Losartan Aurovitas 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Losartán Aurovitas 100 mg film-coated tablets EFG

potassium losartan

Read the entire 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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Losartán Aurovitas is and what it is used for
2. What you need to know before taking Losartán Aurovitas
3. How to take Losartán Aurovitas
4. Possible adverse effects
5. Storage of Losartán Aurovitas
6. Contents of the pack and other information

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

Losartan belongs to a group of medicines 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 blocks angiotensin II from binding to these receptors, resulting in blood vessel relaxation, which in turn lowers blood pressure. Losartan slows the progression of renal impairment in patients with high blood pressure and type 2 diabetes.

Losartán Aurovitas is used

• to treat patients with high blood pressure (hypertension) in adults and in 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 impairment and proteinuria ≥ 0.5 g per day (a condition in which the urine contains an abnormally high amount of protein).
• to treat patients with chronic heart failure, when their doctor considers that treatment with specific medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors, medicines 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 thickening of the left ventricle of the heart, Losartán Aurovitas has been shown to reduce the risk of stroke (LIFE indication).

2. What you need to know before taking Losartán Aurovitas

Do not take Losartán Aurovitas

• if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6),
• if you have severely impaired liver function,
• if you are more than 3 months pregnant (Losartán Aurovitas is also best avoided at the beginning of pregnancy – see “Pregnancy”),
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Losartán Aurovitas.

You should inform your doctor if you think you may be pregnant (or could become pregnant). Losartán Aurovitas is not recommended during early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your unborn baby (see section on pregnancy).

Before taking Losartán Aurovitas, it is important to 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 are experiencing excessive vomiting or diarrhoea, which may cause excessive loss of fluid and/or salt from your body,

• if you are taking diuretics (medicines that increase the amount of fluid passing through your kidneys) or are on a low-salt diet that may lead to excessive loss of fluid 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 supplying your kidneys or if you have recently undergone a kidney transplant,

• if you have impaired liver function (see sections 2 “Do not take Losartán Aurovitas” and 3 “Dosage in special patient groups”),

• if you have heart failure with or without kidney impairment or potentially life-threatening concomitant cardiac arrhythmias. Special care is needed if you are also being treated with a beta-blocker,

• if you have heart valve problems or heart muscle disease,

• 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 excessive secretion of the hormone aldosterone by the adrenal gland due to adrenal gland dysfunction),

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,

• aliskiren.

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 Aurovitas”.

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

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

Children and adolescents

Losartán Aurovitas has been studied in children. For further information, speak with 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 its efficacy has not been demonstrated in this age group.

Other medicines and Losartán Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

While being treated with losartan, take particular care 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 be lowered by some of the following medicines/classes of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, including COX-2 inhibitors (medicines 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 angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Losartán Aurovitas” and “Warnings and precautions”).

If you have impaired kidney function, concomitant use of these medicines may lead to worsening of kidney function.

Medicines containing lithium should not be used in combination with losartan without careful monitoring by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate.

Losartán Aurovitas with food and drink

Losartán Aurovitas may be taken with or without food.

Grapefruit juice should be avoided while taking losartan.

Pregnancy, breast-feeding, and fertility

If you are pregnant, breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you think you are pregnant (or could be). Usually, your doctor will advise you to stop taking Losartán Aurovitas before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine to losartan. Losartán Aurovitas is not recommended during early pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to your unborn baby if used beyond the third month of pregnancy.

Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding. Losartán Aurovitas is not recommended for breast-feeding mothers, and your doctor may choose an alternative treatment if you wish to breast-feed, particularly if your baby is a newborn or was born prematurely.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. It is unlikely that Losartán Aurovitas will affect your ability to drive or use machines. However, like 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 such activities.

Losartán Aurovitas contains lactose

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

3. How to take Losartán Aurovitas

Follow exactly the dosing instructions provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the appropriate dose of losartan based on your condition and whether you are taking other medications. It is important to continue taking losartan as prescribed by your doctor to maintain consistent blood pressure control.

Adult patients with high blood pressure

Treatment usually starts with 50 mg of losartan (one tablet of Losartán Aurovitas 50 mg) once daily. The maximum blood pressure-lowering effect is reached within 3 to 6 weeks after starting treatment. Afterwards, in some patients, the dose may be increased to 100 mg of losartan (two tablets of Losartán Aurovitas 50 mg or one tablet of Losartán Aurovitas 100 mg) once daily.

If you feel that 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 its efficacy has not been demonstrated in this age group.

Children aged between 6 and 18 years

The recommended starting dose for patients weighing between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, administered once daily (up to 25 mg of Losartán Aurovitas). Your doctor may increase the dose if blood pressure is not adequately controlled.

Other pharmaceutical forms of this medicine may be more suitable for children; please consult your doctor or pharmacist.

Adult patients with high blood pressure and type 2 diabetes

Treatment usually starts with 50 mg of losartan (one tablet of Losartán Aurovitas 50 mg) once daily. Afterwards, the dose may be increased to 100 mg of losartan (two tablets of Losartán Aurovitas 50 mg or one tablet of Losartán Aurovitas 100 mg) once daily, depending on your blood pressure response.

Losartan may be administered together with other antihypertensive medicines (e.g. diuretics, calcium antagonists, alpha or beta blockers, and centrally acting agents), as well as with insulin and other commonly used medications to lower blood glucose levels (e.g. sulfonylureas, glitazones, and glucosidase inhibitors).

Adult patients with heart failure

Treatment usually starts with 12.5 mg of losartan (half a tablet of Losartán Aurovitas 25 mg) once daily.

The dose is usually gradually increased on a weekly basis (i.e., 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week, 100 mg daily during the fourth week, and 150 mg daily during the fifth week), until a maintenance dose determined by your doctor is reached.

A maximum dose of 150 mg of losartan (for example, three tablets of Losartán Aurovitas 50 mg or one tablet of Losartán Aurovitas 100 mg and one tablet of Losartán Aurovitas 50 mg) may be used once daily.

In the treatment of heart failure, losartan is usually combined with a diuretic (a medicine that increases the amount of fluid passing through your kidneys) and/or digitalis (a medicine that helps your heart beat more strongly and efficiently) and/or a beta-blocker.

Dosage in special patient populations

Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those receiving high-dose diuretics, patients with hepatic impairment, or patients over 75 years of age. The use of losartan is not recommended in patients with severe hepatic impairment (see section "Do not take Losartán Aurovitas").

Administration

The tablets should be swallowed whole with a glass of water. Try to take your daily dose at approximately the same time each day. It is important that you continue taking Losartán Aurovitas unless your doctor tells you otherwise.

If you take more Losartán 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, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Losartán Aurovitas

If you accidentally miss a dose, simply take the next dose as scheduled. Do not take a double dose to make up for missed doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

If you experience the following, stop taking losartan tablets immediately and contact your doctor right away or go to the nearest hospital emergency department:

A serious allergic reaction (rash, itching, swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing).

This is a serious but rare adverse effect, affecting more than 1 in 10,000 patients but less than 1 in 1,000. It may require urgent medical attention or hospitalization.

The following adverse effects have been reported with Losartán Aurovitas:

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

• dizziness,
• low blood pressure (especially after excessive loss of fluid from the blood vessels, e.g. in patients with severe heart failure or receiving high doses of diuretics),
• dose-related orthostatic effects, such as a drop in blood pressure occurring after standing up from a lying or sitting position,
• weakness,
• fatigue,
• low blood sugar (hypoglycaemia),
• high potassium levels in the blood (hyperkalaemia),
• changes in kidney function, including kidney failure,
• reduced number of red blood cells (anaemia),
• increased blood urea, serum creatinine and potassium levels in patients with heart failure.

Uncommon (may affect up to 1 in 100 patients):

• drowsiness,
• headache,
• sleep disorders,
• sensation of rapid heartbeat (palpitations),
• severe chest pain (angina pectoris),
• difficulty breathing (dyspnoea),
• abdominal pain,
• constipation,
• diarrhoea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• rash,
• localized swelling (oedema),
• cough.

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

• hypersensitivity,
• angioedema,
• inflammation of blood vessels (vasculitis, including Schönlein-Henoch purpura),
• numbness or tingling sensation (paraesthesia),
• fainting (syncope),
• very rapid and irregular heartbeat (atrial fibrillation),
• stroke (cerebrovascular accident),
• liver inflammation (hepatitis),
• increased blood levels of alanine aminotransferase (ALT), which usually resolves when treatment is stopped,
• intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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

• reduced number of platelets,
• migraine,
• abnormalities in liver function,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to sunlight (photosensitivity),
• unexplained muscle pain with dark-coloured urine (tea-coloured) (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in blood (hyponatraemia),
• depression,
• general feeling of being unwell (malaise),
• ringing, buzzing, noise or clicking in the ears (tinnitus),
• altered 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging, label of the bottle, and blister pack after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Losartán Aurovitas

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

• The other components (excipients) are:

Tablet core: microcrystalline cellulose, monohydrate lactose, pregelatinized corn starch, low-substituted hydroxypropylcellulose, magnesium stearate.

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

Appearance of the product and contents of the pack

Film-coated tablet.

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

Losartán Aurovitas 100 mg is available in blister packs.

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

Only certain pack 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 medicinal product is authorized in 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 most recent review of this leaflet: January 2025

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