Candesartan/Hydrochlorothiazide Sandoz 16mg/12.5mg 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-derived medicines. If you are not sure, consult your doctor,
• you have severe liver diseaseor bile obstruction(a problem with the drainage of bile from the gallbladder),
• 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 you are affected by any of these conditions, consult your doctor or pharmacist before taking candesartan/hydrochlorothiazide.

Warnings and precautions

Tell your doctor or pharmacist before or during treatment with this medicine 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 had a stroke,
• you have a history of allergyor asthma,
• if you have had breathing difficultiesor 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, seek medical attention immediately.
• you are taking any of the following medicines to treat high blood pressure:

• such as ACE inhibitors(e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,
• aliskiren,

• you have had skin canceror if you develop 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. 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.
• if you suspect you are (or might become) pregnant, you must tell your doctor. 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 levels 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 pronounced fall in blood pressure.

Candesartan/hydrochlorothiazide may cause sensitivity to sunlight.

Consult 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). 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 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 blood tests from time to time.

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 that 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 a day), (a medicine to relieve pain and inflammation),
• potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in your blood),
• heparin, (a medicine to increase the fluidity of your blood),
• diuretics,
• lithium (a medicine for the treatment of mental problems),
• medicines that may affect the levels of potassium 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 (a 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 the treatment of cancer,
• corticosteroids such as prednisolone,
• adrenocorticotropic hormone (ACTH),
• medicines for diabetes (tablets or insulin),
• laxatives,
• amphotericin (a medicine for the treatment of fungal infections),
• carbenoxolone (for the treatment of oesophageal or mouth ulcers),
• penicillin or cotrimoxazole also known as trimethoprim/sulfamethoxazole (antibiotics),
• ciclosporin, a medicine used to prevent organ rejection after a transplant,
• other medicines that may increase the blood pressure-lowering effect, such as baclofen (a medicine to relieve spasticity), amifostine (a medicine used for the treatment of cancer) 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, consult with them before drinking alcohol. Alcohol may make you feel dizzy or cause you to faint.

Pregnancy and breast-feeding

Pregnancy

You must 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 during the first few months of pregnancy, and it must not be taken after the third month of pregnancy, as it may seriously harm your baby.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Candesartan/hydrochlorothiazide is not recommended for women who are breast-feeding, and your doctor may choose another treatment if you want to breast-feed.

Driving and using machines

Some patients taking candesartan/hydrochlorothiazide have experienced dizziness or fatigue. 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, consult them 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. If you are not sure, check with your doctor or pharmacist.

It is important to take candesartan/hydrochlorothiazide every day.

The recommended dose of Candesartan/Hydrochlorothiazide Sandoz is one tablet once a day.

Swallow the tablet with a glass of water.

Try to take the tablets at the same time each day. This will help you 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 National Poison Information Service on 91 562 04 20, stating the name of 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 first talking to your doctor.

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 sodium levels in the blood. If this is significant, you may notice weakness, lack of energy, or muscle cramps,
• increase in potassium levels 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).
• systemic and cutaneous lupus erythematosus (allergic condition that causes fever, joint pain, skin rashes that can include redness, blisters, peeling, and bumps),
• 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 and on the blister after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Store in the original packaging to protect it from moisture.

Expiration after opening the HDPE bottle: 3 months

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. If in 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 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

• The other ingredients are: lactose monohydrate, cornstarch, Povidone K-30, carrageenan (E407), sodium croscarmellose, magnesium stearate, red iron oxide (E 172), and yellow iron oxide (E 172).

Appearance of the Product and Package Contents

Peach-colored, speckled, oval, biconvex tablets with a score on both sides.

The score serves to facilitate fractionation and swallowing but not to divide into equal doses.

Al/Al blister pack with desiccant: 7, 10, 14, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98, or 100 tablets.

Al/Al single-dose blister pack with desiccant: 50x1 tablets.

HDPE bottle with PP cap and desiccant: 7, 14, 21, 28, 56, 84, 98, 100, or 250 tablets.

Not all pack 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

SLO-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 under the following names:

Austria: Candesartan/HCT Sandoz 16 mg/12.5 mg - Tabletten

Belgium: Co-Candesartan Sandoz 16 mg/12.5 mg tabletten

Bulgaria: Candecard H 16 mg/12.5 mg tablets

Denmark: Candemox Comp

Slovenia: Candea HCT 16 mg/12.5 mg tablete

Estonia: Prescanden HCT 16 mg/12.5 mg, tabletid

Finland: Candemox Comp 16 mg/12.5 mg tabletit

France: CANDESARTAN/HYDROCHLOROTHIAZIDE SANDOZ 16 mg/12.5 mg, comprimé

Germany: Candesartan/HCT Sandoz 16 mg/12.5 mg Tabletten

Greece: FYRONEXE PLUS (16+12.5) mg δισκ?α

Italy: CANDESARTAN E IDROCLOROTIAZIDE SANDOZ 16 mg/12.5 mg compresse

Netherlands: Candesartancilexetil/ Hydrochloorthiazide Sandoz 16/12.5 mg, tabletten

Norway: Candemox Comp 16 mg / 12.5 mg tabletter

Poland: CANDEPRES HCT, 16 MG + 12,5 MG, TABLETKI

Portugal: Candesartan + Hidroclorotiazida Sandoz

Slovak Republic: Candesartan/Hydrochlorotiazid Sandoz 16 mg/12.5 mg tablety

Sweden: Candemox Comp 16 mg/12.5 mg tabletter

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/