Losartan Stadafarma 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Losartán STADAFARMA 25 mg film-coated tablets

Losartán STADAFARMA 50 mg film-coated tablets EFG

Losartán STADAFARMA 100 mg film-coated tablets EFG

Losartan potassium

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

Contents of the leaflet

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

1. What Losartán Stadafarma 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 relaxation of the blood vessels, which in turn lowers blood pressure. Losartan slows down the progression of renal impairment in patients with high blood pressure and type 2 diabetes.

Losartan 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 who have laboratory test results indicating renal impairment 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 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 be switched 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 Stadafarma

Do not take losartan

• 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 (losartan should also be avoided in early pregnancy – see Pregnancy),
• if you have severely impaired liver function,
• 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 starting Losartán Stadafarma.

You must inform your doctor if you think you may be pregnant (or could become pregnant). Losartan is not recommended during early pregnancy and must not be used after 3 months of pregnancy, as it may cause serious harm to your unborn baby if used at this stage (see section Pregnancy).

It is important to inform your doctor before taking losartan:

• 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 diarrhoea, leading 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 and 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 have recently undergone a kidney transplant,
• if you have impaired liver function (see sections 2 “Do not take Losartán Stadafarma” 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 flow to the brain),
• if you have primary hyperaldosteronism (a syndrome associated with excessive secretion of the hormone aldosterone by the adrenal gland due to adrenal dysfunction),
• if you are taking any of the following medicines used to treat high blood pressure:
  • 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 levels of electrolytes (e.g. potassium) at regular intervals.

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

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

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

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 there is limited data available in these patient groups. 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 Stadafarma

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 taking losartan, take special care if you are also 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,
• 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 Stadafarma” 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 taken together with losartan unless your doctor closely monitors you. Special precautionary measures (e.g. blood tests) may be appropriate.

Taking Losartán Stadafarma with food and drink

Losartan can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 might be). Your doctor will normally advise you to stop taking losartan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of losartan. Losartan 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 baby if used from the third month of pregnancy onwards.

Breastfeeding

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

Driving and using machines

No studies have been conducted on the effects of losartan on the ability to drive or operate machinery.

It is unlikely that losartan will affect your ability to drive or use machines. However, like many other 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 Stadafarma contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.

3. How to take Losartán Stadafarma

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 losartan, depending on your condition and whether you are taking other medicines. It is important to keep 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 50 mg losartan tablet) once daily. The maximum blood pressure-lowering effect should be achieved within 3 to 6 weeks after starting treatment. Afterwards, in some patients, the dose may be increased up to 100 mg of losartan (two 50 mg losartan tablets or one 100 mg losartan tablet) once daily.

If you feel that the effect of losartan is too strong or too weak, 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 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 50 mg losartan tablet) once daily. Afterwards, the dose may be increased to 100 mg of losartan (two 50 mg losartan tablets or one 100 mg losartan tablet) 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 glucosidase inhibitors).

Adult patients with heart failure

Treatment usually starts with 12.5 mg of losartan (one 12.5 mg losartan tablet) once daily. The dose should usually be 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, 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 50 mg losartan tablets or one 100 mg losartan tablet plus one 50 mg losartan tablet) 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 to become 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 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 Stadafarma”).

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 losartan unless your doctor tells you otherwise.

The Losartán Stadafarma 50 mg tablet may be divided into equal doses.

If you take more Losartán Stadafarma 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 or pharmacist immediately 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 Stadafarma

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, pharmacist, or nurse.

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 immediately and contact your doctor right away 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 fewer 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 people):

• 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 upon 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 serum potassium levels in patients with heart failure.

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

• 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 people):

• hypersensitivity,
• angioedema,
• intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea,
• 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.

Frequency not known (frequency cannot be estimated from 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, pharmacist or nurse, 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Losartan Stadafarma

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

Do not use this medicine after the expiry date which is stated on the packaging or on the blister 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. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

The active substance is losartan potassium.

Losartán Stadafarma 25 mg: each film-coated tablet contains 25 mg of losartan potassium.

Losartán Stadafarma 50 mg: each film-coated tablet contains 50 mg of losartan potassium.

Losartán Stadafarma 100 mg: each film-coated tablet contains 100 mg of losartan potassium.

The other components are:

Tablet core: microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, magnesium stearate.

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

Appearance of the product and contents of the pack

Losartán Stadafarma 25 mg are white, round, film-coated tablets (5 mm in diameter) with an "E" engraved on one side.

Losartán Stadafarma 50 mg are white, round, film-coated tablets, scored on one side.

Losartán Stadafarma 100 mg are white, round, film-coated tablets.

The 25 mg tablets are available in blisters in cardboard packs containing 21, 28, 30, 56, 98 and 100 film-coated tablets, or in unit dose blisters in cardboard packs containing 21x1, 28x1, 30x1, 56x1, 98x1 and 100x1 film-coated tablets.

The 50 mg and 100 mg tablets are available in blisters containing 28, 30, 56, 90, 98 and 100 film-coated tablets, or in perforated unit dose blisters containing 28x1, 30x1, 56x1, 90x1, 98x1 and 100x1 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Clonmel Healthcare Ltd.

Waterford Rd,

Clonmel, Tipperary, E91 D768

Ireland

or

Stada Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

or

Laboratorio Liconsa, S.A.

Avda. Miralcampo, Nº7,

Pol. Ind. Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

This medicinal product is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Lithuania	Losartan 25 mg film-coated tablets Losartan 50 mg film-coated tablets Losartan 100 mg film-coated tablets
Austria	Losartan Aliud 50 mg Filmtabletten Losartan Aliud 100 mg Filmtabletten
Belgium	Losartan Eurogenerics 25 mg film-coated tablets Losartan Eurogenerics 50 mg film-coated tablets Losartan Eurogenerics 100 mg film-coated tablets
Luxembourg	Losartan Eurogenerics 25 mg film-coated tablets Losartan Eurogenerics 50 mg film-coated tablets Losartan Eurogenerics 100 mg film-coated tablets
Germany	Losartan STADA 25 mg Filmtabletten Losartan STADA 50 mg Filmtabletten Losartan STADA 100 mg Filmtabletten
Denmark	Losartan STADA
Spain	Losartan STADAFARMA 25 mg film-coated tablets Losartan STADAFARMA 50 mg film-coated tablets EFG Losartan STADAFARMA 100 mg film-coated tablets EFG
Finland	Losartan STADA 25 mg film-coated tablets Losartan STADA 50 mg film-coated tablets Losartan STADA 100 mg film-coated tablets
France	LOSARTAN EG LABO 50 mg, film-coated tablet LOSARTAN EG LABO 100 mg, film-coated tablet
Ireland	Losartan Clonmel 50 mg film-coated tablets Losartan Clonmel 100 mg film-coated tablets
Iceland	Losartan STADA 25 mg film-coated tablets Losartan STADA 50 mg film-coated tablets Losartan STADA 100 mg film-coated tablets
Italy	LOSARTAN EG STADA ITALIA
Sweden	Losartan STADA 25 mg film-coated tablets Losartan STADA 50 mg film-coated tablets Losartan STADA 100 mg film-coated tablets
Slovakia	Losartan STADA Arzneimittel 50 mg film-coated tablets
Norway	Losartan STADA 25 mg film-coated tablets Losartan STADA 50 mg film-coated tablets Losartan STADA 100 mg film-coated tablets
Estonia	Losartan 25 mg film-coated tablets Losartan 50 mg film-coated tablets Losartan 100 mg film-coated tablets
Latvia	Losartan STADA 25 mg film-coated tablets Losartan STADA 50 mg film-coated tablets Losartan STADA 100 mg film-coated tablets

Date of the most recent review of this leaflet: 02/2025.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)