Candesartan Aurovitas 16 mg Tablets

Introduction

Package Leaflet: Information for the Patient

Candesartan Aurovitas 16mg Tablets EFG

candesartan cilexetil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Your medicine is called Candesartan Aurovitas. The active ingredient is candesartan cilexetil. This belongs to a group of medicines called angiotensin II receptor antagonists. It works by making your blood vessels relax and dilate. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood to all parts of your body.

Candesartan can be used for:

• Treatment of high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to <18 years.< li>
• Treatment of adult patients with heart failure with reduced muscular function of the heart when it is not possible to use angiotensin-converting enzyme inhibitors (ACE inhibitors), or in addition to ACE inhibitors when symptoms persist despite treatment and it is not possible to use mineralocorticoid receptor antagonists (MRAs). (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. What you need to know before you take Candesartan Aurovitas

Do not take Candesartan 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 better to avoid this medicine during the first months of pregnancy – see section “Pregnancy”).
• If you have severe liver disease or biliary obstruction (problem with the release of bile from the gallbladder).
• If the patient is a child under 1 year of age.
• If you have diabetes or kidney impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are not sure if you are in one of these situations, consult your doctor or pharmacist before taking candesartan.

Warnings and precautions

Consult 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 had severe vomiting or have diarrhea.
• 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 if you think you might be). Your doctor will normally advise you to stop taking candesartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of candesartan.
• 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), especially 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 called mineralocorticoid receptor antagonists (MRAs). These medicines are for the treatment of heart failure (see “Other medicines and Candesartan Aurovitas”).

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

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea 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 Candesartan Aurovitas”.

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

If you are going to have surgery, tell your doctor or dentist that you are taking candesartan. This is because candesartan, in combination with some anesthetics, can cause a drop in blood pressure.

Children and adolescents

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

Other medicines and Candesartan Aurovitas

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

Candesartan may affect the way some medicines work and some medicines may affect the effect of candesartan. If you are using certain medicines, your doctor may need to perform blood tests from time to time.

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

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• Non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines to relieve pain and inflammation).
• Acetylsalicylic acid (if you take more than 3 g per day) (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 problems).
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Candesartan Aurovitas” and “Warnings and precautions”).
• If you are being treated with an ACE inhibitor together with other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Taking Candesartan Aurovitas with food, drinks, and alcohol

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

Pregnancy and breastfeeding

Pregnancy

You should tell your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking candesartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of candesartan.

Candesartan should not be used during the first trimester of pregnancy and should not be used at all after the third month of pregnancy, as it may cause serious harm to your baby when administered after this time.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Candesartan is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Some patients may feel tired or dizzy when taking candesartan. If this happens, do not drive or use tools or machines.

Candesartan Aurovitas contains lactose

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

3. How to take Candesartan Aurovitas

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. It is important 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 each day. This will help you remember to take it.

High blood pressure:

• The recommended dose of candesartan is 8 mg once a day. Your doctor may increase this dose to 16 mg once a day and then to 32 mg once a day 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, diarrhea, or because they are taking diuretics), the doctor may prescribe a lower initial dose.
• Some black patients may have a reduced response to this type of medicine when given as the only treatment, and these patients may need a higher dose.

Use in children and adolescents with high blood pressure:

Children from 6 to <18 years of age:< em>

The recommended starting dose is 4 mg once a day.

For patients weighing <50 kg:< em> in some patients whose blood pressure is not adequately controlled, the 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, the 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 usual initial dose of candesartan is 4 mg once a day. Your doctor may increase this dose by doubling the dose at intervals of at least 2 weeks up to 32 mg once a day. Candesartan can be taken with other medicines for heart failure; your doctor will decide what treatment is right for you.

If you take more Candesartan Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Candesartan Aurovitas

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

If you stop taking Candesartan Aurovitas

If you stop taking candesartan, your blood pressure may increase again. Therefore, do not stop taking candesartan without consulting your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. It is important that you know what these side effects may be.

Stop taking candesartan and go to the 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 itching of the skin (with 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 have a fever. If this happens, tell your doctor. Your doctor may perform a blood test from time to time to check that candesartan is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common (may affect up to 1 in 10 people)

• Dizziness.
• Headache.
• Respiratory infection.
• Low blood pressure. This may cause you to feel dizzy or faint.
• 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 situation is severe, you may feel tired, weak, have irregular heartbeats, or have 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.
• A decrease in red or white blood cells. You may feel tired, have an infection, or have a fever.
• Rash, hives.
• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, including liver inflammation (hepatitis). You may feel tired, have a yellowish color of the skin and the whites of the eyes, and symptoms similar to those of 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 with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known (cannot be estimated from the available data)

• Diarrhea.

Other side effects in children

In children treated for high blood pressure, the side effects seem to be similar to those seen in adults, but they occur more frequently. Sore throat is a very common side effect in children but has not been reported in adults, and runny nose, fever, and increased heart rate are common in children but have not been reported in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side 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 which is stated on the carton or blister. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartan Aurovitas

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

Appearance of the product and contents of the pack

Candesartan Aurovitas 16 mg are round, biconvex tablets, yellow in color, marked with “CN” and “16” separated by a score line on one side of the tablet and smooth on the other side.

The tablet can be divided into equal doses by breaking it along the score line.

Candesartan Aurovitas 16 mg tablets are available 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

Phone: 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 last revision of this leaflet: 03/2025

Other sources of information

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/)