Candesartan Teva 4 mg Tablets

Introduction

Package Leaflet: Information for the User

Candesartan Teva 4 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. This belongs to a group of medicines called 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 muscular function of the heart 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 Teva

Do not take Candesartan Teva

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:

• tell your doctor if you are pregnant (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 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.
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have diabetes-related kidney problems.
  • aliskiren.

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 in one of these situations, your doctor may want to see you more often and do some tests.

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

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 anesthetics, may cause a drop in blood pressure.

Children and adolescents

Candesartan has been studied in children. For more information, talk to your doctor. Candesartan should 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.

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 for lowering your blood pressure, including beta-blockers, diazoxide and ACE inhibitors such as enalapril, captopril, lisinopril or ramipril.
• Painkillers, including non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib.
• Aspirin (if you are taking more than 3 g every day) (a medicine for pain relief and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in your blood).
• Heparin (a medicine for thinning the blood).
• Cotrimoxazole (an antibiotic) also known as trimethoprim/sulfamethoxazole.
• Diuretics (medicines that increase the amount of urine you produce).
• Lithium (a medicine for some types of mental illness).

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

Taking Candesartan Teva with food, drink and alcohol

• You can take Candesartan Teva with or without food.
• When Candesartan Teva is prescribed to you, talk to your doctor before taking 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 should 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 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.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Candesartan 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 patients have reported that they feel tired or dizzy when taking Candesartan Teva. If this happens to you, do not drive or use any tools or machines.

Candesartan Teva contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Candesartan Teva

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. It is important that you take Candesartan Teva every day.

You can take Candesartan Teva 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 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 initial dose of candesartan is 4 mg once daily. Your doctor will increase this dose gradually up to 32 mg once daily, taking into account your blood pressure and how well you tolerate the medicine. Candesartan can be taken together with other medicines for heart failure, and your doctor will decide which treatment is suitable for you.

Use in children and adolescents with high blood pressure

Children aged 6 to less than 18 years

The recommended initial 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 8 mg once daily and then to 16 mg once daily.

If you take more Candesartan Teva 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 go to the emergency department of your nearest hospital. Quote 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.

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 raised lumps)

Candesartan may cause a reduction in the number of white blood cells. Your resistance to infections 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 gets serious, you may feel weak, tired or get an irregular heartbeat.

• Affecting 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 liver inflammation (hepatitis). You may feel tired, have yellowing of the skin and the whites of the eyes and flu-like symptoms.
• Nausea.
• Intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting and diarrhea.
• Changes in blood test results:

• A decrease in the level of sodium in your blood. If this gets serious, you may feel weak, tired or get 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 Pharmacovigilance System for Medicinal Products for Human Use: 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.

Aluminum-Aluminum blister: Do not store above 25°C. Store in the original package to protect from moisture.

Aluminum-Aluminum blister with desiccant: Store in the original package to protect from moisture.

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. Container Content and Additional Information

Composition of Candesartan Teva Tablets

The active ingredient is candesartan cilexetil.

Each Candesartan Teva 4 mg tablet contains 4 mg of candesartan cilexetil.

The other components are pregelatinized corn starch, povidone K-30, calcium carmellose, microcrystalline cellulose (E460), lactose monohydrate, magnesium stearate, L-Leucine.

Appearance of the Product and Container Content

White or almost white tablets, capsule-shaped, scored on both sides. One side of the tablets is engraved with "C/4" and the other side is engraved with "4/C".

OPA/Aluminum/PVC-PVC/PVAC/Aluminum blister or OPA/Aluminum/PE with anti-caking agent/PE-PE/Aluminum blister:

Packages: 7, 14, 15, 20, 28, 30, 50, 50 x 1 unit dose blister (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:

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swenswg 5, 2031 GA Haarlem

Netherlands

or

PLIVA Croatia Ltd. (Pliva Hrvatska d.o.o.)

Prilaz baruna Filipovica 25, 10000 Zagreb

Croatia

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

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

Spain: Candesartán Teva 4 mg tablets EFG

France: Candesartan Teva 4 mg scored tablet

Netherlands: Candesartan cilexetil Teva 4 mg, tablets

United Kingdom: Candesartan cilexetil 4 mg Tablets

Sweden: Candesartan Teva 4mg tablets

Date of the Last Revision of this Leaflet:January 2025

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