Candesartan/Hydrochlorothiazide Sandoz 32mg/12.5mg Tablets

Introduction

Package Leaflet: Information for the Patient

Candesartan/Hydrochlorothiazide Sandoz 32 mg/12.5 mg Tablets EFG

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

1. What Candesartan/Hydrochlorothiazide Sandoz is and what it is used for
2. What you need to know before you take Candesartan/Hydrochlorothiazide Sandoz
3. How to take Candesartan/Hydrochlorothiazide Sandoz
4. Possible side effects
5. Storage of Candesartan/Hydrochlorothiazide Sandoz
6. Contents of the pack and other information

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

The name of your medicine is Candesartan/Hydrochlorothiazide Sandoz. It is used to treat high blood pressure (hypertension) in adult patients. It contains two active substances: candesartan cilexetil and hydrochlorothiazide. These work together to lower your blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It makes the blood vessels relax and widen. 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 will prescribe candesartan/hydrochlorothiazide if your blood pressure is not controlled enough with candesartan cilexetil or hydrochlorothiazide alone.

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 gall bladder),
• you have severe kidney disease,
• you are pregnant more than 3 months(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 to treat high blood pressure that contains aliskiren.

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 have vomiting, have recently had severe vomitingor have diarrhoea,
• you have a disease of the adrenal gland called Conn’s syndrome(also called primary hyperaldosteronism),
• you have diabetes,
• you have or have had a disease 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 or lung problems(including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing 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,
• 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.
• . Candesartan/hydrochlorothiazide is not indicated at the start of pregnancy, and must not be taken if you are pregnant more than 3 months, as it may seriously harm your baby if taken at this 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, inform your doctor or dentist, as candesartan/hydrochlorothiazide given with some anaesthetics may cause a drop in blood pressure.

Candesartan/hydrochlorothiazide may cause skin sensitivity due 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 contains an active substance that may give positive results in doping tests.

Other medicines and Candesartan/Hydrochlorothiazide Sandoz

Tell your doctor or pharmacist that 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 effect of candesartan/hydrochlorothiazide. 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 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), (a medicine to relieve pain and inflammation),
• potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in the blood),
• heparin, (a medicine to increase blood fluidity),
• diuretics,
• lithium (a medicine for the treatment of mental problems),
• medicines that may affect potassium levels in the blood, such as some antipsychotics,
• medicines to lower cholesterol levels, 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 to treat epilepsy),
• medicines to treat cancer,
• corticosteroids such as prednisolone,
• pituitary hormone (ACTH),
• medicines for diabetes (tablets or insulin),
• laxatives,
• amphotericin (a medicine to treat fungal infections),
• carbenoxolone (for the treatment of oesophageal or oral ulcers),
• penicillin or cotrimoxazole also known as trimethoprim/sulfamethoxazole (antibiotics),
• cyclosporin, a medicine used to prevent organ rejection after a transplant,
• other medicines that may enhance the blood-pressure-lowering effect, such as baclofen (a medicine to relieve spasticity), amifostine (a medicine used to treat cancer) and some antipsychotic medicines.

TakingCandesartan/Hydrochlorothiazide Sandozwith food, drinks and alcohol

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

Candesartan/hydrochlorothiazide should not be used during the first three months of pregnancy, and must not be used 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 mothers who are breast-feeding, and your doctor will be able to choose another treatment if you want to start breast-feeding, especially if your baby is newborn or premature.

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 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

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

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 remember to take your dose.

If you take moreCandesartan/Hydrochlorothiazide 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 Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to takeCandesartan/Hydrochlorothiazide Sandoz

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

If you stop takingCandesartan/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 (signs 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 a decrease in your 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,
• feeling of 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,
• decrease in vision or eye pain due to elevated 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 does not appear 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 wastewater or household waste. 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 of Candesartan/Hydrochlorothiazide Sandoz

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

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

Product Appearance and Package Contents

Light brown, speckled, oblong, biconvex tablets with the number '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 or 100 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 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

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/