KarbiCombi 32 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Karbicombi 32 mg/12.5 mg tablets EFG

candesartan cilexetil/hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine, because it

contains important information for you.

• Keep this leaflet. 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Karbicombi is and what it is used for

Your medicine is called Karbicombi. It is used to treat high blood pressure (hypertension). It contains two active substances: candesartan cilexetil and hydrochlorothiazide.

Both substances work together to lower your blood pressure.

Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It helps your blood vessels to relax and widen, which makes it easier to reduce your blood pressure.

Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps your body eliminate water and salts such as sodium through the urine. This helps reduce your blood pressure.

Your doctor may prescribe Karbicombi if your blood pressure is not adequately controlled with either candesartan cilexetil or hydrochlorothiazide alone.

2. What you need to know before taking Karbicombi

Do not take Karbicombi

• if you are allergic to candesartan cilexetil or hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sulfonamides. If you are unsure whether this applies to you, consult your doctor.
• if you are more than 3 months pregnant (Karbicombi should also be avoided during the first months of pregnancy – see Pregnancy section).
• if you have severe kidney disease.
• if you have severe liver disease or biliary obstruction (a problem with bile leaving the gallbladder).
• if you have persistently low levels of potassium in your blood.
• if you have persistently high levels of calcium in your blood.
• if you have ever had gout.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Karbicombi:

• if you have diabetes.
• if you have heart, liver, or kidney problems.
• if you have recently received a kidney transplant.
• if you are experiencing vomiting, have recently had frequent severe vomiting, or have diarrhea.
• if you have a disorder of the adrenal gland called Conn’s syndrome (also known as primary hyperaldosteronism).
• if you have ever had a disease called systemic lupus erythematosus (SLE).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you have ever had an allergy or asthma.
• if you are pregnant, think you may be pregnant, or are planning to become pregnant, you must inform your doctor. The use of candesartan/hydrochlorothiazide is not recommended during early pregnancy (first three months), and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby (see Pregnancy section).
• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Karbicombi.
• if you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Karbicombi, seek medical attention immediately.
• if you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, which may occur within hours to a week after taking this medicine. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may have a higher risk of developing this condition.
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril, etc.), 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 Karbicombi".

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

If you are in any of these situations, your doctor may want to see you more frequently and perform additional tests.

If you are scheduled for surgery, inform your doctor or dentist that you are taking Karbicombi. This is because Karbicombi, in combination with certain anesthetics, may cause an excessive drop in blood pressure.

Karbicombi may increase skin sensitivity to sunlight.

Children and adolescents

There is no experience with the use of Karbicombi in children (under 18 years of age).

Therefore, Karbicombi should not be administered to children.

Other medicines and Karbicombi

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

Karbicombi may affect how some medicines work, and some medicines may influence the effect of Karbicombi. 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, medicines containing aliskiren, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, or diclofenac, celecoxib, or etoricoxib (medicines to reduce 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 to increase potassium levels in blood).
• calcium supplements or vitamin D.
• cholesterol-lowering medicines such as colestipol or cholestyramine.
• medicines for diabetes (tablets or insulin).
• medicines to control heart rhythm (antiarrhythmics) such as digoxin and beta-blockers.
• medicines that may be affected by blood potassium levels, such as certain antipsychotics.
• heparin (a medicine to increase blood fluidity).
• diuretics (medicines to promote urine elimination).
• laxatives.
• penicillin or co-trimoxazole also known as trimethoprim/sulfamethoxazole (antibiotics).
• amphotericin (used to treat fungal infections).
• lithium (a medicine for mental health conditions).
• steroids such as prednisolone.
• pituitary hormone (ACTH).
• cancer treatment medicines.
• amantadine (used to treat Parkinson’s disease or serious viral infections).
• barbiturates (a type of sedative, also used to treat epilepsy).
• carbenoxolone (used to treat esophageal disease or oral ulcers).
• anticholinergic agents such as atropine and biperiden.
• Cyclosporine, a medicine used in organ transplantation to prevent organ rejection.
• Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine for relief of spasticity), amifostine (used in cancer treatment), and certain antipsychotics.
• If you are taking an ACE inhibitor or aliskiren (see also information under the headings "Do not take Karbicombi" and "Warnings and precautions").

Taking Karbicombi with food, drinks, and alcohol

• You may take Karbicombi with or without food.

When Karbicombi is prescribed for you, consult your doctor before drinking alcohol. Alcohol may make you feel dizzy or lightheaded.

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

Inform your doctor if you think you are pregnant (or could be). Your doctor will usually advise you to stop treatment with Karbicombi before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Karbicombi. Karbicombi is not recommended during pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. The use of Karbicombi is not recommended for breastfeeding mothers, and your doctor may choose a different treatment for you if you wish to breastfeed.

Driving and using machines

Some patients may feel tired or dizzy when taking Karbicombi. If this happens to you, do not drive or operate tools or machinery.

Karbicombi contains lactose

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

3. How to take Karbicombi

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

It is important that you continue taking Karbicombi every day.

The recommended dose is one tablet once daily.

Swallow the tablet with a glass of water.

Try to take the tablet at the same time each day. This will help you remember to take it.

If you take more Karbicombi than you should

In case of overdose, contact your doctor immediately or go directly to the hospital to receive immediate medical attention.

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

If you forget to take Karbicombi

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

Simply take the next dose as scheduled.

If you stop taking Karbicombi

If you stop taking Karbicombi, your blood pressure may rise again. Therefore, do not stop taking Karbicombi 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, this medicine can cause adverse effects, although not everyone will experience them. It is important that you are aware of what these adverse effects might be. Some of the adverse effects of Karbicombi are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop taking Karbicombi and see a 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 skin rash).

Karbicombi 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 Karbicombi is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Common (may affect up to 1 in 10 people)

• Changes in blood test results:
• A reduction in blood sodium levels. If severe, you may feel weak, lack energy or have muscle cramps.
• An increase or decrease in blood potassium levels, especially if you already have kidney problems or heart failure. If this is severe, you may experience tiredness, weakness, irregular heartbeat or tingling.
• An increase in blood cholesterol, glucose or uric acid levels.
• Presence of glucose in urine.
• Feeling dizzy or weak.
• Headache.
• Respiratory infection.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This may cause dizziness or fainting.
• Loss of appetite, diarrhoea, constipation, stomach irritation.
• Skin rash, hives, skin reaction caused by sensitivity to sunlight.

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

• Jaundice (yellowing of the skin and whites of the eyes). If this occurs, contact your doctor immediately.
• Effects on kidney function, especially if you already have kidney problems or heart failure.
• Difficulty sleeping, depression or restlessness.
• Tingling or prickling sensations in arms and legs.
• Blurred vision for a short period of time.
• Abnormal heartbeat.
• Difficulty breathing (including lung inflammation and fluid in the lungs).
• High temperature (fever).
• Inflammation of the pancreas. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels causing red or purple spots on the skin.
• A decrease in red blood cells, white blood cells or platelets. You may feel tired, have an infection, fever or bruise easily.
• Severe skin reaction that develops rapidly, causing blisters and skin peeling, and possibly mouth ulcers.

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

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

• 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.

  • Acute breathing difficulty (symptoms include severe breathlessness, fever, weakness and confusion).

Adverse effects with unknown frequency (cannot be estimated from available data)

• Skin and lip cancer (non-melanoma skin cancer).

• Sudden myopia.

• Decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

• Systemic and cutaneous lupus erythematosus (an allergic condition causing fever, joint pain, skin rashes which may include redness, blisters, peeling and lumps).

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 can also report them directly via the national reporting system: Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Karbicombi

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.

Tablets in PVC/PVDC film and aluminium foil blisters:

Do not store above 30°C.

Tablets in OPA/Al/PVC laminate and aluminium foil blisters:

This medicine does not require any special storage temperature.

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

6. Contents of the pack and other information

Composition of Karbicombi

• The active substances are candesartan cilexetil and hydrochlorothiazide.

Each tablet contains 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

• The other components are monohydrate lactose, corn starch, hydroxypropylcellulose,
  magnesium stearate, calcium carmellose, macrogol 8000 and yellow iron oxide E-172. See section 2: "Karbicombi contains lactose".

Appearance of Karbicombi and contents of the pack

Karbicombi 32 mg/12.5 mg tablets are yellowish-white, biconvex, oval tablets, with a score line on one side.

The score line is intended to facilitate breaking the tablet for ease of swallowing, but not for dividing into equal doses.

Available in blisters of 14, 15, 28, 30, 56, 60, 84, 90, 98 tablets per pack.

Only certain pack sizes may be commercially available.

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: October 2025

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