Candesartan/Hydrochlorothiazide KRKA 16 mg/12.5 mg Tablets

Introduction

Patient Information: Summary of Product Characteristics

Candesartan/Hydrochlorothiazide Krka 16 mg/12.5 mg film-coated tablets

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What Candesartan/Hydrochlorothiazide Krka is and what it is used for
2. What you need to know before you take Candesartan/Hydrochlorothiazide Krka
3. How to take Candesartan/Hydrochlorothiazide Krka
4. Possible side effects

5 Storage of Candesartan/Hydrochlorothiazide Krka

1. Contents of the pack and other information

1. What Candesartan/Hydrochlorothiazide Krka is and what it is used for

Your medicine is called Candesartan/Hydrochlorothiazide Krka. It is used to treat high blood pressure (hypertension) in adults. 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 makes your blood vessels relax and dilate. This helps to lower your blood pressure.

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

Your doctor may prescribe candesartan/hydrochlorothiazide if your blood pressure is not controlled well enough with candesartan cilexetil or hydrochlorothiazide alone.

2. What you need to know before you take Candesartan/Hydrochlorothiazide Krka

Do not take Candesartan/Hydrochlorothiazide 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 not sure, consult your doctor.
• if you are more than 3 months pregnant. (It is also better to avoid Candesartan/Hydrochlorothiazide Krka during the first months of pregnancy – see section Pregnancy).
• if you have severe kidney disease.
• if you have severe liver disease or biliary obstruction (problems with the drainage of bile from the gallbladder).
• if you have persistent low potassium levels in your blood.
• if you have persistent high calcium levels in your blood.
• if you have ever had gout.
• if you have diabetes or kidney problems and are treated with a blood pressure lowering medicine containing aliskiren.

If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking candesartan/hydrochlorothiazide.

Warnings and precautions

Talk to your doctor or pharmacist before taking candesartan/hydrochlorothiazide:

• if you have diabetes.
• if you have heart, liver or kidney problems.
• if you have recently had a kidney transplant.
• if you are vomiting or have recently had severe vomiting or have diarrhea.
• if you have a condition called primary hyperaldosteronism (also known as Conn’s syndrome).
• 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 ever had an allergy or asthma.
• if you are pregnant, think you might be pregnant or are planning to become pregnant, you must tell your doctor. Candesartan/hydrochlorothiazide is not recommended during pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby (see section Pregnancy).
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Candesartan/Hydrochlorothiazide Krka.
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or difficulty breathing after taking Candesartan/Hydrochlorothiazide 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 pressure in the eye and can occur within hours to a week after taking this medicine. This can lead to permanent visual impairment if not treated. If you have previously been allergic to penicillin or sulfonamide, you may be at higher risk of developing it.
• if you are taking any of the following medicines used to treat high blood pressure:
• a medicine called an ACE inhibitor (e.g. enalapril, lisinopril, ramipril, etc.), especially if you have kidney problems related to diabetes,
• aliskiren.

Your doctor may check your kidney function, blood pressure, and the levels of electrolytes (e.g. potassium) in your blood at regular intervals.

See also the information under the heading “Do not take Candesartan/Hydrochlorothiazide Krka”.

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

If you are going to have surgery, tell your doctor or dentist that you are taking candesartan/hydrochlorothiazide. This is because candesartan/hydrochlorothiazide, in combination with some anesthetics, may cause a significant drop in blood pressure.

Candesartan/hydrochlorothiazide may increase the sensitivity of your skin to sunlight.

Children and adolescents

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

Therefore, candesartan/hydrochlorothiazide should not be given to children.

Other medicines and Candesartan/Hydrochlorothiazide Krka

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

Candesartan/hydrochlorothiazide may affect the way some medicines work and some medicines may affect the way candesartan/hydrochlorothiazide works. If you are using certain medicines, your doctor may need to do blood tests from time to time.

In particular, tell your doctor if you are using any of the following medicines, as your doctor may need to change 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 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 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 or vitamin D supplements.
• medicines to lower cholesterol, such as colestipol or cholestyramine.
• medicines for diabetes (tablets or insulin).
• medicines to control heart rhythm (anti-arrhythmic agents) such as digoxin and beta-blockers.
• medicines that may be affected by potassium levels in the blood, such as certain antipsychotic medicines.
• heparin (a medicine to increase blood fluidity).
• diuretics (medicines to promote urine production).
• laxatives.
• penicillin or cotrimoxazole also known as trimethoprim/sulfamethoxazole (antibiotic medicines).
• amphotericin (for the treatment of fungal infections).
• lithium (a medicine for mental health problems).
• corticosteroids such as prednisolone.
• adrenocorticotropic hormone (ACTH).
• medicines for cancer treatment.
• amantadine (for the treatment of Parkinson's disease or 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.
• cyclosporine, a medicine used in organ transplantation to prevent organ rejection.
• other medicines that may increase the blood pressure-lowering effect, such as baclofen (a medicine to relieve spasticity), amifostine (used in cancer treatment) and certain antipsychotic medicines.

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

Taking Candesartan/Hydrochlorothiazide Krka with food, drinks and alcohol

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

When Candesartan/Hydrochlorothiazide Krka is prescribed, consult your doctor before taking alcohol. Alcohol may make you feel dizzy or faint

Pregnancy and breastfeeding

Pregnancy

You must tell your doctor if you think you are pregnant or might become pregnant. Your doctor will normally advise you to stop taking candesartan/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of candesartan/hydrochlorothiazide. Candesartan/hydrochlorothiazide is not recommended during pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are breastfeeding, or about to start breastfeeding. Candesartan/hydrochlorothiazide is not recommended for mothers who are breastfeeding, and your doctor may choose a different treatment for you if you want 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 use tools or machines.

Candesartan/Hydrochlorothiazide Krka contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Candesartan/Hydrochlorothiazide Krka

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

It is important that you take candesartan/hydrochlorothiazide 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 each day. This will help you remember to take it.

If you take more Candesartan/Hydrochlorothiazide Krka than you should

If you take more candesartan/hydrochlorothiazide than you should, talk to your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Candesartan/Hydrochlorothiazide Krka

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

Just take the next dose as normal.

If you stop taking Candesartan/Hydrochlorothiazide Krka

If you stop taking candesartan/hydrochlorothiazide, your blood pressure may increase again. Therefore, do not stop taking candesartan/hydrochlorothiazide without talking to your doctor first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. It is important that you know what these side effects may be. Some of the side effects of candesartan/hydrochlorothiazide are due to candesartan cilexetil and some are due to hydrochlorothiazide.

Stop taking candesartan/hydrochlorothiazide and see a 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 rash).

Candesartan/hydrochlorothiazide may cause a decrease in white blood cells. Your resistance to infection may be decreased and you may feel tired, get an infection or fever. If this happens, tell your doctor. Your doctor may do blood tests from time to time to check that candesartan/hydrochlorothiazide is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common(may affect up to 1 in 10 people)

• 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.
• An increase or decrease in potassium levels in the blood, especially if you already have kidney problems or heart failure. If this situation is severe, you may feel tired, weak, have irregular heartbeats or tingling.
• An increase in cholesterol, glucose or uric acid levels in the blood.
• 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.
• Lack of appetite, diarrhea, constipation, stomach upset.
• 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 the whites of the eyes). If this happens, contact your doctor immediately.
• Effects on kidney function, especially if you already have kidney problems or heart failure.
• Difficulty sleeping, depression or anxiety.
• Tingling or numbness in arms and legs.
• Blurred vision for a short time.
• Abnormal heartbeats.
• Breathing difficulties (including inflammation of the lungs and fluid in the lungs).
• High temperature (fever).
• Pancreatitis. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels that cause red or purple spots on the skin.
• A decrease in red blood cells, white blood cells or platelets. You may feel tired, get an infection, fever or bruise easily.
• A severe skin reaction that develops rapidly, causing blisters or peeling of the skin 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, pain in the joints and muscles.
• Changes in liver function, including liver inflammation (hepatitis). You may feel tired, have yellowing of the skin and the whites of the eyes and have flu-like symptoms.
• Cough.
• Nausea.
• Acute breathing difficulties (signs include severe breathing difficulties, fever, weakness and confusion).

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

• Skin and lip cancer (non-melanoma skin cancer).
• Diarrhea
• Sudden onset of 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 lupus erythematosus and cutaneous lupus (a condition that causes fever, joint pain, skin rashes that can include redness, blisters, peeling and lumps).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side 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 which is stated on the carton after CAD. The expiry date is the last day of the month indicated.

Tablets in PVC/PVDC and aluminum blister packs:

Do not store above 30°C.

Tablets in OPA/Al/PVC and aluminum blister packs:

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofCandesartan/Hydrochlorothiazide 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 ingredients are lactose monohydrate, corn starch, macrogol 8000, hydroxypropylcellulose, calcium carmellose, magnesium stearate, and red iron oxide E-172. See section 2: “Candesartan/Hydrochlorothiazide Krka contains lactose”.

Appearance ofCandesartan/Hydrochlorothiazide Krkaand Package Contents

Candesartan/Hydrochlorothiazide Krka 16 mg/12.5 mg tablets are pale pink, biconvex, oval, with a score line on one side.

The score line is to facilitate breaking and 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.

Not all 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 more information about this medicine 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:February 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/