Losartan tarbis farma 100 mg comprimidos recubiertos con pelicula efg

Leaflet: information for the user

Losartán Tarbis Farma 25 mg film-coated tablets

Losartán Tarbis Farma 50 mg film-coated tablets

Losartán Tarbis Farma 100 mg film-coated tablets

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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only; do not give it to others even if they have similar symptoms to 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.

Losartán belongs to a group of medications 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 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.ramiento of the function renal in patients with high blood pressure and type 2 diabetes.

Losartán potassium is used

• to treat patients with elevated blood pressure (hypertension) in adults and in children and adolescents from 6 to 18 years old.
• 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, they should not be switched to losartan.
• in patients with elevated blood pressure and increased thickness of the left ventricle of the heart, losartan has demonstrated that it reduces the risk of stroke (“LIFE indication”).

Do not take Losartan Tarbis Farma:

• 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 best to avoid losartan at the beginning of pregnancy - see Pregnancy),
• if your liver function is severely damaged,
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskirén.

Warnings and precautions

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Losartan Tarbis Farma. Your doctor will decide on the treatment to follow. Do not stop taking Losartan Tarbis Farma on your own.

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

You must inform your doctor if you think you are pregnant (or may be). Losartan 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 leading to your kidneys or if you have recently undergone a kidney transplant,
• if your liver function is altered (see sections 2 “Do not take Losartan Tarbis Farma” 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 being treated at the same time with a beta-blocker,
• if you have heart valve problems or heart muscle problems,
• 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 aldosteronism (a syndrome associated with an elevated secretion of the aldosterone hormone by the adrenal gland due to an alteration of this gland),
• if you are taking any of the following medicines 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 electrolyte levels (e.g. potassium), at regular intervals.

See also the information under the heading“Do not take Losartan Tarbis Farma”.

• if you are taking other medicines that may increase serum potassium (see section 2 “Taking losartan with other medicines”).

Children and adolescents

Losartan has been studied in children. For more information, consult your doctor.

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

Taking losartan with other medicines

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

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

While taking losartan, be particularly cautious if you take 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 reduced by some of the following medicines/classes of medicines: tricyclic antidepressants, antipsychotics, baclofeno, amifostina,
• non-steroidal anti-inflammatory drugs, such as indometacina, 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 aliskirén (see also the information under the headings“Do not take Losartan Tarbis Farma” and “Warnings and precautions”).

If your kidney function is altered, the concomitant use of these medicines may lead to a worsening of kidney function.

Medicines containing lithium should not be taken in combination with losartan without your doctor's close supervision. It may be necessary to take special precautions (e.g. blood tests).

Taking losartan with food and drinks

Losartan can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you think you are pregnant (or may be). Normally, your doctor will advise you to stop taking losartan before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of losartan. Losartan 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.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start breastfeeding. Losartan 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.

Consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

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

It is unlikely that losartan will affect your ability to drive or use machines. However, as 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 these activities.

Losartan contains lactose

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

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. After that, 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 losartan's action 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 shown to be effective in this age group.

Children aged 6-18 years

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 your 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. After that, 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 taken 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 reduce 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 the treatment of heart failure, losartan is usually 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.

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 doses of diuretics, patients with severe liver dysfunction, or patients over 75 years old. Losartan is not recommended for use in patients with severe liver dysfunction (see "Do not take losartan").

Administration

Swallow the tablets whole with a glass of water. Try to take your daily dose at approximately the same time each day. It is essential to continue taking losartan until your doctor tells you otherwise.

The tablet can be divided into equal doses (only for 25 mg and 50 mg).

If you take more losartan 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.

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

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.

Like all medicines, this medicine can 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:

Common(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 taking 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 kidney function, including kidney failure,
• reduced red blood cell count (anemia),
• increased urea in the blood, serum creatinine, and serum potassium in patients with heart failure.

Uncommon(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,
• 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.
• Intestinal angioedema: an inflammation in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known(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,
• pancreatitis (inflammation of the pancreas),
• low sodium levels in the blood (hyponatremia),
• depression,
• usually feeling unwell (malaise),
• ringing, buzzing, or clicking sounds in the ears (tinnitus),
• alteration of taste (dysgeusia).

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

Reporting 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.

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 after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special temperature for conservation.

Store in the original packaging to protect it from moisture.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Losartán Tarbis Farma

The active ingredient is losartan potassium.

Each losartan 25mg tablet contains 25 mg of losartan potassium.

Each losartan 50mg tablet contains 50 mg of losartan potassium.

Each losartan 100mg tablet contains 100 mg of losartan potassium.

The other components are:

Microcrystalline cellulose (PH 102 & PH 200), lactose monohydrate, pregelatinized cornstarch, low-substitution hydroxypropylcellulose, crospovidone (type A), magnesium stearate, hypromellose 2910 6cP (E-464), titanium dioxide (E-171), and carnauba wax.

Appearance of the product and contents of the package

Losartán Tarbis Farma 25 mg film-coated tablets

White to off-white, oval-shaped, biconvex, film-coated tablets, approximately 8.3 x 4.5 mm, with "I" on one face and "5" on the other face with a notch.

The tablet can be divided into equal doses.

Losartán Tarbis Farma 50 mg film-coated tablets

Oval-shaped, white to off-white, film-coated tablets, approximately 10.4 x 5.5 mm, with "I" on one face and "6" on the other face with a notch.

The tablet can be divided into equal doses.

Losartán Tarbis Farma 100 mg film-coated tablets

White to off-white, tear-drop shaped, film-coated tablets, approximately 11.8 x 7.2 mm, with "H" on one face and "145" on the other face.

Aluminum-PVC/PVdC blister pack containing 28, 30, 56, 90, 98, or 250 film-coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicinal product is authorized in the member states of the European Economic Area under the following names:

Germany:Losartan-Kalium Amarox 25 mg/50 mg/100 mg Filmtabletten

Spain:Losartán Tarbis Farma 25 mg/50 mg/100 mg film-coated tabletsEFG

Netherlands:Losartankalium Amarox 25 mg/50 mg/100 mg, filmomhulde tabletten

Revision date of this leaflet:

December 2024

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/