CANDESARTAN STADAFARMA 16 mg TABLETS

Introduction

Patient Information Leaflet

Candesartan Stadafarma 16 mg tablets EFG

candesartan cilexetil

Read the entire leaflet carefully before starting to take this medication, as 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

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

5 Storage of Candesartan Stadafarma

1. Package contents and additional information

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

The name of your medication is Candesartan Stadafarma. The active ingredient is candesartan cilexetil. This belongs to a group of medications called angiotensin II receptor antagonists. It works by making blood vessels relax and dilate. This helps to lower blood pressure. It also helps your heart 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 from 6 to 18 years.
• treatment of adult patients with heart failure with reduced muscle function when it is not possible to use Angiotensin-Converting Enzyme Inhibitors (ACEIs), or added to ACEIs when symptoms persist despite treatment and it is not possible to use Mineralocorticoid Receptor Antagonists (MRAs) (ACEIs and MRAs are medications used to treat heart failure).

2. What you need to know before taking Candesartan Stadafarma

Do not take Candesartan Stadafarma:

• if you are allergic to candesartan cilexetil or any of the other ingredients of this medication (listed in section 6).
• if you are pregnant for more than 3 months (it is also best to avoid this medication during the first months of pregnancy – see section Pregnancy).
• if you have severe liver disease or bile obstruction (problem with bile leaving 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 medication containing aliskiren.

If you are unsure if you are in any of these situations, consult your doctor or pharmacist before taking candesartan.

Warnings and precautions

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

• if you have heart, liver, or kidney problems or are undergoing dialysis.
• if you have recently had a kidney transplant.
• if you have vomited, have recently had intense 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 may be pregnant). Candesartan is not recommended during pregnancy and should not be taken if you are more than 3 months pregnant, as it can cause serious harm to your baby (see section Pregnancy).
• if you are taking any of the following medications used to treat high blood pressure:
• • an angiotensin-converting enzyme inhibitor (ACEI) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
  • aliskiren.
• if you are taking an ACEI along with a medication belonging to the class of drugs called mineralocorticoid receptor antagonists (MRAs). These medications are for the treatment of heart failure (see "Other medications and Candesartan Stadafarma")

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.

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 Candesartan Stadafarma".

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

If you are going to undergo 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 developing kidneys.

Other medications and Candesartan Stadafarma

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Candesartan may affect how some medications work, and some medications may affect candesartan. If you are using certain medications, your doctor may need to perform blood tests from time to time.

In particular, inform your doctor if you are using any of the following medications, as your doctor may need to adjust your dose and/or take other precautions:

• Other medications to help lower your blood pressure, including beta blockers, diazoxide, and ACEIs such as enalapril, captopril, lisinopril, or ramipril.
• Non-steroidal anti-inflammatory medications (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medications to relieve pain and inflammation).
• Acetylsalicylic acid (if you take more than 3 g per day) (medication to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medications that increase the amount of potassium in your blood).
• Heparin (a medication to increase blood fluidity).
• Cotrimoxazole (an antibiotic medication) also known as trimethoprim/sulfamethoxazole.
• Diuretics (medications to promote urine elimination).
• Lithium (a medication for mental health problems).
• If you are taking an ACEI 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 ACEI along with other specific medications 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 can make you feel dizzy or unwell.

Pregnancy and breastfeeding

Breastfeeding

Tell your doctor if you are breastfeeding or plan to start breastfeeding. 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 certain sugars, consult with them before taking this medication.

3. How to take Candesartan Stadafarma

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. 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 every 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 a day. Your doctor may increase this dose to 16 mg once a day and up to 32 mg once a day based on 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 medication when given as monotherapy, and these patients may need a higher dose.

Use in children and adolescents:

Children and adolescents from 6 to 18 years:

The recommended initial dose is 4 mg once a day.

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 a day and up to 16 mg once a day.

Heart failure in adults:

• The recommended starting dose of candesartan 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 can be taken with other medications 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, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Candesartan Stadafarma

Do not take a double dose to make up for missed 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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them. It is important that you know what these side effects might 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 can 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, inform 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:

Frequent: 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 will notice fatigue, weakness, 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 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 will 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 reduction 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 symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known: cannot be estimated from available data

• Diarrhea.

Other side effects in children

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Candesartan Stadafarma

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the carton, blister, or bottle after "EXP". The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Candesartan Stadafarma

The active ingredient is candesartan cilexetil.

The tablets contain 16 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 package contents

Candesartan 16 mg: round tablet, 7 mm in size, pink in color (not uniform, possibly with small dark spots or white color) with a score line on one side and the engraving "16" 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 medication is authorized in the member states of the European Economic Area with the following names:

Denmark Candesartan STADA

Austria Candesartan Aliud 16 mg Tabletten

Belgium Candesartan Eurogenerics 16 mg tablets

Luxembourg Candesartan Eurogenerics 16 mg comprimés

Finland Candesartan STADA 16 mg tabletti

France CANDESARTAN EG LABO 16 mg, comprimé sécable

Germany Candesartan STADA 16 mg Tabletten

Ireland Candesartan Clonmel 16 mg tablets

Portugal Candesartan Ciclum Farma

Slovakia Kandesartan STADA 16 mg tablety

Spain Candesartán STADAFARMA 16 mg comprimidos EFG

Sweden Candesartan STADA 16 mg tabletter

Iceland Candesartan STADA 16 mg töflur

Norway Candesartan STADA 16 mg tabletter

Malta Candesartan Clonmel 16 mg tablets

Date of the last revision of this leaflet:December 2024

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