Candesartan Kern Pharma 32 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Candesartán Kern Pharma 32 mg tablets EFG

Candesartán cilexetilo

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 and should not be given to other people, even if they have the same symptoms as you, as it may 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 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. How to store 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. This belongs to a group of medicines known as angiotensin II receptor antagonists. It works by causing blood vessels to relax and widen, thereby helping to 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 the early stages of pregnancy – see section Pregnancy, breastfeeding, and fertility).
• if you have severe liver disease or biliary obstruction (a problem with bile flow from the gallbladder).
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether you are in any of these situations, 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 plan 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 severe harm to your baby – see section Pregnancy.

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (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 you are in any of these situations, 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 diarrhea after taking Candesartán Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Candesartán Kern Pharma as monotherapy without medical advice.

If you are due to undergo surgery, inform your doctor or dentist that you are taking Candesartán Kern Pharma. This is because Candesartán Kern Pharma, 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 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 angiotensin-converting enzyme (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 (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Candesartán Kern Pharma” 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 (MRA) (e.g., spironolactone, eplerenone).

Taking Candesartán Kern Pharma with food, drinks, 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 make you feel faint or dizzy.

Pregnancy, breastfeeding, and fertility

Pregnancy

Inform your doctor if you are pregnant, suspect you might be pregnant, or plan to become pregnant. Generally, your doctor will advise you to stop taking Candesartán before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative antihypertensive treatment. Candesartan is not recommended during early pregnancy and must not be administered from the third month of pregnancy onwards, as it may cause severe harm to your baby when used from that stage.

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 choose a treatment more suitable if you intend to breastfeed, especially if the infant is a newborn or premature.

Driving and using machines

Some patients may feel tired or dizzy while 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 diagnosed you with 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 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 some 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 Kern Pharma 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 (for example, due to vomiting, diarrhoea, or because they 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 monotherapy, and may therefore require a higher dose.

Heart failure:

• The usual starting dose of Candesartán Kern Pharma 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 Kern Pharma 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.

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 produce 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 blood tests from time to time to check that Candesartán Kern Pharma is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Frequent (may affect up to 1 to 10 in every 10 patients)

• Dizziness
• Headache
• Respiratory infection
• Low blood pressure. This may cause dizziness or fainting
• Changes in blood test results:
  • Increase in blood potassium levels, especially if you already have kidney problems or heart failure. If this 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 (may affect up to 1 in every 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 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
• 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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging or blister after EXP. 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 containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the container and additional information

Composition of Candesartán Kern Pharma

• The active substance is candesartan cilexetil. The tablets contain 32 mg of candesartan cilexetil.

• The other components are: sodium docusate, sodium lauryl sulfate, calcium carmellose, pregelatinized corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, iron oxide red (E172), and purified water.

Appearance of the product and contents of the container

Candesartán Kern Pharma 32 mg tablets are light red, elliptical, biconvex tablets, engraved with "CC" on one side and "32" on the same side (length: 16.0 ± 0.2 mm).

Candesartán Kern Pharma 32 mg tablets are marketed in PVC-PVDC-aluminum blisters containing 28 tablets.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

or

Bluepharma Indústria Farmacêutica, S.A.

• Martinho do Bispo,

3045-016 Coimbra,

Portugal

Date of the most recent review of this leaflet: February 2025

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