Candesartan/hydrochlorothiazide Cinfamed 8 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Candesartán/ Hidroclorotiazida cinfamed 8 mg/12.5 mg tablets EFG

candesartan cilexetil / hydrochlorothiazide

Read all of this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if such reactions are not listed in this leaflet. See section 4.

Leaflet contents

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

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

Your medicine is called Candesartán/Hidroclorotiazida cinfamed. It is used to treat high blood pressure (hypertension). It contains two active substances: 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 helps blood vessels to relax and widen, which makes 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 also helps reduce blood pressure.

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

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

Do not take Candesartan/Hydrochlorothiazide cinfamed:

• if you are allergic to candesartan cilexetil or hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sulfonamides. If you are unsure whether this applies to you, consult your doctor.
• if you are more than 3 months pregnant. (It is also advisable to avoid candesartan/hydrochlorothiazide during the first months of pregnancy – see Pregnancy section.)
• if you have severe kidney disease.
• if you have severe liver disease or biliary obstruction (a problem with bile drainage from the gallbladder).
• if you have persistently low levels of potassium in your blood.
• if you have persistently high levels of calcium in your blood.
• if you have ever had gout.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine if:

• you have diabetes.
• you have heart, liver, or kidney problems.
• you have recently received a kidney transplant.
• you are experiencing vomiting, have had frequent vomiting recently, or have diarrhea.
• you have a disorder of the adrenal gland called Conn's syndrome (also known as primary hyperaldosteronism).
• you have ever had a disease called systemic lupus erythematosus (SLE).
• you have low blood pressure.
• you have ever had a stroke.
• you have had allergies or asthma.
• you are pregnant (or suspect you might be). Candesartan/hydrochlorothiazide is not recommended in early pregnancy, and you must not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby when used from this point onward (see Pregnancy section).
• you are taking any of the following medicines used to treat high blood pressure (hypertension):
  • an angiotensin-converting enzyme (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 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 exposure to sunlight and UV rays while taking candesartan/hydrochlorothiazide.
• if you experience vision changes or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, occurring within hours to a week after taking this medicine. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk.
• you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking this medicine, contact your doctor immediately.

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

See also the information under the heading “Do not take Candesartan/Hydrochlorothiazide cinfamed.”

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

If any of these situations apply to you, your doctor may want to see you more frequently and perform certain tests.

If you are scheduled for surgery, inform your doctor or dentist that you are taking candesartan/hydrochlorothiazide. This is because candesartan/hydrochlorothiazide, in combination with certain anesthetics, may cause an excessive drop in blood pressure.

Candesartan/hydrochlorothiazide may increase your skin's sensitivity to sunlight.

Children and adolescents

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

Other medicines and Candesartan/Hydrochlorothiazide cinfamed

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:

• Other blood pressure-lowering medicines, including beta-blockers, medicines containing aliskiren, diazoxide, and angiotensin-converting enzyme (ACE) inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines for pain and inflammation relief).
• Acetylsalicylic acid (if taking more than 3 g per day) (a medicine for pain and inflammation relief).
• Potassium supplements or potassium-containing salt substitutes (medicines to increase blood potassium levels).
• Calcium or vitamin D supplements.
• Cholesterol-lowering medicines such as colestipol or cholestyramine.
• Medicines for diabetes (tablets or insulin).
• Medicines to control heart rhythm (antiarrhythmics) such as digoxin and beta-blockers.
• Medicines that may be affected by blood potassium levels, such as certain antipsychotics.
• Heparin (a medicine to increase blood fluidity).
• Diuretics (medicines to promote urine elimination).
• Laxatives.
• Penicillin or cotrimoxazole (also known as trimethoprim/sulfamethoxazole) (antibiotic medicines).
• Amphotericin (for treating fungal infections).
• Lithium (a medicine for mental health conditions).
• Steroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines for cancer treatment.
• Amantadine (for treating Parkinson's disease or serious viral infections).
• Barbiturates (a type of sedative, also used to treat epilepsy).
• Carbenoxolone (for treating esophageal disease or oral ulcers).
• Anticholinergic agents such as atropine and biperidene.
• Cyclosporine, a medicine used in organ transplantation to prevent organ rejection.
• Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine for relieving spasms), amifostine (used in cancer treatment), and certain antipsychotics.
• If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Candesartan/Hydrochlorothiazide cinfamed” and “Warnings and precautions”).

Taking Candesartan/Hydrochlorothiazide cinfamed with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Breast-feeding

Inform your doctor if you are breast-feeding or are planning to start breast-feeding. The use of candesartan/hydrochlorothiazide is not recommended during breast-feeding, and your doctor will choose an alternative treatment if you wish to breast-feed.

Consult your doctor or pharmacist before taking any medicine.

Driving and use of machines

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

Candesartan/Hydrochlorothiazide cinfamed contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

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

Use in athletes: this medicine contains hydrochlorothiazide, which may result in a positive doping test.

3. How to take Candesartán/Hydrochlorothiazide cinfamed

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. It is important that you continue taking candesartan/hydrochlorothiazide every day.

The recommended dose is one tablet once daily. Swallow the tablet with a glass of water.

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

The tablet has a score line to assist splitting if you have difficulty swallowing it whole.

If you take more Candesartán/Hydrochlorothiazide cinfamed than you should

If you have taken more candesartan/hydrochlorothiazide 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 Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Candesartán/Hydrochlorothiazide cinfamed

Do not take a double dose to make up for a missed dose. Simply take the next dose as scheduled.

If you stop taking Candesartán/Hydrochlorothiazide cinfamed

If you stop taking candesartan/hydrochlorothiazide, your blood pressure may rise again. Therefore, do not stop taking candesartan/hydrochlorothiazide 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 everybody will experience them.

It is important that you are aware of the possible adverse effects. Some of the adverse effects of candesartan/hydrochlorothiazide are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop taking this medicine and contact 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 itching of the skin (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 that candesartan/hydrochlorothiazide is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Common (may affect up to 1 in 10 people)

• Changes in blood test results:
  • A reduction in blood sodium levels. If severe, you may feel weak, lack energy or have muscle cramps.
  • An increase or reduction in blood potassium levels, especially if you already have kidney problems or heart failure. If this condition is severe, you may feel tired, weak, have irregular heartbeats or tingling sensations.
  • An increase in blood cholesterol, glucose or uric acid levels.
• Presence of glucose in urine.
• Feeling dizzy or weak.
• Headache.
• Respiratory infection.

Uncommon (may affect up to 1 in 100 people)

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

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

• Jaundice (yellowing of the skin and whites 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.
• Tingling or prickling sensations in arms and legs.
• Blurred vision for a short period of time.
• Abnormal heartbeats.
• Difficulty breathing (including lung inflammation and fluid in the lungs).
• High temperature (fever).
• Inflammation of the pancreas. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels causing red or purple spots on the skin.
• A decrease in red blood cells, white blood cells or platelets. You may feel tired, have an infection, fever or bruise easily.
• Severe skin reaction developing rapidly, causing blisters and peeling of the skin 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 whites of the eyes, and flu-like symptoms.
• Cough.
• Nausea.
• Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness and confusion).
• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Frequency not known (cannot be estimated from available data)

• Sudden onset of myopia.
• Decreased vision or eye pain due to increased 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, skin rashes which may include redness, blisters, peeling and lumps).
• Diarrhoea.
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan/Hydrochlorothiazide cinfamed

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

Do not store above 30 °C. Keep in the original packaging to protect from light.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please consult your pharmacist on how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartán/Hydrochlorothiazide cinfamed

• The active substances are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 8 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• The other components are: monohydrate lactose, corn starch, hypromellose, calcium stearate, hydroxypropyl cellulose, disodium edetate, and microcrystalline cellulose.

Appearance of the medicinal product and contents of the pack

Uncoated tablets, white to off-white, oval-shaped, biconvex, with bevelled edges and scored on both sides.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte, Navarra
Spain

Manufacturer

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial 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 Nuremberg
Germany

Or

Interpharma Services Ltd.
Chemi Vrach Blvd, 43A
1407 Sofia
Bulgaria

Date of the most recent revision of this leaflet: February 2025

Detailed 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/

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/86534/P_86534.html

QR code: https://cima.aemps.es/cima/dochtml/p/86534/P_86534.html