Kandoset 16 mg/5 mg tablets

Package leaflet: Information for the user

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 the entire leaflet carefully before starting to take 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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may 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.

Contents of the leaflet:

1. What Kandoset is and what it is used for
2. What you need to know before taking Kandoset
3. How to take Kandoset
4. Possible side effects
5. How to store Kandoset
6. Contents of the pack and other information

1. What Kandoset is and what it is used for

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

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

The action of both substances helps prevent the narrowing of blood vessels, allowing them to relax and thereby reducing blood pressure.

Kandoset is used for the treatment of high blood pressure (hypertension) in patients who are already being treated with candesartan cilexetil and amlodipine at these doses, as an alternative to taking two separate medicines.

2. What you need to know before taking Kandoset

Do not take Kandoset

• If you are allergic to candesartan cilexetil, amlodipine, or any other calcium channel blocker, or to 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 in early pregnancy – see Pregnancy section).
• If you have severe liver disease or biliary obstruction (a problem with bile flow from the gallbladder).
• If the patient is a child under 1 year of age.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
  • If you have very low blood pressure (hypotension).
  • If you have narrowing of the heart's aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to pump enough blood to the body).
  • If you suffer from heart failure following a heart attack.

If you are unsure whether any of these apply to you, consult your doctor or pharmacist before taking Kandoset.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Kandoset.

Inform your doctor if you have or have had any of the following conditions:

• 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 had severe vomiting recently, 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 (or planning to become pregnant), inform your doctor. Use of Kandoset is not recommended in early pregnancy and must not be used after the third month of pregnancy because it may cause severe harm to your baby (see Pregnancy section).
• recent heart attack,
  • heart failure,
  • severe increase in blood pressure (hypertensive crisis),
  • you are elderly 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), particularly if you have kidney problems related to diabetes.
• aliskiren.

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 Kandoset”.

Contact 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 scheduled for surgery, inform your doctor or dentist that you are taking Kandoset. This is because this medicine, in combination with certain anesthetics, may 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 need to take any other medicines.

Kandoset may affect how some medicines work, and some medicines may influence the effect of Kandoset. 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 to relieve pain and inflammation).
• Acetylsalicylic acid (if taking more than 3 g per day) (a medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that increase potassium levels in your blood).
• Heparin (a medicine to increase blood fluidity).
• Medicines to promote urine elimination (diuretics).
• Lithium (a medicine for mental health conditions).
• If you are taking an ACE inhibitor or aliskiren (see also 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 (by infusion for severe abnormalities in body temperature).
  • Tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify immune system function).
  • Simvastatin (a medicine that lowers cholesterol).
  • Cyclosporine (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 must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could lead to an unpredictable increase in the blood pressure-lowering effect of this medicine.

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will generally advise you to stop taking Kandoset before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive treatment. Candesartan use is not recommended in early pregnancy and must not be used after the third month of pregnancy, as it may cause severe harm to your baby when administered from that point onward.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Kandoset is not recommended for breastfeeding women, and your doctor may decide to prescribe a more suitable treatment if you intend to breastfeed, especially if the newborn is premature.

It has been shown that amlodipine passes 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 unwell, dizzy, tired, or cause headache, do not drive or operate machinery and consult your doctor immediately.

Kandoset contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per dose; therefore, it is essentially "sodium-free".

3. How to take Kandoset

Follow exactly the instructions for using this medicine as 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 continue taking Kandoset until your doctor tells you otherwise.

If you take more Kandoset than you should

Taking too many tablets may cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, lightheaded, experience postural dizziness when standing up, or weakness. If the drop in blood pressure is severe enough, shock may occur. You may feel cold and clammy skin and could lose consciousness.

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

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

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 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 advise you how long you should take this medicine. Your condition may return if you stop taking this medicine before your doctor tells you to stop.

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 cause adverse effects, although not everyone experiences them.

Stop taking Kandoset and go to your doctor immediately if you experience any of the following effects after taking this medicine:

• Sudden wheezing (sudden onset of whistling sounds when breathing), chest pain, shortness of breath or difficulty breathing.
• Swelling of the eyelids, face or lips.
• Swelling of the tongue and throat causing severe difficulty in breathing.
• Severe skin reactions including intense rash, hives, redness of the skin all over the body, severe itching, blistering, peeling and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions.
• Heart attack, irregular heartbeat.
• Inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a marked feeling of illness.

Candesartan, one of the components 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 occurs, inform your doctor. Your doctor may perform blood tests periodically 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.

• Headache.

• Respiratory infection.

• Low blood pressure. This may cause dizziness or fainting.

• Changes in blood test results:

  • Increased levels of potassium in the blood, 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 (may affect up to 1 in 10,000 people):

• 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 (urticaria).

• Itching.

• Back pain, joint and muscle pain.

  • Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

• Changes in liver function, including inflammation of the liver (hepatitis). You may feel tired, have yellowing of the skin and whites of the eyes, and flu-like symptoms.

• Cough.

• Nausea.

• Changes in blood test results:

  • Reduction in sodium levels in the blood. If severe, you may feel weak, lack energy or have muscle cramps.

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

• Diarrhoea.

Possible adverse effects of AMLODIPINE:

The following very common adverse effect has been reported. If this causes problems or lasts longer than one week, consult your doctor.

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

• Oedema (fluid retention).

The following common adverse effects have been reported. If any of these cause you problems or last longer than one week, consult your doctor.

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

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

Other adverse effects have been reported and are listed below. 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.

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

• Mood changes, anxiety, depression, insomnia,

• Tremor, taste disturbances, fainting,

• Numbness or tingling sensation in the limbs, loss of pain sensation,

• Ringing in the ears,

• Decreased blood pressure,

• Sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis),

• Cough,

• Dry mouth, vomiting (feeling unwell),

• Hair loss, increased sweating, skin itching, red spots on the skin, skin discoloration,

• Urination disorders, increased need to urinate at night, increased frequency of urination,

• Inability to achieve an erection, discomfort or enlargement of the breasts in men,

• Pain, feeling unwell,

• Muscle or joint pain, back pain,

• Weight gain or weight 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, decrease in blood platelets which may cause easy bleeding or unusual bruising,
• High blood sugar (hyperglycaemia),
• A nerve disorder which may cause muscle weakness, tingling or numbness,
• Inflammation of the gums,
• Abdominal swelling (gastritis),
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain medical tests,
• Increased muscle tension,
• Inflammation of blood vessels, often with skin rashes,
• Light sensitivity.

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

• Tremor, rigid posture, mask-like face, slow movements, and unsteady, unbalanced gait.

Reporting of adverse effects

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

5. Storage of Kandoset

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 packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Kandoset

• The active substances are candesartan cilexetil and amlodipine.

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

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

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

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

See section 2 “Kandoset contains lactose and sodium”.

Appearance of the product and contents of the pack

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

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 specks and marked with the code 16-5; the other side is white or almost white, with a diameter of 9 mm and a thickness of 4.0 mm - 5.0 mm.

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 specks and marked with the code 16-10; the other side is white or almost white, with a diameter of 8 mm and a thickness of 3.7 mm - 4.7 mm.

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

Kandoset is also available in packs 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 perforated unit-dose blister packs.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

For further information about this medicinal product, please contact 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: June 2025

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/