Candesartan Teva-Ratio 32 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Candesartán Teva-ratio 32 mg 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 and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Candesartán Teva-ratio is and what it is used for

2. What you need to know before taking Candesartán Teva-ratio

3. How to take Candesartán Teva-ratio

4. Possible side effects

5. How to store Candesartán Teva-ratio

6. Contents of the pack and other information

1. What Candesartán Teva-ratio is and what it is used for

Your medicine is called Candesartán Teva-ratio. The active substance is candesartán cilexetilo. It belongs to a group of medicines known as angiotensin II receptor antagonists. It works by making the blood vessels relax and widen, which helps lower blood pressure. It also helps the heart pump blood more easily to all parts of the body.

This medicine is used for:

• the treatment of high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to less than 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 added 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 Teva-ratio

Do not take Candesartán Teva-ratio

• 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 better to avoid this medicine in early pregnancy – see section 2: Pregnancy and breastfeeding).
• if you have severe liver disease or biliary obstruction (a problem with bile outflow 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 containing aliskiren.

If you are unsure whether any of these apply to you, consult your doctor or pharmacist before starting this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Candesartán Teva-ratio:

• if you have heart, liver or kidney problems or are undergoing dialysis.
• if you have recently received a kidney transplant.
• if you are experiencing vomiting, have recently had severe vomiting, or have diarrhoea.
• 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.
• inform your doctor if you are pregnant (or think you might be). This medicine is not recommended during early pregnancy, and you must not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby when used from that stage onward (see section 2: Pregnancy and breastfeeding).
• if you are taking any of the following medicines for high blood pressure (hypertension):
  • an angiotensin-converting enzyme inhibitor (ACEI) (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 a class of drugs called mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see “Taking Candesartán Teva-ratio with other medicines”).

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

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

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

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea 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 scheduled for surgery, inform your doctor or dentist that you are taking candesartan. This is because this medicine, in combination with certain anaesthetics, may cause an excessive drop in blood pressure.

Children and adolescents

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

Taking Candesartán Teva-ratio with other medicines

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

Candesartan may affect how some medicines work, and some medicines may influence the effect of candesartan. If you are taking certain medicines, your doctor may need to carry out blood tests from time to time.

In particular, 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 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 potassium levels in your blood).
• Heparin (a medicine used to make your blood less likely to clot).
• Cotrimoxazole (an antibiotic), also known as trimethoprim/sulfamethoxazole.
• Diuretics (medicines that increase urine production).
• Lithium (a medicine used for mental health conditions).

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

• if you are taking an angiotensin-converting enzyme inhibitor (ACEI) or aliskiren (see also 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) (e.g. spironolactone, eplerenone).

Taking Candesartán Teva-ratio with food, drink and alcohol

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

Pregnancy and breastfeeding

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

You must inform your doctor if you think you are (or could be) pregnant. Your doctor will advise you to stop taking candesartan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Candesartan is not recommended during early pregnancy and must 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. Candesartan is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to continue breastfeeding, especially if your baby is a newborn or premature.

Driving and using machines

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

Candesartán Teva-ratio contains lactose

This medicine contains lactose, which is a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Candesartán Teva-ratio

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

It is important that you continue taking this medicine 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 daily. Your doctor may increase this dose to 16 mg once daily and then up 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 diuretic use), 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 therefore require a higher dose.

Heart failure:

• The recommended starting dose of candesartan is 4 mg once daily. Your doctor may increase this dose by doubling it at intervals of at least 2 weeks up to a maximum of 32 mg once daily. Candesartan may be taken together with other medicines for heart failure, and your doctor will decide which treatment is appropriate for you.

Use in children and adolescents with high blood pressure

Children aged 6 to less than 18 years:

The recommended starting dose is 4 mg once daily.

For patients weighing less than 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 once daily.

For patients weighing 50 kg or more: 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.

The tablet may be divided into equal doses.

If you take more Candesartán 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, 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 Teva-ratio

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

If you stop taking Candesartán Teva-ratio

If you stop taking candesartan, your blood pressure may rise again. Therefore, do not stop taking this medicine 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 can cause adverse effects, although not everyone will experience them.

It is important that you are aware of what these adverse effects could be.

Stop taking Candesartán Teva-ratio and seek immediate medical help 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 itching of the skin (with 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 whether candesartan has affected your blood (agranulocytosis).

Other possible adverse effects include

Common (may affect up to 1 in 10 people)

• Feeling dizzy.

• Headache.

• Respiratory infections.

• Low blood pressure. This may cause dizziness or fainting.

• Changes in blood test results:

• An increase in blood potassium levels, especially if you already have kidney problems or heart failure. If this condition is severe, you may notice fatigue, weakness, irregular heartbeat, or tingling.

• Effects on kidney function, especially if you already have kidney problems. 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 blood cells or white blood cells. You may feel tired, or 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 may feel tired, have yellowing of the skin and whites of the eyes, and flu-like symptoms.

• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

• Nausea.

• Changes in blood test results:

• A reduction in blood sodium levels. If severe, you may feel weak, lack energy, or have muscle cramps.

Frequency not known (cannot be estimated from available data)

• Diarrhea

Additional adverse effects in children and adolescents

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

Reporting of adverse effects

If you experience any type of adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan Teva-ratio

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 container after EXP. The expiry date is 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 containers and unused medicines at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartán Teva-ratio

The active substance is candesartan cilexetil.

Each Candesartán Teva-ratio 32 mg tablet contains 32 mg of candesartan cilexetil.

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

Appearance of the product and contents of the pack

Pink, capsule-shaped tablets, 12.2 mm in length and 5.4 mm thick,
scored on one side. One side is marked with the number “32”. The other side of the tablet is marked with “C/C”. The tablet can be divided into equal doses.

Blister OPA/Aluminum/PVC-PVC/PVAC/Aluminum/OPA:

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B
28108 Alcobendas, Madrid, Spain

Manufacturer:

Teva Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen
Hungary

or

Teva Operations Poland Sp.z.o.o
80 Mogilska Str. (Kraków) - 31-546
Poland

or

Pharmachemie B.V.
Swenswg 5, 2031 GA Haarlem
The Netherlands

or

PLIVA Hrvatska D.O.O.
Prilaz baruna Filipovica 25, 10000 Zagreb
Croatia

or

Teva Pharma S.L.U.
C/ C, n 4 Polígono Industrial Malpica (Zaragoza) - 50016 - Spain

or

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

This medicinal product is registered in the Member States of the EEA under the following names:

Spain: Candesartán Teva-ratio 32 mg tablets EFG

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

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

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75342/P_75342.html