Leaflet: Information for the User

Candesartán Teva-ratio 8 mg Tablets EFG

candesartán cilexetilo

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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must notgiveit to other people 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.

Contents of the pack and additional information

Your medicine is called Candesartán Teva-ratio. The active ingredient is candesartán cilexetilo. This belongs to a group of medicines called angiotensin II receptor antagonists. It works by making blood vessels relax and dilate. This makes it easier for your blood pressure to decrease. It also makes it easier for your heart to pump blood to all parts of your body.

This medicine is used for:

• treatment of high blood pressure (hypertension) in adult patientsand in children and adolescents from6 toless than 18 years.
• 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).

Do not take Candesartán Teva-ratio

• 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 better to avoid this medicine at the beginning of pregnancy – see section 2: Pregnancy and breastfeeding).
• if you have severe liver disease or biliary obstruction (a problem with the bile flowing out of the gallbladder).
• if the patient is 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 are in any of these situations, consult your doctor or pharmacist before starting to take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Candesartán Teva-ratio :

• 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) affecting the adrenal gland.
• if you have low blood pressure.
• if you have ever had a stroke.
• inform your doctor if you are pregnant (or if you suspect you may be). This medicine is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby when administered from that point onwards (see section 2: Pregnancy and breastfeeding).
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
• • a converting enzyme inhibitor (ACE inhibitor) (for example, 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 known as mineralocorticoid receptor antagonists (MRAs). These medicines are for the treatment of heart failure (see “Taking Candesartán Teva-ratio with other medicines”).

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

See also the information under the heading “Do not take Candesartán Teva-ratio ”.

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

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartán Teva-ratio . Your doctor will decide whether to continue treatment. Do not stop taking this medicine on your own.

If you are about to undergo surgery, inform your doctor or dentist that you are taking candesartán. This is because this medicine, in combination with some anesthetics, may cause an excessive drop in blood pressure.

Children and adolescents

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

Taking Candesartán Teva-ratio with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine, including those obtained without a prescription.

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

Particularly, inform your doctor if you are taking any of the following medicines:

• 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).
• Aspirin (if you take more than 3 g per day) (medicines 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).
• Cotrimoxazol (an antibiotic) also known as trimetoprim/sulfametoxazol.
• Diuretics (medicines to promote urine elimination).
• Lithium (a medicine for mental health problems).

Your doctor may need to adjust your dose and/or take other precautions:

• if you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Candesartán Teva-ratio ” 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) (for example, spironolactone, eplerenone).

Taking Candesartán Teva-ratio with food, drinks, and alcohol

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

Pregnancy and breastfeeding

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

Pregnancy

You should inform your doctor if you think you are (or may be) pregnant. Your doctor will advise you to stop taking candesartán before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of candesartán. Candesartán is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Candesartán is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment if you wish to continue breastfeeding, especially if your baby is newborn or premature.

Driving and operating machinery

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

Candesartán Teva-ratio contains lactose

This medicine containslactose, a type of sugar. If your doctor has told you that you have anintolerance to some sugars, consult with them 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 this medication 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 every day. This will help you remember to take it.

Hypertension:

• The recommended dose of candesartan 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 based on 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 black patients may present a reduced response to this type of medication, when given as a single treatment, and these patients may need a higher dose.

Heart failure:

• The initial recommended dose of candesartan 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. Candesartan can be taken with other medications for heart failure, and your doctor will decide what treatment is suitable for you.

Use in children and adolescents with hypertension:

Children from 6 to less than 18 years:

The initial recommended dose is 4 mg once a day.

For patients weighing less than 50 kg: In some patients whose blood pressure is not adequately controlled, your doctor may decide that the dose should be increased up to a maximum of 8 mg once a day.

For patients weighing 50 kg or more: In some patients whose blood pressure is not adequately controlled, your doctor may decide that the dose should be increased to 8 mg once a day and to 16 mg once a day.

The tablet can be divided into equal doses.

If you take more Candesartan Teva-ratio than you should:

If you have taken more candesartan 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 Candesartan Teva-ratio:

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

If you interrupt treatment with Candesartan Teva-ratio:

If you stop taking candesartan, your blood pressure may increase again. Therefore, do not stop taking this medication before consulting your doctor.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

It is essential that you know which side effects could occur.

Stop taking Candesartán Teva-ratio and seek medical help 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 that may cause difficulty swallowing,
• Severe skin itching (with skin rash)

This medicine may cause a reduction in the number of white blood cells. Your resistance to infections may decrease, and you may notice fatigue, infection, or fever. If this occurs, contact your doctor. Your doctor may occasionally perform blood tests to check if candesartán has affected your blood (agranulocytosis).

Other possible side effects include

Frequent (may affect up to 1 in 10 people)

• Dizziness
• Headache.
• Respiratory infections.
• 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 notice fatigue, weakness, irregular heartbeats, or numbness.

• Effects on kidney function, especially if you already have kidney problems. In very rare cases, kidney failure may occur.

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 fever.
• Skin rash, hives.
• Itching.
• Cough.
• 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.
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• 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.

Unknown frequency (cannot be estimated from available data)

• Diarrhea

Additional side effects in children and adolescents

In children treated for high blood pressure, side effects appear to be similar to those observed in adults, but occur more frequently. Throat pain is a very frequent side effect in children but not reported in adults, and nasal discharge, fever, and increased heart rate are frequent in children but not reported in adults.

Reporting side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 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 in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Candesartán Teva-ratio Composition

The active ingredient is candesartan cilexetilo.

Each Candesartán Teva-ratio 8 mg tablet contains 8 mg of candesartan cilexetilo.

The other components (excipients) are pregelatinized cornstarch, povidone K-30, calcium carmelose, microcrystalline cellulose (E460), lactose monohydrate, magnesium stearate, poloxamer 188, and iron oxide red (E172).

Product Appearance and Packaging Content

Pink capsules, 7.7 mm in length, 3.5 mm in thickness, scored on both sides. One side of the capsule is engraved with “C/8” and the other side is engraved with “8/C.” The capsule can be divided into equal doses.

OPA/Aluminum/PVC-PVC/PVAC/Aluminum/OPA blister:

Packages: 7, 14, 15, 20, 28, 30, 50, 50 x 1 single-dose blister (hospital package), 56, 60, 84, 90, 98, 100, 250, and 300 tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B

28108 Alcobendas, Madrid

Responsible Manufacturer:

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Teva Operations Poland Sp.z.o.o

80 Mogilska Str. (Cracow) - 31-546

Poland

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

or

PLIVA Hrvatska D.O.O.

Prilaz baruna Filipovića 25, 10000 Zagreb

Croatia

or

Teva Pharma S.L.U.

C/ C, n 4 Industrial Estate Malpica (Zaragoza) - 50016 - Spain

or

Merckle GmbH

Ludwig-Merckle Strasse 3, (Blaubeuren) – D- 89143

Germany

This medicine is registered in the Member States of the EEA with the following names:

Spain:Candesartán Teva-ratio 8 mg tablets EFG

Last review date of this leaflet:January 2025

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.