Leaflet: information for the user

Losartán SUN 100 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you and you should not give it to others even if they have similar symptoms to yours, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Losartánbelongs to a group of medications known asangiotensin II receptor antagonists. Angiotensin IIis 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.

LosartánSUNis used

• to treat patients with elevated blood pressure (hypertension) in adults and 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 insufficiency and proteinuria ≥0.5 gper day (a situationin 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, calledangiotensin-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 demonstrated that it reduces the risk of stroke (LIFE indication).

Do not take Losartán SUN:

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• if your liver function is severely impaired,
• if you are more than 3 months pregnant. (It is also recommended to avoid Losartán SUN during the first months of pregnancy – see Pregnancy section).
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure medication containing aliskirén.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Losartán SUN.

You should inform your doctor if you think you are pregnant (or may be). Losartán SUN is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered if you are more than three months pregnant, as it may cause serious harm to your child (see Pregnancy section).

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

Before taking Losartán SUN, 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 fluid and/or salt loss from your body,
• if you are taking diuretics (medications that increase the amount of water that passes through your kidneys) or if you are following a low-sodium diet that causes excessive fluid or salt loss from your body (see section 3. Dosage in special patient groups),
• if you know you have narrowing or blockage of the blood vessels leading to your kidneys or if you have recently undergone a kidney transplant,
• if your liver function is altered (see sections 2. Do not take Losartán SUN and 3. Dosage in special patient groups),
• if you have heart failure with or without kidney insufficiency or potentially fatal cardiac arrhythmias. Special attention is required when being treated with a beta-blocker at the same time,
• if you have heart valve problems or heart muscle problems,
• 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 excessive secretion of the 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):
• 1. - an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  2. - aliskirén

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

See also the section under the heading “Do not take Losartán SUN”.

• if you are taking other medications that may increase serum potassium levels (see section 2 “Taking Losartan SUN with other medications”).

Children and adolescents

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

Losartan is not recommended for use in children with kidney or liver problems, as there is limited data available for these patient groups. 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.

Taking Losartan SUN with other medications:

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

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

While taking Losartan SUN, be particularly cautious if you are taking any of the following medications:

• other medications that lower blood pressure, as they may cause additional blood pressure reduction. Blood pressure may also decrease with some of the following medications/classes of medications: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• nonsteroidal anti-inflammatory drugs (NSAIDs), 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 losartan.

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

If you are taking an ACE inhibitor or aliskirén (see also information under the headings “Do not take Losartan SUN” 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 losartan without your doctor's careful monitoring. It may be necessary to take special precautions (e.g., blood tests).

Taking Losartan SUN with food and beverages:

Losartan SUN can be taken with or without food.

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

Pregnancy and lactation

Pregnancy

You should inform your doctor if you think you are pregnant (or may be). Your doctor will usually recommend that you stop taking Losartan SUN before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of Losartan SUN. Losartan SUN is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered after the third month of pregnancy, as it may cause serious harm to your child when administered from that point on.

Lactation

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery:

No studies have been conducted on the effects on the ability to drive and operate machinery.

It is unlikely that Losartan SUN will affect your ability to drive or operate machinery. However, as many medications used to treat high blood pressure, losartan may cause dizziness or drowsiness in some individuals. If you experience dizziness or drowsiness, consult your doctor before engaging in these activities.

Losartan SUN contains lactose

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.Your doctor will decide the appropriate dose of Losartán SUN, depending on your condition and if you are taking other medications. It is essential to continue taking Losartán SUN as prescribed by your doctor to maintain constant blood pressure control.

Adult patients with high blood pressure

Treatment usually starts with 50 mg of losartan (one Losartan SUN 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 losartan (2 Losartan SUN 50 mg tablets or 1 losartan 100 mg tablet) once a day.

If you estimate that the action 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 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

Treatment usually starts with 50 mg of losartan (one Losartan SUN 50 mg tablet) once a day. After that, the dose may be increased to 100 mg of losartan (2 Losartan SUN 50 mg tablets or 1 losartan 100 mg tablet) once a day, depending on your blood pressure response.

Losartan tablets can be taken 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).

Adult patients with heart failure

Treatment usually starts with 12.5 mg of losartan once a day. Treatment is usually increased gradually, 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), to a maintenance dose determined by your doctor. A maximum dose of 150 mg of losartan (e.g., 3 losartan 50 mg tablets or 1 losartan 100 mg tablet and 1 losartan 50 mg tablet) once a day may be used.

In the treatment of heart failure, losartan is usually 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 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 SUN").

Administration

Tablets should be taken with a glass of water. Try to take your daily dose at approximately the same time each day. It is essential to continue taking Losartan SUN until your doctor tells you otherwise.

If you take more Losartan SUN 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, 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 SUN:

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

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

Like all medicines, Losartán SUN can cause side effects, although not everyone will experience them.

If you experience any of the following, stop taking losartán 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 fewer than 1 in 1,000. You may need urgent medical attention or hospitalization.

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 water loss from the body within blood vessels, for example, in patients with severe heart failure or those taking high doses of diuretics),
• orthostatic effects related to the dose, such as a decrease in blood pressure that occurs after standing up from a lying or sitting position,

• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• high potassium levels in the blood (hyperkalemia).
• Liver function changes, including renal insufficiency
• reduced red blood cell count (anemia)
• increased urea, creatinine, and potassium levels in the blood in patients with heart failure

Less frequent (may affect up to 1 in 100 patients):

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

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

• hypersensitivity
• angioedema
• intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea,
• inflammation of blood vessels (vasculitis, including Schonlein-Henoch purpura),
• numbness or tingling (paresthesia),
• syncope (fainting),
• 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 upon discontinuing treatment.

Unknown frequency (frequency 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)
• Unknown origin muscle pain with dark-colored urine (rhabdomyolysis)
• Impotence
• pancreatitis (inflammation of the pancreas)
• low sodium levels in the blood (hyponatremia)
• Depression
• Generally feeling unwell (malaise)
• tinnitus, buzzing, ringing, or clicking in the ears (saccharin)
• alteration of taste (dysgeusia)

The 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 prospectus. 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 medication.

Keep this medication out of the 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.

No special storage conditions are required.

Conserve Losartán SUNin the original packaging

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection pointat 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 LosartanSUN

The active ingredient of Losartan SUNis losartan potassium.

Each Losartan SUNtablet contains 100 mg of losartan (as potassium salt).

The other components are:microcrystalline cellulose, anhydrous lactose,pregelatinized cornstarch, magnesium stearate, anhydrous colloidal silica, talc, hypromellose, titanium dioxide (E 171), propylene glycol (1,108 mg) and hydroxypropyl cellulose.

Losartan SUN100 mg contains potassium in the following amount: 8.48mg (0.216 mEq)

Appearance of the product and content of the container

LosartanSUN100 mg is supplied as biconvex, circular, white film-coated tablets, with the text “L4” embossed on one face and plain on the other face.

LosartanSUNis supplied in the following container sizes:

Aluminum/PVC-Al-Polyamide blister or in aluminum blisters, in containers of 28 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing.

Holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands

Responsible for manufacturing

TERAPIA, S.A.

124 Fabricii Street

400 632 Cluj Napoca, Romania

Or

SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.

Polarisavenue, 87

2132 JH Hoofddorp, Netherlands

You can request more information about this medication by contacting

the local representative of the holder of the marketing authorization

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona.

Spain

Tel.: +34 93 342 78 90

Revision date of this leaflet:December 2024

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/