Candesartan Stadafarma 16 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Candesartán Stadafarma 16 mg tablets EFG

candesartan cilexetil

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it 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.

Package leaflet contents

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

2. What you need to know before taking Candesartán Stadafarma

3. How to take Candesartán Stadafarma

4. Possible side effects

5. Storage of Candesartán Stadafarma

6. Contents of the pack and other information

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

The name of your medicine is Candesartán Stadafarma. The active substance is candesartán cilexetilo. It belongs to a group of medicines known as angiotensin II receptor antagonists. It works by causing blood vessels to relax and widen, thereby helping to lower blood pressure. It also helps the heart pump blood more easily to all parts of the body.

Candesartán may be 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 Stadafarma

Do not take Candesartán Stadafarma:

• 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 (this medicine should also be avoided during the first months 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 candesartan.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you have heart, liver, or kidney problems or are on dialysis.
• if you have recently received a kidney transplant.
• if you are experiencing 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). Use of candesartan is not recommended at the beginning of pregnancy and must not be used after the first 3 months of pregnancy, as it may cause serious harm to your baby from that stage onward (see Pregnancy section).
• if you are taking any of the following medicines for high blood pressure:
  • an angiotensin-converting enzyme inhibitor (ACEI) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren.
• if you are taking an ACEI together with a medicine belonging to the class known as mineralocorticoid receptor antagonists (MRA). These medicines are used to treat heart failure (see “Other medicines and Candesartán Stadafarma”).

Talk to 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 Candesartán Stadafarma.”

If any of these situations 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 candesartan. This is because candesartan, in combination with certain anesthetics, may cause excessive lowering of blood pressure.

Children and adolescents

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

Other medicines and Candesartán Stadafarma

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

Candesartan may affect how some medicines work, and some medicines may affect candesartan. 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 your blood pressure, including beta-blockers, diazoxide, and 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 thin the blood).
• 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 (ACEI) or aliskiren (see also information under the headings “Do not take Candesartán Stadafarma” and “Warnings and precautions”).
• If you are being treated with an ACEI together with other specific medicines for heart failure, known as mineralocorticoid receptor antagonists (MRA) (e.g., spironolactone, eplerenone).

Taking Candesartán Stadafarma with food, drinks, and alcohol

• You may 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

Inform your doctor if you are breastfeeding or planning to breastfeed. Candesartan is not recommended during breastfeeding. Your doctor will choose an alternative treatment for you if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

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

Candesartán Stadafarma contains lactose

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

3. How to take Candesartán Stadafarma

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. It is important that you take candesartan every day.

You may 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, diarrhoea, or use of 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:

Children and adolescents 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 candesartan 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. Candesartan 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 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Candesartán Stadafarma

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

If you stop taking Candesartán Stadafarma

If you stop taking candesartan, your blood pressure may rise again. Therefore, do not stop taking candesartan 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 will experience them. It is important that you are aware of what these adverse effects could be.

Stop taking candesartan and consult your 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 itching of the skin (with skin rash)

Candesartan may cause a decrease in white blood cells. Your resistance to infections may be reduced, and you may feel tired, develop an infection, or have a fever. If this occurs, inform your doctor. Your doctor may carry out blood tests from time to time to check that candesartan is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Common: may affect up to 1 in 10 people

• Dizziness
• Headache
• Respiratory infection
• Low blood pressure. This may cause dizziness or fainting
• 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 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
• A decrease in red blood cells 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 inflammation of the liver (hepatitis). You may feel tired, have yellowing of the skin and whites of the eyes, and flu-like symptoms
• Nausea
• Changes in blood test results:
  • A reduction in blood sodium levels. If severe, you may feel weak, lack energy, or have muscle cramps
• Cough
• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Frequency not known: cannot be estimated from available data

• Diarrhea

Other adverse effects in children

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, and rhinorrhea (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 or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartán Stadafarma

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

Do not use this medicine after the expiry date stated on the carton, blister pack, or bottle after “EXP”. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartán Stadafarma

The active substance is candesartan cilexetilo.

The tablets contain 16 mg of candesartan cilexetilo.

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

Appearance of the product and contents of the pack

Candesartán 16 mg: round tablet, 7 mm in diameter, pink in colour (non-uniform, possibly with small dark or white spots), with a score line on one side and engraved "16" on the other side.

Tablets are available in:

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

Bottles: 100 tablets.

Only certain 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

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 medicinal product is authorised in the European Economic Area (EEA) member states under the following names:

Denmark: Candesartan STADA
Austria: Candesartan Aliud 16 mg Tabletten
Belgium: Candesartan Eurogenerics 16 mg tabletten
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 most recent revision of this leaflet: December 2024

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