CANDESARTAN KERN PHARMA 32 mg TABLETS

2. What you need to know before you take Candesartan Kern Pharma

Do not take Candesartan Kern Pharma

• if you are allergic to candesartan cilexetil or any of the other ingredients of Candesartan 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 at the start of your pregnancy – see section Pregnancy, breast-feeding and fertility).
• if you have severe liver disease or biliary obstruction (problem with the release of bile from the gallbladder).
• if you have diabetes or kidney impairment and you are treated with a blood pressure-lowering medicine containing aliskiren.

If you are not sure if you are in one of these situations, consult your doctor or pharmacist before taking Candesartan Kern Pharma.

Warnings and precautions

Before taking, or while you are taking Candesartan Kern Pharma, tell your doctor:

• if you have heart, liver or kidney problems, or if you are on dialysis.
• if you have recently had a kidney transplant.
• if you have vomiting, have recently had severe vomiting or have diarrhea.
• if you have a disease of 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.
• if you are pregnant, think you might be pregnant, or plan to become pregnant, you must inform your doctor. It is not recommended to use candesartan at the start of pregnancy (first 3 months) and in no case should it be administered from the third month of pregnancybecause it may cause serious 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), 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 drugs called mineralocorticoid receptor antagonists (MRAs). These medicines are for the treatment of heart failure (see "Use of Candesartan Kern Pharma with other medicines").

Your doctor may want to check 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 Candesartan Kern Pharma”.

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

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartan Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Candesartan Kern Pharma on your own.

If you are going to have surgery, tell your doctor or dentist that you are taking Candesartan Kern Pharma. This is because Candesartan Kern Pharma, in combination with some anesthetics, can cause a drop in blood pressure.

Children and adolescents

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

Use of Candesartan Kern Pharma with other medicines

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

Candesartan may affect the way some medicines work and some medicines may affect the effect of candesartan. If you are using certain medicines, your doctor may need to perform blood tests from time to time.

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

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and ACE inhibitors such as 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 take more than 3 g per 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 blood fluidity).
• Diuretics (medicines to promote urine elimination).
• Lithium (a medicine for mental health problems).
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Candesartan Kern Pharma” and “Warnings and precautions”). If you are being treated with an ACE inhibitor together with other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Taking Candesartan Kern Pharma with food, drinks, and alcohol

• You can take Candesartan Kern Pharma with or without food.
• When you are prescribed Candesartan Kern Pharma, consult your doctor before taking alcohol. Alcohol can make you feel dizzy or faint.

Pregnancy, breast-feeding, and fertility

Pregnancy

You must inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant. In general, your doctor will advise you to stop taking Candesartan before you become pregnant or as soon as you find out you are pregnant, and recommend that you take another blood pressure-lowering medicine instead. It is not recommended to use Candesartan at the start of pregnancy and in no case should it be administered from the third month of pregnancybecause it may cause serious harm to your baby when administered from that time on.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding, as it is not recommended to take Candesartan during this period. Your doctor may decide to give you a treatment that is more suitable if you want to breast-feed, especially newborns or premature babies.

Driving and using machines

Some patients may feel tired or dizzy when taking Candesartan Kern Pharma. If this happens to you, do not drive or use tools or machines.

Candesartan Kern Pharma contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Candesartan Kern Pharma

Follow exactly the instructions of administration of Candesartan Kern Pharma indicated by your doctor. Consult your doctor or pharmacist if you have doubts. It is important that you keep taking Candesartan Kern Pharma every day.

You can take Candesartan 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 Candesartan Kern Pharma is 8 mg once a day. Your doctor may increase this dose to 16 mg once a day and then to 32 mg once a day 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, diarrhea, or because they are taking diuretics, the doctor may prescribe a lower initial dose.
• Some black patients may have a reduced response to this type of medicine when given as sole treatment, and these patients may need a higher dose.

Heart failure:

• The usual initial dose of Candesartan Kern Pharma is 4 mg once a day. Your doctor may increase this dose by doubling the dose at intervals of at least 2 weeks up to 32 mg once a day. Candesartan Kern Pharma can be taken with other medicines for heart failure, and your doctor will decide what treatment is suitable for you.

If you take more Candesartan Kern Pharma than you should

If you have taken more Candesartan Kern Pharma than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Candesartan Kern Pharma

Do not take a double dose to make up for forgotten doses. Simply take the next dose.

If you stop taking Candesartan Kern Pharma

If you stop taking Candesartan Kern Pharma, your blood pressure may increase again. Therefore, do not stop taking Candesartan Kern Pharma before consulting 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, Candesartan Kern Pharma can cause side effects, although not everybody gets them. It is important that you know what these side effects may be.

Stop taking Candesartan Kern Pharma and go to the doctor 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 swallowing
• severe itching of the skin (with rash)

Candesartan 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 happens, tell your doctor. Your doctor may perform a blood test from time to time to check that Candesartan Kern Pharma is not affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (may affect up to 1 in 10 people)

• Dizziness.
• Headache.
• Respiratory infection.
• Low blood pressure. This may cause you to feel dizzy or faint.
• Changes in blood test results:

• An increase in potassium levels in the blood, especially if you already have kidney problems or heart failure. If this situation is severe, you may feel tired, weak, have irregular heartbeats, 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 10,000 people)

• 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.
• Rash, hives.
• Itching.
• Back pain, pain in the joints and muscles.
• Changes in liver function, including liver inflammation (hepatitis). You may feel tired, have a yellowish color of the skin and the whites of the eyes, and symptoms similar to those of the flu.
• Nausea.
• Changes in blood test results:
• • A decrease in sodium levels in the blood. If severe, you may feel weak, lack energy, or have muscle cramps.
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known (cannot be estimated from the available data)

• Diarrhea.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan Kern Pharma

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 or blister after EXP. The expiry date is the last day of the month stated.

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. Contents of the pack and further information

Composition of Candesartan Kern Pharma

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

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

Appearance of the product and contents of the pack

Candesartan Kern Pharma 32 mg tablets are elliptical, biconvex, light red, and have the engraving CC on one side and the engraving 32 on the same face (length: 16.0 ± 0.2 mm).

Candesartan Kern Pharma 32 mg tablets are marketed in PVC-PVDC-Aluminum blisters of 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 last revision of this leaflet: February 2025

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