LOSARTAN CINFA 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

losartán cinfa 12.5 mg starting film-coated tablets EFG

potassium losartan

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist or nurse.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is losartán cinfa and what is it used for
2. What you need to know before taking losartán cinfa
3. How to take losartán cinfa
4. Possible side effects
5. Storage of losartán cinfa

1. Contents of the pack and further information

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

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 narrow. This leads to an increase in blood pressure.

Losartán prevents angiotensin II from binding to these receptors, which causes the blood vessels to relax, thereby reducing blood pressure. Losartán reduces the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Losartán cinfa is used:

• to treat patients with high blood pressure (hypertension) in adults and in children and adolescents from 6 to 18 years of age.
• to protect the kidneys in hypertensive patients with type 2 diabetes and laboratory test results indicating kidney failure and proteinuria ≥ 0.5 g per day (a condition in which the urine contains an abnormal amount of protein).
• 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 lower high blood pressure) is not suitable. If your heart failure has been stabilized with an ACE inhibitor, you should not switch to losartán.
• in patients with high blood pressure and increased thickness of the left ventricle of the heart, losartán has been shown to reduce the risk of stroke (LIFE indication).

2. What you need to know before taking losartán cinfa

Do not take losartán cinfa

• If you are allergic to losartán or any of the other ingredients of this medication (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 section Pregnancy and lactation).
• If your liver function is severely impaired.
• If you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.

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 should inform your doctor if you think you are pregnant (or might be). Losartán is not recommended 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 child (see section Pregnancy and lactation).

Before taking losartán, it is essential that you 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 loss of fluid and/or salt from your body.
• If you are taking diuretics (medications that increase the amount of water that passes 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 that supply your kidneys or if you have recently undergone a kidney transplant.
• If your liver function is impaired (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 life-threatening heart rhythm disorders. Special attention is necessary when you are being treated with a beta-blocker at the same time.
• If you have problems with the valves in your heart or with the heart muscle.
• 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 high secretion of the hormone aldosterone by the adrenal gland due to a disorder 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

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".

Children and adolescents

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

Losartán is not recommended for use in children with kidney or liver problems, as there is limited data available in 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 medications

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

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

While you are being treated with losartán, be particularly cautious if you take any of the following medications:

• Other medications that lower blood pressure, as they may cause additional blood pressure reduction. Blood pressure may also be lowered by some of the following medications/classes of medications: tricyclic antidepressants, antipsychotics, baclofen, amifostine.
• Non-steroidal anti-inflammatory medications, such as indomethacin, 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 ACE inhibitor or aliskiren (see also the information under the headings "Do not take losartán cinfa" and "Warnings and precautions").

If your kidney function is impaired, concomitant use of these medications may worsen kidney function.

Medications containing lithium should not be used in combination with losartán without your doctor's careful monitoring. Special precautions may be necessary (e.g., blood tests).

Taking losartán cinfa with food and drinks

Losartán can be taken with or without food.

Pregnancy and lactation

Pregnancy

You should inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking losartán before becoming pregnant or as soon as you know you are pregnant and recommend a different medication. Losartán is not recommended 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 child if used after the third month of pregnancy.

Lactation

Tell your doctor if you are breastfeeding or about to start breastfeeding. Losartán is not recommended for breastfeeding mothers, and your doctor may choose a different treatment for you if you wish to breastfeed. Especially if your child is a newborn or was born prematurely.

Consult your doctor or pharmacist before using this medication.

Driving and using machines

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, like 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 performing 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 medication.

3. How to take losartán cinfa

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

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

Adult patients with high blood pressure

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

If you think the effect of losartán is too strong or too weak, please inform your doctor or pharmacist.

Use in children and adolescents

Children under 6 years of age

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.

Children between 6 and 18 years of age

The recommended starting dose in patients weighing between 20 and 50 kg is 0.7 mg of losartán per kg of body weight, administered once a day (up to 25 mg of losartán). The 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

Normally, treatment starts with 50 mg of losartán (one losartán cinfa 50 mg tablet) once a day. After that, the dose may be increased to 100 mg of losartán (two losartán cinfa 50 mg tablets or one losartán cinfa 100 mg tablet) once a day, depending on the response of your blood pressure.

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

Adult patients with heart failure

Normally, treatment starts with 12.5 mg of losartán (one losartán cinfa 12.5 mg starting tablet) once a day. Normally, the dose is gradually increased weekly (i.e., 12.5 mg per day during the first week, 25 mg per day during the second week, 50 mg per day during the third week, 100 mg per day during the fourth week, 150 mg per day during the fifth week), up to a maintenance dose determined by your doctor. A maximum dose of 150 mg of losartán (e.g., three losartán cinfa 50 mg tablets or one losartán cinfa 100 mg tablet and one losartán cinfa 50 mg tablet) may be used once a day.

In the treatment of heart failure, losartán is normally 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.

Dosage in special patient groups

Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those treated with high-dose diuretics, patients with liver failure, or patients over 75 years of age. Losartán is not recommended for use in patients with severe liver failure (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 essential to continue taking losartán as prescribed by your doctor.

If you take more losartán 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 losartán cinfa

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

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

This is a serious but rare adverse effect that can affect up to 1 in 1,000 patients. You may need urgent medical attention or hospitalization.

Adverse effects of medicines are classified as follows:

The following adverse effects have been reported with losartan:

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

• dizziness,
• low blood pressure (especially after excessive loss of water from the body within the blood vessels, for example in patients with severe heart failure or being treated with high doses of diuretics),
• dose-related orthostatic effects, such as a decrease in blood pressure that occurs after standing up from lying down or sitting,
• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• high potassium levels in the blood (hyperkalemia),
• changes in liver function, including kidney failure,
• reduced number of red blood cells (anemia),

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

Infrequent (may affect up to 1 in 100 patients)

• drowsiness
• headache
• sleep disorders
• feeling 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 the blood vessels (vasculitis, including Schonlein-Henoch purpura),
• numbness or tingling sensation (paresthesia),
• fainting (syncope),
• very 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 when treatment is discontinued.
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known(cannot be estimated from available data)

• reduced number of platelets,
• migraine,
• liver function abnormalities,
• 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) (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in the blood (hyponatremia),
• depression,
• generally feeling unwell (malaise),
• ringing, buzzing, noise, or clicking in the ears (tinnitus),
• alteration of taste (dysgeusia).

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Store in the original packaging.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Losartan Cinfa

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

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

Appearance of the Product and Package Contents

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

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

Only certain package 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 Last Revision of this Prospectus: February 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (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