Candesartan Sandoz 16 mg Tablets

Introduction

Package Leaflet: Information for the Patient

Candesartan Sandoz 16 mg Tablets EFG

Candesartan cilexetil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

The name of the medicine is Candesartan 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. This makes it easier to get the blood to all the parts of your body.

This medicine can be used for:

• treatment of high blood pressure (hypertension) in adult and children and adolescents aged 6 to <18 years,< li>
• treatment in adult patients with heart failure with reduced muscular function of the heart when it is not possible to use ACE inhibitors, or added to ACE inhibitors when symptoms persist despite treatment and it is not possible to use mineralocorticoid receptor antagonists (MRAs) (ACE inhibitors and MRAs are a group of medicines used to treat heart failure).

2. What you need to know before you take Candesartan Sandoz

Do not take Candesartan Sandoz

• if you are allergic to candesartan cilexetil or any of the other ingredients of this medicine (listed in section 6),
• if you are more than 3 months pregnant. It is also better to avoid taking candesartan at the start of pregnancy (see section “Pregnancy”),
• if you have severe liver disease or biliary obstruction (a problem with the release of bile from the gallbladder),
• if you have diabetes or kidney impairment and are treated with an ACE inhibitor or aliskiren,
• if the patient is a child under 1 year of age.

If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking candesartan.

Warnings and precautions

Talk to your doctor or pharmacist before taking candesartan:

• if you have heart, liver or kidney problems, or are undergoing dialysis,
• if you have recently had a kidney transplant,
• if you are vomiting, have recently vomited, or have diarrhea,
• if you have a disease of the adrenal glands called Conn's syndrome (also called 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:

• an ACE inhibitor (such as enalapril, lisinopril, ramipril) especially if you have kidney problems related to diabetes,
• aliskiren,
• if you are taking an ACE inhibitor along with other medicines that belong to another class of medicines called mineralocorticoid receptor antagonists (MRAs). These medicines are for the treatment of heart failure (see “Other medicines and Candesartan Sandoz”),
• if you are pregnant (or think you might be). Candesartan should not be used at the start of pregnancy (first 3 months) and should not be used at all after the third month of pregnancy, as it may cause serious harm to your baby if used after this time (see section “Pregnancy”).

Your doctor may check 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 Candesartan Sandoz”.

If you are in any of these situations, you should visit your doctor more often and have some tests.

If you are going to have surgery, tell your doctor or dentist that you are taking Candesartan Sandoz. This is because Candesartan Sandoz, in combination with some anesthetics, can cause a drop in blood pressure.

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

Children and adolescents

Candesartan cilexetil has been studied in children. For more information, talk to your doctor. Candesartan should not be given to children under 1 year of age due to the potential risk to the developing kidneys.

Other medicines and Candesartan Sandoz

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Candesartan may affect the way other medicines work and some medicines may have an effect on candesartan. In the case of certain medicines, your doctor may need to take regular blood tests.

Especially, tell your doctor if you are using any of the following medicines, as your doctor may need to change your dose and/or take other precautions:

• other medicines that help 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 to relieve pain and inflammation),
• acetylsalicylic acid (if you are taking more than 3 g per day) (medicine to relieve pain and inflammation),
• potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in the blood),
• heparin (medicine to increase blood fluidity),
• cotrimoxazole (an antibiotic medicine) also known as trimethoprim/sulfamethoxazole,
• diuretics (medicines to promote urine elimination),
• lithium (a medicine to treat mental health problems),
• if you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Candesartan Sandoz” and “Warnings and precautions”),
• if you are taking an ACE inhibitor along with other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone).

Taking Candesartan Sandoz with food, drinks, and alcohol

• You can take candesartan with or without food.
• Talk to your doctor before drinking alcohol if he prescribes candesartan. Alcohol can 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will normally advise you to stop taking candesartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of candesartan. Candesartan should not be used during the first trimester of pregnancy and should not be used at all after the third month of pregnancy, as it may cause serious harm to your baby if used after this time.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Candesartan should not be used 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 use tools or machines.

Candesartan Sandoz contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

Candesartan 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 Candesartan Sandoz

Follow exactly the instructions of administration of this medicine indicated by your doctor. 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 the help of a glass of water.

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

Division of the tablets:

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

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 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 medicine may be reduced when used as sole treatment, so they may need a higher dose.

Use in children and adolescents with high blood pressure

Children from 6 to <18 years of age:< p>

The recommended initial dose is 4 mg once a day.

For patients weighing <50 kg: in patients whose blood pressure is not adequately controlled, the doctor may decide that dose needs to be increased a maximum of 8 mg once day.< p>

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

Heart failure:

• the recommended initial dose of candesartan is 4 mg once a day. The doctor may increase this dose, doubling the dose at intervals of at least 2 weeks, up to a dose of 32 mg once a day. Candesartan can be taken with other medicines for heart failure. The doctor will decide what treatment is best 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Candesartan Sandoz

Do not take a double dose to make up for forgotten doses. Simply take the next dose when it is due.

If you stop taking Candesartan Sandoz

If you stop taking candesartan, your blood pressure may increase again. Therefore, do not stop taking candesartan without talking to your doctor first.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. However, it is important that you know these possible side effects.

Stop taking Candesartan 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 can cause difficulty swallowing,
• severe itching of the skin (with rash).

Candesartan 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 have a fever. Contact your doctor if this happens. Your doctor may perform a blood test from time to time to check that candesartan is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common (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 may notice 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,
• decrease in red 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 liver inflammation (hepatitis). You may feel tired, yellowing of the skin, the whites of the eyes, and symptoms similar to those of the flu,
• nausea,
• changes in blood test results:

• reduction 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 side effects in children and adolescents

In children treated for high blood pressure, the side effects seem to be similar to those observed in adults, but they occur more frequently. Sore throat is a very common side 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 side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the carton and blister/ bottle after “EXP”. The expiry date is the last day of the month stated.

Store in the original package to protect from moisture.

Shelf life after first opening of the bottle:

3 months

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Candesartan Sandoz 16 mg tablets

• The active ingredient is candesartan cilexetil.

Each tablet contains 16 mg of candesartan cilexetil.

• The other ingredients are:

Lactose monohydrate (lactose)

Corn starch

Povidone 30

Carrageenan

Sodium croscarmellose

Magnesium stearate

Red iron oxide (E 172)

Titanium dioxide (E 171)

Appearance of the product and container content

Tablet.

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

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

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

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

Perforated Al/Al blister pack in unit 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 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 δισκία

Italy: CANDESARTAN SANDOZ

Denmark: Candemox, tabletter

Czech Republic: Xaleec 16 mg

Slovak Republic: Candesartan Sandoz 16 mg tablety

Slovenia: Candea 16 mg tablete

Spain: Candesartan Sandoz 16 mg comprimidos EFG

Estonia: Prescanden 16mg

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 last revision of this leaflet: February 2025

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