Candesartan Kern Pharma 16 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Candesartan Kern Pharma 16 mg tablets EFG

Candesartan cilexetil

Read the entire 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 questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Candesartan Kern Pharma is and what it is used for
2. What you need to know before taking Candesartan Kern Pharma
3. How to take Candesartan Kern Pharma
4. Possible adverse effects
5. How to store Candesartan 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 known as 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 more easily to all parts of the body.

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 as an add-on 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 outflow 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 taking Candesartán Kern Pharma, inform your doctor:

• if you have heart, liver or kidney problems, or if you are undergoing dialysis.

• if you have recently received a kidney transplant.

• if you are experiencing vomiting, have recently had severe vomiting, or have diarrhea.

• 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 might 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 onward, as it may cause severe 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 ACE inhibitor together with a medicine belonging to the class of drugs known as mineralocorticoid receptor antagonists (MRA). 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 perform certain tests.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartán Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Candesartán Kern Pharma when used 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 anesthetics, 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, have recently used, or might 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 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 to 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 (MRA) (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 consuming alcohol. Alcohol may cause dizziness or fainting.

Pregnancy, breastfeeding, and fertility

Pregnancy

Inform your doctor if you are pregnant, suspect you might be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking Candesartán before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive treatment. Candesartan is not recommended during early pregnancy and must under no circumstances be administered from the third month of pregnancy onward, as it may cause severe harm to your baby when administered from that point.

Breast-feeding

Inform your doctor if you are planning to breastfeed 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 the infant is a newborn or premature.

Driving and use of 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

Follow exactly the administration instructions for Candesartán Kern Pharma given 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 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 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: 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 forgotten doses. Simply take the 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 product, 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 see 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 rash)

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

Other possible adverse effects include:

Common (affects 1 to 10 in every 100 patients)

• Dizziness
• Headache
• Respiratory infection
• Low blood pressure. This may cause dizziness or fainting
• Changes in blood test results:
  • A reduction in blood sodium levels. If severe, you may feel weak, lack energy, or have muscle cramps
  • An increase in blood potassium levels, especially if you already have kidney problems or heart failure. If this is severe, you may experience 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 every 10,000 patients)

• Swelling of the face, lips, tongue and/or throat
• A decrease in red or white blood cells. You may feel tired, or have an infection or fever
• Skin rash, hives
• Itching
• 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
• Nausea
• Changes in blood test results:
  • A 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 Medicinal Products: 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 which is stated on the container or blister pack. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartan Kern Pharma

• The active substance is candesartan cilexetilo. Each tablet contains 16 mg of candesartan cilexetilo.
• The other components are: monohydrate lactose, pregelatinized corn starch, macrogol 8000, povidone K-25, microcrystalline cellulose, hydroxypropylcellulose and magnesium stearate.

Appearance of the product and contents of the pack

Candesartan Kern Pharma 16 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.

Candesartan Kern Pharma 16 mg tablets are available in packs of 28 tablets and 500 tablets (clinical pack), packed in PVC/PVDC/Aluminum blisters.

Other presentations

Candesartan Kern Pharma 4 mg tablets EFG

Candesartan Kern Pharma 8 mg tablets EFG

Candesartan 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