Candesartan Stadapharm 8 mg Tablets

Introduction

Patient Information: Summary of Product Characteristics

Candesartan Stadafarma 8 mg Tablets EFG

candesartan cilexetil

Read this 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 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 experience 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

1. What is Candesartan Stadafarma and what is it used for
2. What you need to know before you take Candesartan Stadafarma
3. How to take Candesartan Stadafarma
4. Possible side effects

5 Storage of Candesartan Stadafarma

1. Contents of the Pack and Further Information

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

The name of your medicine is Candesartan Stadafarma. 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.

Candesartan can be used for:

• treatment of high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to 18 years.
• treatment of adult patients with heart failure with reduced cardiac function when ACE inhibitors (a type of medicine used to treat heart failure) cannot be used, or when added to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (a type of medicine used to treat heart failure) cannot be used.

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

Do not take Candesartan Stadafarma:

• 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 (it is also better to avoid this medicine during the first months of pregnancy – see section Pregnancy).
• if you have 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 medicine containing aliskiren.

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medicine:

• if you have 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 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 are pregnant (or think you might be). Candesartan is not recommended during the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may harm your baby (see section Pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure:
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially 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 known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see "Other Medicines and Candesartan Stadafarma")

Tell 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.

Your doctor may 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 Stadafarma".

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, inform your doctor or dentist that you are taking candesartan. This is because candesartan, in combination with some anesthetics, can cause a significant drop in blood pressure.

Children and Adolescents

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

Other Medicines and Candesartan Stadafarma

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Candesartan may affect how some medicines work and some medicines may have an effect on candesartan. 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 help 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 per 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 medicine) 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 Stadafarma" 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 Stadafarma with Food, Drinks, and Alcohol

• You can take candesartan with or without food.
• When prescribed candesartan, consult your doctor before drinking alcohol. Alcohol may make you feel dizzy or unwell.

Pregnancy and Breastfeeding

Breastfeeding

Tell your doctor if you are breastfeeding or plan to start breastfeeding. The use of candesartan is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and Using Machines

Some patients may feel tired or dizzy when taking candesartan. If this happens, do not drive or operate tools or machines.

Candesartan Stadafarma Contains Lactose

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

3. How to Take Candesartan Stadafarma

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. It is important that you take candesartan every day.

You can take candesartan with or without food. Swallow the tablet with water.

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

The tablet can be divided into equal doses.

High Blood Pressure:

• The recommended dose of candesartan is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily and 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, 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 the only treatment, and these patients may need a higher dose.

Use in Children and Adolescents:

Children and adolescents aged 6 to 18 years:

The recommended initial dose is 4 mg once daily.

For patients weighing less than 50 kg: in some patients whose blood pressure is not adequately controlled, the 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, the doctor may decide to increase the dose to 8 mg once daily and up to 16 mg once daily.

Heart Failure in Adults:

• The recommended starting dose of candesartan is 4 mg once daily. Your doctor may increase this dose by doubling the dose at intervals of at least 2 weeks up to 32 mg once daily. Candesartan 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 Stadafarma Than You Should

If you have taken more candesartan than prescribed by your doctor, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If You Forget to Take Candesartan Stadafarma

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

If You Stop Taking Candesartan Stadafarma

If you stop taking candesartan, your blood pressure may increase again. Therefore, do not stop taking candesartan 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 and consult 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 skin itching (with rash)

Candesartan may cause a decrease in white blood cells. Your resistance to infections may decrease, and you may feel tired, have an infection, or have a fever. If this happens, tell your doctor. It is possible that your doctor will perform a blood test from time to time to check that candesartan is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common: may affect up to 1 in 10 people

• Dizziness.
• Headache.
• Respiratory infection.
• Low blood pressure. This can cause dizziness or fainting.
• 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 have 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 or have an infection or fever.
• Skin rash, hives.
• 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.
• 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.
• Cough.
• Intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency Not Known: cannot be estimated from the available data

• Diarrhea.

Other Side Effects in Children

In children treated for high blood pressure, side effects seem to be similar to those seen in adults but 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. 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: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan Stadafarma

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, blister, or bottle after "EXP". The expiry date refers to the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Candesartan Stadafarma

The active substance is candesartan cilexetil.

The tablets contain 8 mg of candesartan cilexetil.

The other ingredients (excipients) are: lactose monohydrate, cornstarch, hydroxypropylcellulose, calcium carmellose, macrogol 8000, magnesium stearate, red iron oxide (E-172).

Appearance of the Product and Contents of the Pack

Candesartan 8 mg: round tablet, 6.4 mm in diameter, pink (non-uniform, possibly with small dark spots or white color) with a score line on one side and the engraving "8" on the other side.

The tablets are available in:

Blister packs: 14, 20, 28, 30, 50, 56, 84, 90, 98, and 100 tablets.

Bottles: 100 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

Laboratorios Liconsa, S.A.

Avda. Miralcampo, 7

Pol. Ind. Miralcampo, 19200

Azuqueca de Henares, Guadalajara

Spain

Or

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

Or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

Or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark Candesartan STADA

Austria Candesartan Aliud 8 mg Tablets

Belgium Candesartan Eurogenerics 8 mg tablets

Luxembourg Candesartan Eurogenerics 8 mg tablets

Finland Candesartan STADA 8 mg tablets

France CANDESARTAN EG LABO 8 mg, scored tablet

Germany Candesartan STADA 8 mg Tablets

Ireland Candesartan Clonmel 8 mg tablets

Portugal Candesartan Ciclum Farma

Slovakia Kandesartan STADA 8 mg tablets

Spain Candesartán STADAFARMA 8 mg tablets EFG

Sweden Candesartan STADA 8 mg tablets

Iceland Candesartan STADA 8 mg tablets

Norway Candesartan STADA 8 mg tablets

Malta Candesartan Clonmel 8 mg tablets

Date of Last Revision of this Leaflet:December 2024

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