Candesartan Kern Pharma 4 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Candesartán Kern Pharma 4 mg tablets EFG

Candesartán cilexetilo

Read the entire leaflet carefully before you start taking this medicine, as 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Candesartán Kern Pharma is and what it is used for

2. What you need to know before taking Candesartán Kern Pharma

3. How to take Candesartán Kern Pharma

4. Possible side effects

5. Storage of Candesartán Kern Pharma

6. Contents of the pack and other information

1. What Candesartán Kern Pharma is and what it is used for

Your medicine is called Candesartán Kern Pharma. The active substance is candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor antagonists. It works by relaxing and widening the blood vessels, which helps lower blood pressure. It also helps the heart pump blood to all parts of the body more easily.

This medicine is used for:

• the treatment of high blood pressure (hypertension) in adult patients.
• the treatment of adult patients with heart failure and reduced heart muscle function when angiotensin-converting enzyme inhibitors (ACE inhibitors) cannot be used, or in addition 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 Kern Pharma

Do not take Candesartán Kern Pharma

• if you are allergic to candesartan cilexetil or to any of the other ingredients of Candesartán Kern Pharma (listed in section 6).
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during early pregnancy – see Pregnancy section).
• if you have severe liver disease or biliary obstruction (a problem with bile drainage from the gallbladder).
• if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether any of these situations apply to you, consult your doctor or pharmacist before taking Candesartán Kern Pharma.

Warnings and precautions

Before taking, or while you are taking Candesartán Kern Pharma, inform your doctor:

• 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.

• if you are pregnant, suspect you may be pregnant, or are planning to become pregnant, you must inform your doctor. Use of candesartan is not recommended during early pregnancy (first 3 months), and must under no circumstances be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby – see Pregnancy section.

• if you are taking any of the following medicines used to treat 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 ACEI together with a medicine belonging to the class of drugs known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see "Use of Candesartán Kern Pharma 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 Kern Pharma”.

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

Consult your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Candesartán Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Candesartán Kern Pharma as monotherapy.

If you are scheduled for surgery, inform your doctor or dentist that you are taking Candesartán Kern Pharma. This is because candesartan, in combination with certain anaesthetics, may cause a drop in blood pressure.

Children and adolescents

There is no experience with the use of candesartan in children (under 18 years of age). Therefore, candesartan should not be administered to children.

Use of Candesartán Kern Pharma with other medicines

Inform your doctor or pharmacist if you are using or have recently used 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 perform blood tests periodically.

In particular, inform your doctor if you are taking any of the following medicines, as your doctor may need to adjust your dose and/or take other precautions:

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and so-called 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 increase blood fluidity).

• Diuretics (medicines that promote urine elimination). Lithium (a medicine used for mental health conditions).

• If you are taking an angiotensin-converting enzyme inhibitor (ACEI) or aliskiren (see also information under the headings “Do not take Candesartán Kern Pharma” and “Warnings and precautions”).

• If you are being treated with an ACEI together with other specific medicines for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Use of Candesartán Kern Pharma with food, drink and alcohol

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

Pregnancy, breastfeeding and fertility

Pregnancy

Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning to become pregnant. Your doctor will generally advise you to stop taking Candesartán before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative antihypertensive medicine. Candesartán is not recommended during early pregnancy and must under no circumstances be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that time.

Breastfeeding

Inform your doctor if you are planning to start or are currently breastfeeding, as Candesartán is not recommended for women during this period. Your doctor may decide to prescribe a more suitable treatment if you intend to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

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

Candesartán Kern Pharma contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Candesartán Kern Pharma

Follow exactly the administration instructions for Candesartán Kern Pharma provided by your doctor. Consult your doctor or pharmacist if you have any doubts. It is important that you continue taking Candesartán Kern Pharma every day.

You may take Candesartán Kern Pharma 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 usual dose of Candesartán 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 or 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 initial dose.
• Some black patients may have a reduced response to this type of medicine when used as monotherapy, and may require a higher dose.

Heart failure:

• The usual starting dose of Candesartán 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. Candesartán may be taken together with other heart failure medications, and your doctor will decide which treatment is appropriate for you.

If you take more Candesartán Kern Pharma than you should

If you have taken more Candesartán Kern Pharma 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 medication and the amount ingested.

If you forget to take Candesartán Kern Pharma

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

If you stop taking Candesartán Kern Pharma

If you stop taking Candesartán Kern Pharma, your blood pressure may rise again. Therefore, do not stop taking Candesartán Kern Pharma 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, Candesartán Kern Pharma may cause adverse effects, although not everyone experiences them. It is important that you are aware of what these adverse effects could be.

Stop taking Candesartán Kern Pharma and contact 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 itching of the skin (with skin rash)

Candesartán Kern Pharma may cause a decrease in white blood cells. Your resistance to infections may be reduced, and you may feel tired, have an infection, or develop a fever. If this occurs, inform your doctor. Your doctor may perform blood tests from time to time to ensure that Candesartán Kern Pharma is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Common (affects 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:
  • Reduction in blood sodium levels. If severe, you may feel weak, lack energy, or experience muscle cramps
  • 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 or heart failure. In very rare cases, kidney failure may occur

Very rare (affects less than 1 in 10,000 patients)

• Swelling of the face, lips, tongue, and/or throat
• Decrease in red blood cells or white blood cells. You may feel tired, or have an infection or fever
• Skin rash, hives
• Itching
• Back pain, joint pain, 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
• Nausea
• Changes in blood test results:
  • Reduction in blood sodium levels. If severe, you may feel weak, lack energy, or have muscle cramps
• Cough
• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Frequency not known (cannot be estimated from available data)

• Diarrhea

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartán Kern Pharma

• Keep out of the reach and sight of children.
• Do not use Candesartán Kern Pharma after the expiry date stated on the packaging or blister. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Pack contents and other information

Composition of Candesartán Kern Pharma

• The active substance is candesartan cilexetilo. Each tablet contains 4 mg of candesartan cilexetilo.
• The other components are: lactose monohydrate, pregelatinized corn starch, macrogol 8000, povidone K-25, microcrystalline cellulose, hydroxypropylcellulose and magnesium stearate.

Appearance of the product and pack contents

Candesartán Kern Pharma 4 mg tablets are white, round tablets, scored on one side and marked with a "K" on the other. The tablet can be divided into equal halves.

Candesartán Kern Pharma 4 mg tablets are available in packs of 14 tablets or 500 tablets (hospital pack), packed in PVC/PVDC/Aluminum blisters.

Other presentations

Candesartán Kern Pharma 8 mg tablets EFG

Candesartán Kern Pharma 16 mg tablets EFG

Candesartán Kern Pharma 32 mg tablets EFG

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

This leaflet was last reviewed in February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es