Leaflet: information for the user

Losartán/Hydrochlorothiazide cinfa 100 mg/12.5 mg film-coated tablets

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you, and you should 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 section4.

Losartán/hidroclorotiazida is a combination of an angiotensin II receptor antagonist (losartán) and a diuretic (hidroclorotiazida).

The 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 is indicated for the treatment of essential hypertension (high blood pressure).

Do not take Losartán/Hidroclorotiazida cinfa

• If you are allergic to losartan, hydrochlorothiazide, or any of the other components of this medication (listed in section 6).
• If you are allergic (hypersensitive) to other sulfonamide-derived substances (e.g. other thiazides, some antibacterials such as cotrimoxazole, ask your doctor if you are unsure).
• If you are more than 3 months pregnant. (It is also best to avoid losartan/hydrochlorothiazide during the first months of pregnancy (see Pregnancy section).
• If you have severe liver failure.
• If you have severe kidney failure or your kidneys do not produce urine.
• If you have low levels of potassium or sodium, high levels of calcium that cannot be corrected with treatment.
• If you have gout..
• • If you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take losartan/hydrochlorothiazide.

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

If you experience a decrease in vision or eye pain, these 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 losartan/hydrochlorothiazide. 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.

Inform your doctor if you are pregnant (or if you suspect you may be). Losartan/hydrochlorothiazide is not recommended for use at the beginning of pregnancy, and it should not be taken 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).

It is essential to inform your doctor before taking losartan/hydrochlorothiazide:

• If you have previously experienced swelling of the face, lips, tongue, or throat.
• If you are taking diuretics (medications to urinate).
• If you follow 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 Losartan/Hidroclorotiazida cinfa).
• If you have narrowed arteries leading to the kidney (renal artery stenosis), if you only have one functioning kidney, or if you have recently undergone a kidney transplant.
• If you have atherosclerosis (narrowing of the arteries), angina (chest pain due to poor heart function).
• If you have mitral or aortic 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 condition that causes joint pain, skin eruptions, and fever (systemic lupus erythematosus).
• If you have high levels of calcium or low levels of potassium or if you follow a low-potassium diet.
• If you need anesthesia (even for dental procedures) or before surgery, or if you are undergoing tests to determine your parathyroid function, inform your doctor or healthcare provider that you are taking losartan potassium and hydrochlorothiazide tablets.
• If you have primary hyperaldosteronism (a syndrome associated with an elevated secretion of aldosterone hormone by the adrenal gland due to an alteration of this gland).
• • If you are taking any of the following medications used to treat high blood pressure (hypertension):
  • • An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), 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 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 this medication.
• 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 losartan/hydrochlorothiazide, seek medical attention immediately.

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

See also the information under the heading “Do not take Losartán/Hidroclorotiazida cinfa”.

Other medications and Losartán/Hidroclorotiazida cinfa

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

Diuretics such as hydrochlorothiazide contained in losartan/hydrochlorothiazide may interact with other medications. Preparations containing lithium should not be taken with losartan/hydrochlorothiazide without your doctor's careful monitoring. Special precautions may be necessary (e.g. blood tests) if you take potassium supplements, salt substitutes containing potassium, or potassium-sparing medications, diuretics (urine tablets), some laxatives, medications for gout, medications to control heart rhythm or diabetes (oral medications or insulin). It is also essential that your doctor knows if you are taking other medications to lower your blood pressure, steroids, cancer medications, pain medications, medications for fungal infections, or medications for arthritis, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping pills; opioid medications such as morphine, “pressor amines” such as adrenaline or other medications in the same group; (oral diabetes medications or insulin).

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

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Losartán/Hidroclorotiazida cinfa” and “Warnings and precautions”).

Please inform your doctor when you plan to have a contrast agent with iodine.

Taking Losartán/Hidroclorotiazida cinfa with food, drinks, and alcohol

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

Excessive salt in the diet may counteract the effect of losartan/hydrochlorothiazide tablets.

Losartan/hydrochlorothiazide tablets can be taken with or without food.

It is recommended to avoid grapefruit juice while taking this medication.

Pregnancy, fertility, and lactation

Pregnancy

You must inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you stop taking losartan/hydrochlorothiazide as soon as you know you are pregnant and will recommend that you take another medication instead of losartan/hydrochlorothiazide. Losartan/hydrochlorothiazide is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that point onwards.

Lactation

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

Consult your doctor or pharmacist before using any medication.

Use in children and adolescents

There is no experience with the use of losartan/hydrochlorothiazide in children. Therefore, this medication should not be administered to children.

Use in elderly patients

Losartan/hydrochlorothiazide 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.

Driving and operating machinery

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

Losartán/Hidroclorotiazida cinfa contains lactose

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

Use in athletes

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of losartan/hidroclorotiazide, depending on your condition and if you are taking other medications. It is essential to continue taking losartan/hidroclorotiazide 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 tablet of losartan/hidroclorotiazide 50 mg/12.5 mg per day to control blood pressure for 24 hours. It can be increased to 2 tablets of losartan/hidroclorotiazide 50 mg/12.5 mg per day or changed to 1 tablet of losartan/hidroclorotiazide 100 mg/25 mg (a higher dose) per day. The maximum daily dose is 2 tablets of 50 mg losartan/12.5 mg hidroclorotiazide per day or 1 tablet of 100 mg losartan/25 mg hidroclorotiazide per day..

If You Take More Losartán/Hidroclorotiazida cinfa Than You Should

In case of an overdose, contact your doctor immediately or go directly to the hospital for immediate medical attention.

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.

An overdose may cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration..

If You Forget to Take Losartán/Hidroclorotiazida cinfa

Try to take losartan/hidroclorotiazide at the same time each day as prescribed. Do not take a double dose to compensate for missed doses. Simply return to your regular schedule.

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

If you experience any of the following, stop taking the 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 less 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 people):

• Cough, respiratory infection, nasal congestion, sinusitis, breast disorder.
• 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 people):

• 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 cells, coagulation problems, reduced platelets.
• Loss of appetite, high uric acid levels or manifest gout, high blood glucose levels, abnormal electrolyte levels in the blood.
• Anxiety, nervousness, panic disorder (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, 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, sounds, or crackling 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, 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 people):

• 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 (may affect up to 1 in 10,000 people):

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

Unknown frequency (cannot be estimated from available data):

• Muscle pain of unknown origin with dark-colored urine (tea-colored urine) (rhabdomyolysis),
• Skin 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 leaflet. 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 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.

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 Losartán/Hidroclorotiazida cinfa

• The active principles are losartan potassium and hydrochlorothiazide. Each tablet contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.
• The other components are:

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

Coating: hypromellose, titanium dioxide (E-171) and macrogol.

Appearance of the product and content of the container

Coated tablets, cylindrical with a diameter of 10.5 mm, white in color, and marked with a “L” on one face. They are presented in PVC-PE-PVDC/AL blisters. Each container contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

Cinfa Laboratories, S.A

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

or

Liconsa Laboratories S.A.

Miralcampo Avenue, 7; Miralcampo Industrial Estate

19200 Azuqueca de Henares, Guadalajara (Spain)

Date of the last review of this prospectus:February 2025

The detailed information of 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 with your smartphone the QR code included in the prospectus and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/89223/P_89223.html

QR code to:https://cima.aemps.es/cima/dochtml/p/89223/P_89223.html