Candesartan/Hydrochlorothiazide Cinfamed 8 mg/12.5 mg Tablets

2. What you need to know before you take 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 not sure if you are in this situation, consult your doctor.
• if you are more than 3 months pregnant. (It is also better to avoid candesartan/hydrochlorothiazide during the first months of pregnancy – see section on Pregnancy).
• if you have severe kidney disease.
• if you have severe liver disease or biliary obstruction (problem with bile leaving the gallbladder).
• if you have persistent low potassium levels in your blood.
• if you have persistent high calcium levels in your blood.
• if you have ever had gout.
• if you have diabetes or kidney problems and are being treated with a blood pressure medicine that contains aliskiren.

If you are not sure if you are in any of these situations, consult your doctor or pharmacist before taking candesartan/ 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 frequent vomiting recently, or have diarrhea.
• if you have a disease of the adrenal gland called Conn's syndrome (also known as primary hyperaldosteronism).
• if you have ever had a disease called systemic lupus erythematosus (SLE).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you have ever had an allergy or asthma.
• if you are pregnant (or think you might be). Candesartan/ hydrochlorothiazide is not recommended during pregnancy, and you should not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby.
• if you are taking any of the following medicines to treat high blood pressure:
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril, etc.), especially if you have kidney problems related to diabetes.
  • aliskiren.
• if you have had skin cancer or if you get an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially 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 sun exposure and UV rays while taking candesartan/ hydrochlorothiazide.
• if 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 pressure in the eye, and can occur within hours to a week after taking this medicine. 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 of developing it.
• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking this medicine, seek medical attention immediately.

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (such as potassium) at regular intervals.

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

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

If you are going to have surgery, inform your doctor or dentist that you are taking candesartan/ hydrochlorothiazide. This is because candesartan/ hydrochlorothiazide, in combination with some anesthetics, can cause a significant drop in blood pressure.

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

Children and adolescents

There is no experience with the use of candesartan/ hydrochlorothiazide in children (under 18 years). 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 take any other medicines.

Candesartan/ hydrochlorothiazide may affect the way some medicines work and some medicines may affect the way candesartan/ hydrochlorothiazide works. If you are using certain medicines, your doctor may need to perform blood tests at regular intervals.

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

• Other medicines to lower your blood pressure, including beta-blockers, medicines that contain aliskiren, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• Non-steroidal anti-inflammatory drugs (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 that contain potassium (medicines to increase potassium levels in the blood).
• Calcium supplements or vitamin D.
• Medicines to lower cholesterol, such as colestipol or cholestyramine.
• Medicines for diabetes (tablets or insulin).
• Medicines to control heart rhythm (anti-arrhythmic 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 production).
• Laxatives.
• Penicillin or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (antibiotics).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medicine for mental health problems).
• Corticosteroids 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.
• Cyclosporin, a medicine used for organ transplants to prevent organ rejection.
• Other medicines that may increase the antihypertensive effect, such as baclofen (a medicine for relief of 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 Candesartan/ Hydrochlorothiazide Cinfamed” and “Warnings and precautions”).

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

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

Pregnancy and breastfeeding

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

Breastfeeding

Tell your doctor if you are breastfeeding or plan to start breastfeeding. Candesartan/ hydrochlorothiazide is not recommended during breastfeeding, and your doctor will choose a different treatment for you if you want to breastfeed.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Candesartan/ Hydrochlorothiazide Cinfamed contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

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

3. How to take Candesartan/ Hydrochlorothiazide Cinfamed

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are not sure, consult your doctor or pharmacist again. It is important that you keep taking candesartan/ hydrochlorothiazide 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 each day. This will help you remember to take it.

The score line is only to help you break the tablet if you have difficulty swallowing it whole.

If you take more Candesartan/ Hydrochlorothiazide Cinfamed than you should

If you have taken more candesartan/ hydrochlorothiazide than your doctor prescribed, 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, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Candesartan/ Hydrochlorothiazide Cinfamed

Do not take a double dose to make up for forgotten doses. Simply take the next dose.

If you stop taking Candesartan/ Hydrochlorothiazide Cinfamed

If you stop taking candesartan/ hydrochlorothiazide, your blood pressure may increase again. Therefore, do not stop taking candesartan/ hydrochlorothiazide without consulting your doctor.

If you have any further questions on 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 all people suffer from them.

It is essential that you know what these adverse effects might be. Some of the adverse effects of candesartan/hydrochlorothiazide are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop taking this medicine and go to the doctor immediately if you have 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 can cause difficulty swallowing.
• Severe skin itching (with 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 happens, inform your doctor. It is possible that your doctor will perform blood tests from time to time to check that candesartan/hydrochlorothiazide is not affecting your blood (agranulocytosis).

Other possible adverse 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 reduction in potassium levels in the blood, especially if you already have kidney problems or heart failure. If this situation is severe, you may feel tired, weak, have irregular heartbeats, or tingling.
  • An increase in cholesterol, glucose, or uric acid levels in the blood.
• Presence of glucose in urine.
• Feeling of dizziness or weakness.
• Headache.
• Respiratory infection.

Infrequent (may affect up to 1 in 100 people)

• Low blood pressure. This can cause dizziness or fainting.
• Lack of appetite, diarrhea, constipation, stomach irritation.
• 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 the 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 pinching in arms and legs.
• Blurred vision for a short period.
• Abnormal heartbeats.
• Difficulty breathing (including pulmonary inflammation and fluid in the lungs).
• High temperature (fever).
• Pancreatitis. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels that produce 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 that develops rapidly, causing blisters and peeling of the skin, and possibly ulcers in the mouth.

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 a yellowing of the skin and the whites of the eyes, and have flu-like symptoms.
• Cough.
• Nausea.
• Acute difficulty breathing (signs 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 the available data)

• Sudden myopia.
• Decreased vision or eye pain due to high 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 (allergic condition that causes fever, joint pain, skin rashes that can include redness, blisters, peeling, and bumps).
• Diarrhea.
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of Adverse Effects

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

5. Storage of Candesartan/Hydrochlorothiazide Cinfamed

Keep this medicine out of sight and reach of children.

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

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Candesartan/Hydrochlorothiazide Cinfamed

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

Appearance of the Product and Package Contents

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 Nürnberg

Germany

Or

Interpharma Services Ltd.

Chemi Vrach Blvd, 43A

1407 Sofia

Bulgaria

Date of the Last Revision of this Prospectus:February 2025

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

You can access detailed and updated information about this medicine 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/86534/P_86534.html

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