Leaflet: information for the user

Candesartán Almus 16 mg tablets EFG

Candesartán cilexetilo

Read this 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, 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Candesartán Almus

3.How to take Candesartán Almus

4.Possible side effects

5.Storage of Candesartán Almus

6.Contents of the pack and additional information

The name of this medication is Candesartán Almus. The active ingredient is candesartan cilexetilo. It belongs to a group of medications called angiotensin II receptor antagonists. It works by causing blood vessels to relax and widen. This helps to lower blood pressure. This makes it easier for the heart to pump blood to all parts of the body.

This medication is 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 Almus:

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6);
• if you are more than 3 months pregnant (it is also recommended to avoid this medication at the beginning of pregnancy; see the section on pregnancy);
• if you have severe liver disease or bile duct obstruction (a problem related to the drainage of bile from the gallbladder);
• if the patient is under 1 year of age.
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén.

If you are unsure whether any of the above applies to you, speak with your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• if you have heart, liver, or kidney problems or are on dialysis;
• if you have recently undergone a kidney transplant;
• if you experience vomiting, have recently had intense vomiting, or have diarrhea;
• if you have a condition called "Conn's syndrome" (also known as primary hyperaldosteronism) affecting the adrenal glands;
• if you have very low blood pressure;
• if you have ever had a stroke;
• inform your doctor if you suspect you are (or could become) pregnant. Candesartán is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if used during this stage (see the section on "Pregnancy").
• if you are taking any of the following medications used to treat high blood pressure (hypertension):

- an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

- aliskirén

• if you are taking an ACE inhibitor along with a medication belonging to the class of drugs known as mineralocorticoid receptor antagonists (MRAs). These medications are used to treat heart failure (see "Other medications and Candesartán Almus").

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

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

See also the information under the heading "Do not take Candesartán Almus".

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

If you have a scheduled procedure, inform your doctor or dentist that you are taking this medication. This is because candesartán, when combined with certain anesthetics, may lower blood pressure excessively.

Children and adolescents

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

Other medications and Candesartán Almus

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

Candesartán may affect how other medications work, and certain medications may affect how this medication works. If you are taking certain medications, your doctor may want to perform blood tests at regular intervals.

In particular, inform your doctor if you are taking any of the following medications:

• other medications to help lower your blood pressure, including beta blockers, diazoxide, 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 (a medication to relieve pain and inflammation);
• potassium supplements or salt substitutes containing potassium (medications that increase potassium levels in the blood);
• heparin (an anticoagulant medication);
• trimethoprim/sulfamethoxazole (an antibiotic medication);
• diuretics;
• lithium (a medication for mental health conditions).

• if you are taking an ACE inhibitor or aliskirén (see also the information under the headings "Do not take Candesartán Almus" and "Warnings and precautions");
• if you are being treated with an ACE inhibitor along with other medications specifically used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Taking Candesartán Almus with food, drinks, and alcohol

• You can take this medication with or without food.
• When your doctor prescribes this medication, inform them if you can consume alcohol. Alcohol may cause you to feel weak or dizzy.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you suspect you may be pregnant, consult your doctor or pharmacist before using this medication.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. This medication is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment for you if you wish to start breastfeeding, especially if your baby is a newborn or premature.

Driving and operating machinery

Some people may feel tired or dizzy when taking this medication. If this happens to you, do not drive vehicles or operate tools or machinery.

Candesartán Almus contains lactose

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is essential to take this medication every day.

You can take this medication with or without food.

Swallow the tablet with the help of water.

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

Hypertension:

• The recommended dose ofthis medicationis 8 mg once a day. Your doctor may increase this dose up to 16 mg once a day and subsequently up to 32 mg once a day, depending on your blood pressure response.
• For some patients, such as those with liver or kidney problems, or those who have recently lost body fluids, for example, due to vomiting or diarrhea or the use of diuretics, the doctor may prescribe lower initial doses.

• Someblack patientsmay present a reduced response to this type of medication when used as a single treatment and may require higher doses.

Use in children and adolescents with hypertension:

Children from 6 to <18

The recommended starting dose is 4 mg once a day.

For patients with a weight <50

For patients with a weight ≥ 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 recommended initial dose ofthis medicationis 4 mg once a day. Your doctor may increase this dose by doubling it at 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 most suitable for you.

If you take more Candesartán Almusdel than you should

If you take more candesartan than prescribed, contact your doctor or pharmacist immediately for advice on what to do.

If you forgot to take Candesartán Almus

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

Take the next dose as usual.

If you interrupt treatment with Candesartán Almus

If you interrupt treatment with this medicationyour blood pressure may increase again. Therefore, do not stop taking this medication without first talking to 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 what these side effects may consist of.

Stop taking this medicine and consult a 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;
• Intense itching of the skin (with the appearance of bumps).

Candesartan may reduce the number of white blood cells in the blood. Your resistance to infections may decrease and you may experience fatigue, infections, or fever. If this occurs, contact your doctor. Your doctor may occasionally ask you to undergo tests to check if this medicine has affected your blood (agranulocytosis).

Other possible side effects include:

Frequent (may affect up to 1 in 10 people)

• Sensation of dizziness/dizziness.
• Headache.
• Respiratory infection.
• Low blood pressure. This may make you feel weak or dizzy.
• Changes in blood test results:

• Increased amount of potassium in the blood, especially if you have kidney problems or heart failure. If the increase is intense, you may feel fatigue, weakness, irregular heartbeats, or tingling.

• Effects on kidney function, especially if you 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)

• Swelling of the face, lips, tongue, and/or throat.
• Reduction in the number of red or white blood cells. You may feel fatigue, experience an infection, or have a fever.
• Skin rash, urticaria.
• Itching.
• Back, muscle, and joint pain.
• Changes in liver function, including hepatitis. You may feel fatigue, yellowing of the skin and the white of the eyes, and flu-like symptoms.
• Nausea.
• Changes in blood test results:

• Reduction in the amount of sodium in the blood. If it is intense, you may feel fatigue, lack of energy, or 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 and adolescents

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 rhinorrhea, 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 the Vigilance of Medicines for Human Usehttps://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

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

This medication does not require special storage conditions.

Medicines should not be thrown into the drains or trash.Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the 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 Almus

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

The other components are: hydroxypropylcellulose (E463), lactose monohydrate, magnesium stearate, cornstarch, diethylenglycol monoethyl ether (Transcutol) and iron oxide red (E172).

Appearance of Candesartán Almus and contents of the packaging

The 16 mg tablets are round, pink, and scored on one of their faces.

Candesartán Almus 16 mg tablets EFG are supplied in: transparent ALU/PVC blisters with 7, 14, 15, 20, 28, 30, 50, 50x1 (single-unit dose), 56, 98, 98x1 (single-unit dose), 100, and 300 tablets.

Only some sizes of packaging may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email:[email protected]

Responsible manufacturer:

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº 7, Industrial Estate Miralcampo

19200 Azuqueca de Henares (Guadalajara),

Spain

This medicine is authorized in the EEA member states with the following names:

NL: Candesartán cilexetil Liconsa 16 mg tablets

ES: Candesartán Almus 16 mg tablets EFG

Last review date of this leaflet: 03/2025

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