Candesartan/hidroclorotiazida sandoz 16 mg/12,5 mg comprimidos efg

Patient Information Leaflet

Candesartán/Hidroclorotiazida Sandoz 16 mg/12,5 mg Tablets EFG

candesartán cilexetilo/hidroclorotiazida

Read this leaflet carefully before you start taking the medicine, because it contains important information for you.

-Keep this leaflet, as 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Candesartán/Hidroclorotiazida Sandoz

3.How to take Candesartán/Hidroclorotiazida Sandoz

4.Possible side effects

5.Storage of Candesartán/Hidroclorotiazida Sandoz

6.Contents of the pack and additional information

Your medication is called Candesartán/Hidroclorotiazida Sandoz. It is used for the treatment of high blood pressure (hypertension) in adult patients. It contains two active ingredients: 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 makes blood vessels relax and dilate. This facilitates a decrease in blood pressure.
• Hidroclorotiazida belongs to the group of medicines called diuretics. It promotes the body to eliminate water and salts, such as sodium, in the urine. This facilitates a decrease in blood pressure.

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

Do not takeCandesartán/Hidroclorotiazida Sandoz, if:

• You areallergicto candesartán cilexetilo, hidroclorotiazida or to any of the other components of this medication (listed in section 6),
• You are allergic to sulfonamide-derived medications. If you are unsure, consult your doctor,
• You have aserious liver diseaseor abiliary obstruction(problem with the bile flow from the gallbladder),
• You have aserious kidney disease,,

• You aremore than 3 months pregnant(it is recommended to avoid taking candesartán/hidroclorotiazida at the beginning of pregnancy – see section “Pregnancy”),
• You have ever hadgout,
• You have persistentlow levels of potassium in the blood,
• You have persistenthigh levels of calcium in the blood,
• You havediabetesorkidney insufficiencyand are being treated with a medication for high blood pressure that containsaliskirén.

If you are unsure about any of these conditions, consult your doctor or pharmacist before taking candesartán/hidroclorotiazida.

Warnings and precautions

Consult your doctor or pharmacist before or during taking this medication, if:

• You have heart, liver or kidney problems,
• You have recently had akidney transplant,
• You havevomiting, have had recent severe vomiting ordiarrhea,
• You have acondition called Conn's disease (also known as primary aldosteronism),
• You havediabetes,
• You have or have had a condition calledsystemic lupus erythematosus (SLE),
• You havelow blood pressure,
• You have ever had astroke,
• You have a history ofallergyorasthma,
• You have hadrespiratory or pulmonary problems(including inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking candesartán/hidroclorotiazida, seek medical attention immediately.
• You are taking any of the following medications for high blood pressure:

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

• You have hadskin canceror if you develop anunexpected skin lesionduring treatment. The treatment with hidroclorotiazida, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from the sun and UV rays while taking candesartán/hidroclorotiazida,
• If you experience a decrease in vision or eye pain. This could be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours to a week after taking candesartán/hidroclorotiazida. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk.
• if you suspect you are (or may be) pregnant, inform your doctor. Candesartán/hidroclorotiazida is not indicated at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may harm your baby if taken at this time (see section “Pregnancy”).

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

See also the information in the section “Do not take Candesartán/Hidroclorotiazida 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 to undergo surgery and are taking this medication, inform your doctor or dentist, as candesartán/hidroclorotiazida, when taken with certain anesthetics, may cause excessive lowering of blood pressure.

Candesartán/hidroclorotiazida may cause skin sensitivity to the sun.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartán/Hidroclorotiazida Sandoz. Your doctor will decide whether to continue treatment. Do not stop taking Candesartán/Hidroclorotiazida Sandoz on your own.

Children and adolescents

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

Inform your doctor if you are anathlete subject to doping control,as candesartán/hidroclorotiazida contains an active ingredient that may give positive results in doping control tests.

Other medications and Candesartán/Hidroclorotiazida Sandoz

Inform your doctor or pharmacist that you are using, have used recently or may need to use any other medication.

Candesartán/hidroclorotiazida may affect the way some medications work, and some medications may influence the effect of Candesartán/Hidroclorotiazida. If you are using certain medications, your doctor may need to perform blood tests at regular intervals.

Especially, inform your doctor if you are using any of the following medications, as your doctor may need to adjust your dose and/or take other precautions:

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

• other medications to lower blood pressure, such as beta-blockers, medications containing aliskirén, diazoxide, and the so-called ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril,
• medications to regulate heart rhythm (antiarrhythmic agents), such as digoxin and beta-blockers,
• other non-steroidal anti-inflammatory drugs (NSAIDs) such as: ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medications to relieve pain and inflammation),
• aspirin (if you take more than3 gper day), (medication to relieve pain and inflammation),
• potassium supplements or salt substitutes containing potassium (medications to increase potassium levels in the blood),
• heparin, (medication to increase blood fluidity),
• diuretics,
• lithium (medication for mental health problems),
• medications that may affect potassium levels in the blood, such as some antipsychotics,
• medications to lower cholesterol levels, such as colestipol or colestiramine,
• calcium or vitamin D supplements,
• anticholinergic medications (such as atropine and biperiden),
• amantadine (medication for Parkinson's disease or for treating severe viral infections),
• barbiturates (a type of sedative used to treat epilepsy),
• medications for cancer,
• steroids such as prednisolone,
• pituitary hormone (ACTH),
• medications for diabetes (tablets or insulin),
• laxatives,
• amphotericin (medication for fungal infections),
• carbenoxolone (for treating esophageal diseases or oral ulcers),
• penicillin or trimethoprim/sulfamethoxazole (also known as cotrimoxazol) (antibiotics),
• ciclosporin, a medication used to prevent organ rejection after a transplant,
• other medications that may potentiate the antihypertensive effect such as baclofen (medication to relieve muscle spasms), amifostine (medication used to treat cancer) and some antipsychotics.

Taking Candesartán/Hidroclorotiazida with food, drinks, and alcohol

• Candesartán/hidroclorotiazida can be taken with or without food.
• If your doctor has prescribed this medication, consult with them before taking alcohol. Alcohol may cause dizziness orpasses out.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you think you are (or may be) pregnant.Normally, your doctor will inform you of the need to interrupt treatment with candesartán/hidroclorotiazida before becoming pregnant, or as soon as you know you are pregnant, advising you to take another medication instead of candesartán/hidroclorotiazida. Candesartán/hidroclorotiazida is not recommended for use at the beginning of pregnancy, and it should not be taken after 3 months of pregnancy, as it may harm your baby if taken after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Candesartán/hidroclorotiazida is not recommended for use in mothers who are breastfeeding, and your doctor may select another treatment if you want to start breastfeeding.

Driving and operating machinery

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

Candesartán/Hidroclorotiazida Sandoz contains lactose and sodium

If your doctor has told you that you have a intolerance to certain sugars, consult with them before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

It is essential to take candesartán/hidroclorotiazida every day.

The recommended dose of Candesartán/Hidroclorotiazida Sandoz is 1 tablet once a day.

Take the tablets with a glass of water.

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

If you take more Candesartán/Hidroclorotiazida 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeCandesartán/Hidroclorotiazida Sandoz

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

If you interrupt treatment withCandesartán/Hidroclorotiazida Sandoz

If you interrupt treatment with Candesartán/Hidroclorotiazida Sandoz, your blood pressure is likely to rise. Therefore, do not interrupt treatment with Candesartán/Hidroclorotiazida Sandoz without first consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. It is essential that you know these side effects. Some of these side effects are due to candesartan cilexetil and others are due to hydrochlorothiazide.

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

• 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 (skin rash).

Also, stop taking Candesartán/Hidroclorotiazida Sandoz and seek medical attention immediately ifyou develop acute respiratory distress (the signs include severe difficulty breathing, fever, weakness, and confusion); this is a very rare side effect (may affect up to 1 in 10,000 people).

Candesartán/hidroclorotiazida may cause a reduction in the number of white blood cells. This may cause you to feel tired, experience an infection, or fever. If this happens, contact your doctor, who will decide to perform occasional blood tests to check if candesartán/hidroclorotiazida has caused any effect on your blood (agranulocytosis).

Other possible side effects are:

Frequent (may affect up to 1 in 10 people)

• changesin blood test results:
• decrease in the amount of sodium in the blood. If this is significant, you may feel weak, lack energy, or experience muscle cramps,
• increase in the amount of potassium in the blood, especially if you have kidney problems or heart failure. If this is significant, you may feel tired, weak, irregular heartbeat, numbness, and tingling,
• increase in the level of cholesterol, sugar, or uric acid in the blood,
• sugar in the urine,
• feeling of dizziness, weakness,
• headache,
• respiratory infection.

Occasional (may affect up to 1 in 100 people)

• sudden dropin blood pressure. This may cause you to faint or feel dizzy
• lossof appetite, diarrhea, constipation, stomach 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 the white of the eyes). If this happens, contact your doctor immediately,
• alteration in 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,
• blurred vision,
• irregular heartbeat,
• difficulty breathing (including lung inflammation and fluid accumulation in the lungs),
• fever,
• pancreatitis. This causes moderate to severe stomach pain,
• muscle cramps,
• damageto blood vessels, causing red or purple spots on the skin,
• reduction in the number of white or red blood cells or platelets in the blood. You may feel tired, experience an infection, fever, or the appearance of bruises easily.
• severe erythema, which appears suddenly with blisters or peeling of the skin 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 pain, and joint pain,
• alteration in liver function, including liver inflammation (hepatitis). You may feel tired, yellowing of the skin and the white 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 high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma).
• systemic and cutaneous lupus erythematosus (allergic condition that causes fever, joint pain, skin rash that may include redness, blisters, exfoliation, and nodules),
• skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects

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

Keep this medication out of the sight and reach of children

Do not use this medicationafter the expiration date that appears on the packaging and in the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

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

Expiration date after the first opening of the HDPE bottle: 3 months

Medicines should not be thrown away through drains or in the trash. Dispose of the packaging and medicines you no longer need at theSIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition ofCandesartán/Hidroclorotiazida Sandoz

• The active ingredients are: candesartán cilexetilo and hidroclorotiazida. Each tablet contains 16 mg of candesartán cilexetilo and 12.5 mg of hidroclorotiazida.

• The other components are: lactose monohydrate, cornstarch, Povidona K-30, carragenano (E407), croscarmelosa sódica, estearato de magnesio, óxido de hierro rojo (E 172) and óxido de hierro amarillo (E 172).

Appearance of the product and contents of the package

Orange-colored, speckled, oval, biconvex tablets with a groove on both sides.

The groove serves to break and facilitate swallowing but not to divide into equal doses.

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

Aluminum/Aluminum pre-cut single-dose blister with desiccant: 50x1 tablets.

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible 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 with the following names::

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

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

Bulgaria:Candecard H 16 mg/12.5 mg tablets

Denmark:Candemox Comp

Slovenia:Candea HCT 16 mg/12.5 mg tablets

Estonia:Prescanden HCT 16 mg/12.5 mg, tablets

Finland:Candemox Comp 16 mg/12.5 mg tablets

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

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

Greece:FYRONEXE PLUS (16+12.5) mg tablets

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

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

Norway:Candemox Comp 16 mg / 12.5 mg tablets

Poland:CANDEPRES HCT, 16 MG + 12.5 MG, tablets

Portugal:Candesartan + Hidroclorotiazida Sandoz

Slovakia:Candesartan/Hydrochlorotiazid Sandoz 16 mg/12.5 mg tablets

Sweden:Candemox Comp 16 mg/12.5 mg tablets

Last review date of this leaflet: February 2025

The detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/