Candesartan Tarbis 16 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Candesartán Tarbis 16 mg tablets EFG

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

Leaflet contents:

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

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

The name of your medicine is Candesartán Tarbis. The active substance is candesartan cilexetilo. This belongs to a group of medicines called angiotensin II receptor antagonists. It works by relaxing and widening the blood vessels, which helps lower blood pressure. It also helps the heart pump blood more easily to all parts of the body.

Candesartán Tarbis 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 in addition 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 Tarbis

Do not take Candesartán Tarbis:

• 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 best 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 flow 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 an antihypertensive medicine containing aliskiren.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Candesartán Tarbis:

• if you have heart, liver or kidney problems, or are on 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 Tarbis 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 onward (see Pregnancy section).

• if you are taking any of the following medicines for high blood pressure (hypertension):

• an angiotensin-converting enzyme (ACE) inhibitor (e.g., 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 section "Taking Candesartán Tarbis with other medicines").

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 Tarbis”.

If any of these situations apply to you, your doctor may want to see you more frequently and carry out certain tests.

If you are due to undergo surgery, inform your doctor or dentist that you are taking Candesartán Tarbis. This is because Candesartán Tarbis, in combination with certain anesthetics, may cause a drop in blood pressure.

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.

Children and adolescents

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

Taking Candesartán Tarbis with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Candesartán Tarbis may affect how some medicines work, and some medicines may influence the effect of Candesartán Tarbis. If you are taking certain medicines, your doctor may need to perform 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 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 salt substitutes containing potassium (medicines that increase blood potassium levels).

• Heparin (a medicine used to thin the blood).

• Diuretics (medicines that increase urine production).

• 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 Tarbis” 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 Tarbis with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually recommend that you take a different medicine instead of Candesartán Tarbis before becoming pregnant or as soon as you know you are pregnant. Use of Candesartán Tarbis is not recommended during early pregnancy, and must under no circumstances be used after the third month of pregnancy, as it may cause serious harm to your baby from this stage onward.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Use of Candesartán Tarbis is not recommended during breastfeeding. Your doctor will choose another 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 Candesartán Tarbis. If this happens to you, do not drive or operate tools or machinery.

Candesartán Tarbis contains lactose

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

3. How to take Candesartán Tarbis

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

You may take Candesartán Tarbis with or without food.

Swallow the tablet with a little water.

The tablet may be divided into equal doses.

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 Candesartán Tarbis is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily and then 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 use of diuretics), 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 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 with body weight < 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 with body 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 daily and then to 16 mg once daily.

Heart failure in adults:

• The usual initial dose of Candesartán Tarbis is 4 mg once daily. Your doctor may increase this dose by doubling it at intervals of at least 2 weeks up to 32 mg once daily.

Candesartán Tarbis may be taken together with other medicines for heart failure, and your doctor will decide which treatment is appropriate for you.

If you take more Candesartán Tarbis than you should

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

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, indicating the medicine and the amount ingested.

If you forget to take Candesartán Tarbis

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

If you stop taking Candesartán Tarbis

If you stop taking Candesartán Tarbis, your blood pressure may rise again. Therefore, do not stop taking Candesartán Tarbis 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 may cause adverse effects, although not everybody gets them. It is important that you are aware of what these possible adverse effects could be.

Stop taking Candesartán Tarbis 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).

Candesartán Tarbis may cause a decrease in white blood cells. Your resistance to infections may be reduced, and you may feel tired, have an infection or fever. If this occurs, inform your doctor. Your doctor may perform blood tests from time to time to check that Candesartán Tarbis is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Common (affects 1 to 10 in every 100 patients)

• 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 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 (affects fewer than 1 in every 10,000 patients)

• Swelling of the face, lips, tongue and/or throat.
• A 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:
  • A 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 diarrhoea.

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

• Diarrhoea.

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 adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via 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 Candesartán Tarbis

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

Do not use this medicine after the expiry date stated on the packaging and blister after 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartán Tarbis

The active substance is candesartan cilexetilo. Each Candesartán Tarbis 16 mg tablet contains 16 mg of candesartan cilexetilo.

The other components are: hydroxypropylcellulose (E463), monohydrate lactose, magnesium stearate, corn starch, diethylene glycol monoethyl ether (Transcutol), red iron oxide (E172).

Appearance of the product and contents of the pack

The 16 mg tablets are round, pink in colour and scored on one side.

Candesartán Tarbis 16 mg tablets EFG are supplied in: transparent ALU/PVC blisters containing 28 tablets, and clinical pack containing 300 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 - Barcelona

Manufacturer:

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara),

Spain

Date of the most recent revision of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es