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.
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:
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:
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:
Taking Candesartán/Hidroclorotiazida with food, drinks, and alcohol
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:
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)
Occasional (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Unknown (cannot be estimated from available data)
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
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/
O preço médio do Candesartan/hidroclorotiazida sandoz 16 mg/12,5 mg comprimidos efg em julho de 2025 é de cerca de 10.46 EUR. Os valores podem variar consoante a região, a farmácia e a necessidade de receita. Confirme sempre com uma farmácia local ou fonte online para obter informações atualizadas.
Tem perguntas sobre este medicamento ou sintomas? Obtenha orientação de um médico qualificado, de forma prática e segura.