Patient Information Leaflet

Candesartán Aurovitas 4mg Tablets EFG

candesartán cilexetilo

Read this leaflet carefully before you start taking this medicine, as 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

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

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

3.How to take Candesartán Aurovitas

4.Possible side effects

5.Storage of Candesartán Aurovitas

6.Contents of the pack and additional information

Your medication is called Candesartán Aurovitas. The active ingredient is candesartan cilexetilo. This 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.

Candesartán can be used for:

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

Do not take Candesartán Aurovitas:

• If you areallergic to candesartán cilexetilo or to any of the other components of this medication (including those listed in the section6).
• If you are more than 3months pregnant. (It is better to avoid this medication during the first months of pregnancy – see section “Pregnancy”).
• If you have severe liver disease or biliary obstruction (problem with the bile flow from the gallbladder).
• If the patient is a child under 1 year of age.
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.

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 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.
• Ifyou have vomiting, have recently had severe vomiting, or have diarrhea.
• If you have a condition called Conn's syndrome (also known as primary aldosteronism) affecting the adrenal gland.
• If you have low blood pressure.
• Ifyou have ever had a stroke.
• If you are pregnant (or if you suspect you may be). Do not use candesartán at the beginning of pregnancy (first 3months) andin no case should it be administered if you are more than three months pregnant,as it may cause serious harm to your baby when administered from that point on (see section “Pregnancy”).
• If you are taking any of the following medications used to treat high blood pressure (hypertension):
• 1. - An angiotensin-converting enzyme inhibitor (ACEI) (for example, enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  2. - Aliskirén.
• If you are taking an ACEI along with a medication belonging to the class of drugs known as mineralocorticoid receptor antagonists (MRAs). These medications are for the treatment of heart failure (see “Other medications and Candesartán Aurovitas”).

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

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

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

If you fall into any of these situations, your doctor may want to see you more frequently and perform some tests.

If you are about to undergo surgery, inform your doctor or dentist that you are taking candesartán. This is because candesartán, in combination with some anesthetics, may cause a drop in blood pressure.

Children and adolescents

Candesartán 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 a potential risk to developing kidneys.

Other medications and Candesartán Aurovitas

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

Candesartán may affect how some medications work and some medications may influence the effect of candesartán. If you are using certain medications, your doctor may need to perform blood tests at regular intervals.

In particular, inform your doctor if you are using any of the following medications, asyour doctor may need to modify your dose and/or take other precautions:

• Other medications to lower your blood pressure, including beta-blockers, diazoxide, and the so-called 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 take more than 3g per day) (medication to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medications that increase the amount of potassium in your blood).
• Heparin (a medication to increase blood fluidity).
• Cotrimoxazol (an antibiotic medication) also known as trimetoprima/sulfametoxazol.
• Diuretics (medications to promote urine elimination).
• Lithium (a medication for mental health problems).
• If you are taking an ACEI or aliskirén (see also the information under the headings “Do not take Candesartán Aurovitas” and “Warnings and precautions”).
• If you are being treated with an ACEI along with other specific medications for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example, spironolactone, eplerenone).

Taking Candesartán Aurovitas with food, drinks, and alcohol

• You can take candesartán with or without food.
• When prescribed candesartán, consult your doctor before taking alcohol. Alcohol may cause dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you stop takingcandesartánbefore becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead ofcandesartán.

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 on.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. 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 Aurovitas contains lactose

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

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 that you continue taking candesartan every day.

You can take candesartan with or without food.

Swallow the tablet with a little water.

Try to take the tablet at the same time every day. This will help you remember to take it.

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 up to 32 mg once a day based on 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 taking diuretics, your doctor may prescribe a lower initial dose.
• Some black patients may have a reduced response to this type of medication when given as a single treatment, and these patients may need 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 a day.

For patients weighing <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 per day.

For patients weighing ≥ 50 kg:In some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose to 8 mg once a day and to 16 mg once a day.

Heart failure in adults:

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

If you take more Candesartán Aurovitas than you should:

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 forgot to take Candesartán Aurovitas:

Do not take a double dose to compensate for the missed doses. Simply take the next dose.

If you interrupt the treatment with Candesartán Aurovitas:

If you stop taking candesartan, your blood pressure may increase again. Therefore, do not stop taking candesartan before consulting your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. It is important that you know which side effects could occur.

Stop taking candesartan and see 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, which may cause difficulty swallowing.
• Severe skin itching (with skin rash).

Candesartan 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 occurs, inform your doctor. It is possible that your doctor will perform a blood test at regular intervals to check that candesartan is not affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (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 potassium levels in the blood, especially if you already have kidney problems or heart failure. If this is severe, you will feel tired, weak, have irregular heartbeats, or numbness.

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

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.
• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, including inflammation of the liver (hepatitis). You will feel tired, have a yellowish discoloration of the skin and the white of the eyes, and symptoms similar to the flu.
• Nausea.
• Changes in blood test results:
• • Decrease in sodium levels in the blood. If severe, you may feel weak, lack energy, or have muscle cramps.
• Cough.

• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known (cannot be estimated from available data)

• Diarrhea.

Other side effects in children

In children treated for hypertension, side effects appear to be similar to those seen in adults, but occur more frequently. Throat pain 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, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: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 or blister. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofCandesartán Aurovitas

• The active ingredient is candesartan cilexetil. The tablets contain 4mg of candesartan cilexetil.
• The other components are: lactose monohydrate, hydroxypropylcellulose, calcium carmelose, aluminium and magnesium metasilicate, propylene glycol and magnesium stearate.

Appearance of the product and contents of the packaging

Candesartán Aurovitas 4mg are round, biconvex tablets, white to off-white in color, marked with “CN” and “4” separated by a groove on one face of the tablet and smooth on the other face.

The tablet can be divided into equal doses by splitting it along the groove.

Candesartán Aurovitas 4mg tablets are marketed in blisters, in packs containing 14 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

Amadora 2700-487

Portugal

Last review date of this leaflet: 03 2025

Other sources of information

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