Leaflet: information for the patient

Candesartán/Hidroclorotiazida Sandoz 32 mg/12,5 mg tablets EFG

candesartán cilexetilo/hidroclorotiazida

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. Do 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 is Candesartán/Hidroclorotiazida Sandoz and what it is used for

2.What you need to know before starting to take Candesartán/Hidroclorotiazida Sandoz

3.How to take Candesartán/Hidroclorotiazida Sandoz

4.Possible side effects

5.Storage of Candesartán/Hidroclorotiazida Sandoz

6. Contents of the pack and additional informationto

Your medicine is called Candesartán/Hidroclorotiazida Sandoz. It is used for the treatment of high blood pressure (hypertension) in adult patients. It contains two active ingredients: candesartán cilexetilo and hidroclorotiazida. These work together to lower your blood pressure.

• Candesartán cilexetilo belongs to a group of medicines called angiotensin II receptor antagonists. It makes blood vessels relax and dilate. This facilitates a decrease in blood pressure.
• Hidroclorotiazida belongs to the group of medicines called diuretics. It promotes the body to eliminate water and salts, such as sodium, in urine. This facilitates a decrease in blood pressure.

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

Do not takeCandesartán/Hidroclorotiazida Sandoz, if:

• You areallergicto candesartán cilexetilo, to hidroclorotiazida or to any of the other components of this medication (listed in section 6),
• You are allergic to sulfonamide-derived medications. If you are unsure, consult your doctor,
• You have asevere liver diseaseor abiliary obstruction(problem with the bile flow from the gallbladder),
• You have asevere kidney disease,
• You arepregnant for more than 3 months(it is recommended to avoid taking candesartán/hidroclorotiazida at the beginning of pregnancy – see section “Pregnancy”),

-You have ever hadgout,

-You have persistentlow levels of potassium in the blood,,

• You have persistenthigh levels of calcium in the blood,,
• You havediabetesorkidney insufficiencyand are being treated with a medication to treat high blood pressure that containsaliskirén.

If you are unsure about any of these conditions, consult your doctor or pharmacist before taking candesartán/hidroclorotiazida.

Warnings and precautions

Consult your doctor or pharmacist before or during taking this medication, if:

• You have heart, liver or kidney problems,
• You have recently had akidney transplant,,
• You havevomiting, have hadrecently severe vomitingordiarrhea,,
• You have aConn's syndrome(also known as primary aldosteronism),
• You havediabetes,,
• You have or have had a disease calledsystemic lupus erythematosus(SLE),
• You havelow blood pressure,,
• You have ever had astroke,,
• You have a history ofallergyorasthma,,
• You have hadrespiratory or pulmonary problems(including inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking candesartán/hidroclorotiazida, seek medical attention immediately.
• You are taking any of the following medications to treat high blood pressure:
• • such asACE inhibitors(e.g., enalapril, lisinopril, ramipril) particularly if you have kidney problems related to diabetes,
  • aliskirén,
• You have hadskin canceror if you develop anunexpected skin lesionduring treatment. The treatment with hidroclorotiazida, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from the sun and UV rays while taking candesartán/hidroclorotiazida,
• If you experience a decrease in vision or eye pain.This could be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur within a few hours to a week after taking candesartán/hidroclorotiazida. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it.
• You suspect you are (or could be) pregnant, you must inform your doctor.Candesartán/hidroclorotiazida is not indicated at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it could severely harm the baby if taken at that time (see section “Pregnancy”).

Your doctor may regularly check your kidney function, blood pressure, and the amount of electrolytes (e.g., potassium) in your blood.

See also the information in the section “Do not take Candesartán/Hidroclorotiazida Sandoz”.

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

If you are to undergo surgery and are taking this medication, inform your doctor or dentist, as candesartán/hidroclorotiazida administered with some anesthetics may cause a drop in blood pressure.

Candesartán/hidroclorotiazida may cause skin sensitivity due to the sun.

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

Children and adolescents

There is no experience with the use of candesartán/hidroclorotiazida in children and adolescents (under 18 years of age). Therefore, candesartán/hidroclorotiazida should not be administered to children and adolescents.

Inform your doctor if you are aathlete subject to doping control,as candesartán/hidroclorotiazida contains an active ingredient that may give positive results in doping control tests.

Other medications and Candesartán/Hidroclorotiazida Sandoz

Inform your doctor or pharmacist that you are using, have used recently or may need to use any other medication.

Candesartán/hidroclorotiazida may affect the way some medications work, and some medications may influence the effect of candesartán/hidroclorotiazida. 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 adjust your dose and/or take other precautions:

• An ACE inhibitor or aliskirén (see also the information in the sections “Do not take Candesartán/Hidroclorotiazida Sandoz” and “Warnings and precautions”),

• Other medications to lower blood pressure, such as beta-blockers, medications containing aliskirén, diazoxide, and the so-called ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril,
• Medications to regulate heart rhythm (antiarrhythmic agents), such as digoxin and beta-blockers,
• Other non-steroidal anti-inflammatory drugs (NSAIDs) such as: ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medications to relieve pain and inflammation),
• Aspirin (if you take more than3 gper day), (medication to relieve pain and inflammation),
• Potassium supplements or salt substitutes containing potassium (medications that increase potassium levels in the blood),
• Heparin, (medication to increase blood fluidity),
• Diuretics,
• Lithium (medication for mental health problems),
• Medications that may affect potassium levels in the blood, such as some antipsychotics,
• Medications to lower cholesterol levels, such as colestipol or colestiramine,
• Calcium or vitamin D supplements,
• Anticholinergic medications (such as atropine and biperiden),
• Amantadine (medication for Parkinson's disease or for the treatment of severe viral infections),
• Barbiturates (a type of sedative used to treat epilepsy),
• Cancer medications,
• Glucocorticoids such as prednisolone,
• Pituitary hormone (ACTH),
• Diabetes medications (tablets or insulin),
• Laxatives,
• Ampotericin (medication for fungal infections),
• Carbenoxolone (for the treatment of esophageal diseases or oral ulcers),
• Penicillin or cotrimoxazol also known as trimethoprim/sulfamethoxazole (antibiotics),
• Ciclosporin, a medication used to prevent organ rejection after transplantation,
• Other medications that may potentiate the antihypertensive effect such as baclofen (medication to relieve spasticity), amifostine (medication used to treat cancer) and some antipsychotics.

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

• Candesartán/Hidroclorotiazida Sandoz can be taken with or without food.
• If your doctor has prescribed this medication, consult with them before taking alcohol. Alcohol may cause dizziness orpasses out.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you think you are (or could be) pregnant.Normally, your doctor will inform you of the need to interrupt treatment with candesartán/hidroclorotiazida before becoming pregnant, or as soon as you know you are pregnant, advising you to take another medication instead of candesartán/hidroclorotiazida.

Candesartán/hidroclorotiazida is not recommended to be used at the beginning of pregnancy, and it should not be taken after 3 months of pregnancy, as it could severely harm the baby if taken after the third month of pregnancy.

Lactation

Inform your doctor if you are breastfeeding or plan to start. Candesartán/hidroclorotiazida is not recommended for use in mothers who are breastfeeding, and your doctor may select another treatment if you want to start breastfeeding, especially if your baby is newborn or premature.

Driving and operating machines

Some patients taking candesartán/hidroclorotiazida have experienced dizziness or fatigue. If this happens to you, do not drive or operate machines.

Candesartán/Hidroclorotiazida Sandoz 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 tablet; it is essentially “sodium-free”.

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

It is essential to take candesartán/hidroclorotiazida every day.

The recommended dose is 1 tablet once a day.

Take the tablets with a glass of water.

Try to take the tablets every day at the same time. This will help you remember to take your dose.

If you take moreCandesartán/Hidroclorotiazida Sandozthan you should

If you have taken too many tablets, contact 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 forgot to takeCandesartán/Hidroclorotiazida Sandoz

Do not take a double dose to compensate for the missed doses. Take the next dose as usual.

If you interrupt treatment withCandesartán/Hidroclorotiazida Sandoz

If you interrupt treatment with Candesartán/Hidroclorotiazida Sandoz, it is likely that your blood pressure will rise.

Therefore, do not interrupt treatment with Candesartán/Hidroclorotiazida Sandoz without having consulted your doctor first.

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. It is important that you know these side effects. Some of these side effects are due to candesartan cilexetil and others are due to hydrochlorothiazide.

If you notice any of the following side effects, stop taking this medicine and seek medical attention immediately:

• difficulty breathing, with or without swelling of the face, lips, tongue, and throat,
• swelling of the face, lips, tongue, and throat, which may cause difficulty swallowing,
• severe urticaria (skin rash).

You should also stop taking Candesartán/Hidroclorotiazida Sandoz and seek medical attention immediately ifyou develop acute respiratory distress (the signs include severe difficulty breathing, fever, weakness, and confusion); this is a very rare side effect (it may affect up to 1 in 10,000 people).

Candesartán/hidroclorotiazida may cause a reduction in the number of white blood cells. This may cause you to feel tired, have an infection, or fever. If this happens, contact your doctor, who will decide to perform occasional blood tests to check if candesartán/hidroclorotiazida has caused any effect on your blood (agranulocytosis).

Other possible side effects are:

Frequent (may affect up to 1 in 10 people)

• changesin blood test results:
• decrease in the amount of sodium in the blood. If this is important, you may feel weakness, lack of energy, or muscle cramps,
• increase in the amount of potassium in the blood, especially if you already have kidney problems or heart failure. If this is important, you may feel tired, weakness, irregular heartbeat, numbness, and tingling,
• increase in the level of cholesterol, sugar, or uric acid in the blood,
• sugar in the urine,
• feeling of dizziness, weakness,
• headache,
• respiratory infection.

Occasional (may affect up to 1 in 100 people)

• sudden dropin blood pressure. This may cause you to faint or feel dizzy,
• lossof appetite, diarrhea, constipation, stomach irritation,
• skin rash, urticaria, skin rash caused by sensitivity to sunlight.

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

• jaundice (yellowing of the skin or the white of the eyes). If this happens, contact your doctor immediately,
• alteration in kidney function, especially if you have kidney problems or heart failure,
• difficulty falling asleep, depression, or nervousness,
• tingling or itching in the arms or legs,
• blurred vision,
• irregular heartbeat,
• difficulty breathing (including lung inflammation and fluid accumulation in the lungs),
• fever,
• pancreatitis. This causes moderate to severe stomach pain,
• muscle cramps,
• damageto blood vessels, causing red or purple spots on the skin,
• reduction in the number of white or red blood cells or platelets in the blood. You may feel tired, have an infection, fever, or the appearance of bruises easily,
• severe erythema, which appears suddenly with blisters or peeling of the skin and possibly burning in the mouth.

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

• swelling of the face, lips, tongue, and throat,
• itching,
• back pain, muscle pain, and joint pain,
• alteration in liver function, including liver inflammation (hepatitis). You may feel tired, yellowing of the skin and the white of the eyes, and flu-like symptoms,
• cough,
• nausea,
• angioedema intestinal: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown (cannot be estimated from available data)

• sudden loss of vision,
• decrease in 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),
• systemic and cutaneous lupus erythematosus (allergic condition that causes fever, joint pain, skin rash that may include redness, blisters, exfoliation, and nodules),
• skin and lip cancer (non-melanoma skin cancer).

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: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 medicationafter the expiration date that appears on the packaging, label or blister after CAD/EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Expiration after the first opening of the HDPE bottle: 3 months.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGREPointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Candesartan/Hidroclorotiazida Sandoz Composition

• The active ingredients are: candesartan cilexetilo and hidroclorotiazida.
• Each tablet contains 32 mg of candesartan cilexetilo and 12.5 mg of hidroclorotiazida.

• The other components are: lactose monohydrate, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), cornstarch, povidone K30, carrageenan (E407), croscarmelosa sodium, and magnesium stearate.

Product Appearance and Packaging Content

Light brown, speckled, oblong, biconvex tablets with the number ‘32’ engraved on one face and scored on both sides.

The score is for breaking and facilitating swallowing but not for dividing into equal doses.

Aluminum/Aluminum blister with desiccant: 7, 10, 14, 28, 30, 56, 60, 90, 98, 100, or 300 tablets.

HDPE bottle with PP cap and desiccant: 56 or 100 tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible Manufacturer

Lek Pharmaceuticals d.d.

Verovška 57

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Trimlini 2D

9220 Lendava

Slovenia

or

LEK S.A.

ul. Domaniewska 50 C

02-672 Warszawa

Poland

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany: Candesartan/HCT Sandoz comp 32 mg/12.5 mg Tabletten

Austria: Candesartan/HCT Sandoz 32 mg/12.5 mg – Tabletten

Belgium: Co-Candesartan Sandoz 32mg/12.5 mg tabletten

Estonia: Prescanden HCT, 32 mg/12.5 mg tabletid

Greece: FYRONEXE PLUS (32+12.5) mg δισκ?α

Italy: CANDESARTAN E IDROCLOROTIAZIDE SANDOZ 32 mg/12.5 mg compresse

Norway: Candemox Comp 32 mg/12.5 mg tabletter

Poland: CANDEPRES HCT, 32 MG + 12.5 MG, TABLETKI

Sweden: Candemox Comp 32 mg/12.5 mg tabletter

Slovenia: Candea HCT 32 mg/12.5 mg tablete

Last review date of this leaflet: February 2025

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