KANDOSET 16 mg/5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Kandoset 8 mg/5 mg tablets

Kandoset 16 mg/5 mg tablets

Kandoset 16 mg/10 mg tablets

candesartan cilexetil/amlodipine

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you experience 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 package leaflet:

1. What is Kandoset and what is it used for
2. What you need to know before you take Kandoset
3. How to take Kandoset
4. Possible side effects
5. Storing Kandoset
6. Package contents and further information

1. What is Kandoset and what is it used for

Kandoset contains two active substances called candesartan cilexetil and amlodipine. Both substances help to control high blood pressure.

• Candesartan cilexetil belongs to a group of medicines called “angiotensin II receptor antagonists”.
• Amlodipine belongs to a group of medicines called “calcium channel blockers”.

The action of both substances contributes to preventing the narrowing of blood vessels, so that they relax and blood pressure decreases.

Kandoset is used to treat high blood pressure (hypertension) in patients who are already taking candesartan cilexetil and amlodipine at these doses, instead of taking two separate medicines.

2. What you need to know before you take Kandoset

Do not take Kandoset

• If you are allergic to candesartan cilexetil, amlodipine, or any other calcium channel blocker, or any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant (in any case, it is better to avoid taking Kandoset also at the start of your pregnancy – see section on Pregnancy).
• If you have severe liver disease or biliary obstruction (a problem with the release of bile from the gallbladder).
• If the patient is a child under 1 year of age.
• If you have diabetes or kidney problems and are being treated with a blood pressure medicine that contains aliskiren.
  • If you have very low blood pressure (hypotension).
  • If you have narrowing of the aortic valve in your heart (aortic stenosis) or cardiogenic shock (a disease in which the heart is unable to pump enough blood to the body).
  • If you have heart failure after a heart attack.

If you are not sure if you are in any of these situations, consult your doctor or pharmacist before taking Kandoset.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Kandoset.

Tell your doctor if you suffer or have suffered from any of the following diseases:

• if you have heart, liver, or kidney problems; or are undergoing dialysis,
• if you have recently had a kidney transplant,
• if you have vomiting, have had severe vomiting recently, 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 (or plan to become pregnant) you should inform your doctor. Kandoset is not recommended during pregnancy and should not be taken after the third month of pregnancy because it can cause serious harm to your baby (see section on Pregnancy).
• recent heart attack,
  • heart failure,
  • severe increase in blood pressure (hypertensive crisis),
  • you are an elderly person and your dose needs to be increased.

Talk to your doctor before taking Kandoset:

• if you are taking digoxin,
• 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.

Your doctor may 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 Kandoset”.

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

If you are going to have surgery, inform your doctor or dentist that you are taking Kandoset. This is because this medicine, in combination with some anesthetics, can cause a drop in blood pressure.

Children and adolescents

Kandoset is not recommended for children and adolescents under 18 years of age.

Other medicines and Kandoset

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

In particular, inform 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).
• Acetylsalicylic acid (if you take more than 3 g per day) (medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes that contain potassium (medicines that increase the amount of potassium in your blood).
• Heparin (a medicine to increase blood fluidity).
• Medicines to promote urine production (diuretics).
• 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 Kandoset” and “Warnings and precautions”).
  • Ketoconazole, itraconazole (antifungal medicines).
  • Ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat HIV).
  • Rifampicin, erythromycin, clarithromycin (for bacterial infections).
  • Hypericum perforatum (St. John's Wort).
  • Verapamil, diltiazem (medicines for the heart).
  • Dantrolene (in infusion for severe body temperature abnormalities).
  • Tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the immune system).
  • Simvastatin (a medicine that lowers cholesterol).
  • Ciclosporin (an immunosuppressant).

If you are already taking other medicines to treat high blood pressure, Kandoset may lower your blood pressure even further.

Taking Kandoset with food, drinks, and alcohol

People taking Kandoset should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active ingredient amlodipine in the blood, which can cause an unpredictable increase in the blood pressure-lowering effect of this medicine.

When prescribed Kandoset, consult your doctor before taking alcohol. Alcohol can make you feel dizzy or faint.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should inform your doctor if you are pregnant (or might be). Your doctor will usually advise you to stop taking Kandoset before you become pregnant or as soon as you find out you are pregnant, and recommend that you take another blood pressure medicine instead of Kandoset. Candesartan is not recommended during pregnancy and should not be taken after the third month of pregnancy because it can cause serious harm to your baby when administered from that time on.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Kandoset is not recommended for women who are breastfeeding, and your doctor may decide to give you a treatment that is more suitable if you want to breastfeed, especially newborns or premature babies.

Amlodipine has been shown to pass into breast milk in small amounts.

Driving and using machines

Kandoset may affect your ability to drive or use machines. If the tablets make you feel sick, dizzy, or tired, or give you a headache, do not drive or use machinery and consult your doctor immediately.

Kandoset contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

3. How to take Kandoset

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose of Kandoset is one tablet per day.

The tablets can be taken with a glass of water, with or without food. If possible, take your daily dose at the same time each day. Do not take Kandoset with grapefruit juice.

It is important that you keep taking Kandoset until your doctor tells you to stop.

If you take more Kandoset than you should

Taking too many tablets can cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, faint, or experience dizziness when standing up or weakness. If the drop in blood pressure is severe, it can cause shock. You may feel your skin cold and sweaty, and you could lose consciousness.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can develop up to 24-48 hours after ingestion.

Seek medical attention immediately if you take too many Kandoset tablets.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Kandoset

Do not worry. If you forget to take a tablet, do not take that dose. Take the next dose at the correct time. Do not take a double dose to make up for forgotten doses.

If you stop taking Kandoset

Your doctor will tell you for how long you should take this medicine. Your illness may come back if you stop taking this medicine before your doctor tells you to.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can have adverse effects, although not all people suffer from them.

Stop taking Kandoset and go to the doctor immediatelyif you have any of the following effects after taking this medicine:

• Sudden whistling when breathing (sudden wheezing), chest pain, shortness of breath or difficulty breathing.
• Swelling of the eyelids, face or lips.
• Swelling of the tongue and throat that causes great difficulty breathing.
• Severe skin reactions that include intense skin rash, hives, redness of the skin all over the body, severe itching, blistering, peeling and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions.
• Heart attack, abnormal heartbeat.
• Pancreatitis that can cause severe abdominal pain and back pain accompanied by a great feeling of discomfort.

Candesartan, a component of this medicine, 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, inform your doctor. Your doctor may perform a blood test from time to time to check that Kandoset is not affecting your blood (agranulocytosis).

Possible Adverse Effects of CANDESARTAN:

Frequent(may affect up to 1 in 10 people):

• Dizziness/vertigo sensation.
• Headache.
• Respiratory infection.
• Low blood pressure. This can cause dizziness or fainting.
• 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 will notice fatigue, weakness, 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 blood cells or white blood cells. You may feel tired or have an infection or fever.
• Skin rash, hives (urticaria).
• Itching.
• Back pain, joint and muscle pain.
  • Intestinal angioedema: swelling in the intestine that occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

• Changes in liver function, including liver inflammation (hepatitis). You will feel tired, have a yellowish color of the skin and the whites of the eyes, and symptoms similar to those of the flu.
• Cough.
• Nausea.
• Changes in blood test results:
  • A reduction in sodium levels in the blood. If it is severe, you may feel weak, lack energy, or have muscle cramps.

Frequency Not Known(cannot be estimated from the available data):

• Diarrhea.

Possible Adverse Effects of AMLODIPINO:

The following very frequent adverse effect has been reported. If this causes problems or lasts more than a week, consult your doctor.

Very Frequent(may affect more than 1 in 10 people):

• Edema (fluid retention).

The following frequent adverse effects have been reported. If any of these cause problems or last more than a week, consult your doctor.

Frequent(may affect up to 1 in 10 people):

• Headache, dizziness, drowsiness (especially at the beginning of treatment),
• Palpitations (feeling heartbeats), flushing,
• Abdominal pain, feeling unwell (nausea),
• Changes in bowel habits, diarrhea, constipation, indigestion,
• Fatigue, weakness,
• Visual disturbances, double vision,
• Muscle cramps,
• Swelling of the ankles.

Other adverse effects have been reported, which are included in the following list. If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Uncommon(may affect up to 1 in 100 people):

• Mood changes, anxiety, depression, insomnia,
• Tremors, taste disturbances, fainting,
• Numbness or tingling sensation in the limbs, loss of pain sensation,
• Ringing in the ears,
• Decrease in blood pressure,
• Sneezing/nasal secretion caused by inflammation of the nasal mucosa (rhinitis),
• Cough,
• Dry mouth, vomiting (discomfort),
• Hair loss, increased sweating, itching of the skin, red spots on the skin, skin discoloration,
• Urination disorder, increased need to urinate at night, increased number of times urinating,
• Impotence, discomfort or breast enlargement in men,
• Pain, feeling unwell,

• Muscle or joint pain, back pain,
• Weight gain or loss.

Rare(may affect up to 1 in 1,000 people):

• Confusion.

Very Rare(may affect up to 1 in 10,000 people):

• Decrease in the number of white blood cells in the blood, decrease in blood platelets that can cause easy bleeding or unusual bruising,
• Excess sugar in the blood (hyperglycemia),
• A disorder in the nerves that can cause muscle weakness, tingling or numbness,
• Gingivitis,
• Abdominal swelling (gastritis),
• Abnormal liver function, liver inflammation (hepatitis), yellowish color of the skin (jaundice), increased liver enzymes that may have an effect on some medical tests,
• Increased muscle tension,
• Inflammation of blood vessels, often with skin rashes,
• Sensitivity to light.

Frequency Not Known(cannot be estimated from the available data):

• Tremors, rigid posture, mask-like face, slow and unbalanced gait.

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 mentioned in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Kandoset

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Keep in the original packaging to protect it from light and moisture.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Kandoset

• The active ingredients are candesartan cilexetil and amlodipine.

Each tablet contains 8 mg of candesartan cilexetil and 5 mg of amlodipine (as besylate).

Each tablet contains 16 mg of candesartan cilexetil and 5 mg of amlodipine (as besylate).

Each tablet contains 16 mg of candesartan cilexetil and 10 mg of amlodipine (as besylate).

• The other components are: microcrystalline cellulose, type 102 (E460(i)); pregelatinized starch (corn); sodium carboxymethyl starch (type A) (potato); colloidal anhydrous silica; magnesium stearate; lactose monohydrate; corn starch; macrogol 8000; hydroxypropylcellulose, type EF; calcium carmellose and yellow iron oxide (E172) – only for the 8 mg/5 mg and 16 mg/10 mg tablets and red iron oxide (E172) – only for the 16 mg/5 mg and 16 mg/10 mg tablets.

See section 2 "Kandoset contains lactose and sodium".

Appearance of the Product and Package Contents

Kandoset 8 mg/5 mg: round, biconvex, two-layer tablets. One side of the tablet is pale yellow with possible light spots and engraved with the mark 8-5, the other side of the tablet is white or almost white, with a diameter of 8 mm and 3.7 mm - 4.7 mm thickness.

Kandoset 16 mg/5 mg: round, slightly biconvex, two-layer tablets. One side of the tablet is light pink with possible light spots and dark spots and engraved with the mark 16-5, the other side of the tablet is white or almost white, with a diameter of 9 mm and 4.0 mm-5.0 mm thickness.

Kandoset 16 mg/10 mg: round, slightly biconvex, two-layer tablets. One side of the tablet is light pink with possible light spots and dark spots and engraved with the mark 16-10, the other side of the tablet is white or almost white, with a diameter of 8 mm and 3.7 mm-4.7 mm thickness.

Kandoset is available in packages of 7, 10, 14, 28, 30, 50, 56, 60, 90, 98 and 100 tablets in blisters.

Kandoset is available in packages of 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1, 90 x 1, 98 x 1 and 100 x 1 tablets in single-dose perforated blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area with the following names:

Date of the Last Revision of this Prospectus:June 2025

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