Leaflet: information for the user

Losartan/Hydrochlorothiazide Cinfa 50 mg/12.5 mg film-coated tablets

Losartan potassium and hydrochlorothiazide

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, 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.

Contents of the pack and additional information.

losartán/hidroclorotiazida cinfa is a combination of an angiotensin II receptor antagonist (losartán) and a diuretic (hidroclorotiazida). Angiotensin II is a substance produced in the body that binds to receptors present in blood vessels, causing them to constrict. This results in an increase in blood pressure. Losartán prevents the binding of angiotensin II to these receptors, causing blood vessels to relax, which in turn reduces blood pressure. Hidroclorotiazida causes the kidneys to eliminate a greater amount of water and salts. This also helps to reduce blood pressure.

losartán/hidroclorotiazida cinfa is indicated for the treatment of essential hypertension (high blood pressure).

Do not take losartán/hidroclorotiazida cinfa

• If you are allergic to losartán, hidroclorotiazida or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other sulfonamide-derived substances (for example, other thiazides, some antibacterial medicines such as cotrimoxazol, ask your doctor if you are unsure).
• If you have severe liver failure.
• If you have low levels of potassium or sodium, or high levels of calcium that cannot be corrected with treatment.
• If you have gout.
• If you are more than 3 months pregnant. (It is best to avoid losartán/hidroclorotiazida at the beginning of pregnancy – see Pregnancy section).
• If you have severe kidney failure or your kidneys do not produce urine.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskirén.

Warnings and precautions

Consult your doctor or pharmacist before starting to take losartán/hidroclorotiazida cinfa.

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

If you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and may occur within a few hours to several weeks after taking losartán/hidroclorotiazida. If left untreated, this can lead to permanent vision loss. You may be at a higher risk of developing this if you have previously had an allergy to penicillin or sulfonamide.

You must inform your doctor if you think you are pregnant (or may be). Losartán/hidroclorotiazida is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see Pregnancy section).

It is essential to inform your doctor before taking losartán/hidroclorotiazida:

• If you have previously experienced swelling of the face, lips, tongue or throat;
• If you are taking diuretics (urine medicines);
• If you are following a low-sodium diet;
• If you have excessive vomiting and/or diarrhea;
• If you have heart failure;
• If your liver function is altered (see section 2 “Do not take losartán/hidroclorotiazida cinfa”);
• If you have narrowed arteries (arterial stenosis), if you only have one functioning kidney, or if you have recently undergone a kidney transplant;
• If you have atherosclerosis, angina pectoris (chest pain due to heart dysfunction);
• If you have aortic or mitral valve stenosis (narrowing of the heart valves) or hypertrophic cardiomyopathy (a disease that causes thickening of the heart valves);
• If you are diabetic;
• If you have had gout;
• If you have or have had an allergic reaction, asthma, or a disease that causes joint pain, skin eruptions, and fever (systemic lupus erythematosus);
• If you have high calcium levels or low potassium levels, or if you are following a low-potassium diet;
• If you need anesthesia (including dental anesthesia) or before surgery, or if you are undergoing tests to determine your parathyroid function, inform your doctor or healthcare professional that you are taking losartán potassium and hidroclorotiazida tablets;
• If you have primary aldosteronism (a syndrome associated with an elevated secretion of aldosterone hormone by the adrenal gland due to a glandular alteration);
• If you are taking any of the following blood pressure-lowering medicines:

• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (for example, enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes;
• Aliskirén.

• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking losartán/hidroclorotiazida cinfa, see your doctor immediately.

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

See also section 2“Do not take losartán/hidroclorotiazida cinfa”.

• If you are taking other medicines that may increase serum potassium levels (see section 2 “Other medicines and losartán/hidroclorotiazida cinfa”);
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. 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 sun exposure and UV rays while taking losartán/hidroclorotiazida.

Children and adolescents

There is no experience with the use of losartán/hidroclorotiazida in children. Therefore, losartán/hidroclorotiazida should not be administered to children.

Other medicines and losartán/hidroclorotiazida cinfa

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

Inform your doctor if you are taking potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, or other medicines that may increase serum potassium levels (e.g., trimetoprim-containing medicines), as the combination with losartán/hidroclorotiazida is not recommended.

Diuretics like the hidroclorotiazida in losartán/hidroclorotiazida may interact with other medicines.

Lithium preparations should not be taken with losartán/hidroclorotiazida without your doctor's careful monitoring.

You may need to take special precautions (e.g., blood tests) if you are taking other diuretics (urine tablets), some laxatives, medicines for gout treatment, heart rhythm control medicines, or diabetes medicines (oral or insulin).

It is also essential that your doctor knows if you are taking:

• Other blood pressure-lowering medicines,
• Steroids,
• Cancer medicines,
• Pain medicines,
• Fungal infection medicines,
• Arthritis medicines,
• Cholesterol-lowering resins like colestiramina,
• Muscle relaxants,
• Sleeping tablets;
• Opioid medicines like morphine,
• "pressor amines" like adrenaline or other medicines in the same group,
• Oral diabetes medicines or insulin.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskirén (see also sections“Do not take losartán/hidroclorotiazida cinfa”and“Warnings and precautions”).

When taking losartán/hidroclorotiazida, inform your doctor if you are to undergo a radiographic test with a contrast medium containing iodine.

Losartán/hidroclorotiazida cinfa with food, drinks, and alcohol

It is recommended that you do not drink alcohol while taking these tablets: alcohol and losartán/hidroclorotiazida tablets may increase the effects of the other.

Excessive salt in the diet may counteract the effect of losartán/hidroclorotiazida tablets.

Losartán/hidroclorotiazida can be taken with or without food.

Pregnancy and lactation

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

Pregnancy

You must inform your doctor if you are pregnant (or think you may be). Your doctor will usually recommend that you stop taking losartán/hidroclorotiazida as soon as you know you are pregnant and will recommend that you take another medicine instead of losartán/hidroclorotiazida. Losartán/hidroclorotiazida is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage.

Lactation

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Losartán/hidroclorotiazida is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed.

Use in elderly patients

Losartán/hidroclorotiazida acts with equal efficacy and is equally well tolerated by most elderly patients and young patients. Most elderly patients require the same dose as younger patients.

Use in athletes

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

Driving and operating machinery

When starting treatment with this medicine, you should not perform tasks that require special attention (e.g., driving a car or operating hazardous machinery) until you know how you tolerate the medicine.

Losartán/hidroclorotiazida cinfa contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will decide on the appropriate dose of losartán/hidroclorotiazida, depending on your condition and if you are taking other medications. It is essential to continue taking losartán/hidroclorotiazida as prescribed by your doctor to maintain consistent blood pressure control.

High blood pressure :

For most patients with high blood pressure, the recommended dose is 1 losartán/hidroclorotiazida 50 mg/12.5 mg tablet per day to control blood pressure for 24 hours. It can be increased to 2 losartán 50 mg/hidroclorotiazida 12.5 mg tablets per day or changed to 1 losartán/hidroclorotiazida 100 mg/25 mg (a stronger dose) tablet per day. The maximum daily dose is 2 losartán 50 mg/hidroclorotiazida 12.5 mg tablets per day or 1 losartán 100 mg/hidroclorotiazida 25 mg tablet per day.

Administration

The tablets should be swallowed whole with a glass of water.

If you take more losartán/hidroclorotiazida cinfa than you should

In case of an overdose, contact your doctor immediately for immediate medical attention. An overdose may cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

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 forget to take losartán/hidroclorotiazida cinfa

Try to take losartán/hidroclorotiazida at the same time each day as prescribed. However, if you forget a dose, do not take an extra dose. Simply return to your regular schedule.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following, stop taking losartan/hydrochlorothiazide tablets and inform your doctor immediately or go to the emergency service of your nearest hospital:

Severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth, or throat that may cause difficulty swallowing or breathing).

This is a serious but rare side effect that affects more than 1 in 10,000 patients but fewer than 1 in 1,000. You may need urgent medical attention or hospitalization.

The following side effects have been reported:

Frequent (may affect up to 1 in 10 patients):

• Cough, upper respiratory tract infection, nasal congestion, sinusitis, breast tenderness.
• Diarrhea, abdominal pain, nausea, indigestion.
• Muscle pain or cramps, leg pain, back pain.
• Insomnia, headache, dizziness.
• Weakness, fatigue, chest pain.
• High potassium levels (which may cause abnormal heart rhythm), decreased hemoglobin levels.
• Changes in renal function, including renal insufficiency.
• Low blood sugar (hypoglycemia).

Infrequent (may affect up to 1 in 100 patients):

• Anemia, red or brown spots on the skin (sometimes especially on the feet, legs, arms, and buttocks, with joint pain, swelling of the hands and feet, and abdominal pain), hematoma, reduced white blood cell count, coagulation problems, and reduced platelet count.
• Loss of appetite, high uric acid levels or manifest gout, high blood glucose levels, abnormal electrolyte levels in the blood.
• Anxiety, nervousness, panic attacks (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory alteration.
• Tickling or similar sensations, limb pain, tremor, migraine, fainting.
• Blurred vision, eye itching or stinging, conjunctivitis, worsening vision, seeing things in yellow.
• Ringing, buzzing, or clicking sounds in the ears, vertigo.
• Low blood pressure that may be associated with changes in posture (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (transient ischemic attack, "mini-stroke"), heart attack, palpitations.
• Inflammation of blood vessels that often occurs with a skin rash or hematoma.
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which may cause difficulty breathing), nasal bleeding, runny nose, congestion.
• Constipation, chronic constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, salivary gland inflammation, tooth pain.
• Jaundice (yellow discoloration of the eyes and skin), pancreatitis inflammation.
• Hives, itching, skin inflammation, skin rash, redness of the skin, light sensitivity, dry skin, flushing, sweating, hair loss.
• Pain in the arms, shoulders, hips, knees, or other joints, joint swelling, stiffness, muscle weakness.
• Frequent urination even at night, abnormal renal function, including kidney inflammation, urinary tract infection, sugar in the urine.
• Decreased libido, impotence.
• Swelling of the face, localized swelling (edema), fever.

Rare (may affect up to 1 in 1,000 patients):

• Hepatitis (liver inflammation), abnormal liver function tests.
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Very rare:

• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Frequency not known (cannot be estimated from available data):

• Symptoms similar to the flu.
• Muscle pain of unknown origin with dark-colored urine (rhabdomyolysis).
• Low sodium levels in the blood (hyponatremia).
• Generally feeling unwell (malaise).
• Alteration of taste (dysgeusia).
• Skin cancer and lip cancer (non-melanoma skin cancer).
• 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].

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 Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

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

Do not store at a temperature above 30°C. Store in the original packaging.

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 losartan/hydrochlorothiazide cinfa

• The active principles are losartan potassium and hydrochlorothiazide. Each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.
• The other excipients are:

Tablet core: microcrystalline cellulose, lactose monohydrate, pregelatinized cornstarch and magnesium stearate.

Coating: hydroxypropylmethylcellulose, hypromellose, titanium dioxide (E-171) and yellow iron oxide (E-172).

Appearance of the product and contents of the packaging

Film-coated, cylindrical tablets, yellow in color.

Presented in PVC-PE-PVDC/Aluminum blisters. Each package contains 28 or 500 (clinical package) film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Cinfa Laboratories, S.A.

Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Responsible manufacturer

LICONSA, S.A.

Miralcampo Avenue, No. 7, Miralcampo Industrial Estate 19200

Azuqueca de Henares (Guadalajara), Spain

Last review date of this leaflet:February 2025

Detailed information about this medicine 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 medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/69057/P_69057.html

QR code to:https://cima.aemps.es/cima/dochtml/p/69057/P_69057.html