Leaflet: information for the user

Losartán Aurovitas 50 mg film-coated tablets EFG

losartan potassium

Read this leaflet carefully before you start taking this medicine, as 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 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 leaflet. See section 4.

1. What Losartán Aurovitas is and for what it is used

2. What you need to know before starting to take Losartán Aurovitas

3. How to take Losartán Aurovitas

4. Possible side effects

5. Storage of Losartán Aurovitas

6. Contents of the pack and additional information

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 Aurovitas 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) 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, Losartán Aurovitas has demonstrated that it reduces the risk of stroke (LIFE indication).

Do not take Losartán Aurovitas

• if you are allergic to losartan or any of the other ingredients of this medicine (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 Aurovitas at the beginning of pregnancy – see “Pregnancy”),
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medication containing aliskirén.

Warnings and precautions

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

You should inform your doctor if you think you are pregnant (or could be). Losartán Aurovitas 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 severe damage to your child (see the Pregnancy section).

Before taking Losartán Aurovitas, 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 follow a low-sodium diet that causes excessive loss of fluids or salt from your body (see section 3 “Posology in special patient groups”),
• if you know that 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 Aurovitas” and 3 “Posology in special patient groups”),
• if you have heart failure with or without renal impairment 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 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 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 medications 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 renal function, blood pressure, and blood electrolyte levels (e.g. potassium), at regular intervals.

See also the information under the heading “Do not take Losartán Aurovitas”.

• if you aretakingother medications that may increase serum potassium (see section 2 “Other medications and Losartán Aurovitas”).

Children and adolescents

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

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

Other medications and Losartán Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, 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 (e.g. heparin, medications containing trimetoprim), as the combination with losartan is not recommended.

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

• other medications that lower blood pressure, as they may cause an additional reduction in blood pressure. Blood pressure may also decrease with some of the following medications/classes of medications: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• nonsteroidal anti-inflammatory drugs, 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 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 Aurovitas” and “Warnings and precautions”).

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

Medications containing lithium 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 Aurovitas with food and drinks

Losartán Aurovitas can be taken with or without food.

It is recommended to avoid grapefruit juice while taking losartan.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should inform your doctor if you think you are pregnant (or could be). Normally, your doctor will recommend that you stop taking Losartán Aurovitas before becoming pregnant or as soon as you know you are pregnant and advise you to take another medication different from losartan. Losartán Aurovitas 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 severe damage to your child if used after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Losartán Aurovitas 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.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and use machines. It is unlikely that Losartán Aurovitas will affect your ability to drive or use machines. However, as many medications 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 Aurovitas contains lactose

Losartán Aurovitas contains lactose monohydrate. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Your doctor will decide on the appropriate dose of losartan, depending on your condition and whether you are taking other medications. It is essential to continue taking losartan 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 Losartan Aurovitas 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 Losartan Aurovitas 50 mg tablets or one Losartan Aurovitas 100 mg tablet) once a day.

If you estimate that the losartan effect 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 Aurovitas). 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 Losartan Aurovitas 50 mg tablet) once a day. Subsequently, the dose may be increased to 100 mg of losartan (two Losartan Aurovitas 50 mg tablets or one Losartan Aurovitas 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 reduce blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Adult patients with heart failure

Typically, treatment begins with 12.5 mg of losartan (half a Losartan Aurovitas 25 mg tablet) once a day.

Typically, the dose is gradually increased weekly (i.e., 12.5 mg per day for the first week, 25 mg per day for the second week, 50 mg per day for the third week, 100 mg per day for the fourth week, 150 mg per day for the fifth week), to a maintenance dose determined by your doctor.

A maximum dose of 150 mg of losartan (e.g., three Losartan Aurovitas 50 mg tablets or one Losartan Aurovitas 100 mg tablet and one Losartan Aurovitas 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.

Posology 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 Aurovitas").

Administration

Tablets should be taken 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 Losartan Aurovitas until your doctor tells you otherwise.

If you take more Losartan Aurovitas 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, Telephone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Losartan Aurovitas

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

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 Losartán Aurovitas:

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

• 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 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),
• 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.

Infrequent (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 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 discontinuation of treatment.

Unknown frequency (frequency cannot be estimated from available data):

• reduced platelet count,
• migraine,
• liver function abnormalities,
• 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,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in the blood (hyponatremia),
• depression,
• usually feeling unwell (malaise),
• ringing, buzzing, or clicking in the ears (tinnitus),
• alteration of taste (dysgeusia).

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 not listed in this leaflet. 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 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, the bottle label, and the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Losartán Aurovitas

• The active ingredient is losartan potassium. Each Losartán Aurovitas 50 mg tablet contains 50 mg of losartan potassium, equivalent to 45.8 mg of losartan.

• The other components (excipients) are:

Tablet core:microcrystalline cellulose, lactose monohydrate, pregelatinized cornstarch, low-substitution hydroxypropylcellulose, magnesium stearate.

Coating:hydroxypropylcellulose, hypromellose, and titanium dioxide (E171).

Appearance of the product and contents of the packaging

Coated tablet.

White to off-white, oval, biconvex tablets, marked with “E” on one face and “4” and “6” separated by a groove on the other face of the tablet. The tablet can be divided into equal doses.

Losartán Aurovitas 50 mg is available in blister packaging.

Packaging sizes:14, 28, 30, 56, and 98 coated tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the EEA member states under the following names::

Belgium:Losartan AB 50 mg, film-coated tablets

Portugal:Losartan Aurovitas

Spain:Losartán Aurovitas 50 mg coated tablets EFG

Last review date of this leaflet:February 2023

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