADA”).

Talk to your doctor if, after taking Candesartan EG STADA, you experience abdominal pain, nausea,
vomiting or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop
taking Candesartan EG STADA on your own.
Your doctor may check your kidney function, blood pressure and levels of electrolytes (e.g. potassium) in your
blood at regular intervals.
See also the information under the section "Do not take Candesartan EG STADA".
Your doctor may need to see you more often 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 EG STADA.
This is because Candesartan EG STADA, when combined with certain anaesthetics, may cause a drop in
blood pressure.
Children and adolescents
Candesartan EG STADA has been studied in children. For further information, consult your doctor.
Candesartan EG STADA must 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 may affect how other medicines work, and some medicines may affect Candesartan EG STADA. 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, as your doctor may need to adjust your 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 used to relieve pain and inflammatory conditions);
• acetylsalicylic acid (if you are taking more than 3 g per day) (a medicine used to relieve pain and inflammatory conditions);
• potassium supplements or potassium-containing salt substitutes (medicines that increase potassium levels in the blood);
• heparin (a medicine used to thin the blood);
• cotrimoxazole, also known as trimethoprim/sulfamethoxazole (an antibiotic);
• tablets that help you pass urine (diuretics);
• lithium (a medicine used for mental health conditions);
• if you are taking an ACE inhibitor or aliskiren (see also 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) (e.g. spironolactone, eplerenone).

Candesartan EG STADA with food, drinks and alcohol

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

Pregnancy and breastfeeding
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 EG STADA before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Candesartan EG STADA. Candesartan EG STADA is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. 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 a newborn or was born prematurely.
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 machinery.
Candesartan EG STADA contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Candesartan EG STADA

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 EG STADA
every day. Candesartan EG STADA may 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 remember to take it.
The 4 mg, 8 mg, 16 mg and 32 mg tablets may be divided into equal doses.

High blood pressure:

• The recommended dose of Candesartan EG STADA is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily and further increase it 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 due to, for example, vomiting, diarrhoea, or taking tablets that increase urine production, your doctor may prescribe a lower starting dose.
• Some patients of Black origin may have a reduced response to this medicine when used as the only treatment, and may require a higher dose.

Use in children and adolescents
Children and adolescents aged 6 to 18 years:
The recommended starting dose is 4 mg once daily.
For patients weighing less than 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 or more: 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 of Candesartan EG STADA is 4 mg once daily. Your doctor may increase this dose by doubling it at intervals of at least 2 weeks, up to a maximum of 32 mg once daily. Candesartan EG STADA 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 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 the forgotten tablet. Take only the next dose as usual.

If you stop taking Candesartan EG STADA
If you stop treatment with Candesartan EG STADA, your blood pressure may rise again. Therefore, do not stop treatment with Candesartan EG STADA 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 the possible side effects.
Stop taking Candesartan EG STADA 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 rashes).

Candesartan EG STADA may reduce the number of white blood cells in your blood. Your resistance to infections may decrease, and you may experience fatigue, infection or fever. If this occurs, contact your doctor. Your doctor may occasionally perform blood tests to check whether Candesartan EG STADA has affected your blood (agranulocytosis).
Other possible side effects include:
Common: may affect up to 1 in 10 people

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

Not known (frequency cannot be estimated from the available data)

• diarrhoea.

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 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 EG STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.
This medicine does not require any special storage conditions.

6. Package contents and other information

What Candesartan EG STADA contains
The active substance is candesartan cilexetil.
Candesartan EG Stada 4 mg tablets contain 4 mg of candesartan cilexetil.
Candesartan EG Stada 8 mg tablets contain 8 mg of candesartan cilexetil.
Candesartan EG Stada 16 mg tablets contain 16 mg of candesartan cilexetil.
Candesartan EG Stada 32 mg tablets contain 32 mg of candesartan cilexetil.
The other components are:
Monohydrate lactose, maize 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: white to off-white, round tablet, 7 mm in diameter, with a score line on one side and "4" on the other side.
Candesartan EG STADA 8 mg: round, pink tablet (non-uniform, possibly with small darker or white spots), 6.4 mm in diameter, with a score line on one side and "8" on the other side.
Candesartan EG STADA 16 mg: round, pink tablet (non-uniform, possibly with small darker or white spots), 7 mm in diameter, with a score line on one side and "16" on the other side.
Candesartan EG STADA 32 mg: round, pink tablet (non-uniform, possibly with small darker or white spots), 9.5 mm in diameter, with a score line on one side and "32" on the other side.

Tablets are available in:
Pack sizes of 4 mg:
Blister packs: 10, 14, 28, 30, 50, 56, 90, 98, 100 tablets.
Pack sizes of 8 mg:
Blister packs: 10, 14, 28, 30, 50, 56, 90, 98, 100 tablets.
Pack sizes of 16 mg:
Blister packs: 10, 14, 28, 30, 50, 56, 90, 98, 100 tablets.
Pack sizes of 32 mg:
Blister packs: 10, 14, 28, 30, 50, 56, 90, 98, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milano, Italy

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 authorized in the European Economic Area countries under the following names:
DE Candesartan AL 2 mg/4 mg/8 mg/16 mg/32 mg Tabletten
DK Candesartan STADA Arzneimittel AG
IT Candesartan EG STADA