CANDESARTAN TEVA 16 mg TABLETS

Introduction

Package Leaflet: Information for the User

Candesartan Teva 16 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. 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 Teva and what is it used for
2. What you need to know before you take Candesartan Teva
3. How to take Candesartan Teva
4. Possible side effects
5. Storage of Candesartan Teva
6. Contents of the pack and other information

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

Your medicine is called Candesartan Teva. The active substance is candesartan cilexetil. It belongs to a group of medicines known as angiotensin II receptor antagonists. It works by making your blood vessels relax and dilate. This helps to lower your blood pressure. 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 patients and in children and adolescents aged 6 to less than 18 years.
• treatment of adult patients with heart failure with reduced cardiac function when ACE inhibitors (a type of medicine used to treat heart failure) are not suitable, or when they are added to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (a type of medicine used to treat heart failure) cannot be used.

2. What you need to know before you take Candesartan Teva

Do not take Candesartan Teva

• 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 also better to avoid Candesartan Teva in early pregnancy – see section 2: Pregnancy and breast-feeding).
• if you have severe liver disease or biliary obstruction (a problem with the drainage of the bile from the gall bladder).
• if the patient is a child under 1 year of age.
• if you have diabetes or kidney problems and you are treated with a blood pressure lowering medicine containing aliskiren.

If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Candesartan Teva.

Warnings and precautions

Talk to your doctor or pharmacist before taking Candesartan Teva:

• if you have heart, liver or kidney problems, or if you are on dialysis.
• if you have recently received a kidney transplant.
• if you have vomiting, recently have had severe vomiting or have diarrhea.
• if you have a condition affecting 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.
• tell your doctor if you are pregnant (or think you might be) or if you are planning to become pregnant. Your doctor will normally advise you to stop taking Candesartan Teva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Candesartan Teva. Candesartan Teva is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may seriously harm your baby if used after the third month of pregnancy.
• if you are taking any of the following medicines used to treat high blood pressure:
• • an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
  • aliskiren.
• if you are taking an ACE inhibitor together with a medicine belonging to the class of medicines known as mineralocorticoid receptor antagonists (e.g. spironolactone, eplerenone) for heart failure. See also the information under the heading “Do not take Candesartan Teva”.

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

See also the information under the heading “Do not take Candesartan Teva”.

If you are concerned about any of these, talk to your doctor. Your doctor may want to see you more often and do some tests if you have any of these conditions.

Talk to your doctor if you get any of the following symptoms: abdominal pain, nausea, vomiting, or diarrhea after taking Candesartan Teva. Your doctor will decide whether you should continue to take Candesartan Teva.

Do not stop taking Candesartan Teva without talking to your doctor first.

If you are going to have an operation, tell your doctor or dentist that you are taking candesartan. This is because Candesartan Teva, when combined with some anaesthetics, may cause a sudden fall in blood pressure.

Children and adolescents

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

Taking Candesartan Teva with other medicines

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

Candesartan may affect the way some other medicines work and some medicines may affect the way candesartan works. If you are taking certain medicines, your doctor may need to do blood tests from time to time.

In particular, tell 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 (e.g. enalapril, captopril, lisinopril or ramipril).
• non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines to relieve pain and inflammation).
• aspirin (if you are taking more than 3 g every day) (medicine 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 the fluidity of your blood).
• trimethoprim/sulfamethoxazole (an antibiotic) also known as cotrimoxazole.
• diuretics (medicines to increase the production of urine).
• lithium (a medicine for mental health conditions).

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

• if you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Candesartan Teva” and “Warnings and precautions”).
• if you are treated with an ACE inhibitor together with other specific medicines for your heart failure, known as mineralocorticoid receptor antagonists (e.g. spironolactone, eplerenone).

Taking Candesartan Teva with food and drink

• You can take Candesartan Teva with or without food.
• When you are prescribed candesartan, talk to your doctor before drinking alcohol. Alcohol may make you feel faint or dizzy.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Candesartan Teva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Candesartan Teva. Candesartan Teva is not recommended in early pregnancy and must not be taken when more than 3 months pregnant, as it may seriously harm your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Candesartan Teva is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you want to breast-feed, especially if your baby is a newborn or was born prematurely.

Driving and using machines

Some people may feel tired or dizzy when taking this medicine. If you feel like this, do not drive or use tools or machines.

Candesartan Teva contains lactose

This medicine contains lactose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Candesartan Teva

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. It is important to take 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 to 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 to 32 mg once daily depending on your blood pressure response.
• In some patients, such as those with liver or kidney problems or those who have recently lost fluid (e.g. through vomiting, diarrhea, or because you are taking 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 the only treatment, and these patients may need a higher dose.

Heart failure:

• The recommended starting dose of candesartan is 4 mg once daily. Your doctor will then increase the dose to 8 mg once daily and then to 32 mg once daily or the highest dose you can tolerate, over a period of a few weeks.

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 who weigh less than 50 kg: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose to a maximum of 8 mg once daily.

For patients who weigh 50 kg or more: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose to a maximum of 8 mg once daily and then to 16 mg once daily.

The tablet can be divided into two equal doses.

If you take more Candesartan Teva than you should

If you have taken more candesartan than you should, talk to a doctor or pharmacist immediately. If you have accidentally ingested the medicine or if you experience severe overdose, contact your doctor, pharmacist, or the national information center (91 562 04 20), indicating the medicine and the amount taken.

If you forget to take Candesartan Teva

Do not take a double dose to make up for a forgotten dose. Just take the next dose as normal.

If you stop taking Candesartan Teva

If you stop taking candesartan, your blood pressure may increase again. Therefore, do not stop taking Candesartan Teva without talking to your doctor first.

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 Teva and seek medical help 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 may cause difficulty in swallowing,
• severe itching of the skin (with rash).

This medicine may cause a reduction in the number of white blood cells: your resistance to infection may be decreased and you may notice tiredness, infection or fever. If this happens, contact your doctor. Your doctor may need to do blood tests to check the effect of candesartan on your blood (agranulocytosis).

Other possible side effects include:

Common (may affect up to 1 in 10 people)

• dizziness.
• headache.
• respiratory infections.
• low blood pressure. This may cause you to feel dizzy or faint.
• changes in blood test results:

• an increase in the level of potassium in your blood, especially if you already have kidney problems or heart failure. If this becomes serious, you may notice tiredness, weakness, an irregular heartbeat or pins and needles.

• effects on your kidneys, especially if you already have kidney problems. In rare cases, kidney failure has been reported.

Very rare (may affect up to 1 in 10,000 people)

• swelling of the face, lips, tongue and/or throat.
• a decrease in the number of red or white blood cells. You may notice tiredness, infection or fever.
• rash, itching.
• itching.
• cough.
• back pain, pain in the joints and muscles.
• changes in liver function, including inflammation of the liver (hepatitis). You may feel tired, have a yellowing of your skin and the whites of your eyes and flu-like symptoms.
• intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• nausea.
• changes in blood test results:

• a decrease in the level of sodium in your blood. If this becomes serious, you may feel weak, lack energy or have muscle cramps.

Frequency not known (cannot be estimated from the 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 seen in adults, but happen more often. Sore throat is a very common side effect in children but not reported in adults, and runny nose, fever, and increased heart rate are common in children but not reported in adults.

Reporting of side effects

If you get 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 Information System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan Teva

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 after EXP. The expiry date refers to the last day of that month.

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 to protect the environment.

6. Container Contents and Additional Information

Composition of Candesartan Teva

The active ingredient is candesartan cilexetil.

Each Candesartan Teva 16 mg tablet contains 16 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 Container Contents

Pink, capsule-shaped tablets, 9.7 mm in length and 4.3 mm in thickness, scored on one side. One side is engraved with the number "16". The other side of the tablet is engraved with "C/C". The tablet can be divided into equal doses.

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B

28108 Alcobendas, Madrid

Manufacturer:

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25, 10000 Zagreb

Croatia

or

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143-Blaubeuren (Germany)

or

Teva Pharma S.L.U.

C/C nº 4, Polígono Industrial Malpica

50016 Zaragoza

Spain

or

Teva Operations Poland Sp. z o.o.

Ul. Mogilska 80 31-546, Krakow

Poland

or

Pharmachemie B.V.

Swenswg 5, 2031 GA Haarlem

Netherlands

This medication is registered in the EEA Member States under the following names:

Belgium: Candesarteva 16 mg tablets

Spain: Candesartán Teva 16 mg EFG tablets

France: Candesartan Teva 16 mg scored tablet

Italy: Candesartan Teva Italia 16 mg tablets

Netherlands: Candesartan cilexetil Teva 16 mg, tablets

Portugal: Candesartan Teva 16 mg tablet

United Kingdom: Candesartan cilexetil 16 mg Tablets

Date of the last revision of this prospectus: January 2025

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