Candesartan Tárbis 8 mg Tablets

Introduction

Package Leaflet: Information for the User

Candesartan Tarbis 8 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, 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 and other information

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

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

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

Candesartan Tarbis 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 cardiac muscle function when it is not possible to use angiotensin-converting enzyme inhibitors (ACE inhibitors), or added 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 Tarbis

Do not take Candesartan Tarbis:

• 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 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 bile leaving the gallbladder).
• if the patient is a child under 1 year of age.
• if you have diabetes or kidney problems and are being treated with a medicine containing aliskiren.

If you are not sure if you are in any of these situations, consult your doctor or pharmacist before taking Candesartan Tarbis.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Candesartan Tarbis.

• if you have heart, liver or kidney problems or are on 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). It is not recommended to use Candesartan Tarbis at the start of pregnancy (first 3 months), and in no case should it be administered if you are more than 3 months pregnant, as it may cause serious harm to your baby when administered from that time on (see section Pregnancy).
• if you are taking any of the following medicines 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.
• aliskiren.

• if you are taking an ACE inhibitor along with a medicine belonging to the class of drugs called mineralocorticoid receptor antagonists (MRAs). These medicines are for the treatment of heart failure (see "Taking Candesartan Tarbis with other medicines")

Your doctor may check 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 Candesartan Tarbis".

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

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

Children and adolescents

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

Taking Candesartan Tarbis with other medicines

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

Candesartan Tarbis may affect the way some medicines work and some medicines may affect the effect of Candesartan Tarbis. 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 drugs (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 the blood).
• Heparin (a medicine to increase blood fluidity).
• 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 Tarbis" and "Warnings and precautions").
• If you are being treated with an ACE inhibitor along with other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Taking Candesartan Tarbis with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy

You should inform your doctor if you are pregnant (or if you think you might be). Your doctor will normally recommend that you take a different medicine instead of Candesartan Tarbis before you become pregnant or as soon as you know you are pregnant, and will recommend that you take a different medicine instead of Candesartan Tarbis. It is not recommended to use Candesartan Tarbis at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time on.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. It is not recommended to use Candesartan Tarbis during breastfeeding, and your doctor will choose a different 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 Tarbis. If this happens to you, do not drive or use tools or machines.

Candesartan Tarbis 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 Tarbis

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. It is important that you continue taking Candesartan Tarbis every day.

You can take Candesartan Tarbis with or without food.

Swallow the tablet with a little water.

The tablet can 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 Candesartan Tarbis 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, for example 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 sole treatment, and these patients may need a higher dose.

Use in children and adolescents with high blood pressure:

Children aged 6 to <18 years:< p>

The recommended starting dose is 4 mg once a day.

For patients weighing <50 kg: in some patients whose blood pressure is not adequately controlled, the doctor may decide to increase dose a maximum of 8 mg per day.< p>

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 Tarbis 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 Tarbis can be taken with other medicines for heart failure, and your doctor will decide what treatment is suitable for you.

If you take more Candesartan Tarbis than you should

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

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

If you forget to take Candesartan Tarbis

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

If you stop taking Candesartan Tarbis

If you stop taking Candesartan Tarbis, your blood pressure may rise again. Therefore, do not stop taking Candesartan Tarbis without consulting your doctor.

If you have any further questions on the use of this product, 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 Tarbis and go to your 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 can cause difficulty swallowing;
• severe skin itching (with rash).

Candesartan Tarbis 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, inform your doctor. It is possible that your doctor will perform a blood test from time to time to check that Candesartan Tarbis is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common (affect 1 to 10 in every 100 patients)

• Dizziness.
• Headache.
• Respiratory infection.
• Low blood pressure. This can 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 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 (affect less than 1 in every 10,000 patients)

• 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.
• Skin 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.

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

• Diarrhea

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 via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan Tarbis

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 and blister after EXP. 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartan Tarbis

The active substance is candesartan cilexetil. Each Candesartan Tarbis 8 mg tablet contains 8 mg of candesartan cilexetil.

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

Appearance of the product and pack contents

The 8 mg tablets are bisected, round, pink, and scored on one side.

Candesartan Tarbis 8 mg tablets EFG are supplied in: transparent ALU/PVC blisters with 28 tablets and clinical packaging with 300 tablets.

Not all 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:

LICONSA LABORATORIES, S.A.

Avda. Miralcampo, Nº 7, Miralcampo Industrial Estate

19200 Azuqueca de Henares (Guadalajara),

Spain

Date of last revision of this leaflet: April 2018

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