Candesartan Stada 32 mg Tablets

Introduction

Package Leaflet: Information for the User

Candesartan STADA 32 mg film-coated tablets EFG

Candesartan cilexetil

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

Your medicine is called Candesartan STADA. The active substance is candesartan cilexetil. This belongs to a group of medicines called angiotensin II receptor antagonists. It works by making your blood vessels relax and dilate. This helps to lower your 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 aged 6 to <18 years.< li>

• treatment of adult patients with heart failure with reduced functional capacity of the heart muscle 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).

2. What you need to know before you take Candesartan STADA

Do not takeCandesartan STADA

• if you are allergic to candesartan cilexetil 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 Candesartan STADA at the start of pregnancy - see section on Pregnancy),
• if you have a severe liver disease or biliary obstruction (a problem with the release of bile from the gallbladder).

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

If you are not sure if you are in one of these situations, consult your doctor or pharmacist before taking Candesartan STADA.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting Candesartan STADA.

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

• if you have recently had a kidney transplant,
• if you have vomited, have recently had severe vomiting or have had diarrhea,
• if you have a disease of the adrenal gland called Conn's syndrome (also known as primary hyperaldosteronism),
• if you have low blood pressure,
• if you have ever had a stroke,
• if you suspect that you are (or may be) pregnant, you must inform your doctor. It is not recommended to use Candesartan STADA at the start of pregnancy and it should not be taken if you are more than 3 months pregnant, as it can cause serious harm to your baby if used after the third month of pregnancy.
• 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 along 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 Candesartan STADA with other medicines").

Your doctor may want to check 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 Candesartan STADA".

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

If you are going to have surgery, tell your doctor or dentist that you are taking Candesartan STADA. This is because Candesartan STADA, in combination with some anesthetics, can 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. Candesartan STADA should not be given to children under 1 year of age due to a potential risk to the developing kidneys.

Other medicines and Candesartan STADA

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

Candesartan STADA may affect the way some medicines work and some medicines may affect the effect of Candesartan STADA. If you are using certain medicines, your doctor may need to perform blood tests from time to time.

In particular, tell your doctor if you are using any of the following medicines, as your doctor may need to change 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 medicines (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines to relieve pain and inflammation).
• Acetylsalicylic acid (if you take more than 3 g per day) (medicine to relieve pain and inflammation).
• 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 medicine) also known as trimethoprim/sulfamethoxazole.
• Diuretics (medicines to promote urine elimination).
• Lithium (a medicine for mental health problems).
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Candesartan STADA" and "Warnings and precautions")
• If you are being treated with an ACE inhibitor along with other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Taking Candesartan STADA with food, drinks, and alcohol

• You can take Candesartan STADA with or without food.
• When Candesartan STADA is prescribed, consult 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should inform your doctor if you think you are (or might be) pregnant. Your doctor will normally advise you to stop taking Candesartan STADA before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Candesartan STADA. It is not recommended to use Candesartan STADA at the start of pregnancy and it should not be taken after the third month of pregnancy, as it can cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are about to start or are already breastfeeding. Candesartan 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 using machines

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

Candesartan STADA contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially, "sodium-free".

3. How to take Candesartan STADA

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

It is important that you take Candesartan STADA every day. You can take Candesartan 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 each day. This will help you remember to take it.

High blood pressure:

• The recommended dose of Candesartan STADA is 8 mg once a day. Your doctor may increase this dose to 16 mg once a day and then up to 32 mg once a day depending on your 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 have a reduced response to this type of medicine when given as sole treatment, and these patients may need a higher dose.

Use in children and adolescents with high blood pressure:

Children from 6 to <18 years of age:< p>

The recommended starting dose is 4 mg once a day.

For patients with a weight <50 kg: in some patients whose blood pressure is not adequately controlled, the doctor may decide to increase dose up a maximum of 8 mg per day.< p>

For patients with a weight ≥ 50 kg: in some patients whose blood pressure is not adequately controlled, the 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 initial recommended dose of Candesartan STADA 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 STADA can be taken with other medicines for heart failure, and your doctor will decide what treatment is suitable for you.

If you take more Candesartan STADA than you should

If you take more Candesartan 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 Toxicology Information Service, telephone: 91 5620420, indicating the medicine and the amount taken.

If you forget to take Candesartan STADA

Do not take a double dose to make up for forgotten doses. Simply take the next dose as usual.

If you stop taking Candesartan STADA

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

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 everybody gets them. It is important that you know what these side effects may be.

Stop taking Candesartan STADA and go to your doctor immediately if you have 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 rash).

Candesartan 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 have a fever. If this happens, inform your doctor. It is possible that your doctor will perform a blood test from time to time to check that Candesartan STADA is not affecting your blood (agranulocytosis).

Other possible side effects include:

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

• dizziness/lightheadedness.
• headache.
• respiratory infection.
• low blood pressure. This can 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 situation is severe, you may feel tired, weak, have irregular heartbeats, 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.
• a decrease in red or white blood cells. You may feel tired, have an infection, or have a fever.
• skin rash, hives (urticaria).
• itching.
• back pain, joint and muscle pain.
• changes in liver function, including liver inflammation (hepatitis). You may feel tired, have a yellowish color of the skin and the whites of the eyes, and symptoms similar to those of 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 have muscle cramps.

• 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 the available data)

• diarrhea

In children treated for high blood pressure, the side effects seem to be similar to those seen in adults, but they occur more frequently. Sore throat is a very common side effect in children but has not been reported in adults, and runny nose, fever, and increased heart rate are common in children but have not been reported in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use. https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Candesartan 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 carton or blister after EXP. The expiry date refers to the last day of the month shown.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Candesartan STADA contains

• The active substance is candesartan cilexetil. Each tablet contains 32 mg of candesartan cilexetil.
• The other ingredients are: lactose monohydrate, corn starch, hydroxypropylcellulose, sodium croscarmellose, magnesium stearate, and triethyl citrate

Appearance and packaging

Candesartan STADA are white, biconvex tablets with a score line on one side and C32 embossed on the same side. The tablet can be divided into equal doses.

Pack sizes:

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

info@stada.es

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

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

Date of last revision of this leaflet:February 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/