Candesartan/hydrochlorothiazide Sandoz 16 mg/12.5 mg tablets EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the patient

Candesartan/Hydrochlorothiazide Sandoz 16 mg/12.5 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. You may need to read it again.
• If you have any questions, ask 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. It could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Candesartan/Hydrochlorothiazide Sandoz is and what it is used for
2. What you need to know before taking Candesartan/Hydrochlorothiazide Sandoz
3. How to take Candesartan/Hydrochlorothiazide Sandoz
4. Possible side effects
5. How to store Candesartan/Hydrochlorothiazide 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 for the treatment of 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 helps blood vessels to relax and widen, making it easier to 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 Candesartán/Hydrochlorothiazide Sandoz

DO NOT take Candesartán/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 about this, consult your doctor,
• you have severe liver disease or biliary obstruction (a problem with bile flow 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 beginning of pregnancy – see section “Pregnancy”),
• you have ever had gout,
• you have persistently low levels of potassium in the blood,
• you have persistently high levels of calcium in the blood,
• you have diabetes or renal insufficiency and are being treated with a medicine for high blood pressure 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 disease (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 experienced respiratory or pulmonary 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 a decrease in vision 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. This may lead to permanent vision loss if not treated. 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 at the beginning of pregnancy and must not be taken after 3 months of pregnancy, as it may seriously harm the baby if taken during this time (see section “Pregnancy”).

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

See also the information in the section “Do not take Candesartán/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 undergoing surgery and are taking this medicine, inform your doctor or dentist, as candesartan/hydrochlorothiazide, when used together with certain anesthetics, may cause excessive lowering of blood pressure.

Candesartan/hydrochlorothiazide may cause skin sensitivity to sunlight.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartán/Hydrochlorothiazide Sandoz. Your doctor will decide whether to continue treatment. Do not stop taking Candesartán/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 subject to doping controls, as candesartan/hydrochlorothiazide contains an active substance that may lead to positive results in doping tests.

Other medicines and Candesartán/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 blood tests periodically.

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 Candesartán/Hydrochlorothiazide Sandoz” and “Warnings and precautions”),

• other blood pressure-lowering medicines, such as beta-blockers, medicines containing aliskiren, diazoxide, and 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 used to increase blood fluidity),

• diuretics,

• lithium (a medicine used to treat mental disorders),

• 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 biperidene),

• amantadine (a medicine used to treat Parkinson’s disease or serious viral infections),

• barbiturates (a type of sedative used to treat epilepsy),

• anticancer medicines,

• steroids such as prednisolone,

• pituitary hormone (ACTH),

• medicines for diabetes (tablets or insulin),

• laxatives,

• amphotericin (a medicine used to treat fungal infections),

• carbenoxolone (for treating esophageal diseases 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 spasticity), amifostine (a medicine used in cancer treatment), and some antipsychotics.

Taking Candesartán/Hydrochlorothiazide with food, drinks, and alcohol

• Candesartán/Hydrochlorothiazide can be taken with or without food.
• If your doctor has prescribed this medicine, consult him before consuming 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 instead of candesartan/hydrochlorothiazide. 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 from the third month of pregnancy onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. The use of candesartan/hydrochlorothiazide is not recommended in breastfeeding mothers, and your doctor may choose an alternative treatment if you plan to start breastfeeding.

Driving and using machines

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

Candesartán/Hydrochlorothiazide Sandoz contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, 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 in doubt, consult your doctor or pharmacist again.

It is important that you take candesartan/hydrochlorothiazide every day.

The recommended dose of Candesartan/Hydrochlorothiazide Sandoz 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 telephone number: 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, while others are due to hydrochlorothiazide.

If you notice any of the following adverse effects, stop taking this medicine immediately and seek 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 urticaria (with skin rash).

Also stop taking Candesartán/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, which could decrease your resistance to infections. You may notice 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 blood sodium levels. If significant, you may experience weakness, lack of energy, or muscle cramps,
• increase in blood potassium levels, especially if you already have kidney problems or heart failure. If significant, you may notice fatigue, weakness, irregular heartbeat, tingling, or pricking sensations,
• increased levels of cholesterol, glucose, or uric acid in blood,
• glucose in 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, 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 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 heartbeats,
• difficulty breathing (including pulmonary inflammation and fluid accumulation in the lungs),
• increased body 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 blood cells, 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 mouth burning.

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 liver inflammation (hepatitis). You may feel tired, notice yellowing of the skin and whites of the eyes, and experience 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),
• systemic and cutaneous lupus erythematosus (an allergic condition causing fever, joint pain, and 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 and on the blister after CAD/EXP. The expiry date refers to the last day of the month indicated.

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

Expiry after first opening of the HDPE bottle: 3 months

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

6. Contents of the pack and other information

Composition of Candesartán/Hidroclorotiazida Sandoz

• The active substances are: candesartan cilexetil and hydrochlorothiazide. Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

• The other components are: lactose monohydrate, corn starch, povidone K-30, carrageenan (E407), sodium croscarmellose, magnesium stearate, iron oxide red (E 172) and iron oxide yellow (E 172).

Appearance of the product and contents of the pack

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

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

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

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

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

Only certain 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 medicinal product is authorized in the European Economic Area member states 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
Slovakia: Candesartan/Hydrochlorotiazid Sandoz 16 mg/12.5 mg tablety
Sweden: Candemox Comp 16 mg/12.5 mg tabletter

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 Health Products (AEMPS) http://www.aemps.gob.es/