Candesartan Stada 8 mg Tablets

Introduction

Package Leaflet: Information for the User

Candesartan STADA 8 mg 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. Storing 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 ingredient 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 ejection fraction when angiotensin-converting enzyme (ACE) inhibitors are not tolerated or as add-on therapy to ACE inhibitors when beta-blockers are not tolerated or contraindicated, or when a patient is already being treated with an ACE inhibitor and a beta-blocker but remains symptomatic (ACE inhibitors and beta-blockers are medicines used to treat heart failure).

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

Do not take Candesartan 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 recommended to avoid Candesartan STADA at the start of pregnancy - see section on Pregnancy),
• if you have severe liver disease or biliary obstruction (a problem with the drainage of bile from the gallbladder).

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

If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Candesartan STADA.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Candesartan STADA.

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

• if you have recently had a kidney transplant,
• if you are vomiting, have recently had severe vomiting or have had diarrhea,
• if you have a condition affecting the adrenal gland called primary hyperaldosteronism (also known as Conn's syndrome),
• if you have low blood pressure,
• if you have ever had a stroke,
• if you think you might be pregnant, you must tell your doctor. It is not recommended to take Candesartan STADA during the first few months of pregnancy and it must not be taken if you are more than 3 months pregnant, as it may harm your baby if used after the third month of pregnancy (see section on 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), especially if you have kidney problems associated with diabetes.
• • aliskiren

• if you are taking an ACE inhibitor together with a medicine belonging to the class of medicines known as mineralocorticoid receptor antagonists (MRAs) 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 any of these situations, your doctor may want to see you more often and do 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, may cause a drop in blood pressure.

Talk to your doctor if you get 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, talk to 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 way Candesartan STADA works. If you are taking certain medicines, your doctor may need to do 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 change your dose and/or take other precautions:

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and 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 every day) (a 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) also known as trimethoprim/sulfamethoxazole.
• Diuretics (medicines to promote urine production).
• 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 together 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, 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should tell your doctor if you think you might be pregnant or are planning to become 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 take Candesartan STADA during the first few months of pregnancy and it must not be taken after the third month of pregnancy, as it may harm your baby if used after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start 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 a 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, contact them before taking this medicine.

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

3. How to take Candesartan STADA

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

It is important to 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 to 32 mg once a day, depending on your blood pressure response.
• In some patients, such as those with liver or kidney problems, or those who have recently lost body fluids (e.g. due to vomiting, diarrhea, or because they are taking diuretics), your doctor may prescribe a lower initial dose.
• Some black patients may have a reduced response to this type of medicine, when given as the only treatment, and these patients may need a higher dose.

Use in children and adolescents with high blood pressure:

Children aged 6 to <18 years:< p>

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, your doctor may decide to increase the dose up to a maximum of 8 mg per day.

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 a day and then to 16 mg once a day.

Heart failure in adults:

The recommended initial 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, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 5620420, stating the medicine and the amount taken.

If you forget to take Candesartan STADA

Do not take a double dose to make up for a forgotten dose. 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 talking to 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 see a 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 infection may be reduced, and you may feel tired, get an infection, or have a fever. If this happens, tell your doctor. It is possible that your doctor will do 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/spinning sensation.
• headache.
• respiratory infection.
• low blood pressure. This may cause dizziness or weakness.
• changes in blood test results.

• an increase in blood potassium levels, especially if you already have kidney problems or heart failure. If this is severe, you may feel tired, weak, have irregular heartbeats, or tingling.

• effects on your kidney function, especially if you already have kidney problems or heart failure. In 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, get an infection, or have a fever.
• skin rash, hives (urticaria).
• itching.
• back pain, pain in the joints and muscles.
• changes in liver function, including liver inflammation (hepatitis). You may feel tired, have yellowing of the skin and the whites of the eyes, and flu-like symptoms.
• 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, side effects seem to be similar to those seen in adults, but they occur more often. 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 that month.

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 8 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 C8 embossed on the same side. The tablet can be divided into equal doses.

Package 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.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

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/