Prospect: Information for the User

Candesartán STADA 32 mg Tablets EFG

Candesartán cilexetilo

Read this prospect carefully before starting to take this medication, as it contains important information for you.Read this prospect carefully before starting to take this medication, as it contains important information for you.

Keep this prospect, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Candesartán STADA and what is it used for.

2.What you need to know before starting to take Candesartán STADA.

3.How to take Candesartán STADA.

4.Possible adverse effects.

5.Storage of Candesartán STADA.

6.Contents of the package and additional information.

Your medicine is called Candesartán STADA. The active ingredient is candesartán cilexetilo. This belongs to a group of medicines called angiotensin II receptor antagonists. It works by making blood vessels relax and dilate. This helps to reduce blood pressure. It also makes it easier for your heart to pump blood to all parts of your body.

This medicine is used for:

• treatment of high blood pressure (hypertension) in adult patients and in children and adolescents from 6 to <18 years old

• treatment of adult patients with heart failure with reduced cardiac muscle function when it is not possible to use angiotensin-converting enzyme inhibitors (ACE inhibitors), or added to ACE inhibitors when symptoms persist despite treatment and it is not possible to use mineralocorticoid receptor antagonists (MRAs). (ACE inhibitors and MRAs are medicines used to treat heart failure)

Do not takeCandesartán STADA

• if you are allergic to candesartan cilexetilo or any of the other ingredients of this medicine (listed in section 6),
• if you are more than 3 months pregnant (in any case, it is better to avoid Candesartán STADA at the beginning of pregnancy - see Pregnancy section),
• if you have a severe liver disease or biliary obstruction (a problem with the bile flow from the gallbladder).

• if the patient is a child under 1 year of age
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

If you are unsure whether you are in any of these situations, consult your doctor or pharmacist before taking Candesartán STADA.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Candesartán STADA.

• if you have had heart, liver, or kidney problems, or are undergoing dialysis,

• if you have recently had a kidney transplant,
• if you have vomiting, have recently had severe vomiting, or have had diarrhea,
• if you have a condition called Conn's syndrome (also known as primary aldosteronism),
• if you have low blood pressure,
• if you have ever had a stroke,
• if you suspect that you (or may be) are pregnant, you must inform your doctor. Candesartán STADA is not recommended for use at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see Pregnancy section).
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (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 the class of drugs called mineralocorticoid receptor antagonists (MRAs). These medicines are for the treatment of heart failure (see "Taking Candesartán STADA with other medicines").

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Candesartán STADA”.

If you are in any of these situations, your doctor may want to see you more frequently and perform some tests.

If you are to undergo surgery, inform your doctor or dentist that you are taking Candesartán STADA. This is because Candesartán STADA, in combination with some anesthetics, may cause a drop in blood pressure.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking candesartan. Your doctor will decide whether to continue treatment. Do not stop taking candesartan on your own.

Children and adolescents

Candesartan has been studied in children. For more information, consult your doctor. Candesartán STADA should not be administered to children under 1 year of age due to a potential risk to the developing kidneys.

Other medicines and Candesartán STADA

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

Candesartán STADA may affect how some medicines work and some medicines may influence the effect of Candesartán STADA. If you are using certain medicines, your doctor may need to perform blood tests at regular intervals.

Especially, inform your doctor if you are using any of the following medicinesas your doctor may need to adjust your dose and/or take other precautions:

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and the so-called ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (pain-relieving and anti-inflammatory medicines).
• Acetylsalicylic acid (if you take more than 3 g per day) (pain-relieving and anti-inflammatory medicine).
• Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in your blood).
• Heparin (a medicine to increase blood fluidity).
• Cotrimoxazole (an antibiotic) also known as trimethoprim/sulfamethoxazole.
• Diuretics (medicines to promote urine excretion).
• Lithium (a medicine for mental health problems).
• ACE inhibitors or aliskiren (see also the information under the headings “Do not take Candesartán STADA” and “Warnings and precautions”)
• ACE inhibitors together with other specific medicines for the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Taking Candesartán STADA with food, drinks, and alcohol

• You can take Candesartán STADA with or without food.
• When Candesartán STADA is prescribed, consult your doctor before taking alcohol. Alcohol may make you feel weak or dizzy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must inform your doctor if you think you (or may be) are pregnant. Your doctor will usually advise you to stop taking Candesartán STADA before becoming pregnant or as soon as you become pregnant, and recommend taking another medicine instead of Candesartan STADA. Candesartán STADA is not recommended for use at the beginning of pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are to start or are breastfeeding. Candesartán STADA is not recommended for women who are breastfeeding, and your doctor may choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and operating machines

Some people may feel tired or dizzy when taking Candesartán STADA. If this happens to you, do not drive or operate tools or machines.

Candesartán STADA contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is essential to take Candesartán STADA every day. You can take Candesartán STADA with or without food. Swallow the tablet with a glass of water. The tablet can be divided into equal doses.

Try to take the tablet at the same time every day. This will help you remember to take it.

High Blood Pressure:

• The recommended dose of Candesartán STADA is 8 mg once a day. Your doctor may increase this dose to 16 mg once a day and then to 32 mg once a day based on blood pressure response.
• In some patients, such as those with liver problems, kidney problems, or those who have recently lost body fluids, for example, due to vomiting, diarrhea, or because they are taking diuretics, the doctor may prescribe a lower initial dose.
• Some black patients may present a reduced response to this type of medication when given as a single treatment, and these patients may need a higher dose.

Use in children and adolescents with high blood pressure:

Children from 6 to <18

The recommended starting dose is 4 mg once a day.

For patients weighing <50

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 a day and to 16 mg once a day.

Heart Failure in Adults:

The recommended initial dose of Candesartán STADA is 4 mg once a day. Your doctor may increase this dose by doubling the dose in intervals of at least 2 weeks up to 32 mg once a day. Candesartán STADA can be taken with other medications for heart failure, and your doctor will decide what treatment is suitable for you.

If you take more Candesartán STADA than you should

If you take more Candesartán STADA than prescribed by your doctor, contact your doctor or pharmacist immediately. If you have taken more candesartan than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount taken.

If you forget to take Candesartán STADA

Do not take a double dose to compensate for the missed doses. Simply take the next dose as usual.

If you interrupt treatment with Candesartán STADA

If you stop taking Candesartán STADA, your blood pressure may increase again. Therefore, do not stop taking Candesartán STADA without consulting your doctor first.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. It is important that you know which side effects could occur.

Stop taking Candesartán STADA and see your doctor immediately 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 skin itching (skin rash).

Candesartán STADA may cause a decrease in the number of white blood cells. Your resistance to infections may be reduced, and you may feel tired, have an infection, or fever. If this occurs, inform your doctor. It is possible that your doctor will perform a blood test at regular intervals to check that Candesartán STADA is not affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (may affect up to 1 in 10 people):

• Dizziness or vertigo.
• Headache.
• Respiratory infection.
• Low blood pressure. This may cause dizziness or weakness.
• Changes in blood test results.

• An increase in potassium levels in the blood, especially if you already have kidney problems or heart failure. If this is severe, you will feel tired, weak, have irregular heartbeats, or experience numbness.

• Effects on kidney function, especially if you already have kidney problems or heart failure. In very rare cases, kidney failure may occur.

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 feel tired, have an infection, or fever.
• Skin rash, hives (urticaria).
• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, including inflammation of the liver (hepatitis). You will feel tired, have a yellowish discoloration of the skin and the white of the eyes, and symptoms similar to the flu.
• Cough.
• Nausea.
• Changes in blood test results:

• A decrease in sodium levels in the blood. If severe, you may feel weak, lack energy, or experience muscle cramps.

• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

• Diarrhea

In children treated for hypertension, side effects appear to be similar to those seen in adults, but occur more frequently. Throat pain is a very frequent side effect in children but has not been reported in adults, and runny nose, fever, and increased heart rate are frequent in children but have not been reported in adults.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them through the Spanish System for the Pharmacovigilance of Medicines for Human Use. https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging or blister. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Do not dispose of the medication through the drains or trash. Deposit the packaging and medication that you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medication that you no longer need. This will help protect the environment.

Composition of Candesartán STADA

• The active ingredient is candesartan cilexetil. Each tablet contains 32 mg of candesartan cilexetil.
• The other components are: lactose monohydrate, cornstarch, hydroxypropylcellulose, sodium croscarmellose, magnesium stearate, and triethyl citrate.

Appearance of the product and content of the container

Candesartán STADA are white, biconvex tablets with a notch on one side and C32 in relief on the same side. The tablet can be divided into equal doses.

Container sizes:

7, 7x1 (single-dose), 10, 10x1 (single-dose), 14, 14x1 (single-dose), 28, 28x1 (single-dose), 30, 30x1 (single-dose), 50, 50x1 (single-dose), 56, 56x1 (single-dose), 90, 90x1 (single-dose), 98, 98x1 (single-dose), 100, 100x1 (single-dose), 112, 112x1 (single-dose), 126, 126x1 (single-dose), 140, 140x1 (single-dose), 154, 154x1 (single-dose), 168, 168x1 (single-dose), 182, 182x1 (single-dose), 196, 196x1 (single-dose) tablets.

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

or

Eurogenerics N.V.

Heizel Esplanade B22

1020 Brussels

Belgium

or

LAMP SAN PROSPERO S.p.A.

Via della Pace, 25/A

41030 San Prospero (Modena)

Italy

or

Siegfried Malta Ltd.

HHF070 Hal Far Industrial Estate, Hal Far

BBG3000

Malta

Last review date of this leaflet: February 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/