Package Insert: Information for the Patient

Losartan Sandoz 50 mg Film-Coated Tablets

Losartan Sandoz 100 mg Film-Coated Tablets

potassium losartan

Read this package insert carefully before you start taking this medicine, because it contains important information for you

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

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 Sandoz 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) is 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 Sandoz:

• if you are allergic to losartan or any of the other ingredients of this medicine (listed in section 6),
• if you are more than 3 months pregnant. (It is also best to avoid Losartán Sandoz during the first months of pregnancy – see Pregnancy section),
• if your liver function is severely impaired,
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskirén.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Losartán Sandoz.

Inform your doctor if you think you are pregnant (or may be). Losartan is not recommended at the start of pregnancy, and should not be taken 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 losartan. Your doctor will decide whether to continue treatment. Do not stop taking losartan on your own.

Before taking losartan, it is essential that you 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 are following 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 Sandoz and 3. Dosage in special patient groups),
• if you have heart failure with or without kidney failure or potentially fatal cardiac arrhythmias. Special attention is required when you are 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 high secretion of the aldosterone hormone by the adrenal gland due to an alteration of this gland),
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
• • a 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 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 Sandoz”.

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 the available data in these patient groups are limited. 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.

Other medicines and Losartán Sandoz

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

While taking losartan, be particularly cautious if you take any of the following medicines:

• other medicines that lower blood pressure, as they may cause an additional reduction in blood pressure. Blood pressure may also be lowered by some of the following medicines/classes of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• medicines that retain potassium or that may increase potassium levels (e.g. potassium supplements, salt substitutes containing potassium, or potassium-sparing medicines such as certain diuretics [amiloride, triamterene, spironolactone] or heparin),
• non-steroidal anti-inflammatory medicines, such as indomethacin, including COX-2 inhibitors (medicines that reduce inflammation and that 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 ACE inhibitor or aliskirén (see also the information under the headings “Do not take Losartán Sandoz” and “Warnings and precautions”).

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

Lithium-containing medicines 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).

Losartán Sandoz with food and drinks

Losartan Sandoz can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine. Normally, your doctor will recommend that you stop taking Losartán Sandoz before becoming pregnant or as soon as you know you are pregnant and advise you to take another medicine different from Losartan Sandoz. Losartan is not recommended at the start of pregnancy, and should not be taken if you are more than three months pregnant, as it may cause serious harm to your child if used after the third month of pregnancy.

Breastfeeding

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

Consult your doctor or pharmacist before using this medicine.

Driving and operating machines

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

It is unlikely that Losartan Sandoz will affect your ability to drive or use machines. However, as 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 these activities.

Losartán Sandoz contains lactose and sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

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 indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide on the appropriate dose of Losartán Sandoz, depending on your condition and if you are taking other medications. It is essential to continue taking Losartán Sandoz 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 Losartán Sandoz 50 mg tablet) once a day. The maximum blood pressure-lowering effect is achieved between 3 to 6 weeks of starting treatment. Subsequently, in some patients, the dose may be increased to 100 mg of losartan (two Losartán Sandoz 50 mg tablets or one Losartán Sandoz 100 mg tablet) once a day.

If you estimate that losartan's action 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 demonstrated 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 Losartán Sandoz 50 mg tablet) once a day. Subsequently, the dose may be increased to 100 mg of losartan (two Losartán Sandoz 50 mg tablets or one Losartán Sandoz 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 decrease blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Adult patients with heart failure

Typically, treatment begins with 12.5 mg 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, and 50 mg per day during the third week, 100 mg per day during the fourth week, and 150 mg per day during the fifth week), to a maintenance dose determined by your doctor. A maximum dose of 150 mg of losartan (e.g., three Losartán Sandoz 50 mg tablets or one Losartán Sandoz 100 mg tablet and one Losartán Sandoz 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.

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 Losartán Sandoz").

Administration

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

If you take more Losartán Sandoz 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.

If you have taken more Losartán Sandoz than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Losartán Sandoz

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 or pharmacist.

Like all medicines, this medicine may 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:

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 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 loss of body water within blood vessels, e.g., in patients with severe heart failure or those treated with high doses of diuretics),
• orthostatic effects related to the dose, 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 kidney function, including renal failure,
• reduced red blood cell count (anemia),
• increased urea, creatinine, and potassium levels in the blood in patients with heart failure.

Occasional (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,
• 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),
• 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.
• intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea,

Frequency unknown(the frequency cannot be estimated from available data):

• reduced platelet count,
• migraine,
• abnormal liver function,
• 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 (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).

The side effects in children are similar to those observed in adults.

Reporting 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: 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.

The shelf life of Losartán Sandoz packaged in HDPE bottle, once the bottle is opened, is 6 months.

Blisters

This medication does not require special storage conditions.

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

Bottle

No special storage conditions are required.

Once the bottle is opened, do not store at a temperature above 25°C.

Medications should not be disposed of through drains or in the trash. Dispose of the 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 Sandoz

• The active ingredient is losartan potassium.

Losartan Sandoz 50 mg tablets: each tablet contains 50 mg of losartan potassium.

Losartan Sandoz 100 mg tablets: each tablet contains 100 mg of losartan potassium.

• The other components are

Core: carboxymethylstarch sodium (type A) (derived from potato starch), microcrystalline cellulose, magnesium stearate, povidone, anhydrous colloidal silica.

Coating: Opadry white (OY-L-28900), which contains: titanium dioxide, hypromellose, lactose monohydrate, and macrogol 4000.

Appearance of the product and contents of the package

Losartan Sandoz 50 mg are white, film-coated, oval-shaped tablets with "3" printed on one side and a notch on both sides.The tablet can be divided into equal doses.

Losartan Sandoz 100 mg are white, film-coated, oblong-shaped tablets with "5" printed on one side and 3 notches on both sides. The tablet can be divided into equal doses.

Losartan Sandoz is supplied in the following package sizes:

PVC/PVDC/Aluminum blister pack, in packages of 28 film-coated tablets.

HDPE bottle, in packages of 28 film-coated tablets.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble,

C/Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer:

Salutas Pharma GmbH

Otto-von-Guericke-Allee, 1

39179 Barleben

Germany

Ó

Lek Pharmaceuticals d.d.

Trimlini 2D, 9220

Lendava,

Slovenia

Ó

Lek Pharmaceutical Company d.d.

Verovskova, 57

Ljubljana 1526

Slovenia

O

Lek S.A.

Ul. Podlipie 16

95 010 Strykow

Poland

Last review date of this leaflet: February 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) www.aemps.gob.es