Package Insert: Information for the Patient

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

Your medication is called Candesartán Alter. The active ingredient is candesartán 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 Altercan be used for:

• treatment of high blood pressure (hypertension) in adult patients and in children and adolescents from 6 to <18 years old
• treatment of 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 Alter

• if you are allergic to candesartán cilexetilo or any of the othercomponents of this medication (listed in section 6).
• if you are more than 3 months pregnant. (It is best to avoid this medication during the first months of pregnancy– see Pregnancy section).
• if you have severe liver disease or bile duct obstruction (problem with the bile flowing out of the gallbladder).
• if the patient is a child under 1 year of age.
• if you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskirén.

If you are unsure if you fall into any of these situations, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor before starting to take Candesartán Alter

• 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 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.
• if you have ever had a stroke.
• if you are pregnant (or if you suspect you may be). Candesartán Alter is not recommended for use at the beginning of pregnancy (first 3 months) andshould not be administered if you are more than 3 months pregnant,as it may cause serious harm to your baby when administered from that point onwards (see Pregnancy section).
• if you are taking any of the following blood pressure medications:
• • a converting enzyme inhibitor (ACEI) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • 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 “Taking Candesartán Alter with other medications”)

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartán Alter. Your doctor will decide whether to continue treatment. Do not stop taking Candesartán Alter in monotherapy.

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 Alter”.

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 the developing kidneys.

Other medications and Candesartán Alter

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

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

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 blood pressure medications, 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 3 g 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) 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 Alter” 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) (e.g., spironolactone, eplerenone).

Taking Candesartán Alter with food, drinks, and alcohol

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

Pregnancy and breastfeeding

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Candesartán Alter 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 Alter. If this happens to you, do not drive or operate tools or machinery.

Candesartán Alter 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.

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 continue taking candesartan every day.

You can take this medication 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.

The groove is only for breaking the tablet if it is difficult to swallow it whole.

Hypertension:

• The recommended dose of this medication 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, the doctor may prescribe a lower initial dose.
• Some black patients may present 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 from 6 to <18>

The recommended starting dose is 4 mg once a day.

For patients weighing <50>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 to 8 mg once a day and to 16 mg once a day.

Heart failure in adults:

• The initial recommended dose 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, and your doctor will decide what treatment is suitable for you.

If you take more Candesartan Alter 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Candesartan Alter

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

If you interrupt treatment with Candesartan Alter

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

If you have any other questions 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 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 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 from time to time 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 tingling.
• 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.
• A 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:
• • A 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 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 leaflet. 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 after CAD. 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 in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of 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 of Candesartán Alter

• The active ingredient is candesartan cilexetil. Each tablet contains 16 mg of candesartan cilexetil.

The other components are lactose monohydrate, maize pregelatinized starch, hydroxypropylcellulose, calcium carboxymethylcellulose, triethyl citrate, and magnesium stearate. See section 2Candesartán Alter contains lactose.

Appearance of the product and contents of the packaging

White, round, biconvex tablets with a notch on one face.

Candesartán Alter 16 mg is available in a blister pack with 28 tablets.

Marketing authorization holder and manufacturer responsible

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review date of this leaflet:February 2025.

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