LOSARTAN SANDOZ 50 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Losartan Sandoz 50 mg film-coated tablets EFG

Losartan Sandoz 100 mg film-coated tablets EFG

potassium losartan

Read this entire 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Losartan Sandoz and what is it 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 blood vessels, causing them to narrow. This results in an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, which causes the blood vessels to relax, thereby lowering blood pressure. Losartan reduces the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Losartan Sandoz 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 your 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 has been shown to reduce the risk of stroke (LIFE indication).

2. What you need to know before you take Losartan Sandoz

Do not take Losartan Sandoz:

• 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 recommended to avoid Losartan Sandoz during the first months of pregnancy – see section Pregnancy),
• if your liver function is severely impaired,
• 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 or pharmacist before starting to take Losartan Sandoz.

Tell your doctor if you think you might be pregnant (or might become pregnant). Losartan is not recommended at the start of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby (see section Pregnancy).

Talk to 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 that you tell 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 (medicines 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 from your body (see section 3. Dosage in special patient groups),
• if you know you have narrowing or blockage of the blood vessels that supply your kidneys or if you have recently had a kidney transplant,
• if your liver function is impaired (see sections 2. Do not take Losartan Sandoz and 3. Dosage in special patient groups),
• if you have heart failure with or without kidney failure or life-threatening heart rhythm disorders. Special attention is needed when you are being treated at the same time with a beta-blocker,
• if you have problems with the valves in your heart or with the 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 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 Losartan Sandoz”.

Children and adolescents

Losartan 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 the available data in these patient groups are limited. Losartan is not recommended for use in children under 6 years of age, as it has not been shown to work in this age group.

Other medicines and Losartan Sandoz

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

While you are being treated with losartan, be particularly careful if you take any of the following medicines:

• other medicines that lower blood pressure, as they may cause additional lowering of 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, salt substitutes containing potassium, or potassium-sparing diuretics [e.g., amiloride, triamterene, spironolactone] or heparin),
• non-steroidal anti-inflammatory medicines, such as indomethacin, including COX-2 inhibitors (medicines that reduce inflammation and can 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 Sandoz” and “Warnings and precautions”).

If your kidney function is impaired, taking these medicines together may worsen kidney function.

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

Taking Losartan Sandoz with food and drinks

Losartan 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine. Normally, your doctor will advise you to stop taking Losartan Sandoz before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Losartan Sandoz. Losartan Sandoz is not recommended during the first trimester of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Losartan is not recommended for breastfeeding mothers, and your doctor may choose a different treatment for you if you want to breastfeed. Especially if your baby is a newborn or was born prematurely.

Talk to your doctor or pharmacist before taking this medicine.

Driving and using machines

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

It is unlikely that Losartan Sandoz will affect your ability to drive or use machines. However, as with many medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, talk to your doctor before performing these activities.

Losartan 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 told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Losartan Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Your doctor will decide the appropriate dose of Losartan Sandoz, depending on your condition and whether you are taking other medicines. It is important to keep taking Losartan Sandoz as long as your doctor prescribes it to maintain constant blood pressure control.

Adult patients with high blood pressure

Normally, treatment starts with 50 mg of losartan (one Losartan Sandoz 50 mg tablet) once a day. The maximum blood pressure-lowering effect is achieved between 3 to 6 weeks after starting treatment. After that, in some patients, the dose may be increased to 100 mg of losartan (2 Losartan Sandoz 50 mg tablets or 1 Losartan Sandoz 100 mg tablet) once a day.

If you think the effect of losartan is too strong or too weak, please talk to 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 work 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, given once a day (up to 25 mg of losartan). The doctor may increase the dose if blood pressure is not controlled.

Another pharmaceutical form of this medicine 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 Sandoz 50 mg tablet) once a day. After that, the dose may be increased to 100 mg of losartan (2 Losartan Sandoz 50 mg tablets or 1 Losartan Sandoz 100 mg tablet) once a day, depending on your blood pressure response.

Losartan can be given with other medicines that lower blood pressure (e.g., diuretics, calcium antagonists, alpha or beta blockers, and centrally acting agents), as well as with insulin and other medicines 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 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, and 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., 3 Losartan Sandoz 50 mg tablets or 1 Losartan Sandoz 100 mg tablet and 1 Losartan Sandoz 50 mg tablet) can be used once a day.

In the treatment of heart failure, losartan is normally combined with a diuretic (a medicine that increases the amount of water that passes through your kidneys) and/or digitalis (a medicine that helps your heart beat stronger and more 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 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 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 to keep taking Losartan Sandoz until your doctor tells you to stop.

If you take more Losartan Sandoz 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.

If you have taken more Losartan Sandoz than you should, talk to your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Losartan Sandoz

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

If you have any further questions on 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 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:

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 undergoing high-dose diuretic treatment),
• dose-related orthostatic effects, 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 number of red blood cells (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 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.
• intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea,

Frequency not known(frequency cannot be estimated from the 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),
• 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 that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es.

By reporting adverse effects, you can contribute to providing 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 expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

The validity period of Losartan Sandoz packaged in an HDPE bottle, once the bottle is opened, is 6 months.

Blister

This medicine does not require special storage conditions.

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

Bottle

It does not require special storage conditions.

Once the bottle is opened, do not store above 25°C.

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 Sandoz

• The active ingredient is losartan potassium.

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

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

• The other ingredients are

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

Coating: Opadry white (OY-L-28900), which contains: titanium dioxide, hypromellose, lactose monohydrate, and macrogol 4000.

Appearance of the Product and Package Contents

Losartan Sandoz 50 mg are white, oval, film-coated tablets with the inscription "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, oblong, film-coated tablets with the inscription "5" on one side and 3 score lines on both sides. The tablet can be divided into equal doses.

Losartan Sandoz is supplied in the following package sizes:

PVC/PVDC/Aluminum blister pack, in packages of 28 film-coated tablets.

HDPE bottle, in packages of 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 Last Revision of this Leaflet: February 2025

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