Leaflet: information for the user

Candesartán Tarbis 8 mg tablets EFG

Read 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, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to take Candesartán Tarbis

3.How to take Candesartán Tarbis

4.Possible side effects

5.Storage of Candesartán Tarbis

6.Contents of the pack and additional information

The name of your medication is Candesartán Tarbis. The active ingredient is candesartán cilexetilo.This belongs to a group of medications called angiotensin II receptor antagonists. It works by causing blood vessels to relax and dilate. This facilitates a decrease in blood pressure. It also facilitates your heart pumping blood to all parts of your body.

Candesartán Tarbis can be used for:

• treatment of high blood pressure (hypertension) in adult patients and in children and adolescents from 6 to <18 years old
• treatment of adult patients with heart failure with reduced cardiac muscle function when it is not possible to use angiotensin-converting enzyme inhibitors (ACEIs), or added to ACEIs when symptoms persist despite treatment and it is not possible to use mineralocorticoid receptor antagonists (MRAs). (ACEIs and MRAs are medications used to treat heart failure)

Do not take Candesartán Tarbis:

• if you are allergic to candesartán cilexetilo or 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 bile duct obstruction (problem with the 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 a blood pressure-lowering medicine that contains aliskirén.

If you are unsure whether you fall into any of these situations, consult your doctor or pharmacist before taking Candesartán Tarbis.

Warnings and precautions

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

• 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 condition called "Conn's syndrome" (also known as primary aldosteronism).
• if you have low blood pressure;
• if you have ever had a stroke;
• if you are pregnant (or if you suspect you may be). Candesartán Tarbis is not recommended for use during the first 3 months of pregnancy, andin 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 point on (see Pregnancy section).
• if you are taking any of the following blood pressure-lowering medicines:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskirén.

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

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

Children and adolescents

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

Taking Candesartán Tarbis with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

Candesartán Tarbis may affect the way some medicines work and some medicines may influence the effect of Candesartán Tarbis. If you are using certain medicines, your doctor may need to perform blood tests at regular intervals.

Especially, inform your doctor if you are using any of the following medicines, as your doctor may need to modify your dose and/or take other precautions:

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and the so-called ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines to relieve pain and inflammation).
• Aspirin (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 excretion).
• Lithium (a medicine for mental health problems).

• If you are taking an ACE inhibitor or aliskirén (see also the 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 the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone).

Taking Candesartán Tarbis with food, drinks, and alcohol

• You can take Candesartán Tarbis with or without food.
• When you are prescribedCandesartán Tarbis, consult your doctor before taking alcohol. Alcohol may make you feel dizzy or lightheaded.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

You should inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you take another medicine instead of Candesartán Tarbis before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of Candesartán Tarbis. Candesartán Tarbis is not recommended for use during the first 3 months of pregnancy, and in no case should it be administered from the third month of pregnancy, as it may cause serious harm to your baby when administered from that point on.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Candesartán Tarbis is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

Some patients may feel tired or dizzy when 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 told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. It is essential to continue taking Candesartán Tarbis every day.

You can take Candesartán 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 every day. This will help you remember to take it.

Hypertension:

• The recommended dose of Candesartán Tarbis is 8 mg once a day. Your doctor may increase this dose up to 16 mg once a day and then up to 32 mg once a day, depending on the 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 taking diuretics, your doctor may prescribe a lower initial dose.

• Some patients of black race may present a reduced response to this type of medication, when given as a single treatment, and these patients may need a higher dose.

Use in children and adolescents with high blood pressure:

Children from 6 to <18

The recommended starting dose is 4 mg once a day.

For patients with a weight <50

For patients with a 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 a day and to 16 mg once a day.

Heart failure in adults:

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

Candesartán Tarbis can be taken with other medications for heart failure, and your doctor will decide what treatment is suitable 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Candesartán Tarbis

Do not take a double dose to compensate for the missed doses. Simply take the next dose.

If you interrupt treatment with Candesartán Tarbis

If you stop taking Candesartán Tarbis, your blood pressure may increase again. Therefore, do not stop taking Candesartán Tarbis before consulting your doctor.

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

Like all medications, this medication may cause side effects, although not everyone will experience them. It is essential that you know which side effects could occur.

Stop taking Candesartán Tarbis and see your 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 skin itching (with skin rash).

Candesartán Tarbis 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 perform a blood test from time to time to check if Candesartán Tarbis is affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (affecting 1 to 10 out of 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 will feel tired, weak, have irregular heartbeats, or experience numbness.
• Effects on kidney function, especially if you already have kidney problems or heart failure. In rare cases, kidney failure may occur.

Very rare (affecting fewer than 1 in 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 fever.
• Skin rash, hives.
• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, including liver inflammation (hepatitis). You will feel tired, have a yellowish discoloration of the skin and the white of the eyes, and symptoms similar to 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 experience muscle cramps.

• Cough.

Unknown frequency (cannot be estimated from available data)

• Diarrhea

In children treated for hypertension, side effects appear to be similar to those seen in adults, but 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointofthe pharmacy. Incase of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Candesartán Tarbis

The active ingredient is candesartan cilexetil. Each Candesartán Tarbis 8 mg tablet contains 8 mg of candesartan cilexetil.

The other components are: hydroxypropylcellulose (E463), lactose monohydrate, magnesium stearate, cornstarch, diethylenglycol monoethyl ether (Transcutol), iron oxide red (E172).

Appearance of the product and contents of the packaging

The 8 mg tablets are bisected, round, pink in color, and scored on one of their faces.

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

Only some package sizes may be commercially available.

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, Industrial Estate Miralcampo

19200 Azuqueca de Henares (Guadalajara),

Spain

Last review date of this leaflet: April 2018

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es