Prospect: information for the patient

Candesartán/Hidroclorotiazida Sandoz 32 mg/25 mg tablets EFG

candesartán cilexetilo/hidroclorotiazida

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you and should not be given to other people, 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 prospect. (See section 4)

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

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

3.How to take Candesartán/Hidroclorotiazida Sandoz

4.Possible adverse effects

5.Storage of Candesartán/Hidroclorotiazida Sandoz

6.Contents of the package and additional information

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 the urine. This facilitates a decrease in blood pressure.

Your doctor will prescribe candesartán/hidroclorotiazida if your blood pressure is not controlled adequately 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 medicine (listed in section 6),
• you are allergic to sulfonamide-derived medicines. If you are unsure, consult your doctor,
• you have asevere liver diseaseor abile duct obstruction(a problem with the bile flowing out of 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 persistentlylow levels of potassium in your blood,,
• you have persistentlyhigh levels of calcium in your blood,,
• you havediabetesorkidney insufficiencyand are being treated with a medicine to treat high blood pressure that contains aliskirén.

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 medicine, if:

• you have heart, liver or kidney problems,
• you have recently had akidney transplant,,
• you havevomiting, have recently had severe vomiting or havediarrhea,,
• 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,,

• if 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 medicines 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.These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a few hours to a week after taking Candesartán/Hidroclorotiazida Sandoz. 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.
• if you suspect that 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 medicine, 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 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 Sandoz contains an active ingredient that may give positive results in doping control tests.

Other medicines and Candesartán/Hidroclorotiazida Sandoz

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

Candesartán/hidroclorotiazida may affect the way 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 at regular intervals.

Especially, 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:

Especially, 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:

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

• other medicines to lower blood pressure, such as beta-blockers, medicines containing aliskirén, diazoxide, and the so-called ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril,
• medicines 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 (medicines to relieve pain and inflammation),
• aspirin (if you take more than3 gper day), (a medicine to relieve pain and inflammation),
• potassium supplements or salt substitutes containing potassium (medicines that increase potassium levels in the blood),
• heparin, (a medicine to increase blood fluidity),
• diuretics,
• lithium (a medicine to treat mental problems),
• medicines that may affect potassium levels in the blood, such as some antipsychotics,
• medicines to lower cholesterol levels, such as colestipol or colestiramine,
• calcium or vitamin D supplements,
• anticholinergic medicines (such as atropine and biperideno),
• amantadine (a medicine to treat Parkinson's disease or to treat severe viral infections),
• barbiturates (a type of sedative used to treat epilepsy),
• medicines to treat cancer,
• steroids such as prednisolone,
• pituitary hormone (ACTH),
• medicines to treat diabetes (tablets or insulin),
• laxatives,
• amphotericin (a medicine to treat fungal infections),
• carbenoxolone (to treat esophageal diseases or oral ulcers),
• penicillin or cotrimoxazol (also known as trimethoprim/sulfamethoxazol) (antibiotic medicines),
• ciclosporina, a medicine used to prevent organ rejection after a transplant,
• other medicines that may potentiate the antihypertensive effect such as baclofen (a medicine to relieve spasticity), amifostine (a medicine 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 medicine, consult with them before taking alcohol. Alcohol may cause dizziness orpasses out.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you suspect that 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 medicine 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 medicine.

This medicine 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. In case of 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 essential 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).

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 (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 experience fatigue, 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 significant, you may experience 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 significant, you may experience fatigue, 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 drop in 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 experience fatigue, 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 experience fatigue, yellowing of the skin and the white of the eyes, and flu-like symptoms,
• cough,
• nausea,
• intestinal angioedema: 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),
• 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. Disposeof the packaging and medicines that you do not need at the SIGREPointof the pharmacy. Incase of doubt, ask your pharmacist how to dispose of the packaging and medicines that you do not need. By doing so, you will help protect the environment.

Composition ofCandesartán/Hidroclorotiazida Sandoz

• The active ingredients are: candesartán cilexetilo and hidroclorotiazida.
• Each tablet contains 32 mg of candesartán cilexetilo and 25 mg of hidroclorotiazida.

• The other components are: lactose monohydrate, iron oxide red (E172), iron oxide black (E172), titanium dioxide (E171), cornstarch, povidone K30, carrageenan (E407), croscarmelosa sodium, and magnesium stearate.

Appearance of the product and contents of the package

Brownish-red, speckled, oval, biconvex tablets with ‘H 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 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Lek Pharmaceuticals d.d.

Verovškova 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. Domaniewska50 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/25 mg Tabletten

Austria: Candesartan/HCT Sandoz 32 mg/25 mg – Tabletten

Estonia: Prescanden HCT, 32 mg/25 mg tabletid

Greece: FYRONEXE PLUS (32+25) mg δισκ?α

Italy: CANDESARTAN E IDROCLOROTIAZIDE SANDOZ 32 mg/25 mg compresse

Poland: CANDEPRES HCT, 32 MG + 25 MG, TABLETKI

Portugal: Candesartan + Hidroclorotiazida Sandoz

Sweden: Candemox Comp 32 mg/25 mg tabletter

Slovenia: Candea HCT 32 mg/25 mg tablete

Last review date of this leaflet: February 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/