Losartan CINFA 12.5 mg starting film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

losartán cinfa 12.5 mg starting dose film-coated tablets EFG

losartan potassium

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if they have the same symptoms as you.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What losartán cinfa is and what it is used for

2. What you need to know before taking losartán cinfa

3. How to take losartán cinfa

4. Possible side effects

5. How to store losartán cinfa

6. Contents of the pack and other information

1. What is losartan cinfa and what is it used for?

Losartan belongs to a group of medicines known as angiotensin II receptor antagonists.

Angiotensin II is a substance produced in the body that binds to receptors in blood vessels, causing them to narrow. This results in increased blood pressure.

Losartan blocks angiotensin II from binding to these receptors, causing blood vessels to relax, thereby lowering blood pressure. Losartan slows the progression of kidney dysfunction in patients with high blood pressure and type 2 diabetes.

losartan cinfa is used:

• to treat patients with high 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 impairment and proteinuria ≥ 0.5 g per day (a condition in which the urine contains an abnormally high amount of protein).
• to treat patients with chronic heart failure when your doctor considers that treatment with specific medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to lower high blood pressure) is not suitable. If your heart failure has been stabilized with an ACE inhibitor, you should not switch to losartan.
• in patients with high blood pressure and thickening of the left ventricle of the heart, losartan has been shown to reduce the risk of stroke (LIFE indication).

2. What you need to know before taking losartan cinfa

Do not take losartán cinfa

• If you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant. (It is also advisable to avoid losartan in early pregnancy (see section Pregnancy and breastfeeding).
• If your liver function is severely impaired.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before starting losartan cinfa.

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

You must inform your doctor if you think you are pregnant (or might be). Losartan is not recommended during early pregnancy, and should not be taken if you are more than three months pregnant, as its use during this period may cause serious harm to your baby (see section Pregnancy and breastfeeding).

Before taking losartan, it is important to inform your doctor:

• If you have a history of angioedema (swelling of the face, lips, tongue, and/or throat) (see also section 4. Possible side effects).
• If you are experiencing excessive vomiting or diarrhea, which may lead to excessive loss of fluid and/or salt from your body.
• If you are taking diuretics (medicines that increase the amount of fluid passing through your kidneys) or if you are on a low-salt diet that may cause 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 supplying your kidneys or if you have recently undergone a kidney transplant.
• If you have impaired liver function (see sections 2. Do not take losartán cinfa and 3. Dosage in special patient groups).
• If you have heart failure with or without kidney impairment or potentially life-threatening concomitant cardiac arrhythmias. Special care is needed if you are also being treated with a beta-blocker.
• If you have heart valve problems or heart muscle disease.
• 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 to the brain).
• If you have primary hyperaldosteronism (a syndrome associated with excessive secretion of the hormone aldosterone by the adrenal gland due to gland dysfunction).
• If you are taking any of the following medicines for 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

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 losartán cinfa”.

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

Children and adolescents

Losartan has been studied in children. For more information, speak with your doctor.

Losartan is not recommended for use in children with kidney or liver problems, as there is limited data available in these patient groups. Losartan is not recommended for use in children under 6 years of age, as efficacy has not been demonstrated in this age group.

Taking losartán cinfa with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor if you are taking potassium supplements, salt substitutes containing potassium, or potassium-sparing medicines such as certain diuretics (amiloride, triamterene, spironolactone), or other medicines that may increase serum potassium (e.g., heparin, medicines containing trimethoprim), as combination with losartan is not recommended.

While being treated with losartan, take particular care if you take any of the following medicines:

• Other medicines that lower blood pressure, as they may cause an additional decrease in blood pressure. Blood pressure may also be lowered by some of the following medicines/classes of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine.
• Non-steroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, including COX-2 inhibitors (medicines that reduce inflammation and may be used to relieve pain), as they may reduce the blood pressure-lowering effect of losartan.

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 aliskiren (see also information under the headings “Do not take losartán cinfa” and “Warnings and precautions”).

If you have impaired kidney function, concomitant use of these medicines may lead to worsening of kidney function.

Medicines containing lithium should not be used in combination with losartan without careful monitoring by your doctor. Special precautionary measures (e.g., blood tests) may be appropriate.

Taking losartán cinfa with food and drink

Losartan can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking losartan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Losartan is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Losartan is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breastfeed. This is especially important if your baby is a newborn or was born prematurely.

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

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

losartán cinfa contains lactose.

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

3. How to take losartán cinfa

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of losartan, depending on your condition and whether you are taking other medicines. It is important to continue taking losartan as prescribed by your doctor in order to maintain consistent blood pressure control.

Adult patients with high blood pressure

Treatment usually starts with 50 mg of losartan (one losartán cinfa 50 mg tablet) once daily. The maximum blood pressure-lowering effect is reached within 3 to 6 weeks after starting treatment. Afterwards, in some patients, the dose may be increased to 100 mg of losartan (two losartán cinfa 50 mg tablets or one losartán cinfa 100 mg tablet) once daily.

If you feel that the effect of losartan 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 its effectiveness has not been demonstrated in this age group.

Children aged between 6 and 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 daily (up to a maximum of 25 mg of losartan). Your doctor may increase the dose if blood pressure is not adequately controlled.

Other pharmaceutical forms of this medicine may be more suitable for children; please consult your doctor or pharmacist.

Adult patients with high blood pressure and type 2 diabetes

Treatment usually starts with 50 mg of losartan (one losartán cinfa 50 mg tablet) once daily. Afterwards, the dose may be increased to 100 mg of losartan (two losartán cinfa 50 mg tablets or one losartán cinfa 100 mg tablet) once daily, depending on your blood pressure response.

Losartan may be administered together with other antihypertensive medicines (e.g. diuretics, calcium antagonists, alpha- or beta-blockers, and centrally acting agents), as well as with insulin and other commonly used medications to lower blood glucose levels (e.g. sulfonylureas, glitazones, and alpha-glucosidase inhibitors).

Adult patients with heart failure

Treatment usually starts with 12.5 mg of losartan (one losartán cinfa 12.5 mg tablet) once daily. The dose is usually gradually increased on a weekly basis (i.e., 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week, 100 mg daily during the fourth week, and 150 mg daily during the fifth week), up to a maintenance dose determined by your doctor. A maximum dose of 150 mg of losartan (e.g., three losartán cinfa 50 mg tablets or one losartán cinfa 100 mg tablet plus one losartán cinfa 50 mg tablet) once daily may be used.

In the treatment of heart failure, losartan is usually combined with a diuretic (a medicine that increases the amount of water passing through your kidneys), and/or digitalis (a medicine that helps your heart become stronger and more efficient), and/or a beta-blocker.

Dosage in special patient groups

Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those receiving high-dose diuretics, patients with hepatic impairment, or patients over 75 years of age. The use of losartan is not recommended in patients with severe hepatic impairment (see section "Do not take losartán cinfa").

Administration

The tablets should be swallowed whole with a glass of water. You should try to take your daily dose at approximately the same time each day. It is important that you continue taking losartan unless your doctor tells you otherwise.

If you take more losartán cinfa than you should

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take losartán cinfa

If you accidentally miss a dose, simply take the next dose as scheduled. Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience the following, stop taking losartan tablets immediately and contact your doctor or go to the nearest hospital emergency department:

• A severe allergic reaction (rash, itching, swelling of the face, lips, mouth, or throat, which may cause difficulty swallowing or breathing).

This is a serious but rare adverse effect, which may affect up to 1 in 1,000 patients. It may require urgent medical attention or hospitalization.

Adverse effects of medicines are classified according to the following:

The following adverse effects have been reported with losartan:

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

• dizziness,
• low blood pressure (especially after excessive loss of fluid from the blood vessels, for example in patients with severe heart failure or those receiving high doses of diuretics),
• dose-related orthostatic effects, such as a drop in blood pressure occurring after standing up from a lying or sitting position,
• weakness,
• fatigue,
• low blood sugar (hypoglycaemia),
• high potassium levels in the blood (hyperkalaemia),
• changes in liver function, including renal failure,
• reduced number of red blood cells (anaemia),
• increased levels of blood urea, serum creatinine, and serum potassium in patients with heart failure.

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

• drowsiness,
• headache,
• sleep disorders,
• sensation of very rapid heartbeat (palpitations),
• severe chest pain (angina),
• difficulty breathing (dyspnoea),
• abdominal pain,
• constipation,
• diarrhoea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• rash,
• localized swelling (oedema),
• cough.

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

• hypersensitivity,
• angioedema,
• inflammation of blood vessels (vasculitis, including Schönlein-Henoch purpura),
• numbness or tingling sensation (paraesthesia),
• fainting (syncope),
• very rapid and irregular heartbeats (atrial fibrillation),
• stroke (cerebrovascular accident),
• inflammation of the liver (hepatitis),
• increased blood levels of alanine aminotransferase (ALT), which usually resolves upon discontinuation of treatment,
• 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):

• reduced number of platelets (thrombocytopenia),
• migraine,
• abnormalities in liver function,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to sunlight (photosensitivity),
• unexplained muscle pain with dark-coloured urine (tea-coloured) (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in blood (hyponatraemia),
• depression,
• general feeling of being unwell (malaise),
• ringing, buzzing, noise, or clicking in the ears (tinnitus),
• altered taste (dysgeusia).

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 losartan cinfa

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

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

This medicine does not require any special storage conditions.

Store in the original container.

Do not open the blister pack until ready to take the medicine.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of losartan cinfa

• The active substance is potassium losartan. Each losartan cinfa 12.5 mg starting film-coated tablet contains 12.5 mg of potassium losartan.
• The other components are: monohydrate lactose, pregelatinized corn starch, microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, hypromellose, titanium dioxide (E-171), and blue lake.

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

Appearance of the medicinal product and contents of the pack

Losartan cinfa film-coated tablets are cylindrical, blue tablets.

losartan cinfa is available in aluminum-PVC/PVDC blisters, in packs of 7 or 500 tablets (hospital pack).
Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

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

Date of the most recent review 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) https://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 web 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