Leaflet: information for the user

Candesartán/ Hidroclorotiazida cinfamed 16 mg/ 12,5 mg tablets EFG

candesartán cilexetilo/ hidroclorotiazida

Read this leaflet carefully before you start to take 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 and should not be given to others, even if they have the same symptoms, 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.

Your medicine is called Candesartán/ Hidroclorotiazida cinfamed. It is used for the treatment of high blood pressure (hypertension). It contains two active ingredients: candesartán cilexetilo and hidroclorotiazida. Both work together to lower blood pressure.

• Candesartán cilexetilo belongs to a group of medicines called angiotensin II receptor antagonists. It makes blood vessels relax and dilate. This facilitates the lowering of blood pressure.
• Hidroclorotiazida belongs to a group of medicines called diuretics. It promotes the body to eliminate water and salt such as sodium in the urine. This facilitates the lowering of blood pressure.

Your doctor may prescribe this medicine if your blood pressure has not been adequately controlled with candesartán cilexetilo or hidroclorotiazida alone.

Do not take Candesartán/ Hidroclorotiazida cinfamed:

• if you are allergic to candesartán cilexetilo or to hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sulfonamides. If you are unsure whether you are in this situation, consult your doctor.
• if you are more than 3 months pregnant. (It is better to avoid candesartán/ hydrochlorothiazide during the first months of pregnancy – see Pregnancy section).
• if you have severe kidney disease.
• if you have severe liver disease or bile duct obstruction (problem with the bile flowing out of the gallbladder).
• if you have persistent low levels of potassium in the blood.
• if you have persistent high levels of calcium in the blood.
• if you have ever had gout.
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medication that contains aliskiren.

If you are unsure whether you are in any of these situations, consult your doctor or pharmacist before taking candesartán/ hydrochlorothiazide.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

• if you are diabetic.
• if you have heart, liver, or kidney problems.
• if you have recently had a kidney transplant.
• if you have been vomiting, have had it frequently recently, or have diarrhea.
• if you have a condition called Conn's syndrome (also known as primary aldosteronism) affecting the adrenal gland.
• if you have ever had a condition called systemic lupus erythematosus (SLE).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you have had an allergy or asthma.
• if you are pregnant (or if you suspect you may be). Do not use candesartán/ hydrochlorothiazide at the beginning of pregnancy, and do not take it if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that point onwards (see Pregnancy section).
• if you are taking any of the following blood pressure-lowering medications:
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril, etc.), particularly if you have kidney problems related to diabetes.
  • aliskiren.
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly its long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from the sun and UV rays while taking candesartán/ hydrochlorothiazide.
• if you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within a few hours to a week after taking this medicine.This may 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 of developing it.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking this medicine, seek medical attention immediately.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels in the blood (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Candesartán/ Hidroclorotiazida cinfamed”.

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

If you are in any of these situations, your doctor may want to see you more frequently and perform some tests.

If you are to undergo surgery, inform your doctor or dentist that you are taking candesartán/ hydrochlorothiazide. This is because candesartán/ hydrochlorothiazide, in combination with some anesthetics, may cause excessive lowering of blood pressure.

Candesartán/ hydrochlorothiazide may increase your skin's sensitivity to the sun.

Children and adolescents

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

Other medicines and Candesartán/ Hidroclorotiazida cinfamed

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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

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

• other medicines to lower your blood pressure, including beta-blockers, medicines containing aliskiren, diazoxide, and the so-called ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• anti-inflammatory non-steroidal 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) (medicine to relieve pain and inflammation).
• potassium supplements or salt substitutes containing potassium (medicines to increase potassium levels in the blood).
• calcium supplements or vitamin D.
• medicines to reduce cholesterol, such as colestipol or colestiramine.
• medicines for diabetes (tablets or insulin).
• medicines to control heart rhythm (antiarrhythmic agents) such as digoxin and beta-blockers.
• medicines that may be affected by potassium levels in the blood, such as some antipsychotic medicines.
• heparin (a medicine to increase blood fluidity).
• diuretics (medicines to promote urine excretion).
• laxatives.
• penicillin or trimethoprim/sulfamethoxazole (also known as cotrimoxazole) (antibiotics).
• amphotericin (for the treatment of fungal infections).
• lithium (a medicine for mental health problems).
• steroids such as prednisolone.
• pituitary hormone (ACTH).
• medicines for cancer treatment.
• amantadine (for the treatment of Parkinson's disease or severe viral infections).
• barbiturates (a type of sedative, also used to treat epilepsy).
• carbenoxolone (for the treatment of esophageal disease or oral ulcers).
• anticholinergic agents such as atropine and biperiden.
• ciclosporin, a medicine used for organ transplants, to prevent organ rejection.
• other medicines that may lead to increased anti-hypertensive effect such as baclofen (a medicine for muscle spasms), amifostine (used in cancer treatment), and some antipsychotic medicines.
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Candesartán/ Hidroclorotiazida cinfamed” and “Warnings and precautions”).

Taking Candesartán/ Hidroclorotiazida cinfamed with food, drinks, and alcohol

• You can take candesartán/ hydrochlorothiazide with or without food.
• When you are prescribed candesartán/ hydrochlorothiazide, consult your doctor before taking alcohol. Alcohol may make you feel dizzy or lightheaded.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant, consult your doctor or pharmacist before using this medicine.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Do not use candesartán/ hydrochlorothiazide during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

Some patients may feel tired or dizzy when taking candesartán/ hydrochlorothiazide. If this happens to you, do not drive or operate tools or machines.

Candesartán/ Hidroclorotiazida cinfamed contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

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

Use in athletes

This medicine contains hydrochlorothiazide, which may produce a positive result in doping control tests.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. It is important that you continue taking candesartán/

hidroclorotiazida every day.

The recommended dose is one tablet once a day.

Swallow the tablet with a glass of water.

Try to take the tablet at the same time every day. This will help you remember to take it.

The groove is only for breaking the tablet if it is difficult for you to swallow it whole.

If you take more Candesartán/ Hidroclorotiazida cinfamed than you should

If you have taken more candesartán/ hidroclorotiazida than prescribed by your doctor, 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 take Candesartán/ Hidroclorotiazida cinfamed

Do not take a double dose to compensate for the missed doses. Simply take the next dose.

If you interrupt the treatment with Candesartán/ Hidroclorotiazida cinfamed

If you stop taking candesartán/ hidroclorotiazida, your blood pressure may increase again. Therefore, do not stop taking candesartán/ hidroclorotiazida before 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 may cause side effects, although not everyone will experience them.

It is essential that you know which side effects could occur. Some side effects of candesartan/hydrochlorothiazide are due to candesartan cilexetilo and others are due to hydrochlorothiazide.

Stop taking this medicine and see your doctor immediately if you experience any of the following allergic reactions:

• Difficulty breathing, with or without swelling of the face, lips, tongue, and/or throat.
• Swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing.
• Severe skin itching (with skin rash).

Candesartan/hydrochlorothiazide may cause a decrease in white blood cells. Your resistance to infections may decrease, and you may feel tired, have an infection, or fever. If this occurs, inform your doctor. Your doctor may perform blood tests from time to time to check if candesartan/hydrochlorothiazide is affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (may affect up to 1 in 10 people)

• Changes in blood test results:
• • A reduction in sodium levels in the blood. If severe, you may feel weak, lack energy, or have muscle cramps.
  • An increase or decrease in potassium levels in the blood, especially if you already have kidney problems or heart failure. If severe, you may feel tired, weak, have irregular heartbeats, or experience numbness.
  • An increase in cholesterol, glucose, or uric acid levels in the blood.
• Presence of glucose in urine.
• Sensation of dizziness or weakness.
• Headache.
• Respiratory infection.

Occasional (may affect up to 1 in 100 people)

• Low blood pressure. This may cause dizziness or fainting.
• Loss of appetite, diarrhea, constipation, stomach irritation.
• Skin rash, hives, skin reaction caused by sensitivity to sunlight.

Rare (may affect up to 1 in 1,000 people)

• Jaundice (yellowing of the skin and white of the eyes). If this occurs, contact your doctor immediately.
• Effects on kidney function, especially if you already have kidney problems or heart failure.
• Difficulty sleeping, depression, or restlessness.
• Itching or prickling in arms and legs.
• Blurred vision for a short period.
• Abnormal heartbeats.
• Difficulty breathing (including pulmonary inflammation and fluid in the lungs).
• Fever.
• Pancreatitis inflammation. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels that produce red or purple spots on the skin.
• Decrease in red blood cells, white blood cells, or platelets. You may feel tired, have an infection, fever, or easily bruise.
• Severe skin reaction that develops rapidly, causing blisters and skin peeling, and possibly mouth ulcers.

Very rare (may affect up to 1 in 10,000 people)

• Swelling of the face, lips, tongue, and/or throat.
• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, including liver inflammation (hepatitis). You may feel tired, have yellowing of the skin and white of the eyes, and experience flu-like symptoms.
• Cough.
• Nausea.
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known (cannot be estimated from available data)

• Sudden nearsightedness.
• Decreased 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].
• SLE and cutaneous lupus (allergic condition that causes fever, joint pain, skin rash that may include redness, blisters, exfoliation, and nodules).
• Diarrhea.
• Skin and lip cancer (non-melanoma skin cancer).

Reporting 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:https://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 store at a temperature above 30 °C.

Do not use this medication after the expiration date that appears on the packaging or blister. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Candesartán/Hidroclorotiazida cinfamed

• The active principles 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, hypromellose, calcium stearate, hydroxypropyl cellulose, disodium edetate, microcrystalline cellulose, red iron oxide (E-172), and yellow iron oxide (E-172).

Appearance of the product and contents of the package

Uncoated tablets of a light orange to melon color, oval, biconvex, with beveled edges and scored on both faces.

The tablets are packaged in Alu/Alu blisters or PVC/PVDC-Alu blisters. The packages contain 28, 56, 84, or 100 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Cinfa Laboratories, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte, Navarra

Spain

Responsible manufacturer

Cinfa Laboratories, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte, Navarra

Spain

Or

Hameln rds s.r.o.

Horná 36

900 01 Modra, Bratislava

Slovakia

Or

Heumann Pharma Gmbh & Co. Generica Kg

Südwestpark 50. Gebersdorf

90449 Nürnberg

Germany

Or

Interpharma Services Ltd.

Chemi Vrach Blvd, 43A

1407 Sofia

Bulgaria

Last review date of this prospectus:February 2025

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

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/86533/P_86533.html

QR code to:https://cima.aemps.es/cima/dochtml/p/86533/P_86533.html