Losartan Sandoz 50 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the patient

Losartan Sandoz 50 mg film-coated tablets EFG

Losartan Sandoz 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. 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. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Losartán Sandoz 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 in the blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartan blocks angiotensin II from binding to these receptors, causing the blood vessels to relax, thereby lowering blood pressure. Losartan also slows down the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Losartán Sandoz 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 your doctor considers that treatment with specific medicines called angiotensin-converting enzyme (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, losartan has been shown to reduce the risk of stroke (LIFE indication).

2. What you need to know before taking Losartán Sandoz

Do not take Losartán Sandoz:

• if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6),
• if you are more than 3 months pregnant. (It is also advisable to avoid Losartán Sandoz during the first months of pregnancy – see Pregnancy section),
• if you have severely impaired liver function,
• if you have diabetes or kidney failure and are being treated with an antihypertensive medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking Losartán Sandoz.

Tell your doctor if you think you may be pregnant (or suspect pregnancy). Losartan is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious harm to your unborn child (see Pregnancy section).

Contact 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 important to inform your doctor:

• if you have ever had angioedema (swelling of the face, lips, tongue, and/or throat) (see also section 4. Possible side effects),
• if you are experiencing excessive vomiting or diarrhea, which may lead to 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 cause 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 Sandoz and 3. Dosage in special patient groups),
• if you have heart failure with or without kidney failure 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 heart's blood vessels) 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 inhibitor (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 Sandoz”.

Children and adolescents

Losartan 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 available data in these patient groups are limited. Losartan is not recommended for use in children under 6 years of age, as efficacy has not been demonstrated in this age group.

Other medicines and Losartán Sandoz

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

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 decrease 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 may increase potassium levels (e.g. potassium supplements, potassium-containing salt substitutes, or potassium-sparing medicines such as certain diuretics [amiloride, triamterene, spironolactone] or heparin),
• 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 inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Losartán Sandoz” 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 unless your doctor closely monitors you. Special precautionary measures (e.g. blood tests) may be appropriate.

Taking Losartán Sandoz with food and drink

Losartán Sandoz can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Usually, your doctor will advise you to stop taking Losartán Sandoz before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine to Losartán Sandoz. Losartán Sandoz 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 child if used after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Losartan is not recommended for nursing mothers, and your doctor may choose an alternative treatment for you if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

It is unlikely that Losartán Sandoz 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 performing such 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 informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Losartán Sandoz

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of Losartán Sandoz, depending on your condition and whether you are taking other medicines. It is important to keep taking Losartán Sandoz 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 Sandoz 50 mg) once daily. The maximum blood pressure-lowering effect is reached between 3 and 6 weeks after starting treatment. Afterwards, in some patients, the dose may be increased to 100 mg of losartan (two tablets of Losartán Sandoz 50 mg or one tablet of Losartán Sandoz 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 effectiveness 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 losartan). 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 Sandoz 50 mg) once daily. Afterwards, the dose may be increased to 100 mg of losartan (two tablets of Losartán Sandoz 50 mg or one tablet of Losartán Sandoz 100 mg) once daily, depending on your blood pressure response.

Losartan may be administered together with other blood pressure-lowering 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 reduce blood glucose levels (e.g. sulfonylureas, glitazones, and alpha-glucosidase inhibitors).

Adult patients with heart failure

Treatment usually starts with 12.5 mg once daily. The dose is usually increased gradually 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), up to a maintenance dose determined by your doctor. A maximum dose of 150 mg of losartan (e.g. three tablets of Losartán Sandoz 50 mg or one tablet of Losartán Sandoz 100 mg plus one tablet of Losartán Sandoz 50 mg) once daily may be used.

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 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 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 Sandoz").

Administration

The tablets should be swallowed whole with a glass of water. You should try to take your daily dose at approximately the same time each day. It is important that you 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. Symptoms of overdose include low blood pressure, increased heart rate, and possibly decreased heart rate.

If you have taken more Losartán Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Losartán Sandoz

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 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 everyone experiences them.

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

A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat which may cause difficulty 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 losartan:

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 decreased blood pressure occurring after rising 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 levels of urea, creatinine and serum potassium in patients with heart failure.

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

• drowsiness,
• headache,
• sleep disorders,
• sensation of very 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),
• inflammation of the liver (hepatitis),
• elevated levels of alanine aminotransferase (ALT) in blood, which usually resolves upon discontinuation of treatment,
• 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,
• generally feeling unwell (malaise),
• ringing, buzzing, noise or clicking in the ears (tinnitus),
• taste disturbance (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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Losartan Sandoz

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

The shelf life of Losartan Sandoz in HDPE bottles, once the bottle has been opened, is 6 months.

Blister

This medicine does not require any special storage conditions.

Do not open the blister until ready to take the medicine.

Bottle

No special storage conditions are required.

After opening the bottle, do not store at temperatures above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Losartan Sandoz

• The active substance is potassium losartan.

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

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

• The other components are:

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

Coating: Opadry White (OY-L-28900), containing: titanium dioxide, hypromellose, lactose monohydrate and macrogol 4000.

Appearance of the product and contents of the pack

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

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

Losartan Sandoz is supplied in the following pack sizes:

PVC/PVDC/Aluminum blister packs containing 28 film-coated tablets.

HDPE bottles containing 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble,

C/Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Salutas Pharma GmbH

Otto-von-Guericke-Allee, 1

39179 Barleben

Germany

Or

Lek Pharmaceuticals d.d.

Trimlini 2D, 9220

Lendava,

Slovenia

Or

Lek Pharmaceutical Company d.d.

Verovskova, 57

Ljubljana 1526

Slovenia

Or

Lek S.A.

Ul. Podlipie 16

95 010 Strykow

Poland

Date of the most recent revision of this leaflet: February 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) www.aemps.gob.es