Candesartan Stada 8 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Candesartán STADA 8 mg tablets EFG

Candesartán cilexetilo

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Your medicine is called Candesartán STADA. The active substance is candesartán cilexetilo. This belongs to a group of medicines known as angiotensin II receptor antagonists. It works by causing the blood vessels to relax and widen. This helps lower blood pressure. It also makes it easier for your heart to pump blood to all parts of the body.

This medicine is used for:

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

• the treatment of adult patients with heart failure and reduced heart muscle function when angiotensin-converting enzyme inhibitors (ACE inhibitors) cannot be used, or as an addition to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRAs) cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. What you need to know before taking Candesartán STADA

DO NOT take Candesartán 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 Candesartán STADA at the beginning of pregnancy – see Pregnancy section),

• if you have severe liver disease or biliary obstruction (a problem with 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 containing aliskiren.

If you are unsure whether any of these apply to you, 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 if you are on dialysis,

• if you have recently received a kidney transplant,

• if you are experiencing vomiting, have recently had severe vomiting, or have had diarrhea,

• if you have an adrenal gland disorder 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 you are (or might be) pregnant, you must inform your doctor. Use of Candesartán STADA is not recommended during early pregnancy and must not be used after 3 months of pregnancy, as it may cause severe harm to your baby if used at this stage (see Pregnancy section),

• if you are taking any of the following medicines for 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 known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat 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 any of these conditions apply to you, your doctor may want to schedule more frequent appointments and perform certain tests.

If you are scheduled for surgery, inform your doctor or dentist that you are taking Candesartán STADA. This is because Candesartán STADA, in combination with certain 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 further information, consult your doctor. Candesartán STADA must not be administered to children under 1 year of age due to potential risk to developing kidneys.

Other medicines and Candesartán STADA

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

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

In particular, inform 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 blood pressure-lowering medicines, including beta-blockers, diazoxide, and angiotensin-converting enzyme (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 inflammation),
• Acetylsalicylic acid (if taking more than 3 g per day) (a medicine used to relieve pain and inflammation),
• Potassium supplements or potassium-containing salt substitutes (medicines that increase potassium levels in your blood),
• Heparin (a medicine used to increase blood fluidity),
• Cotrimoxazole, also known as trimethoprim/sulfamethoxazole (an antibiotic medicine),
• Diuretics (medicines that promote urine elimination),
• Lithium (a medicine used for mental health conditions),
• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “DO NOT take Candesartán STADA” and “Warnings and precautions”),
• If you are being treated with an ACE inhibitor together with other specific medicines for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone).

Taking Candesartán STADA with food, drinks, and alcohol

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

Pregnancy and breastfeeding

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

Pregnancy

Inform your doctor if you think you are (or might be) pregnant. Your doctor will usually advise you to stop taking Candesartán STADA before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative medicine. Candesartán STADA is not recommended during early pregnancy and must not be taken from the third month of pregnancy onward, as it may cause severe harm to your baby if used beyond the third month of pregnancy.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding. Candesartán STADA is not recommended for breastfeeding women, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

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

Candesartán STADA contains lactose and sodium

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Candesartán STADA

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

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

High blood pressure:

• The recommended dose of Candesartán STADA is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily and then up to 32 mg once daily 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 (e.g. due to vomiting, diarrhoea, or because they are taking diuretics), your doctor may prescribe a lower starting dose.
• Some black patients may have a reduced response to this type of medicine when used as monotherapy, and these patients may require a higher dose.

Use in children and adolescents with high blood pressure:

Children aged 6 to <18 years:

The recommended starting dose is 4 mg once daily.

For patients with body weight < 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 daily.

For patients with body weight ≥ 50 kg: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose to 8 mg once daily and then to 16 mg once daily.

Heart failure in adults:

The recommended starting dose of Candesartán STADA is 4 mg once daily. Your doctor may increase this dose by doubling it at intervals of at least 2 weeks up to 32 mg once daily. Candesartán STADA may be taken together with other medicines for heart failure, and your doctor will decide which 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 Toxicology Information Service at telephone: 91 5620420, indicating the medicine and the amount taken.

If you forget to take Candesartán STADA

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

If you stop taking Candesartán STADA

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. It is important that you are aware of what these adverse effects could be.

Stop taking Candesartán STADA and see a 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 (with 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 develop a fever. If this occurs, inform your doctor. Your doctor may carry out blood tests from time to time to check that Candesartán STADA is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

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

• Dizziness/vertigo.
• Headache.
• Respiratory infection.
• Low blood pressure. This may cause dizziness or weakness.
• Changes in blood test results.
• Increase in blood potassium levels, especially if you already have kidney problems or heart failure. If this is severe, you may experience tiredness, weakness, irregular heartbeat, 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.
• Decrease in red or white blood cells. You may feel tired, or 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 may feel tired, have yellowing of the skin and whites of the eyes, and flu-like symptoms.
• Cough.
• Nausea.
• Changes in blood test results:
  • Reduction in blood sodium levels. If severe, you may feel weak, lack energy, or have muscle cramps.
• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.

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

• Diarrhoea.

In children treated for hypertension, adverse effects appear to be similar to those seen in adults, but occur more frequently. Sore throat is a very common adverse effect in children but has not been reported in adults; rhinorrhoea (runny nose), fever, and increased heart rate are common in children but have not been reported in adults.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan STADA

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the container or blister pack. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Do not dispose of medicines via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartan STADA

• The active substance is candesartan cilexetilo. Each tablet contains 8 mg of candesartan cilexetilo.
• The other components are: lactose monohydrate, corn starch, hydroxypropylcellulose, sodium croscarmellose, magnesium stearate and triethyl citrate.

Description of the product and contents of the pack

Candesartan STADA are white, biconvex tablets, with a score on one side and "C8" in relief 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.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 the most recent revision of this leaflet: February 2025

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