Losartan CINFA 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

losartán cinfa 50 mg 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, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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 present in blood vessels, causing them to narrow. This leads to an increase in blood pressure.

Losartan blocks angiotensin II from binding to these receptors, causing blood vessels to relax, which in turn lowers blood pressure. Losartan slows the progression of declining kidney function 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 kidney 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 treatment with specific medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to lower high blood pressure) to be unsuitable. 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 losartan 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 you have severely impaired liver function.
• If you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 must not be taken after the third month of pregnancy, as it may cause severe 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 have excessive vomiting or diarrhea, which may cause excessive fluid and/or salt loss 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 fluid 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 had a kidney transplant.
• If you have impaired liver function (see sections 2. Do not take losartan cinfa and 3. Dosage in special patient groups).
• If you have heart failure with or without renal 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 blood vessels of the heart) or cerebrovascular disease (caused by reduced blood circulation in the brain).
• If you have primary hyperaldosteronism (a syndrome associated with excessive secretion of the hormone aldosterone by the adrenal gland due to adrenal dysfunction).
• If you are taking any of the following medicines 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

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 losartan cinfa”.

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

Children and adolescents

Losartan has been studied in children. For further 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 losartan 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 are taking 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 losartan cinfa” and “Warnings and precautions”).

If you have impaired kidney function, concomitant use of these medicines may lead to worsening of renal 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 losartan 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 after the third month of pregnancy, as it may cause severe harm to your baby if used beyond the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. 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 on the effects on the ability to drive and use machines have been performed.

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.

losartan cinfa contains lactose.

If your doctor has diagnosed you with 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 keep taking losartan as prescribed by your doctor 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 for patients weighing between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, given 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 blood pressure-lowering medicines (e.g., diuretics, calcium antagonists, alpha or beta blockers, and centrally acting agents), as well as with insulin and other commonly used glucose-lowering medicines (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 increased gradually 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 fluid 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, stating 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 the missed dose.

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 right away 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 rare but serious adverse effect that 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 lying down or sitting,
• weakness,
• fatigue,
• low blood sugar (hypoglycaemia),
• high potassium levels in the blood (hyperkalaemia),
• changes in liver function, including kidney 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 pectoris),
• 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),
• liver inflammation (hepatitis),
• elevated levels of alanine aminotransferase (ALT) in blood, 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,
• 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 levels of sodium in the 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 is 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 must not be disposed of via wastewater or household waste. Unused medicines and containers should be taken to the SIGRE Point at your pharmacy. If you are in doubt, 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 losartán cinfa

• The active substance is potassium losartan. Each losartán cinfa 50 mg film-coated tablet contains 50 mg of potassium losartan.
• The other components are: monohydrate lactose, pregelatinized corn starch, microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, hydroxypropylmethylcellulose, and titanium dioxide (E-171).

losartán cinfa 50 mg contains potassium in the following amount: 4.24 mg (0.11 mEq).

Appearance of the product and contents of the container

losartán cinfa film-coated tablets are cylindrical, scored, white tablets.

losartán cinfa is available in aluminum-PVC/PVDC blisters, in pack sizes of 28 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 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67729/P_67729.html

QR code to: https://cima.aemps.es/cima/dochtml/p/67729/P_67729.html