LOSARTAN AUROVITAS 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Losartan Aurovitas 100 mg 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.
• 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, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Losartan Aurovitas and what is it used for
2. What you need to know before taking Losartan Aurovitas
3. How to take Losartan Aurovitas
4. Possible side effects
5. Storage of Losartan Aurovitas
6. Package contents and additional information

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

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

Losartan Aurovitas 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 losartan.
• in patients with high blood pressure and increased thickness of the left ventricle of the heart, Losartan Aurovitas has been shown to reduce the risk of stroke (LIFE indication).

2. What you need to know before taking Losartan Aurovitas

Do not take Losartan Aurovitas

• if you are allergic to losartan or any of the other ingredients of this medication (listed in section 6),
• if your liver function is severely impaired,
• if you are pregnant for more than 3 months (it is also best to avoid Losartan Aurovitas at the beginning of pregnancy – see “Pregnancy”),
• 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, pharmacist, or nurse before starting to take Losartan Aurovitas.

You should inform your doctor if you think you are pregnant (or might be). Losartan Aurovitas is not recommended at the beginning of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your child (see section on pregnancy).

Before taking Losartan Aurovitas, 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 causes 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 causes excessive loss of fluids or salt in 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 impaired (see sections 2 “Do not take Losartan Aurovitas” 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 heart valves or 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:

• 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 need to monitor your kidney function, blood pressure, and electrolyte levels in your blood (e.g., potassium) at regular intervals.

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

• if you are taking other medications that may increase serum potassium levels (see section 2 “Other medications and Losartan Aurovitas”).

Children and adolescents

Losartan 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 is 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 Losartan Aurovitas

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 losartan is not recommended.

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

• other medications that lower blood pressure, as they may cause additional reduction in blood pressure. 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 losartan.

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 Losartan Aurovitas” and “Warnings and precautions”.

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

Medications containing lithium should not be used in combination with losartan without your doctor's careful monitoring. It may be appropriate to take special precautions (e.g., blood tests).

Losartan Aurovitas with food and drinks

Losartan Aurovitas can be taken with or without food.

Grapefruit juice should be avoided 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 might be). Normally, your doctor will advise you to stop taking Losartan Aurovitas before becoming pregnant or as soon as you know you are pregnant and will recommend a different medication instead of losartan. Losartan Aurovitas is not recommended at the beginning of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your child if used after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Losartan Aurovitas 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 premature.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines. It is unlikely that Losartan Aurovitas will affect your ability to drive or use machines. However, like 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 performing these activities.

Losartan Aurovitas contains lactose

Losartan 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.

3. How to take Losartan Aurovitas

Follow the administration instructions for 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 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 constant blood pressure control.

Adult patients with high blood pressure

Normally, treatment starts 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. After that, 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 think the effect 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 between 6 and 18 years of age

The recommended starting dose in patients who weigh 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). 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 losartan (one Losartan Aurovitas 50 mg tablet) once a day. After that, 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 the response of your blood pressure.

Losartan 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 losartan (half a Losartan Aurovitas 25 mg 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 losartan (e.g., three Losartan Aurovitas 50 mg tablets or one Losartan Aurovitas 100 mg tablet and one Losartan Aurovitas 50 mg tablet) may be used once a day.

In the treatment of heart failure, losartan 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. Losartan is not recommended for use in patients with severe liver failure (see section "Do not take Losartan Aurovitas").

Administration

The 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. 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 taken.

If you forget to take Losartan Aurovitas

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.

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, affecting more than 1 patient in 10,000, but less than 1 patient in 1,000. It may require urgent medical attention or hospitalization.

The following adverse effects have been reported with Losartan Aurovitas:

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, e.g., in patients with severe heart failure or on high doses of diuretics),
• dose-related orthostatic effects, such as decreased 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 number of red blood cells (anemia),
• increased urea, creatinine, and potassium levels in the blood in patients with heart failure.

Uncommon (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 upon discontinuation of treatment.

Frequency not known (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),
• 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),
• disturbance 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 leaflet. 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 Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging, label, and blister pack after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in 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 Aurovitas

• The active ingredient is losartan potassium. Each Losartan Aurovitas 100 mg tablet contains 100 mg of losartan potassium, equivalent to 91.7 mg of losartan.

• The other ingredients (excipients) are:

Core of the tablet:microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, low-substituted hydroxypropyl cellulose, magnesium stearate.

Coating:hydroxypropyl cellulose, hypromellose, and titanium dioxide (E171).

Appearance and Package Contents

Film-coated tablet.

White to off-white, oval, biconvex tablets, marked with "E" on one face and "47" on the other face of the tablet.

Losartan Aurovitas 100 mg is available in blister packs.

Package sizes:14, 28, 30, 56, and 98 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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 100 mg, filmomhulde tabletten

Portugal: Losartan Aurovitas

Spain: Losartán Aurovitas 100 mg film-coated tablets EFG

Date of the last revision of this leaflet:February 2023

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