Candesartan Aurovitas 16 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Candesartán Aurovitas 16mg 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 may harm them.
• If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Your medicine is called Candesartán Aurovitas. 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, which helps lower blood pressure. It also helps your heart pump blood more easily to all parts of your body.

Candesartán may be used for:

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

2. What you need to know before taking Candesartán Aurovitas

Do not take Candesartán Aurovitas:

• 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 advisable to avoid this medicine during the first months of pregnancy – see section “Pregnancy”).
• If you have severe liver disease or biliary obstruction (a problem with bile drainage from 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-lowering medicine containing aliskiren.

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

Warnings and precautions

Talk to your doctor before starting to take candesartan:

• 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 experienced severe vomiting, or have diarrhoea.
• If you have a disease of the adrenal gland 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 pregnant). The use of candesartan is not recommended during early pregnancy (first 3 months), and must under no circumstances be used after the third month of pregnancy, as it may cause serious harm to your baby when used from this point onwards (see section “Pregnacy”).
• If you are taking any of the following medicines used to treat high blood pressure (hypertension):
  1. • An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  2. • Aliskiren.
• If you are taking an ACE inhibitor together with a medicine belonging to the class of drugs known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see “Other medicines and Candesartán Aurovitas”).

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

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

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

If you are in any of these situations, your doctor may wish to see you more frequently and carry out 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 anaesthetics, 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 a potential risk to developing kidneys.

Other medicines and Candesartán Aurovitas

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

Candesartan may affect how some medicines work, and some medicines may influence the effect of candesartan. If you are taking certain medicines, your doctor may need to carry out blood tests from time to time.

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 so-called 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 taking more than 3 g per day) (a medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in your blood).
• Heparin (a medicine to increase blood fluidity).
• Cotrimoxazole (an antibiotic medicine), also known as trimethoprim/sulfamethoxazole.
• Diuretics (medicines to promote urine elimination).
• Lithium (a medicine for mental health conditions).
• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Candesartán Aurovitas” and “Warnings and precautions”).
• If you are being treated with an ACE inhibitor together with other specific medicines for the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Taking Candesartán Aurovitas with food, drinks and alcohol

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

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking candesartan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.

The use of candesartan is not recommended during early pregnancy, and must under no circumstances be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that time.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. The use of candesartan is not recommended during breastfeeding, and your doctor will choose an alternative treatment for you if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

Some patients may feel tired or dizzy while taking candesartan. If this happens to you, do not drive or operate tools or machinery.

Candesartán Aurovitas contains lactose

Lactose is a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Candesartán Aurovitas

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

You may take candesartan 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.

High blood pressure:

• The recommended dose of candesartan 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 black patients may have a reduced response to this type of medicine when used as monotherapy, and these patients 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 daily.

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 usual starting dose of candesartan 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 heart failure medications; your doctor will decide which treatment is appropriate for you.

If you take more Candesartán Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Candesartán Aurovitas

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

If you stop taking Candesartán Aurovitas

If you stop taking candesartan, your blood pressure may rise again. Therefore, do not stop taking candesartan 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 experiences 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 develop a 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:

  • Increase in blood potassium levels, 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 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 blood sodium levels. 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 diarrhoea.

Frequency not known (cannot be estimated from available data)

• Diarrhoea.

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 rhinorrhoea, 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan Aurovitas

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

Do not use this medicine after the expiry date stated on the packaging or blister. 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 containers and unused medicines at a SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartán Aurovitas

• The active substance is candesartan cilexetil. The tablets contain 16 mg of candesartan cilexetil.
• The other components are: monohydrate lactose, hydroxypropylcellulose, calcium carmellose, magnesium aluminium metasilicate, propylene glycol, magnesium stearate and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Candesartán Aurovitas 16 mg are round, biconvex, yellow tablets, marked with "CN" and "16" separated by a score line on one side, and smooth on the other side.

The tablet can be divided into equal doses by splitting it at the score line.

Candesartán Aurovitas 16 mg tablets are marketed in blisters, in packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

Amadora 2700-487

Portugal

Date of the most recent revision of this leaflet: 03/2025

Other sources of information

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