Losartan stadafarma 100… – інструкція – Іспанія

Інструкція із застосування Losartan stadafarma 100 mg comprimidos recubiertos con pelicula efg

Introduction

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

Potassium losartan

Read this 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, consult your doctor, pharmacist or nurse.
This medicine has been prescribed for you only; do not pass it on to others even if they have the same symptoms as you, as it may harm them.
If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

What Losartán Stadafarma is and what it is used for
What you need to know before you start taking Losartán Stadafarma
How to take Losartán Stadafarma
Possible side effects
Storage of Losartán Stadafarma
Contents of the pack and additional information

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

Losartán belongs to a group of medications known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that binds to receptors present in blood vessels, causing them to constrict. This results in an increase in blood pressure. Losartán prevents the binding of angiotensin II to these receptors, causing blood vessels to relax, which in turn reduces blood pressure. Losartán reduces the impairment of renal function in patients with high blood pressure and type 2 diabetes.rament of the function renal in patients with high blood pressure and type 2 diabetes.

Losartán is used

to treat patients with elevated 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 clinical tests indicating renal insufficiency and proteinuria ≥ 0.5 g per day (a disease in which the urine contains an abnormal amount of proteins).
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 reduce elevated blood pressure) are not suitable. If their heart failure has been stabilized with an ACE inhibitor, do not change to losartán.
in patients with elevated blood pressure and increased thickness of the left ventricle of the heart, losartán has demonstrated that it reduces the risk of stroke (“LIFE indication”).

2. What you need to know before starting to take Losartan Stadafarma

Do not take losartán

if you are allergic to losartán 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 losartán at the beginning of pregnancy - see Pregnancy),
if your liver function is severely impaired,
if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medication that contains aliskirén.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Losartán Stadafarma.

You should inform your doctor if you think you are pregnant (or may be). Losartán is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see Pregnancy section).

It is essential to inform your doctor before takinglosartán:

if you have had 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 cause 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 follow a low-sodium diet that causes excessive loss of fluids 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 that go to your kidneys or if you have recently had a kidney transplant,
if your liver function is altered (see sections 2 “Do not take Losartán Stadafarma” and 3 “Posology in special patient groups”),
if you have heart failure with or without kidney failure or potentially fatal cardiac arrhythmias. Special attention is required when you are being treated at the same time with a beta-blocker,
if you have problems with your heart valves or heart muscle,
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 an elevated secretion of the hormone aldosterone by the adrenal gland due to an alteration of this gland),
if you are taking any of the following medications used to treat high blood pressure:
- a converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
- aliskirén.

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 medications that may increase serum potassium levels (see section 2 “Other medications and Losartán Stadafarma”).

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

Children and adolescents

Losartán has been studied in children. For more information, talk to your doctor.

Losartán is not recommended for use in children with kidney or liver problems, as there is limited data available for these patient groups. Losartán is not recommended for use in children under 6 years old, as it has not been shown to be effective in this age group.

Other medications and Losartán Stadafarma

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Inform your doctor if you are taking potassium supplements, salt substitutes that contain potassium, or potassium-sparing medications such as certain diuretics (amilorida, triamtereno, spironolactone) or other medications that may increase serum potassium levels (e.g. heparin, medications containing trimetoprim), as the combination with losartán is not recommended.

While taking losartán, be cautious if you are taking any of the following medications:

other medications that lower blood pressure, as they may cause an additional reduction in blood pressure. Blood pressure may also be reduced by some of the following medications/classes of medications: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
nonsteroidal anti-inflammatory drugs (NSAIDs), such as indometacina, including COX-2 inhibitors (medications that reduce inflammation and can be used to relieve pain), as they may reduce the blood pressure-lowering effect of losartán.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Losartán Stadafarma” and “Warnings and precautions”).

If your kidney function is impaired, the concomitant use of these medications may lead to worsening kidney function.

Lithium-containing medications should not be taken in combination with losartán without close monitoring by your doctor. It may be necessary to take special precautions (e.g. blood tests).

Losartán Stadafarma with food and drinks

Losartán can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should inform your doctor if you think you are pregnant (or may be). Normally, your doctor will advise you to stop taking losartán before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medication instead of losartán. Losartán is not recommended at the beginning of pregnancy, and it should 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.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start breastfeeding. Losartán is not recommended for use in breastfeeding mothers, and your doctor may choose another treatment if you wish to continue breastfeeding, especially if your baby is a newborn or premature.

Driving and operating machinery

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

It is unlikely that losartán will affect your ability to drive or use machines. However, as many medications used to treat high blood pressure, losartán may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, consult your doctor before engaging in these activities.

Losartán Stadafarma contains lactose

This medication contains lactose. 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 Losartán Stadafarma

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will decide on the appropriate dose of losartan, depending on your condition and if 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

Typically, treatment begins with 50 mg of losartan (one losartan 50 mg tablet) once a day. The maximum blood pressure-lowering effect should be achieved within 3-6 weeks of starting treatment. Subsequently, in some patients, the dose may be increased to 100 mg of losartan (two losartan 50 mg tablets or one losartan 100 mg tablet) once a day.

If you estimate that the losartan effect is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents

Children under 6 years old

Losartan is not recommended for use in children under 6 years old, as it has not been proven to be effective in this age group.

Children aged 6-18 years old

The recommended starting dose in patients weighing 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). Your 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

Typically, treatment begins with 50 mg of losartan (one losartan 50 mg tablet) once a day. Subsequently, the dose may be increased to 100 mg of losartan (two losartan 50 mg tablets or one losartan 100 mg tablet) once a day, depending on your blood pressure response.

Losartan can be administered with other medications that lower blood pressure (e.g., diuretics, calcium channel blockers, alpha or beta blockers, and central-acting medications), as well as with insulin and other medications frequently used to decrease blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Adult patients with heart failure

Typically, treatment begins with 12.5 mg of losartan (one losartan 12.5 mg tablet) once a day. Typically, the dose should be increased gradually, 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), to a maintenance dose determined by your doctor. A maximum dose of 150 mg of losartan (e.g., three losartan 50 mg tablets or one losartan 100 mg tablet and one losartan 50 mg tablet) once a day may be used.

In heart failure treatment, losartan is typically 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.

Posology in special patient groups

Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those treated with high doses of diuretics, patients with severe liver insufficiency, or patients over 75 years old. Losartan is not recommended for use in patients with severe liver insufficiency (see "Do not take Losartan Stadafarma").

Administration

Tablets should be swallowed whole with a glass of water. You should try to take your daily dose approximately at the same time each day. It is essential to continue taking losartan until your doctor tells you otherwise.

The losartan 50 mg Stadafarma tablet can be divided into equal doses.

If you take more Losartan 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Losartan Stadafarma

If you accidentally forget a dose, simply take the next dose as usual. Do not take a double dose to compensate for the missed doses. If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of the following, stop taking losartan tablets and inform your doctor immediately or go to the emergency service of your nearest hospital:

Severe allergic reaction (rash, itching, swelling of the face, lips, mouth, or throat that may cause difficulty swallowing or breathing).

This is a serious but rare side effect that affects more than 1 in 10,000 patients but less than 1 in 1,000. You may need urgent medical attention or hospitalization.

The following side effects have been reported with losartan:

Frequent (may affect up to 1 in 10 people):

dizziness,
low blood pressure (especially after excessive loss of body water within blood vessels, e.g. in patients with severe heart failure or those treated with high doses of diuretics),
orthostatic effects related to the dose, 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 renal function that include kidney failure,
reduced red blood cell count (anemia),
increased urea in the blood, serum creatinine, and serum potassium in patients with heart failure.

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

drowsiness,
headache,
sleep disturbances,
sensation 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 people):

hypersensitivity,
angioedema,
intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea,
inflammation of blood vessels (vasculitis, including Schönlein-Henoch purpura),
numbness or tingling (paresthesia),
syncope (fainting),
very rapid and irregular heartbeats (atrial fibrillation),
stroke (cerebral attack),
inflammation of the liver (hepatitis),
elevation of alanine aminotransferase (ALT) levels in the blood, which usually resolves upon discontinuing treatment.

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

reduced platelet count,
migraine,
abnormal liver function,
muscle and joint pain,
flu-like symptoms,
back pain and urinary tract infection,
increased sensitivity to sunlight (photosensitivity),
unknown muscle pain with dark-colored urine (tea-colored) (rhabdomyolysis),
impotence,
inflammation of the pancreas (pancreatitis),
low sodium levels in the blood (hyponatremia),
depression,
usually feeling unwell (malaise),
ringing, buzzing, noise, or clicking in the ears (tinnitus),
alteration of taste (dysgeusia).

The side effects in children are similar to those observed in adults.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Losartán Stadafarma

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

Do not use this medication after the expiration date that appears on the packaging or in the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and themedicines that you no longer need at the SIGRE collection pointat the pharmacy. Ask yourpharmacist how to dispose of the packaging and the medicines that you no longer need. This will help protect the environment.

6. Contents of the packaging and additional information

The active ingredient 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:

Core tablet: Microcrystalline cellulose, lactose monohydrate, pregelatinized maize starch, magnesium stearate.

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

Appearance of the product and contents of the package

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

Losartán Stadafarma 50 mg are white, round film-coated tablets with a score on one face.

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

The 25 mg tablets are available in blisters in cartons of 21, 28, 30, 56, 98 and 100 film-coated tablets or in single-dose blisters in cartons of 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 perforated single-dose blisters containing 28x1, 30x1, 56x1, 90x1, 98x1 and 100x1 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Clonmel Healthcare Ltd.

Waterford Rd,

Clonmel, Tipperary, E91 D768

Ireland

Stada Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

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) with the following names:

Lithuania	Losartan 25 mg plevele dengtos tabletes Losartan 50 mg plevele dengtos tabletes Losartan 100 mg plevele dengtos tabletes
Austria	Losartan Aliud 50 mg Filmtabletten Losartan Aliud 100 mg Filmtabletten
Belgium	Losartan Eurogenerics 25 mg filmomhulde tabletten Losartan Eurogenerics 50 mg filmomhulde tabletten Losartan Eurogenerics 100 mg filmomhulde tabletten
Luxembourg	Losartan Eurogenerics 25 mg comprimés pelliculés Losartan Eurogenerics 50 mg comprimés pelliculés Losartan Eurogenerics 100 mg comprimés pelliculés
Germany	Losartan STADA 25 mg Filmtabletten Losartan STADA 50 mg Filmtabletten Losartan STADA 100 mg Filmtabletten
Denmark	Losartan STADA
Spain	Losartán STADAFARMA 25 mg comprimidos recubiertos con película Losartán STADAFARMA 50 mg comprimidos recubiertos con película EFG Losartán STADAFARMA 100 mg comprimidos recubiertos con película EFG
Finland	Losartan STADA 25 mg kalvopäällysteiset tabletit Losartan STADA 50 mg kalvopäällysteiset tabletit Losartan STADA 100 mg kalvopäällysteiset tabletit
France	LOSARTAN EG LABO 50 mg, comprimé pelliculé LOSARTAN EG LABO 100 mg, comprimé pelliculé
Ireland	Losartan Clonmel 50 mg film-coated tablets Losartan Clonmel 100 mg film-coated tablets
Iceland	Losartan STADA 25 mg filmuhúðaðar töflur Losartan STADA 50 mg filmuhúðaðar töflur Losartan STADA 100 mg filmuhúðaðar töflur
Italy	LOSARTAN EG STADA ITALIA
Sweden	Losartan STADA 25 mg filmdragerade tabletter Losartan STADA 50 mg filmdragerade tabletter Losartan STADA 100 mg filmdragerade tabletter
Slovakia	Losartan STADA Arzneimittel 50 mg filmom obalené tablety
Norway	Losartan STADA 25 mg filmdrasjerte tabletter Losartan STADA 50 mg filmdrasjerte tabletter Losartan STADA 100 mg filmdrasjerte tabletter
Estonia	Losartan 25 m õhukese polümeerikattega tabletid Losartan 50 mg õhukese polümeerikattega tabletid Losartan 100 mg õhukese polümeerikattega tabletid
Lithuania	Losartan STADA 25 mg apvalkotas tabletes Losartan STADA 50 mg apvalkotas tabletes Losartan STADA 100 mg apvalkotas tabletes

Last revision date of this leaflet:02/2025.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/)

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