Candesartan/hydrochlorothiazide Sandoz 32 mg/25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Candesartán/Hidroclorotiazida Sandoz 32 mg/25 mg tablets EFG

candesartan cilexetil/hydrochlorothiazide

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. (See section 4)

Leaflet contents:

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

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

The name of your medicine is Candesartán/Hidroclorotiazida Sandoz. It is used to treat high blood pressure (hypertension) in adult patients. It contains two active substances: 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 causes the blood vessels to relax and widen, which helps reduce blood pressure.
• Hidroclorotiazida belongs to a group of medicines called diuretics. It helps the body get rid of water and salts, such as sodium, through the urine. This helps reduce blood pressure.

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

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

DO NOT take Candesartan/Hydrochlorothiazide Sandoz if:

• you are allergic to candesartan cilexetil, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6),
• you are allergic to sulfonamide-derived medicines. If you are unsure, consult your doctor,
• you have severe liver disease or biliary obstruction (a problem with bile drainage from the gallbladder),
• you have severe kidney disease,
• you are more than 3 months pregnant (it is recommended to avoid taking candesartan/hydrochlorothiazide in early pregnancy – see section “Pregnancy”),
• you have ever had gout,
• you persistently have low potassium levels in the blood,
• you persistently have high calcium levels in the blood,
• you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist before taking candesartan/hydrochlorothiazide.

Warnings and precautions

Consult your doctor or pharmacist before or during treatment with this medicine if:

• you have problems with your heart, liver, or kidneys,
• you have recently had a kidney transplant,
• you have vomiting, have recently experienced severe vomiting, or have diarrhea,
• you have an adrenal gland disorder called Conn’s syndrome (also known as primary hyperaldosteronism),
• you have diabetes,
• you have or have had a disease called systemic lupus erythematosus (SLE),
• you have low blood pressure,
• you have ever had a stroke,
• you have a history of allergy or asthma,
• you have had respiratory or lung problems (including lung inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking candesartan/hydrochlorothiazide, seek medical attention immediately,
• you are taking any of the following medicines for high blood pressure:
  • ACE inhibitors (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,
  • aliskiren,
• you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking candesartan/hydrochlorothiazide,
• you experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours to a week after taking Candesartan/Hydrochlorothiazide Sandoz. This may lead to permanent vision loss if untreated. If you have previously been allergic to penicillin or sulfonamides, you may be at higher risk,
• you suspect you are (or might be) pregnant, you must inform your doctor. Candesartan/hydrochlorothiazide is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm your baby if taken at that stage (see section “Pregnancy”).

Your doctor may regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium).

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 frequently and perform some of these tests.

If you are scheduled for surgery and are taking this medicine, inform your doctor or dentist, as candesartan/hydrochlorothiazide, when used with certain anesthetics, may cause a drop in blood pressure.

Candesartan/hydrochlorothiazide may cause skin sensitivity to sunlight.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea 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 regarding the use of candesartan/hydrochlorothiazide in children and adolescents (under 18 years of age). Therefore, candesartan/hydrochlorothiazide should not be administered to children and adolescents.

Inform your doctor if you are an athlete undergoing doping control, as Candesartan/Hydrochlorothiazide Sandoz contains an active substance that may lead to 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 need to take any other medicines.

Candesartan/hydrochlorothiazide may affect how some medicines work, and some medicines may influence the effect of candesartan/hydrochlorothiazide. If you are taking certain medicines, your doctor may need to perform regular blood tests.

In particular, 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 aliskiren (see also information in sections “Do not take Candesartan/Hydrochlorothiazide Sandoz” and “Warnings and precautions”),
• other blood pressure-lowering medicines such as beta-blockers, medicines containing aliskiren, diazoxide, or ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril,
• medicines to regulate heart rhythm (antiarrhythmics), such as digoxin and beta-blockers,
• other non-steroidal anti-inflammatory drugs (NSAIDs) such as: ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines used to relieve pain and inflammation),
• acetylsalicylic acid (if taking more than 3 g per day) (a medicine indicated for pain and inflammation relief),
• potassium supplements or potassium-containing salt substitutes (medicines that increase blood potassium levels),
• heparin (a medicine to increase blood fluidity),
• diuretics,
• lithium (a medicine used to treat mental health conditions),
• medicines that may affect blood potassium levels, such as some antipsychotics,
• cholesterol-lowering medicines such as colestipol or cholestyramine,
• calcium or vitamin D supplements,
• anticholinergic medicines (such as atropine and biperiden),
• amantadine (a medicine used to treat Parkinson’s disease or serious viral infections),
• barbiturates (a type of sedative used to treat epilepsy),
• cancer treatments,
• steroids such as prednisolone,
• pituitary hormones (ACTH),
• diabetes medicines (tablets or insulin),
• laxatives,
• amphotericin (a medicine used to treat fungal infections),
• carbenoxolone (used to treat esophageal disorders or oral ulcers),
• penicillin or cotrimoxazole (also known as trimethoprim/sulfamethoxazole) (antibiotic medicines),
• cyclosporine, a medicine used to prevent organ transplant rejection,
• other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine used to relieve muscle spasticity), amifostine (a medicine used in cancer treatment), and certain antipsychotics.

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, consult them before drinking alcohol. Alcohol may make you feel dizzy or cause fainting.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you think you are (or might be) pregnant. Your doctor will usually advise you to stop treatment with candesartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Candesartan/hydrochlorothiazide is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm your baby if taken beyond the third month.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Candesartan/hydrochlorothiazide is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you plan to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines

Some patients taking candesartan/hydrochlorothiazide have experienced dizziness or fatigue. If this happens to you, do not drive or operate machinery.

Candesartan/Hydrochlorothiazide Sandoz contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult them before taking this medicine.

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

3. How to take Candesartan/Hydrochlorothiazide Sandoz

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. It is important that you take candesartan/hydrochlorothiazide every day.

The recommended dose is 1 tablet once daily.

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 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to take Candesartan/Hydrochlorothiazide Sandoz

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

If you stop taking Candesartan/Hydrochlorothiazide Sandoz

If you stop treatment with Candesartan/Hydrochlorothiazide Sandoz, your blood pressure is likely to rise.

Therefore, do not stop treatment with Candesartan/Hydrochlorothiazide Sandoz without first consulting your doctor.

If you have any further questions about 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 everyone will experience them. It is important that you are aware of these adverse effects. Some of these adverse effects are due to 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 may cause difficulty swallowing,
• severe hives (with skin rash).

Also stop taking Candesartan/Hydrochlorothiazide Sandoz and seek immediate medical attention if you develop acute breathing difficulty (signs include severe shortness of breath, 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 may decrease your resistance to infections, leading to symptoms such as fatigue, infection, or fever. If this occurs, contact your doctor, who may occasionally order blood tests to check whether candesartan/hydrochlorothiazide has affected 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 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 significant, you may experience fatigue, weakness, irregular heartbeat, tingling, or pricking sensations,
• increased levels of cholesterol, glucose, or uric acid in the blood,
• glucose in the urine,
• dizziness, weakness,
• headache,
• respiratory infection.

Uncommon (may affect up to 1 in 100 people)

• sudden drop in blood pressure. This may cause fainting or dizziness,
• loss of appetite, diarrhea, constipation, gastric irritation,
• skin rash, hives, 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 occurs, contact your doctor immediately,
• impaired 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,
• transient blurred vision,
• irregular heartbeat,
• difficulty breathing (including pulmonary inflammation and fluid accumulation in the lungs),
• increased body temperature (fever),
• inflammation of the pancreas. 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 experience fatigue, infection, fever, or bruise easily.
• severe erythema, appearing suddenly with blisters or skin peeling and possibly burning sensation 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,
• impaired liver function, including inflammation of the liver (hepatitis). You may experience fatigue, yellowing of the skin and whites of the eyes, and flu-like symptoms,
• cough,
• nausea,
• intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Not known (frequency cannot be estimated from available data)

• sudden loss of vision,
• decreased 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),
• sudden eye pain (acute angle-closure glaucoma).
• systemic and cutaneous lupus erythematosus (an allergic condition causing fever, joint pain, skin rashes that may include redness, blisters, peeling, and lumps),
• skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

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

5. Storage of Candesartan/Hydrochlorothiazide Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, label or blister after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from moisture.

Shelf-life after first opening of the HDPE bottle: 3 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartan/Hydrochlorothiazide Sandoz

• The active substances are: candesartan cilexetil and hydrochlorothiazide.

• Each tablet contains 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.

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

Appearance of the product and pack contents

Reddish-brown, mottled, oblong, biconvex tablets, marked with ‘H 32’ on one side and scored on both sides.

The score line is intended to facilitate breaking the tablet for ease of swallowing, but does not allow division into equal doses.

Al/Al blister packs 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 certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Park
Roble Building
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 medicinal product is authorized in the European Economic Area member states 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 most recent revision of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/