Candesartan/Hydrochlorothiazide Sandoz 32mg/25mg Tablets

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

Do not takeCandesartan/Hydrochlorothiazide Sandozif:

• you are allergicto candesartan cilexetil, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6),
• you are allergic to sulphonamide medicines. If you are not sure, talk to your doctor,
• you have severe liver diseaseor bile duct obstruction(problems with the drainage of the bile from the gall bladder),
• you have severe kidney disease,
• you are more than 3 months pregnant(it is recommended to avoid taking candesartan/hydrochlorothiazide at the start of pregnancy – see section “Pregnancy”),
• you have ever had gout,
• you have persistently low potassium levels in your blood,
• you have persistently high calcium levels in your blood,
• you have diabetesor kidney problemsand are taking a medicine called aliskiren to treat your high blood pressure.

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

Tell your doctor or pharmacist before or during treatment if:

• you have heart, liver or kidney problems,
• you have recently had a kidney transplant,
• you are vomiting, have recently had severe vomitingor have diarrhoea,
• you have a condition called primary hyperaldosteronism (Conn’s syndrome),
• you have diabetes,
• you have or have had a condition called systemic lupus erythematosus (SLE),
• you have low blood pressure,
• you have ever had a stroke,

you have a history of allergyor asthma,

• if you have had breathing problems or lung problems(including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or difficulty breathing severely after taking candesartan/hydrochlorothiazide, see your doctor immediately.

• you are taking any of the following medicines to treat high blood pressure:
• • such as ACE inhibitors(e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
  • aliskiren,
• you have had skin canceror if you get an unexpected skin lesionduring 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,
• 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 an increase in pressure in the eye and can occur within hours to a week after taking Candesartan/Hydrochlorothiazide Sandoz. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulphonamide, you may be at higher risk of developing it.
• Candesartan/hydrochlorothiazide is not recommended at the start of pregnancy, and must not be taken if you are more than 3 months pregnant, as it may seriously harm your baby if taken at that time (see section “Pregnancy”).

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

See also the information in the section “Do not take Candesartan/Hydrochlorothiazide Sandoz”.

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

If you are going to have surgery, and are taking this medicine, tell your doctor or dentist, as candesartan/hydrochlorothiazide taken with some anaesthetics may cause a drop in blood pressure.

Candesartan/hydrochlorothiazide may cause sensitivity to the sun.

Tell your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Candesartan/Hydrochlorothiazide Sandoz. Your doctor will decide whether to continue treatment. Do not stop taking Candesartan/Hydrochlorothiazide Sandoz on your own.

Children and adolescents

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

Tell your doctor if you are an athlete undergoing doping control, as Candesartan/Hydrochlorothiazide Sandoz contains an active substance that may give positive results in doping tests.

Other medicines and Candesartan/Hydrochlorothiazide Sandoz

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 taking certain medicines, your doctor may need to do regular blood tests.

In particular, tell your doctor if you are taking any of the following medicines, as your doctor may need to change your dose and/or take other precautions:

In particular, tell your doctor if you are taking any of the following medicines, as your doctor may need to change your dose and/or take other precautions:

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

• other medicines to lower your blood pressure, such as beta-blockers, medicines that contain aliskiren, diazoxide and ACE inhibitors such as enalapril, captopril, lisinopril or ramipril,
• medicines to control the heart rhythm (antiarrhythmic agents), such as digoxin and beta-blockers,
• other non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines to relieve 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 containing potassium (medicines that increase the amount of potassium in your blood),
• heparin, (medicine to increase the fluidity of the blood),
• diuretics,
• lithium (medicine for the treatment of mental problems),
• medicines that may affect potassium levels in your blood, such as some antipsychotic medicines,
• medicines to lower your cholesterol, such as colestipol or colestyramine,
• calcium or vitamin D supplements,
• anticholinergic medicines (such as atropine and biperiden),
• amantadine (medicine for the treatment of Parkinson's disease or for the treatment of severe viral infections),
• barbiturates (a type of sedative used for the treatment of epilepsy),
• medicines for cancer treatment,
• corticosteroids such as prednisolone,
• adrenocorticotropic hormone (ACTH),
• medicines for diabetes (tablets or insulin),
• laxatives,
• amphotericin (medicine for the treatment of fungal infections),
• carbenoxolone (for the treatment of oesophageal or mouth ulcers),
• penicillin or cotrimoxazole also known as trimethoprim/sulfamethoxazole (antibiotic medicines),
• ciclosporin, a medicine used to prevent organ rejection after a transplant,
• other medicines that may increase the blood pressure-lowering effect, such as baclofen (medicine to relieve spasticity), amifostine (medicine used for cancer treatment) and some antipsychotic medicines.

Taking Candesartan/Hydrochlorothiazide Sandoz with food, drinks and alcohol

• Candesartan/Hydrochlorothiazide Sandoz can be taken with or without food.
• If your doctor has prescribed this medicine for you, ask your doctor before taking alcohol. Alcohol may make you feel dizzy or faint.

Pregnancy and breast-feeding

Pregnancy

Tell your doctor if you think you are (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. It is not recommended to take candesartan/hydrochlorothiazide at the start of pregnancy, and it must not be taken after the third month of pregnancy, as it may seriously harm your baby if taken after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. It is not recommended to take candesartan/hydrochlorothiazide while breast-feeding, and your doctor will be able to choose another treatment if you want to breast-feed, especially if your baby is newborn or was born prematurely.

Driving and using machines

Some patients taking candesartan/hydrochlorothiazide have experienced dizziness or tiredness. If this happens to you, do not drive or use machines.

Candesartan/Hydrochlorothiazide Sandoz contains lactose and sodium

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

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Candesartan/Hydrochlorothiazide Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. It is important to take candesartan/hydrochlorothiazide every day.

The recommended dose is one tablet once a day.

Take the tablets with a glass of water.

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

If you take more Candesartan/Hydrochlorothiazide Sandoz than 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 Toxicology Information Service, telephone: 91 562 04 20 (indicating the medicine and the amount taken).

If you forget to take Candesartan/Hydrochlorothiazide Sandoz

Do not take a double dose to make up for a forgotten dose. Take the next dose as usual.

If you stop taking Candesartan/Hydrochlorothiazide Sandoz

If you stop taking Candesartan/Hydrochlorothiazide Sandoz, your blood pressure may increase.

Therefore, do not stop taking Candesartan/Hydrochlorothiazide Sandoz without talking to your doctor first.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. It is essential that you know these adverse effects. Some of these adverse effects are a consequence of candesartan cilexetil and others are due to hydrochlorothiazide.

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

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

Also, stop taking Candesartan/Hydrochlorothiazide Sandoz and seek immediate medical attention ifyou develop acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion); this is a very rare adverse effect (may affect up to 1 in 10,000 people).

Candesartan/hydrochlorothiazide may cause a reduction in the number of white blood cells. This can cause you to have decreased resistance to infections, noticing fatigue, infection, or fever. If this happens to you, contact your doctor, who will decide to perform occasional blood tests to check if candesartan/hydrochlorothiazide has caused any effect on your blood (agranulocytosis).

Other possible adverse effects are:

Frequent (may affect up to 1 in 10 people)

• changes in blood test results:
• decrease in the amount of sodium in the blood. If this is significant, you may notice 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 notice fatigue, weakness, irregular heartbeat, tingling, and numbness,
• increase in cholesterol, sugar, or uric acid levels in the blood,
• sugar in the urine,
• dizziness, weakness,
• headache,
• respiratory infection.

Infrequent (may affect up to 1 in 100 people)

• sudden drop in blood pressure. This can cause you to faint or feel dizzy
• loss of appetite, diarrhea, constipation, gastric 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 whites of the eyes). If this happens to you, contact your doctor immediately,
• alteration in kidney function, especially if you have kidney problems or heart failure,
• difficulty sleeping, depression, or nervousness,
• tingling or itching in the arms or legs,
• transient blurred vision,
• irregular heartbeats,
• difficulty breathing (including pulmonary inflammation and fluid accumulation in the lungs),
• increased temperature (fever),
• pancreatitis. This causes moderate to severe stomach pain,
• muscle cramps,
• damage to blood vessels, causing reddish or purplish spots on the skin,
• reduction in the number of white or red blood cells or platelets in the blood. You may notice fatigue, infection, fever, or easy bruising.
• severe erythema, which appears suddenly with blisters or skin peeling 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 and joint pain,
• alteration in liver function, including liver inflammation (hepatitis). You may notice fatigue, yellowing of the skin and whites 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,
• decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma),
• sudden eye pain (acute angle-closure glaucoma).
• systemic and cutaneous lupus erythematosus (allergic condition that causes fever, joint pain, skin rashes that can include redness, blisters, peeling, and lumps),
• skin and lip cancer (non-melanoma skin cancer).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Candesartan/Hydrochlorothiazide Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after 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 opening the HDPE bottle: 3 months.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofCandesartan/Hydrochlorothiazide Sandoz

• The active ingredients are: candesartan cilexetil and hydrochlorothiazide.
• Each tablet contains 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.

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

Appearance of the Product and Package Contents

Brown-red, speckled, oblong, biconvex tablets with 'H 32' engraved on one side and scored on both sides.

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

Al/Al blister pack 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 marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

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. Domaniewska 50 C,

02-672 Warszawa

Poland

This medicine is authorized in the member statesof the European Economic Area under 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

Date of the last revision of this prospectus: February 2025

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