Candesartan Alter 16 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Candesartan Alter 16 mg tablets EFG

candesartan cilexetil

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Your medicine is called Candesartán Alter. The active substance is candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor antagonists. It works by relaxing and widening the blood vessels. This helps lower blood pressure. It also helps your heart pump blood to all parts of your body.

Candesartán Alter can be used for:

• the treatment of high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to < 18 years.
• the treatment of adult patients with heart failure and reduced heart muscle function when angiotensin-converting enzyme inhibitors (ACE inhibitors) cannot be used, or as an add-on to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRAs) cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. What you need to know before taking Candesartán Alter

Do not take Candesartán Alter

• if you are allergic to candesartan cilexetil or to any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant. (It is also advisable to avoid this medicine during the first months of pregnancy – see Pregnancy section).
• if you have severe liver disease or biliary obstruction (a problem with bile outflow from the gallbladder).
• if the patient is a child under 1 year of age.
• if you have diabetes or renal failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether any of these situations apply to you, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor before starting Candesartán Alter

• if you have heart, liver or kidney problems or are undergoing dialysis.
• if you have recently received a kidney transplant.
• if you are experiencing vomiting, have recently had severe vomiting, or have diarrhea.
• if you have an adrenal gland disorder 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 pregnant (or suspect you might be). Use of Candesartán Alter is not recommended during early pregnancy (first 3 months), and must under no circumstances be used if you are more than three months pregnant, as it may cause severe harm to your baby when used from that stage onward (see Pregnancy section).
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
  • an angiotensin-converting enzyme (ACE) inhibitor (for example, enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren.
• if you are taking an ACE inhibitor together with a medicine belonging to the class known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see "Taking Candesartán Alter with other medicines").

Talk to 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 as monotherapy without medical advice.

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 any of these situations apply to you, your doctor may wish to schedule more frequent check-ups and perform certain tests.

If you are scheduled for surgery, inform your doctor or dentist that you are taking candesartan. This is because candesartan, in combination with certain anesthetics, may cause a drop in blood pressure.

Children and adolescents

Candesartan has been studied in children. For further information, consult your doctor. Candesartan must not be given to children under 1 year of age due to the potential risk to developing kidneys.

Other medicines and Candesartán Alter

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

Candesartán Alter may affect how some medicines work, and some medicines may influence the effect of Candesartán Alter. If you are taking certain medicines, your doctor may need to perform blood tests periodically.

In particular, inform your doctor if you are taking any of the following medicines, as your doctor may need to adjust your dose and/or take other precautions:

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and angiotensin-converting enzyme (ACE) inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines used to relieve pain and inflammation).
• Acetylsalicylic acid (if taking more than 3 g per day) (a medicine used to relieve pain and inflammation).
• Potassium supplements or potassium-containing salt substitutes (medicines that increase potassium levels in your blood).
• Heparin (a medicine used to increase blood fluidity).
• Cotrimoxazole (an antibiotic medicine), also known as trimethoprim/sulfamethoxazole.
• Diuretics (medicines that promote urine elimination).
• Lithium (a medicine used for mental health conditions).
• If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Candesartán Alter” and “Warnings and precautions”).
• If you are being treated with an ACE inhibitor together with other specific medicines for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone).

Taking Candesartán Alter with food, drinks, and alcohol

• You may take Candesartán Alter with or without food.
• When Candesartán Alter is prescribed for you, consult your doctor before drinking alcohol. Alcohol may make you feel faint or dizzy.

Pregnancy and breastfeeding

Breast-feeding

Inform your doctor if you are breast-feeding or are planning to start. Use of Candesartán Alter is not recommended during breast-feeding, and your doctor will choose an alternative treatment for you if you wish to breast-feed, especially if your baby is newborn or premature.

Driving and use of machines

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 medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Candersartán Alter

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again. It is important that you continue taking candesartan every day.

You may take this medicine with or without food.

Swallow the tablet with some water.

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

The tablet's score line is intended only for splitting the tablet if you have difficulty swallowing it whole.

High blood pressure:

• The recommended dose of this medicine is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily, and then up to 32 mg once daily, 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 (e.g. due to vomiting, diarrhoea, or diuretic use), your doctor may prescribe a lower starting dose.
• Some patients of Black origin may have a reduced response to this type of medicine when used as sole treatment, and may require 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 daily.

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 daily and then to 16 mg once daily.

Heart failure in adults:

• The recommended starting dose is 4 mg once daily. Your doctor may increase this dose by doubling it at intervals of at least 2 weeks, up to a maximum of 32 mg once daily. Candesartan may be taken together with other medicines for heart failure, and your doctor will decide which treatment is suitable for you.

If you take more Candersartán Alter than you should

If you have taken more candesartan than prescribed by your doctor, contact your doctor or pharmacist immediately.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Candersartán Alter

Do not take a double dose to make up for missed doses. Simply take the next dose as scheduled.

If you stop taking Candersartán Alter

If you stop taking candesartan, your blood pressure may rise again. Therefore, do not stop taking this medicine without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. It is important that you are aware of what these adverse effects might be.

Stop taking candesartan and see 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, which may cause difficulty swallowing
• Severe itching of the skin (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. Your doctor may carry out blood tests from time to time to check that candesartan is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Common (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:
  • Increased levels of potassium in the blood, especially if you already have kidney problems or heart failure. If this condition is severe, you may experience fatigue, 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 blood cells or white blood cells. You may feel tired, or 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 may feel tired, have yellowing of the skin and whites of the eyes, and flu-like symptoms
• Nausea
• Changes in blood test results:
  • Reduction 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 causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known (cannot be estimated from available data)

• Diarrhea

Other adverse effects in children

In children treated for hypertension, adverse effects appear to be similar to those seen in adults, but occur more frequently. Sore throat is a very common adverse effect in children but has not been reported in adults, and rhinorrhea, fever, and increased heart rate are common in children but have not been reported in adults.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Candesartan Alter Storage

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

Do not use this medicine after the expiry date stated on the container following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartán Alter

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

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

Description of the product and contents of the container

White, round, biconvex tablets with a score line on one side.

Candesartán Alter 16 mg is available in blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain

Date of the most recent review of this leaflet: February 2025.

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