Leaflet: information for the user

losartán cinfa 12.5 mg film-coated tablets

losartán potassium

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 or nurse.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. Contents of the pack and additional information

Losartán belongs to a group of medications called angiotensin II receptor antagonists.

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. Losartán reduces the worsening of renal function in patients with high blood pressure and type 2 diabetes.

Losartán cinfa is used:

• To treat patients with elevated blood pressure (hypertension) in adults and in children and adolescents aged 6 to 18 years.
• To protect the kidneys in hypertensive patients with type 2 diabetes and laboratory test results indicating renal insufficiency and proteinuria ≥ 0.5 g per day (a situation in which the urine contains an abnormal amount of proteins).
• To treat patients with chronic heart failure, when their doctor considers that treatment with specific medications, called angiotensin-converting enzyme inhibitors (ACE inhibitors, medications used to reduce elevated blood pressure) are not suitable. If their heart failure has been stabilized with an ACE inhibitor, they should not switch to losartán.
• In patients with elevated blood pressure and left ventricular hypertrophy of the heart, losartán has been shown to reduce the risk of stroke (LIFE indication).

Do not take losartán cinfa

• If you are allergic to losartán or any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant. (It is also recommended to avoid losartán at the beginning of pregnancy (see Pregnancy and breastfeeding section).
• If your liver function is severely damaged.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medication that contains aliskirén.

Warnings and precautions

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

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

You must inform your doctor if you think you are pregnant (or may be). Losartán is not recommended at the beginning of pregnancy, and it should not be taken if you are more than three months pregnant, as it may cause severe damage to your child (see Pregnancy and breastfeeding section).

Before takinglosartán, it is essential to inform your doctor:

• If you have had a history of angioedema (swelling of the face, lips, tongue, and/or throat) (see also section 4. Possible side effects).
• If you have excessive vomiting or diarrhea, which cause excessive loss of fluid and/or salt from your body.
• If you are taking diuretics (medicines that increase the amount of water that passes through your kidneys) or if you follow a low-sodium diet that causes excessive loss of fluids or salt from your body (see section 3, Dosage in special patient groups).
• If you know you have narrowing or blockage of the blood vessels that go to your kidneys or if you have recently had a kidney transplant.
• If your liver function is altered (see sections 2. Do not take losartán cinfa and 3. Dosage in special patient groups).
• If you have heart failure with or without renal impairment or potentially fatal cardiac arrhythmias. Special attention is required when being treated at the same time with a beta-blocker.
• If you have problems with your heart valves or heart muscle.
• If you have coronary heart disease (caused by reduced blood flow in the heart's blood vessels) or cerebrovascular disease (caused by reduced blood circulation in the brain).
• If you have primary aldosteronism (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.
  • Aliskirén

Your doctor may monitor your renal 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 cinfa”.

• If you are taking other medications that may increase serum potassium levels (see section 2 “Taking losartán cinfa with other medicines”).

Children and adolescents

Losartán has been studied in children. For more information, consult your doctor.

Losartán is not recommended for use in children with kidney or liver problems, as there are limited data available for these patient groups. Losartán is not recommended for use in children under 6 years of age, as it has not been shown to be effective in this age group.

Taking losartán cinfa with other medicines

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 that contain potassium, or potassium-sparing medications such as certain diuretics (amilorida, triamtereno, spironolactone) or other medications that may increase serum potassium levels (e.g., heparin, medications containing trimetoprim), as the combination with losartán is not recommended.

While taking losartán, be particularly cautious if you take any of the following medications:

-Other medications that lower blood pressure, as they may cause an additional reduction in blood pressure. Blood pressure may also decrease with some of the following medications/classes of medications: tricyclic antidepressants, antipsychotics, baclofen, amifostine.

-Nonsteroidal anti-inflammatory drugs, such as indometacina, including COX-2 inhibitors (medications that reduce inflammation and may be used to relieve pain), as they may reduce the blood pressure-lowering effect of losartán.

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

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskirén (see also the information under the headings “Do not take losartán cinfa” and “Warnings and precautions”).

If your renal function is impaired, the concomitant use of these medications may cause a worsening of renal function.

Lithium-containing medications should not be used in combination with losartán without your doctor's careful monitoring. It may be necessary to take special precautions (e.g., blood tests).

Taking losartán cinfa with food and drinks

Losartán can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you think you are pregnant (or may be). Normally, your doctor will recommend that you stop taking losartán before becoming pregnant or as soon as you know you are pregnant and advise you to take another medication different from losartán. Losartán is not recommended at the beginning of pregnancy, and it should not be taken if you are more than three months pregnant, as it may cause severe damage to your child if used after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start. Losartán is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you want to breastfeed, especially if your baby is a newborn or premature.

Consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and use machines.

It is unlikely that losartán will affect your ability to drive or use machines. However, as many medications used to treat high blood pressure, losartán may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, consult your doctor before engaging in these activities.

Losartán cinfa contains lactose.

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

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

Your doctor will decide on the appropriate dose of losartan, depending on your condition and if you are taking other medications. It is essential to continue taking losartan as prescribed by your doctor to maintain constant blood pressure control.

Adult patients with high blood pressure

Typically, treatment begins with 50 mg of losartan (one losartan cinfa 50 mg tablet) once a day.The maximum blood pressure-lowering effect is achieved within 3-6 weeks of starting treatment. Subsequently, in some patients, the dose may be increased to 100 mg of losartan (two losartan cinfa 50 mg tablets or one losartan cinfa 100 mg tablet) once a day.

If you estimate that the losartan effect is too strong or too weak, please inform your doctor or pharmacist.

Use in children and adolescents

Children under 6 years of age

Losartan is not recommended for use in children under 6 years of age, as it has not been shown to be effective in this age group.

Children aged 6 to 18 years

The recommended starting dose in patients weighing between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, administered once a day (up to 25 mg of losartan). Your doctor may increase the dose if blood pressure is not controlled.

Other pharmaceutical forms of this medication may be more suitable for children; ask your doctor or pharmacist.

Adult patients with high blood pressure and type 2 diabetes

Typically, treatment begins with 50 mg of losartan (one losartan cinfa 50 mg tablet) once a day. Subsequently, the dose may be increased to 100 mg of losartan (two losartan cinfa 50 mg tablets or one losartan cinfa 100 mg tablet) once a day, depending on your blood pressure response.

Losartan can be administered with other medications that lower blood pressure (e.g., diuretics, calcium channel blockers, alpha or beta blockers, and central-acting medications), as well as with insulin and other medications frequently used to reduce blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Patients with heart failure

Typically, treatment begins with 12.5 mg of losartan (one losartan cinfa 12.5 mg initiation tablet) once a day. Typically, the dose is gradually increased weekly (i.e., 12.5 mg once a day for the first week, 25 mg once a day for the second week, 50 mg once a day for the third week, 100 mg once a day for the fourth week, 150 mg once a day for the fifth week),until a maintenance dose determined by your doctor is reached. A maximum dose of 150 mg of losartan (e.g., three losartan cinfa 50 mg tablets or one losartan cinfa 100 mg tablet and one losartan cinfa 50 mg tablet) once a day may be used.

In the treatment of heart failure, losartan is typically combined with a diuretic (a medication that increases the amount of water that passes through your kidneys) and/or digitalis (a medication that helps your heart be stronger and more efficient) and/or a beta blocker.

Posology in special patient groups

Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those treated with high doses of diuretics, patients with liver insufficiency, or patients over 75 years old. Losartan is not recommended for use in patients with severe liver insufficiency (see "Do not take losartan cinfa").

Administration

The tablets shouldbe taken wholewith a glass of water. You should try to take your daily dose approximately at the same time each day. It is essential that you continue taking losartan until your doctor tells you otherwise.

If you take more losartan cinfa than you should

If you accidentally take too many tablets, contact your doctor immediately. The symptoms of overdose are low blood pressure, increased heart rate, and possibly decreased heart rate.

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 medication and the amount ingested.

If you forget to take losartan cinfa

If you accidentally forget a dose, simply take the next dose as usual. Do not take a double dose to compensatefor the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist or nurse.

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 tablets and inform your doctor immediately or go to the emergency service of your nearest hospital:

• A severe allergic reaction (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 can affect up to 1 in 1,000 patients. You may need urgent medical attention or hospitalization.

Medicine side effects are classified as follows:

The following side effects have been reported with losartan:

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

• dizziness,
• low blood pressure (especially after excessive loss of body water within blood vessels, for example in patients with severe heart failure or those taking high doses of diuretics),
• dose-related orthostatic effects, such as a decrease in blood pressurethat occursafter standing up from lying down or sitting,
• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• high potassium levels (hyperkalemia),
• liver function changes, including renal failure,
• reduced red blood cell count (anemia),

• increased urea levels in the blood, creatinine, and serum potassium in patients with heart failure.

Infrequent (may affect up to 1 in 100 patients)

• drowsiness
• headache
• sleep disturbances
• sensation of very rapid heartbeats (palpitations)
• severe chest pain (angina pectoris)
• difficulty breathing (dyspnea),
• abdominal pain,
• constipation,
• diarrhea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• rash,
• localized swelling (edema).
• cough

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

• hypersensitivity,
• angioedema,
• inflammation of blood vessels (vasculitis, including Henoch-Schönlein purpura),
• numbness or tingling (paresthesia),
• syncope (fainting),
• rapid and irregular heartbeats (atrial fibrillation),
• stroke (cerebrovascular accident),
• inflammation of the liver (hepatitis),
• elevation of alanine aminotransferase (ALT) levels in the blood, which usually resolves upon discontinuing treatment.
• Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency unknown(cannot be estimated from available data)

• reduced platelet count,
• migraine,
• liver function anomalies,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection.
• increased sensitivity to sunlight (photosensitivity),
• muscle pain of unknown origin with dark-colored urine (tea-colored urine) (rhabdomyolysis),
• impotence,
• pancreatitis,
• low sodium levels in the blood (hyponatremia),
• depression,
• usually feeling unwell (malaise),
• ringing, buzzing, or clicking sounds in the ears (tinnitus),
• alteration of taste (dysgeusia).

Side effects in children are similar to those observed in adults.

Reporting of 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.

This medication does not require special storage conditions.

Store in the original packaging.

Do not open the blister pack until you are ready to take the medication.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of losartan cinfa

• The active ingredient is losartan potassium. Each film-coated losartan cinfa 12.5 mg initiation tablet contains 12.5 mg of losartan potassium.
• The other components are: lactose monohydrate, pregelatinized cornstarch, microcrystalline cellulose, magnesium stearate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, titanium dioxide (E-171), and blue lac.

Losartan cinfa 12.5 mg initiation contains potassium in the following amount:1.06 mg(0.03 mEq).

Appearance of the product and contents of the packaging

The film-coated losartan cinfa tablets are cylindrical, blue-colored tablets.

Losartan cinfa is presented in aluminum-PVC/PVDC blisters, in packs of 7 or 500 (clinical pack) tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer:

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet: February 2025

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

You can access detailed and updated information about this medication 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/67735/P_67735.html

QR code to:https://cima.aemps.es/cima/dochtml/p/67735/P_67735.html