Candesartan Stada 16 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Candesartán STADA 16 mg tablets EFG

Candesartan cilexetil

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

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because 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.

Contents of the leaflet

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 adverse 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 candesartan cilexetil. It belongs to a group of medicines known as angiotensin II receptor antagonists. It works by relaxing and widening the blood vessels. This helps lower blood pressure. It also makes it easier for your heart to pump blood to all parts of your 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 added 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 to 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

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

• if you have heart, liver, or kidney problems, or if you are undergoing 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 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 you are (or might be) pregnant, inform your doctor. The use of Candesartán STADA is not recommended at the beginning of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during 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 a class of drugs called mineralocorticoid receptor antagonists (MRA). 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 see you more frequently and carry out 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 anaesthetics, 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 given to children under 1 year of age due to the potential risk to developing kidneys.

Other medicines and Candesartán STADA

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

Candesartán STADA may affect how some 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 medicines to lower blood pressure, including beta-blockers, diazoxide, and 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 (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 salt substitutes containing potassium (medicines that increase potassium levels in your blood).
• Heparin (a medicine used to make the blood less likely to clot).
• Cotrimoxazole (an antibiotic medicine), also known as trimethoprim/sulfamethoxazole.
• Diuretics (medicines that increase urine production).
• 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 (MRA) (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 drinking 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 after the third month of pregnancy, as it may cause serious harm to your baby if used beyond the third month.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding. Candesartán 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 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 that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Candesartán STADA

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

It is important that you 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 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 a maximum of 32 mg once daily. Candesartán STADA may be taken together with other medicines for heart failure, and your doctor will decide which treatment is appropriate 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 number: 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 perform blood tests periodically 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 condition is severe, you may experience fatigue, 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 blood cells 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 liver inflammation (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, fever, and increased heart rate are common in children but have not been reported in adults.

Reporting of adverse effects

If you experience any 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 the sight and reach of children.

Do not use this medicine after the expiry date stated on the outer packaging or blister. The expiry date refers to 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 packaging at the SIGRE point located at your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Candesartán STADA

• The active substance is candesartan cilexetil. Each tablet contains 16 mg of candesartan cilexetil.
• The other components are: lactose monohydrate, corn starch, hydroxypropylcellulose, sodium croscarmellose, magnesium stearate and triethyl citrate.

Appearance of the product and contents of the pack

Candesartán STADA are white, biconvex tablets, with a score line on one side and "C16" 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 some 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 review of this leaflet: February 2025

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