Candesartan Sandoz 16 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Candesartán Sandoz 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

The name of the medicine is Candesartán Sandoz. The active substance is candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor antagonists. It works by making the blood vessels relax and widen, which helps lower blood pressure. It also helps your heart pump blood to all parts of your body.

This medicine can be used:

• for the treatment of high blood pressure (hypertension) in adult patients and children and adolescents aged 6 to < 18 years,
• for the treatment of adult patients with heart failure with reduced heart muscle function when 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 groups of medicines used to treat heart failure).

2. What you need to know before taking Candesartán Sandoz

Do not take Candesartán Sandoz

• 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. It is also advisable to avoid taking candesartan at the beginning of pregnancy (see section “Pregnancy”),
• if you have severe liver disease or biliary obstruction (a problem with bile outflow from the gallbladder),
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren,
• if the patient is a child under 1 year of age.

If you are unsure whether any of these situations apply to you, consult your doctor or pharmacist before taking candesartan.

Warnings and precautions

Talk to your doctor or pharmacist before starting candesartan:

• 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 vomited, 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 for high blood pressure:

• an ACE inhibitor (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,

• aliskiren,

  • if you are taking an ACE inhibitor together with other medicines belonging to another class called mineralocorticoid receptor antagonists (MRA). These medicines are used to treat heart failure (see “Other medicines and Candesartán Sandoz”),
  • if you are pregnant (or suspect you might be pregnant). Candesartan is not recommended during early pregnancy (first 3 months) and must not be used after 3 months of pregnancy, as it may cause serious harm to your baby from that point onward (see section “Pregnancy”).

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 Sandoz”.

If any of these situations apply to you, you may need to visit your doctor more frequently and have certain tests performed.

If you are undergoing surgery, inform your doctor or dentist that you are taking Candesartán Sandoz. This is because Candesartán Sandoz, in combination with certain anesthetics, may cause a drop in blood pressure.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartán Sandoz. Your doctor will decide whether to continue treatment. Do not stop taking the medicine on your own.

Children and adolescents

Candesartan cilexetil 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 Sandoz

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

Candesartan may affect how other medicines work, and some medicines may affect candesartan. If you are taking certain medicines, your doctor may need to perform regular blood tests.

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 that lower 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 the blood),
• heparin (a medicine used to thin the blood),
• cotrimoxazole (an antibiotic medicine), also known as trimethoprim/sulfamethoxazole,
• diuretics (medicines that increase urine output),
• lithium (a medicine used to treat mental health conditions),
• if you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Candesartán Sandoz” and “Warnings and precautions”),
• if you are taking an ACE inhibitor together with other specific medicines for heart failure treatment, known as mineralocorticoid receptor antagonists (MRA) (e.g., spironolactone, eplerenone).

Taking Candesartán Sandoz with food, drinks, and alcohol

• You may take candesartan with or without food.
• Consult your doctor before drinking alcohol while taking candesartan. Alcohol may make you feel weak or dizzy.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. 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 onward, as it may cause serious harm to your baby from that point.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Candesartan is not recommended during breastfeeding, and your doctor will choose an alternative treatment 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, do not drive or operate tools or machinery.

Candesartán Sandoz contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

Candesartán Sandoz contains sodium

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

3. How to take Candesartán Sandoz

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 candesartan every day.

You may take candesartan with or without food.

Swallow the tablet with a glass of water.

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

Tablet splitting:

If necessary, the tablet can be divided into two equal doses. Place the tablet with the break line facing upwards on a flat, hard surface (e.g., a table or a plate). Place your index fingers (or thumbs) on each side of the line and press briefly and firmly at the same time.

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 then 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 use of diuretics), your doctor may prescribe a lower starting dose.
• In some patients of Black race, the response to this type of medication may be reduced when used as monotherapy; therefore, they may require a higher dose.

Use in children and adolescents with high blood pressure

Children aged 6 to < 18 years:

The recommended initial dose is 4 mg once daily.

For patients weighing < 50 kg: if blood pressure is not adequately controlled, your doctor may decide to increase the dose up to a maximum of 8 mg once daily.

For patients weighing ≥ 50 kg: if blood pressure is not adequately controlled, your doctor may decide to increase the dose to 8 mg once daily or to 16 mg once daily.

Heart failure:

• 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 a dose of 32 mg once daily. Candesartan may be taken together with other medications for heart failure. Your doctor will decide which treatment is most suitable for you.

If you take more Candesartán Sandoz than you should

If you take 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 or call the Toxicology Information Service at: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Candesartán Sandoz

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

If you stop taking Candesartán Sandoz

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. However, it is important that you are aware of these possible adverse effects.

Stop taking Candesartán Sandoz and contact 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 that may cause difficulty swallowing,
• severe itching of the skin (with skin rash).

Candesartán may cause a reduction in the number of white blood cells. Your resistance to infections may decrease, and you may feel tired, have an infection or fever. Contact your doctor if this occurs. Your doctor may perform 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:

• an increase in blood potassium levels, especially if you already have kidney problems or heart failure. If this condition is severe, you may notice 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 inflammation of the liver (hepatitis). You may feel tired, have yellowing of the skin or whites of the eyes, and flu-like symptoms,

• nausea,

• changes in blood test results:

• reduction in the amount of sodium in the blood. If severe, you may feel weakness, loss of energy, or muscle cramps,

• cough.

Frequency not known (cannot be estimated from the available data)

• Diarrhea

Additional adverse effects in children and adolescents

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 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 adverse effects

If you experience any type of adverse effect, consult 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan Sandoz

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

Do not use this medicine after the expiry date stated on the packaging and blister/bottle after "EXP". The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Shelf life after first opening of the bottle:

3 months

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartán Sandoz 16 mg tablets

• The active substance is candesartan cilexetil.

Each tablet contains 16 mg of candesartan cilexetil.

• The other components are:

Monohydrate lactose (lactose)

Corn starch

Povidone 30

Carrageenan

Sodium croscarmellose

Magnesium stearate

Red iron oxide (E 172)

Titanium dioxide (E 171)

Appearance of the medicine and contents of the pack

Tablet.

Candesartán Sandoz 16 mg tablets: pink, speckled, round, biconvex tablets marked with "16" on one side and a score line on the other.

Al/Al blister packs: 7, 14, 20, 28, 30, 50, 56, 58, 60, 84, 90, 91, 98, 100, 250, 300 tablets.

Perforated Al/Al unit dose blister packs: 28 x 1, 50 x 1 tablets.

Al/Al blister packs with desiccant: 7, 14, 20, 28, 30, 50, 56, 58, 60, 84, 90, 91, 98, 100, 250, 300 tablets.

Perforated Al/Al unit dose blister packs with desiccant: 50 x 1 tablets.

HDPE bottles with PP cap and silica gel desiccant: 30, 100, 120, 500 tablets.

Warning: The HDPE bottle contains a desiccant. Do not swallow.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57,

1526, Ljubljana

Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2D

9220, Lendava

Slovenia

or

LEK S.A.

ul. Domaniewska 50 C,

02-672, Warszawa

Poland

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179, Barleben

Germany

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

Germany: Candesartan-Sandoz 16 mg Tabletten

Austria: Candesartan Sandoz 16 mg – Tabletten

Belgium: Candesartan Sandoz 16 mg tabletten

Bulgaria: CANDECARD 16 mg tablets

Greece: FYRONEXE 16 mg δισκ?α

Italy: CANDESARTAN SANDOZ

Denmark: Candemox, tabletter

Czech Republic: Xaleec 16 mg

Slovakia: Candesartan Sandoz 16 mg tablety

Slovenia: Candea 16 mg tablete

Spain: Candesartan Sandoz 16 mg comprimidos EFG

Estonia: Prescanden 16 mg

Finland: Candemox 16 mg tabletit

Netherlands: CANDESARTAN CILEXETIL SANDOZ 16 MG, tabletten

Norway: Candesartan Sandoz 16 mg tabletter

Poland: CANDEPRES

Portugal: CANDESARTAN SANDOZ

Romania: CANDESARTAN SANDOZ 16 mg comprimate

United Kingdom: Candesartan Cilexetil 16 mg Tablets

Sweden: Candesartan Sandoz 16 mg, tablett

Date of the most recent revision of this leaflet: February 2025

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/