Prospecto: Information for the Patient

Candesartán/Hidroclorotiazida Krka 16mg/12,5mg tablets EFG

candesartán cilexetilo/hidroclorotiazida

Read this prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What isCandesartán/Hidroclorotiazida Krkaand what is it used for

2.What you need to knowbefore starting to takeCandesartán/Hidroclorotiazida Krka

3.How to takeCandesartán/Hidroclorotiazida Krka

4.Possible adverse effects

5Storage ofCandesartán/Hidroclorotiazida Krka

6.Contents of the package and additional information

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

Both work together to lower your blood pressure.

Candesartán cilexetilo belongs to a group of medicines called angiotensin II receptor antagonists. It makes your blood vessels relax and dilate. This facilitates a decrease in your blood pressure.

Hidroclorotiazida belongs to a group of medicines called diuretics. It promotes your body to eliminate water and salt, such as sodium, in the urine. This facilitates a decrease in your blood pressure.

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

Do not takeCandesartán/Hidroclorotiazida Krka

• if you are allergic to candesartán cilexetilo or to 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 you are in this situation, consult your doctor.
• if you are more than 3 months pregnant. (It is best 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 bile duct obstruction (problem with the bile flowing out of the gallbladder).
• if you have persistent low levels of potassium in the blood.
• if you have persistent high levels of calcium in the blood.
• if you have ever had gout.
• if you have diabetes or kidney dysfunction and are being treated with a blood pressure-lowering medicine that contains aliskiren.

If you are unsure whether you are in any of these situations, consult your doctor or pharmacist before taking candesartán/hidroclorotiazide.

Warnings and precautions

Consult your doctor or pharmacist before starting to take candesartán/hidroclorotiazide:

• if you have diabetes.
• if you have heart, liver or kidney problems.
• if you have recently had a kidney transplant.
• if you have vomiting or 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 ever had a condition called systemic lupus erythematosus (SLE).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you have 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. Candesartán/hidroclorotiazide is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered after the third month of pregnancy because it may cause serious harm to your baby (see Pregnancy section).
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from the sun and UV rays while taking Candesartán/Hidroclorotiazida Krka.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Candesartán/Hidroclorotiazida Krka, seek medical attention immediately.
• if you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and may occur within a few hours to a week after taking this medicine. This can lead to permanent visual impairment if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it.
• if you are taking any of the following blood pressure-lowering medicines:
• 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 the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also the information under the title "Do not take Candesartán/Hidroclorotiazida Krka".

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

If you are to undergo surgery, inform your doctor or dentist that you are taking candesartán/hidroclorotiazide. This is because candesartán/hidroclorotiazide, in combination with some anesthetics, may cause an excessive drop in blood pressure.

Candesartán/hidroclorotiazide may increase your skin's sensitivity to the sun.

Children and adolescents

There is no experience with the use of candesartán/hidroclorotiazide in children (under 18 years).

Therefore, candesartán/hidroclorotiazide should not be administered to children.

Other medicines and Candesartán/Hidroclorotiazida Krka

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

Candesartán/hidroclorotiazide may affect the way some medicines work and some medicines may affect the effect of candesartán/hidroclorotiazide. If you are using certain medicines, your doctor may need to perform blood tests at regular intervals.

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

• other medicines to lower your blood pressure, including beta-blockers,medicines that contain aliskiren,diazoxide and the so-called ACE inhibitorssuch 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).
• aspirin, if you take more than 3 g per day (medicine to relieve pain and inflammation).
• potassium supplements or salt substitutes that contain potassium (medicines to increase potassium levels in the blood).
• calcium supplements or vitamin D.
• medicines to lower cholesterol, such as colestipol or colestiramine.
• medicines for diabetes (tablets or insulin).
• medicines to control heart rhythm (antiarrhythmic agents) such as digoxin and beta-blockers.
• medicines that may be affected by potassium levels in the blood, such as some antipsychotic medicines.
• heparin (a medicine to increase blood fluidity).
• diuretics (medicines to promote urine excretion).
• laxatives.
• penicillin orco-trimoxazolealso known as trimethoprim/sulfamethoxazole(antibiotics).
• amphotericin (for the treatment of fungal infections).
• lithium (a medicine for mental health problems).
• steroids such as prednisolone.
• ACTH (adrenocorticotropic hormone).
• medicines for cancer treatment.
• amantadine (for the treatment of Parkinson's disease or for severe viral infections).
• barbiturates (a type of sedative, also used to treat epilepsy).
• carbenoxolone (for the treatment of esophageal disease or mouth ulcers).
• anticholinergic agents such as atropine and biperiden.
• ciclosporin, a medicine used in organ transplantation to prevent organ rejection.
• other medicines that may increase the antihypertensive effect, such as baclofen (a medicine for muscle spasticity), amifostin (used in cancer treatment) and some antipsychotic medicines.

• if you are taking an ACE inhibitor or aliskiren (see also the information under the title “Do not take Candesartán/Hidroclorotiazida Krka” and “Warnings and precautions”).

Taking Candesartán/Hidroclorotiazida Krka with food, drinks and alcohol

• You can take candesartán/hidroclorotiazide with or without food.

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

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you think you are pregnant (or may be pregnant). Your doctor will usually advise you to stop taking candesartán/hidroclorotiazide before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of candesartán/hidroclorotiazide.Candesartán/hidroclorotiazide is not recommended during pregnancy, and should not be taken if you are more than three months pregnant, as it may cause serious harm to your baby (see Pregnancy section).

Lactation

Inform your doctor if you are breastfeeding, or are about to start breastfeeding. Candesartán/hidroclorotiazide is not recommended for use in breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breastfeed.

Driving and operating machines

Some patients may feel tired or dizzy when taking candesartán/hidroclorotiazide. If this happens to you, do not drive or operate tools or machines.

Candesartán/Hidroclorotiazida Krka contains lactose

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

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

It is essential that you continue to take candesartán/hidroclorotiazida every day.

The recommended dose is one tablet once a day.

Swallow the tablet with a glass of water.

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

If you take moreCandesartán/Hidroclorotiazida Krkathan 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, 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 takeCandesartán/Hidroclorotiazida Krka

Do not take a double dose to compensate for the missed dose.

Simply take the next dose.

If you interrupt treatment withCandesartán/Hidroclorotiazida Krka

If you stop taking candesartán/hidroclorotiazida, your blood pressure may increase again. Therefore, do not stop taking candesartán/hidroclorotiazida before consulting your doctor.

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

Like all medications,this medicationmay have side effects, although not everyone will experience them. It is essential that you know which side effects could occur. Some side effects ofcandesartan/Hydrochlorothiazideare due to candesartan cilexetilo and others are due to hydrochlorothiazide.

Stop takingcandesartan/hydrochlorothiazideand see your 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 skin itching (with skin rash).

Candesartan/hydrochlorothiazidemay 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 ifcandesartan/hydrochlorothiazideis affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent(may affect up to 1 in 10 people)

• Changes in blood test results:
• A reduction in sodium levels in the blood. If severe, you may feel weak, lack energy, or experience muscle cramps.
• An increase or decrease in potassium levels in the blood, especially if you have kidney problems or heart failure. If severe, you may feel tired, weak, experience irregular heartbeats, or numbness.
• An increase in cholesterol, glucose, or uric acid levels in the blood.
• Presence of glucose in urine.
• Dizziness or weakness.
• Headache.
• Respiratory infection.

Infrequent(may affect up to 1 in 100 people)

• Low blood pressure. This may cause dizziness or fainting.
• Loss of appetite, diarrhea, constipation, stomach irritation.
• Skin rash, hives, light sensitivity reaction.

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

• Jaundice (yellowing of the skin and white of the eyes). If this occurs, contact your doctor immediately.
• Effects on kidney function, especially if you have kidney problems or heart failure.
• Difficulty sleeping, depression, or restlessness.
• Itching or pinching in arms and legs.
• Blurred vision for a short period.
• Abnormal heartbeats.
• Difficulty breathing (including pulmonary inflammation and fluid in the lungs).
• Fever.
• Pancreatitis. This causes moderate to severe stomach pain.
• Muscle cramps.
• Vascular damage that produces red or purple spots on the skin.
• Decrease in red blood cells, white blood cells, or platelets. You may feel tired, have an infection, fever, or easily bruise.
• 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.
• Changes in liver function, including liver inflammation (hepatitis). You may feel tired, have yellowing of the skin and white of the eyes, and experience flu-like symptoms.
• Cough.
• Nausea.
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Side effects of unknown frequency(cannot be estimated from available data)

• Skin and lip cancer (non-melanoma skin cancer).
• Diarrhea
• Acute myopia.
• Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma).
• Lupus erythematosus systemic and cutaneous (allergic condition that causes fever, joint pain, skin eruptions that may include redness, blisters, exfoliation, and nodules).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Tablets in PVC/PVDC and aluminum blisters:

Do not store at a temperature above 30°C.

Tablets in OPA/Al/PVC and aluminum blisters:

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition ofCandesartán/Hidroclorotiazida Krka

• The active principles are candesartán cilexetilo and hidroclorotiazida.

Each tabletcontains 16mg of candesartán cilexetilo and 12.5mg of hidroclorotiazida.

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

Appearance ofCandesartán/Hidroclorotiazida Krkaand contents of the package

Candesartán/Hidroclorotiazida Krka 16mg/12.5mg tablets are pale pink, biconvex, oval, with a groove on one side.

The groove serves to split and facilitate swallowing but not to divide into equal doses.

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

Only some package sizes may be marketed.

Marketing Authorization Holder

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

Responsible for manufacturing

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

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

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:February 2022

Further 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/