Leaflet: information for the patient

Kandoset 8 mg/5 mg tablets

Kandoset 16 mg/5 mg tablets

Kandoset 16 mg/10 mg tablets

candesartán cilexetilo/amlodipino

Read this 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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Kandoset is and what it is used for.

2.What you need to know before you start taking Kandoset

3.How to take Kandoset

4.Possible side effects

5.Storage of Kandoset

6.Contents of the pack and additional information.

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

• Candesartan cilexetilbelongs 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 slowing the narrowing of blood vessels, allowing them to relax and blood pressure to decrease.

Kandosetis used for the treatment of high blood pressure (hypertension) in patients who are already taking candesartan cilexetil and amlodipine at these doses, instead of taking two separate medicines.

Do not take Kandoset:

-If you are allergic to candesartan cilexetilo, amlodipine, or any other calcium channel blocker, or to any of the other components of this medication (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 beginning of your pregnancy – see Pregnancy section).

-If you have severe liver disease or biliary obstruction (a problem with the bile flow from the gallbladder).

-If the patient is a child under 1 year old.

-If you have diabetes or kidney failure and are being treated with a blood pressure medication containing aliskireno.

• If you have very low blood pressure (hypotension).
• If you have aortic valve stenosis or cardiogenic shock (a disease in which the heart is unable to pump enough blood to the body).
• If you suffer from heart failure after a heart attack.

If you are unsure whether 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.

Inform your doctor if you suffer or have suffered from any of the following conditions:

-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 condition called Conn's syndrome (also known as primary aldosteronism),

-If you have low blood pressure.

-If you have ever had a stroke,

-If you are pregnant (or if you plan to become pregnant) inform your doctor. Kandoset is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy because it may cause serious harm to your baby (see Pregnancy section).

-Recent heart attack,

• Heart failure,
• Severe high 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 medications used to treat high blood pressure (hypertension):
• a converting enzyme inhibitor (ACEI) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskireno.

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading “Do not take Kandoset”.

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

Children and adolescents

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

Use of Kandoset with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Kandoset may affect the way some medications work and some medications may influence the effect of Kandoset. If you are using certain medications, your doctor may need to perform blood tests at regular intervals.

Especially, inform your doctor if you are using any of the following medications, as your doctor may need to modify your dose and/or take other precautions:

-Other medications to lower your blood pressure, including beta-blockers, diazoxide, and the so-called ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.

-Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medications to relieve pain and inflammation).

-Acetylsalicylic acid (if you take more than 3 g per day) (medication to relieve pain and inflammation).

-Potassium supplements or salt substitutes containing potassium (medications that increase the amount of potassium in your blood).

-Heparin (a medication to increase blood fluidity).

-Diuretics (medications to promote urine elimination).

-Lithium (a medication for mental health problems).

-If you are taking an ACEI oraliskireno(see also the information under the headings “Do not take Kandoset” and “Warnings and precautions”).

• Ketoconazole, itraconazole (antifungal medications).
• 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 (heart medications).
• Dantrolene (in infusion for severe temperature anomalies).
• Tacrolimus, sirolimus, temsirolimus, and everolimus (medications used to modify the functioning of the immune system)
• Simvastatin (a medication to reduce cholesterol).
• Ciclosporin (an immunosuppressant).

If you are already taking other medications 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 may cause an increase in the blood levels of the active ingredient amlodipine, which may cause an unpredictable increase in the blood pressure-lowering effect of this medication.

When you are prescribed Kandoset, consult your doctor before taking alcohol. Alcohol may make you feel dizzy or lightheaded.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should inform your doctor if you are pregnant (or may be). Your doctor will usually advise you to stop taking Kandoset before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead of Kandoset. Candesartan is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy because it may cause serious harm to your baby when administered from that time.

Breastfeeding

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

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

Driving and operating machinery

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

Kandoset contains lactose and sodium

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

This medication contains less than 1 mmol of sodium (23 mg) per dose; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Kandoset is one tablet per day.

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 essential to continue taking Kandoset until your doctor tells you otherwise.

If you take more Kandoset than you should

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

Excess fluid can accumulate in the lungs (pulmonary edema) causing difficulty breathing that can develop up to 24-48 hours after consumption.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication 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 compensate for the missed doses.

If you interrupt treatment with Kandoset

Your doctor will indicate for how long you should take this medication. Your condition may reappear if you stop taking this medication before your doctor tells you to.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Kandoset and see your doctorimmediatelyif you have any of the following side effects after taking this medicine:

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

Candesartan, a component of this medicine, can 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 a blood test from time to time to check that Kandoset is not affecting your blood (agranulocytosis).

Possible side effects of CANDESARTÁN:

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

-Dizziness.

-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 is severe, you will feel tired, weak, have irregular heartbeats, or numbness.

-Effects on kidney function, especially if you already have kidney problems or heart failure. In very rare cases, it may cause kidney failure.

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

-Swelling of the face, lips, tongue, and/or throat.

-Decrease in red or white blood cells. You may feel tired, have an infection, or fever.

-Rash, hives (urticaria).

-Itching.

-Back pain, joint and muscle pain.

-Changes in liver function, including liver inflammation (hepatitis). You will feel tired, have a yellowish discoloration of the skin and the whites of the eyes, and symptoms similar to the flu.

-Cough.

-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.

Unknown frequency (cannot be estimated from available data):

-Diarrhea

Possible side effects of AMLODIPINO:

The following very frequent side 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 side 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), shortness of breath,
• Abdominal pain, feeling unwell (nausea),
• Alteration of bowel habit, diarrhea, constipation, indigestion,
• Tiredness, weakness,
• Visual disturbances, double vision,
• Muscle cramps,
• Swelling of ankles.

The following side effects have been reported. If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

• Confusion.

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

• Decrease in white blood cells, decrease in platelets in the blood that may cause easy bleeding or unusual bruising,
• High blood sugar (hyperglycemia),
• A disorder of the nerves that may cause muscle weakness, numbness, or tingling,
• Inflammation of the gums,
• Abdominal swelling (gastritis),
• Abnormal liver function, liver inflammation (hepatitis), yellowish discoloration of the skin (jaundice), increase in liver enzymes that may affect some medical tests,
• Increased muscle tension,
• Inflammation of blood vessels, often with skin eruptions,
• Sensitivity to light.

Unknown frequency(cannot be estimated from available data):

- Tremor, stiff posture, mask-like face, slow movements, and an unsteady and unbalanced gait.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication 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 above 86°F (30°C).

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Kandoset

• The active ingredients are candesartan cilexetilo and amlodipino.

Each tablet contains 8 mg of candesartan cilexetilo and 5 mg of amlodipino (as besilato).

Each tablet contains 16 mg of candesartan cilexetilo and 5 mg of amlodipino (as besilato).

Each tablet contains 16 mg of candesartan cilexetilo and 10 mg of amlodipino (as besilato).

-The other components are: Microcrystalline cellulose, type 102 (E460(i)); pregelatinized maize starch; sodium carboxymethyl starch (type A) (from potato); anhydrous colloidal silica; magnesium stearate; lactose monohydrate; maize starch; macrogol 8000; hydroxypropylcellulose, type EF; calcium carmelose 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 the section “Kandoset contains lactose and sodium”.

Appearance of Kandoset and packaging contents

Kandoset 8 mg/5 mg: round, biconvex, bilayer tablets. One side of the tablet is pale yellow with possible light spots and marked with the code 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 in thickness.

Kandoset 16 mg/5 mg: round, slightly biconvex, bilayer tablets. One side of the tablet is pale pink with possible light spots and dark points and marked with the code 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 in thickness.

Kandoset 16 mg/10 mg: round, slightly biconvex, bilayer tablets. One side of the tablet is pale pink with possible light spots and dark points and marked with the code 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 in thickness.

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

Kandoset is available in blister 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 single-dose perforated blisters.

Only some packaging 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 with the following names:

Last review date of this leaflet:May 2023

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/