Candesartan Sun 8 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Candesartán Sun 8 mg tablets EFG

Candesartán Sun 16 mg tablets EFG

Candesartán Sun 32 mg tablets EFG

Candesartán cilexetilo

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 may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

This medicine is called Candesartán Sun. The active substance is candesartan cilexetil. This belongs to a group of medicines known as angiotensin II receptor antagonists. It causes 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.

This medicine 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 and reduced heart muscle function when angiotensin-converting enzyme inhibitors (ACE inhibitors) cannot be used, or in 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 Sun

Do not take Candesartán Sun

• 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 taking candesartan at the beginning of pregnancy – see Pregnancy section).
• if you have severe liver disease or biliary obstruction (a problem with bile leaving the gallbladder).
• if the patient is a child under 1 year of age.
• if you have diabetes and kidney impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether you are in any of these situations, consult your doctor or pharmacist before taking Candesartán Sun.

Warnings and precautions:

Talk to your doctor or pharmacist before starting Candesartán Sun:

• 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 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 are taking any of the following medicines used to treat high blood pressure (hypertension):

  • 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 ACE inhibitor together with a medicine belonging to the class of drugs known as mineralocorticoid receptor antagonists (MRA). These medicines are used to treat heart failure (see "Taking Candesartán Sun with other medicines").

Contact your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartán Sun. Your doctor will decide whether you should continue treatment. Do not stop taking Candesartán Sun 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 Sun”

If you are in any of these situations, 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 a drop in 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.

Taking Candesartán Sun with other medicines:

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Candesartán Sun may affect how some medicines work, and some medicines may influence the effect of Candesartán Sun. If you are taking certain medicines, your doctor may need to carry out blood tests from time to time.

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 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 (a medicine used to relieve pain and inflammation) if taking more than 3 g per day.
• potassium supplements or salt substitutes containing potassium (medicines that increase potassium levels in the blood).
• heparin (a medicine to increase blood fluidity).
• cotrimoxazole, also known as trimethoprim/sulfamethoxazole (an antibiotic medicine).
• diuretics (medicines to promote urine elimination).
• lithium (a medicine 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 Sun” 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).

Candesartán Sun 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 faint or dizzy.

Pregnancy and breastfeeding:

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking candesartan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Candesartan is not recommended during early pregnancy, and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from this stage.

Breastfeeding

Inform 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 wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines:

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

Candesartán Sun contains lactose

Lactose is a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Candesartán Sun

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again. It is important that you continue taking candesartan every day.

For high blood pressure:

• The usual dose of candesartan is 8 mg once daily. Your doctor may increase this dose to 16 mg 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 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 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.

Patients weighing less than 50 kg: In some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose to a maximum of 8 mg once daily.

Patients weighing 50 kg or more: In some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose to a maximum of 8 mg once daily or 16 mg once daily.

For heart failure:

• The usual starting dose of candesartan is 4 mg once daily. Your doctor may double this dose at intervals of at least two weeks, up to a maximum of 32 mg once daily. Candesartan may be taken together with other medicines for heart failure, and your doctor will decide which treatment is most suitable for you.

Method of administration:

You may take candesartan with or without food.

Swallow the tablets whole with a glass of water.

Take the tablets at the same time each day. This will help you remember to take them.

INCORRECT CORRECT

If you take more Candesartán Sun than you should

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

You can also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Candesartán Sun

Do not take a double dose to make up for the missed dose. Simply take the next dose at your usual time.

If you stop using Candesartán Sun

If you stop taking candesartan, your blood pressure may increase. 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 experiences them.

It is important that you are aware of what these adverse effects might be.

Serious adverse effects

Stop taking Candesartán Sun 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 itching of the skin (with skin rash)

Candesartán may cause a decrease in white blood cells. Your resistance to infections may decrease, and you may feel tired, have an infection, or fever. If this happens, contact your doctor.

Your doctor may carry out blood tests from time to time to check that candesartán 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:
  • Increased levels of potassium in the blood, especially if you already have kidney problems or heart failure. If this condition is serious, 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
• 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 inflammation of the liver (hepatitis). You may feel tired, have yellowing of the skin and whites of the eyes, and flu-like symptoms
• Nausea
• Cough
• Changes in blood test results:
  • Reduced levels of sodium in the blood. If severe, you may feel weak, lack energy, or have muscle cramps
• 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 available data):

• Diarrhea

Additional adverse effects in children

In children treated for high blood pressure, adverse effects appear to be similar to those observed in adults, but occur more frequently. Sore throat is a very common adverse effect in children, but is not described in adults. In addition, nasal discharge, fever, and increased heart rate are adverse side effects in children, but are not described in adults.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly 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 Candesartán Sun

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 packaging after the abbreviation EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Package contents and other information

Composition of Candesartán Sun

• The active substance is candesartan cilexetilo.

Each tablet contains 8 mg, 16 mg or 32 mg of candesartan cilexetilo.

• The other components are: calcium carmellose, low-substituted hydroxypropylcellulose, red iron oxide (E-172), lactose monohydrate, magnesium stearate, corn starch and macrogol 6000.

Appearance of the product and contents of the pack

Candesartán Sun 8 mg:

Pink mottled, capsule-shaped tablet, approximately 9.1 mm long and 4.6 mm wide, marked with “C” and “10” on either side of the break line on one side, and a break line on the other side.

Candesartán Sun 16 mg:

Capsule-shaped, pink mottled tablet, approximately 11.7 mm long and 5.1 mm wide, with “C” and “11” engraved in relief on either side of the break line on one side, and the break line on the other side.

Candesartán Sun 32 mg:

Oval, pink mottled tablet, approximately 15.1 mm long and 6.6 mm wide, with “C” and “12” engraved on either side of the break line on both sides. The tablets may be divided into equal doses.

Candesartán Sun 8 mg and 16 mg tablets are available in plastic blisters.

Pack sizes: 7, 14, 15, 20, 28, 30, 50, 56, 90, 98 and 100.

Only some pack sizes may be marketed.

Candesartán Sun 32 mg tablets are available in plastic blisters.

Pack sizes: 7, 8, 10, 12, 14, 15, 20, 28, 30, 40, 50, 56, 60, 70, 90, 95, 98, 100 and 105.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The Netherlands

or

Terapia SA

Str. Fabricii nr. 124,

Cluj Napoca 400 632

Romania

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55 P5

08007 Barcelona, Spain

Tel.: +34 93 342 78 90

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:

Germany: CANDESARTAN BASICS 4 mg, 8 mg, 16 mg and 32 mg tablets

Spain: Candesartan Sun 8 mg, 16 mg and 32 mg tablets EFG

Poland: Ranacand

Romania: Tandesar 8 mg, 16 mg and 32 mg tablets

Date of the most recent review of this leaflet: June 2025.

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