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Package Insert: Information for the Patient

Losartán Alter 50 mg Film-Coated Tablets

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 must 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 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 constrict. This results in an increase in blood pressure.

Losartán prevents the binding ofangiotensin IIto 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 Alter 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 gper 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) are not suitable. If their heart failure has been stabilized with an ACE inhibitor, they should not switch to losartan.
• in patients with elevated blood pressure and left ventricular hypertrophy of the heart, losartan has been shown to reduce the risk of stroke (LIFE indication).

Do not take Losartán Alter

• 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 Alter at the beginning of pregnancy - see Pregnancy),
• if your liver function is severely damaged.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskirén.
• Losartán Alter contains soy lecithin. Do not use it in case of an allergy to peanuts or soy.

Warnings and precautions

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

You must inform your doctor if you think you are pregnant (or could be). Losartán Alter is not recommended at the beginning of pregnancy, and it should not be taken if you are more than three months pregnant, as it may cause serious harm to your child (see Pregnancy section).

Before takingLosartán Alter, 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 groups of patients),
• 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 and 3. Dosage in special groups of patients),
• 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 an elevated secretion of 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.

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

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 Alter”.

Children and adolescents

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

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

Losartán Alter with other medicines

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

While taking Losartán Alter, be particularly cautious if you are taking 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 decrease with 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 Alter” and “Warnings and precautions”).

If your kidney function is altered, 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 Alter with food and drinks

Losartán Alter can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you might be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must inform your doctor if you are pregnant (or could be). Normally, your doctor will recommend that you stop taking losartan before becoming pregnant or as soon as you know you are pregnant and advise you to take another medicine different from losartan. Losartan is not recommended at the beginning of pregnancy, and it 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 are about to start. Losartan is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you want to breastfeed, especially if your baby is a newborn or premature.

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 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 Alter contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

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 on the appropriate dose of Losartán Alter, depending on your condition and whether you are taking other medications. It is essential to continue taking Losartán Alter as prescribed by your doctor to maintain consistent blood pressure control.

Adult patients with high blood pressure

Typically, treatment begins with 50 mg of losartan (one Losartán Alter 50 mg tablet) once a day. The maximum blood pressure-lowering effect is achieved within 3-6 weeks of starting treatment. Subsequently, in some patients, the dose may be increased to 100 mg of losartan (two Losartán Alter 50 mg tablets or one Losartán Alter 100 mg tablet) once a day.

If you estimate that the action of Losartán Alter is too strong or too weak, please inform your doctor or pharmacist.

Use in children and adolescents

Children under 6 years of age

Losartán Alter 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 Losartán Alter). Your doctor may increase the dose if your blood pressure is not controlled.

Other available pharmaceutical forms 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 Alter 50 mg tablet) once a day. Subsequently, the dose may be increased to 100 mg of losartán (two Losartán Alter 50 mg tablets or one Losartán Alter 100 mg tablet) once a day, depending on your blood pressure response.

Losartan may 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 of losartan 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), to a maintenance dose determined by your doctor. A maximum dose of 150 mg of losartan (e.g., three Losartán Alter 50 mg tablets or one Losartán Alter 100 mg tablet and another Losartán Alter 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 Alter").

Administration

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

If you take more Losartán Alter 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 Alter

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 can cause side effects, although not everyone will experience them.

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

A 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 (may affect up to 1 in 1,000 people). 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 people):

• dizziness,
• low blood pressure (especially after excessive water loss from the body 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 kidney 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 people):

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

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

• 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 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, roaring, or clicking in the ears (tinnitus),
• alteration of taste (dysgeusia).

The side effects reported 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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Usehttps://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.

Do not store above30°C.

Store in the original packaging to protect it from light and moisture.

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

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

• The active ingredient is losartan. Each tablet contains 50 mg of losartan potassium.
• The other components are: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, anhydrous colloidal silica, magnesium stearate, and Opadry II (polyvinyl alcohol, titanium dioxide (E-171), talc, macrogol 4000, and soy lecithin).

Losartán Alter 50 mg contains 4.24 mg of potassium (0.108 mEq).

Appearance of the product and contents of the packaging

Coated tablets with a lenticular film, white in color, and scored.

Losartán Alter 50 mg is supplied in PVC/PE/PVDC-Aluminum blisters, in packs of 28 tablets.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Madrid

or

Laboratorios Alter, S.A

C/ Zeus 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

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)http://www.aemps.gob.es/