Package Insert: Information for the Patient

Candesartán Sandoz 16 mg Tablets EFG

Candesartán cilexetilo

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Candesartán Sandoz and how is it used

2. What you need to know before starting to take Candesartán Sandoz

3. How to take Candesartán Sandoz

4. Possible adverse effects

5. Storage of Candesartán Sandoz

6. Contents of the package and additional information

The name of the medication is Candesartán Sandoz. The active ingredient is candesartan cilexetil. It belongs to a group of medications called angiotensin II receptor antagonists. It works by causing blood vessels to relax and dilate. This facilitates a decrease in blood pressure. It also facilitates your heart pumping blood to all parts of your body.

This medication can be used for:

• treatment of high blood pressure (hypertension) in adult patients and children and adolescents aged 6 to <18
• treatment in adult patients with heart failure with reduced cardiac muscle function when it is not possible to use angiotensin-converting enzyme inhibitors, or added to ACE inhibitors when symptoms persist despite treatment and it is not possible to use mineralocorticoid receptor antagonists (ACE inhibitors and MRA are a group of medications used to treat heart failure).

Do not take Candesartán Sandoz

• if you are allergic to candesartán cilexetilo or any of the other ingredients of this medication (listed in section 6),
• if you are more than 3 months pregnant. It is also recommended to avoid taking candesartán at the beginning of pregnancy (see section “Pregnancy”),
• if you have severe liver disease or a bile duct obstruction (a problem with the bile flowing from the gallbladder),
• if you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén,
• if the patient is a child under 1 year of age.

If you are unsure whether you fall into any of these situations, consult your doctor or pharmacist before taking candesartán.

Warnings and precautions

Consult your doctor or pharmacist before starting to take candesartán:

• 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 had vomiting recently, or have diarrhea,
• if you have a condition 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 medications used to treat high blood pressure:

-an angiotensin-converting enzyme (ACE) inhibitor (such as enalapril, lisinopril, or ramipril), particularly if you have kidney problems related to diabetes,

-aliskirén,

• if you are taking an ACE inhibitor along with other medications that belong to another class of medications called mineralocorticoid receptor antagonists (MRAs). These medications are for the treatment of heart failure (see “Other medications and Candesartán Sandoz”),
• if you are pregnant (or if you suspect that you may be). Candesartán is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered at all if you are more than 3 months pregnant, as it may cause serious harm to your baby when administered from that point onwards (see section “Pregnancy”).

Your doctor may need to monitor your kidney function, blood pressure, and blood electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading “Do not take Candesartán Sandoz”.

If you fall into any of these situations, you should visit your doctor more frequently and have some tests done.

If you are about to undergo surgery, inform your doctor or dentist that you are taking Candesartán Sandoz. This is because Candesartán Sandoz, in combination with some 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 it on your own.

Children and adolescents

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

Other medications and Candesartán Sandoz

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

Candesartán may affect the way other medications work, and some medications may have an effect on candesartán. If you are using certain medications, your doctor may need to perform regular blood tests.

Especially, 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 that help lower blood pressure, including beta-blockers, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril,
• nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medications to relieve pain and inflammation),
• aspirin (if you are taking more than 3 g per day) (medication to relieve pain and inflammation),
• potassium supplements or salt substitutes that contain potassium (medications that increase the amount of potassium in the blood),
• heparin (medication to increase blood fluidity),
• co-trimoxazole (an antibiotic) also known as trimethoprim/sulfamethoxazole,
• diuretics (medications to promote urine elimination),
• lithium (a medication to treat mental health problems),
• if you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Candesartán Sandoz” and “Warnings and precautions”),
• if you are taking an ACE inhibitor along with other medications specifically for the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone).

Taking Candesartán Sandoz with food, drinks, and alcohol

• You can take candesartán with or without food.
• Consult your doctor before taking alcohol, if you are prescribed candesartán. Alcohol may make you feel weak or dizzy.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will usually recommend that you stop taking candesartán before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of candesartán. Candesartán is not recommended for use at the beginning of pregnancy, and in no case should it be administered from the third month of pregnancy, as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Candesartán is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

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

Candesartán Sandoz contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Candesartán Sandoz contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. It is essential to take candesartan every day.

You can take candesartan with or without food.

Swallow the tablet with the help of a glass of water.

Try to take the tablets at the same time every day. This will make it easier for you to remember to take them.

Division of tablets:

If necessary, the tablet can be divided into two equal doses. Place the tablet with the breaking line upwards on a smooth and hard surface (e.g., a table or a plate). Place your index fingers (or thumbs) on either side of the line and press simultaneously briefly and firmly.

Hypertension:

• The recommended dose of candesartan is 8 mg once a day. Your doctor may increase this dose up to 16 mg once a day and then 32 mg once a day, 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, for example, due to vomiting, diarrhea, or because they are taking diuretics, the doctor may prescribe a lower initial dose,
• In some black patients, the response to this type of medication may be reduced when administered as a single treatment, so they may need a higher dose.

Use in children and adolescents with hypertension

Children from 6 to <18

The recommended initial dose is 4 mg once a day.

For patients weighing <50

For patients weighing ≥ 50 kg: in patients whose blood pressure is not adequately controlled, your doctor may decide that the dose needs to be increased to 8 mg once a day or to 16 mg once a day.

Heart failure:

• The recommended initial dose of candesartan is 4 mg once a day. Your doctor may increase this dose, doubling the dose in intervals of at least 2 weeks, up to a dose of 32 mg once a day. Candesartan can be taken with other medications for heart failure. Your doctor will decide what treatment is most suitable for you.

If you take more Candesartan 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Candesartan Sandoz

Do not take a double dose to compensate for the missed doses. Simply take the next dose when it is due.

If you interrupt treatment with Candesartan Sandoz

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.

Like all medicines, this medicinecan cause side effects, although not everyone will experience them. However, it is important that you know these possible side effects.

Stop taking Candesartán Sandoz and contact 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 that may cause difficulty swallowing,
• severe itching on the skin (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 a blood test from time to time to check if candesartán is affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (may affect up to 1 in 10 people):

• feeling of dizziness,
• headache,
• respiratory infection,
• low blood pressure.This may cause you to feel dizzy or faint,
• 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 is severe, you will feel tired, weak, irregular heartbeat, or tingling,

• effects on kidney function, especially if you already have kidney problems or heart failure. In very rare cases, it may cause kidney failure.

Very rare (may affect up to 1 in 10,000 people):

• swelling of the face, lips, tongue, and/or throat,
• decrease in red or white blood cells. You may feel tired, 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, yellowing of the skin, the white of the eyes, and symptoms similar to the flu,
• 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.

Unknown frequency(cannot be estimated from available data)

• Diarrhea

Additional side effects in children and adolescents

In children treated for high blood pressure, side effects appear to be similar to those observed 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 of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and blister/bottle after “CAD”. The expiration date is the last day of the month indicated.

Storein the original packagingto protect it from moisture.

Duration after the first opening of the bottle:

3 months

Medicines should not be thrown down the drain or in the trash. Dispose of the packaging and medicines you no longer need at your local SIGRE collection pointat your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Candesartán Sandoz 16 mg tablets

• The active ingredient is candesartán cilexetilo.

Each tablet contains 16 mg of candesartán cilexetilo.

• The other components are:

Lactose monohydrate (lactose)

Maize starch

Povidone 30

Carrageenan

Sodium croscarmellose

Magnesium stearate

Iron oxide red (E 172)

Titanium dioxide (E 171)

Appearance of the product and contents of the package

Tablet.

Candesartán Sandoz 16 mg tablets: pink, speckled, round, biconvex, marked with 16 on one face and a notch on the other.

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

Aluminium/Aluminium perforated blister in single-dose: 28 x 1, 50 x 1 tablets.

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

Aluminium/Aluminium perforated blister in single-dose with desiccant: 50 x 1 tablets.

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

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible

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 with 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:Candea16mg tablete

Spain:Candesartan Sandoz 16 mg comprimidos EFG

Estonia:Prescanden16mg

Finland:Candemox 16 mg tabletit

Netherlands: CANDESARTAN CILEXETIL SANDOZ16MG, tabletten

Norway:Candesartan Sandoz16mg tabletter

Poland:CANDEPRES

Portugal:CANDESARTAN SANDOZ

Romania:CANDESARTAN SANDOZ16mg comprimate

United Kingdom: Candesartan Cilexetil 16 mg Tablets

Sweden:Candesartan Sandoz 16 mg, tablett

Last review date of this leaflet: February 2025

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/