Candesartan/hydrochlorothiazide Krka 16 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Candesartán/Hidroclorotiazida Krka 16mg/12.5mg tablets EFG

candesartan cilexetil/hydrochlorothiazide

Read the entire 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, 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 could 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.

Leaflet contents:

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

1. What Candesartán/Hidroclorotiazida Krka is and what it is used for

Your medicine is called Candesartán/Hidroclorotiazida Krka. It is used for the treatment of high blood pressure (hypertension) in adults. It contains two active substances: candesartán cilexetilo and hidroclorotiazida.

Both components work together to lower your blood pressure.

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

Hidroclorotiazida belongs to a group of medicines called diuretics. It helps your body get rid of water and salts such as sodium through the urine. This also helps lower your blood pressure.

Your doctor may prescribe candesartán/hidroclorotiazida if your blood pressure is not adequately controlled with candesartán cilexetilo or hidroclorotiazida alone.

2. What you need to know before taking Candesartán/Hidroclorotiazida Krka

Do not take Candesartán/Hidroclorotiazida Krka

• if you are allergic to candesartan cilexetil or hydrochlorothiazide or 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. (It is also advisable to avoid Candesartán/Hidroclorotiazida Krka 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 flow from 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 dysfunction 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 candesartan/hydrochlorothiazide.

Warnings and precautions

Consult your doctor or pharmacist before starting to take candesartan/hydrochlorothiazide:

• if you have diabetes.
• if you have heart, liver, or kidney problems.
• if you have recently received a kidney transplant.
• if you have vomiting or have recently experienced severe vomiting or 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 had allergies or asthma.
• if you are pregnant, suspect you might be pregnant, or plan to become pregnant, you must inform your doctor. Use of candesartan/hydrochlorothiazide is not recommended during early pregnancy (first 3 months), and must not be used from the third month of pregnancy onwards, as it may cause serious 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 Candesartán/Hidroclorotiazida Krka.
• 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 Candesartán/Hidroclorotiazida Krka, 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 eye pressure, which may occur within a few hours to a week after taking this medicine. This may lead to permanent visual impairment 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 for high blood pressure:
• 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 Candesartán/Hidroclorotiazida Krka".

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

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

If you are scheduled for surgery, inform your doctor or dentist that you are taking candesartan/hydrochlorothiazide. This is because candesartan/hydrochlorothiazide, in combination with certain anesthetics, may cause excessive lowering of blood pressure.

Candesartán/hidroclorotiazida may increase skin sensitivity to sunlight.

Children and adolescents

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

Therefore, candesartán/hidroclorotiazida must not be administered to children.

Other medicines and Candesartán/Hidroclorotiazida Krka

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

Candesartán/hidroclorotiazida may affect how some medicines work, and some medicines may influence the effect of candesartán/hidroclorotiazida. 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 blood pressure-lowering medicines, 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, 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 some antipsychotic medicines.
• heparin (a medicine to increase blood fluidity).
• diuretics (medicines to promote urine elimination).
• laxatives.
• penicillin or cotrimoxazole also known as trimethoprim/sulfamethoxazole (antibiotic medicines).
• amphotericin (for treatment of fungal infections).
• lithium (a medicine for mental health conditions).
• steroids such as prednisolone.
• pituitary hormone (ACTH).
• medicines for cancer treatment.
• amantadine (for treatment of Parkinson's disease or serious viral infections).
• barbiturates (a type of sedative, also used to treat epilepsy).
• carbenoxolone (for treatment of 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 some antipsychotic medicines.
• if you are taking an ACE inhibitor or aliskiren (see also information under the headings “Do not take Candesartán/Hidroclorotiazida Krka” and “Warnings and precautions”).

Taking Candesartán/Hidroclorotiazida Krka with food, drinks, and alcohol

• You may take candesartan/hydrochlorothiazide with or without food.

When prescribed Candesartán/Hidroclorotiazida Krka, consult your doctor before consuming alcohol. Alcohol may make you feel faint or dizzy.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you may be pregnant (or could be). Your doctor will usually advise you to stop treatment with candesartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of candesartan/hydrochlorothiazide. Candesartán/hidroclorotiazida 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 planning to breastfeed. Use of candesartan/hydrochlorothiazide is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breastfeed.

Driving and using machines

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

Candesartán/Hidroclorotiazida Krka contains lactose

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

3. How to take Candesartán/Hidroclorotiazida Krka

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

It is important that you continue taking candesartán/hidroclorotiazida 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 Candesartán/Hidroclorotiazida Krka than you should

If you take more candesartán/hidroclorotiazida than prescribed by your doctor, consult your doctor or pharmacist immediately.

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 Candesartán/Hidroclorotiazida Krka

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

Simply take the next dose as scheduled.

If you stop taking Candesartán/Hidroclorotiazida Krka

If you stop taking candesartán/hidroclorotiazida, your blood pressure may rise again. Therefore, do not stop taking candesartán/hidroclorotiazida before 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 have adverse effects, although not everyone experiences them. It is important that you are aware of what these adverse effects might be. Some of the adverse effects of candesartan/hydrochlorothiazide are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop taking candesartan/hydrochlorothiazide and see your 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 skin rash).

Candesartan/hydrochlorothiazide 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 carry out blood tests from time to time to check that candesartan/hydrochlorothiazide is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Frequent (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 pins and needles in arms and legs.
• Blurred vision for a short period of time.
• Abnormal heartbeat.
• Difficulty breathing (including pulmonary 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 or skin peeling and possibly blisters in the mouth.

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 (signs include severe shortness of breath, fever, weakness and confusion).

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

• Skin and lip cancer (non-melanoma skin cancer).
• Diarrhoea.
• Sudden myopia.
• Decreased vision or eye pain due to elevated 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 that may include redness, blistering, peeling and lumps).

Reporting of adverse effects

If you experience any 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: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan/Hydrochlorothiazide Krka

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Tablets in PVC/PVDC and aluminum blisters:

Do not store above 30°C.

Tablets in OPA/Al/PVC and aluminum laminate blisters:

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Candesartán/Hidroclorotiazida Krka

• The active substances are candesartan cilexetil and hydrochlorothiazide.

Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

• The other components are monohydrate lactose, corn starch, macrogol 8000, hydroxypropylcellulose, calcium carmellose, magnesium stearate and red iron oxide E-172. See section 2: “Candesartán/Hidroclorotiazida Krka contains lactose”.

What Candesartán/Hidroclorotiazida Krka looks like and contents of the pack

Candesartán/Hidroclorotiazida Krka 16 mg/12.5 mg tablets are pale pink, 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 is not intended to divide the tablet into equal doses.

Available in blister packs of 14, 15, 28, 30, 56, 60, 84, 90, 98 tablets in a carton.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

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

Manufacturer

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

TAD Pharma GmbH, Heinz-Lohmann-Str. 5, 27472 Cuxhaven, Germany

You can request further information about this medicinal product 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 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 information about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/