Losartan teva-ratio 50 mg comprimidos recubiertos con pelicula efg

Leaflet: Information for the user

Losartán Teva-ratio 50 mg film-coated tablets

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 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, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Losartán Teva-ratio is and what it is used for

2. What you need to know before you start taking Losartán Teva-ratio

3. How to take Losartán Teva-ratio

4. Possible side effects

5. Storage of Losartán Teva-ratio

6. Contents of the pack and additional information

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 worsening of renal function in patients with high blood pressure and type 2 diabetes.

Losartán Teva-ratio is used for

• treating patients with elevated blood pressure (hypertension) in adults and in children and adolescents aged 6 to 18 years.
• protecting the kidneys 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).
• treating 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 switch to losartan.
• in patients with elevated blood pressure and left ventricular hypertrophy of the heart, losartan has been shown to reduce the risk of stroke (LIFE indication).

Do not take Losartán Teva-ratio

• 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 section),
• if your liver function is severely damaged,
• if you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskirén.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Losartan Teva-ratio.

You must inform your doctor if you think you are pregnant (or could be). Losartan is not recommended at the beginning of pregnancy, and it should not be taken if you are more than three 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 taking losartan:

• 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 groups of patients),
• 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 Teva-ratio and 3. Dosage in special groups of patients),
• 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 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 blood pressure medications:
• an angiotensin-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 Losartán Teva-ratio”.

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

Consult 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.

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 there are limited available data 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.

Other medicines and Losartan Teva-ratio

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 that contain 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 it is not recommended to combine them with losartan.

While taking losartan, be particularly cautious if you are taking 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 decrease with some of the following medicines/classes of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• nonsteroidal 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 angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskirén (see also the information under the headings “Do not take Losartán Teva-ratio” and “Warnings and precautions”).

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

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

Losartan Teva-ratio with food and drinks

Losartan can be taken with or without food.

It is recommended to avoid grapefruit juice while taking losartan.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you think you are pregnant (or could be). Normally, your doctor will advise you to stop taking losartan before becoming pregnant or as soon as you know you are pregnant and 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 three 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 Teva-ratio 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.

Losartán Teva-ratio contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Follow exactly the administration instructions of this medication as 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 whether you are taking other medications. It is essential to continue taking losartan as prescribed by your doctor to maintain consistent blood pressure control.

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 is 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) once a day.

If you estimate that the losartan effect is too strong or too weak, please 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 forms of this medication may be more suitable for children; ask your doctor or pharmacist.

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) 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 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 initiation tablet) once a day. The dose should be gradually increased, weekly (i.e., 12.5 mg once a day for the first week, 25 mg once a day for the second week, 50 mg once a day for the third week, 100 mg once a day for the fourth week, 150 mg once a day for the fifth week), to a dose determined by your doctor. A maximum dose of losartan of 150 mg (e.g., three losartan 50 mg tablets) once a day may be used.

In the treatment of heart failure, 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 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 Teva-ratio").

Administration

The tablets should be taken with a glass of water. 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.

If you take more Losartan Teva-ratio than you should

If you accidentally take too many tablets, or if a child swallows some, 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 Teva-ratio

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 doubts about the use of this medication, ask your doctor or pharmacist.

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:

A severe allergic reaction (skin 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 fewer 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 from the blood vessels, for example 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 after standing up from lying or sitting
• weakness
• fatigue
• low blood sugar (hypoglycemia)
• high potassium levels in the blood (hyperkalemia)
• changes in renal function, including renal insufficiency
• reduced red blood cell count (anemia)
• increased urea in the blood
• increased serum creatinine and potassium levels in patients with heart failure.

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

• drowsiness
• headache
• sleep disturbances
• feeling of very rapid heartbeats (palpitations)
• severe chest pain (angina pectoris)
• difficulty breathing (dyspnea)
• abdominal pain
• constipation
• diarrhea
• nausea
• vomiting
• hives (urticaria)
• itching (pruritus)
• skin rash
• localized swelling (edema)
• cough

Rare (may affect up to 1 in 1,000 people):

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

Frequency not known (the frequency cannot be estimated from 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)
• unknown origin 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 effects, consult your doctor or pharmacist, even if it is a 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, Website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep 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.

Conserve Losartán Teva-ratio in the original packaging..

Blister

No special storage conditions are required.

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

High-density polyethylene (HDPE) opaque white container with a screw cap with desiccant of opaque polypropylene (PP) tamper-evident (Tamper-evident, TE) or tamper-evident / suitable for the elderly (TE / SF).

This medication does not require special storage conditions.

Once opened, expiration date of 6 months

Medicines should not be disposed of through the drains or in the trash. Deposit the containers and unused medications at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the containers and unused medications. In this way, you will help protect the environment.

Composition of Losartán Teva-ratio

- The active ingredient of Losartán Teva-ratio is losartan potassium.

Cada comprimido de Losartán Teva-ratio 50 mg contains 50 mg of losartan (as potassium salt).

- The other components are in the core: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, and magnesium stearate.

Losartán Teva-ratio 50 mg contains potassium in the following amount: 4.24 mg (0.108 mEq).

Losartán Teva-ratio 50 mg tablets also contain in the film coating: alcohol, partially hydrolyzed polyvinyl chloride, titanium dioxide, macrogol, and talc.

Appearance of the product and content of the container

Losartán Teva-ratio is supplied as film-coated tablets, white, oval, slightly arched, engraved with “50” on one side, scored on the other containing 50 mg of losartan potassium.

Losartán Teva-ratio is supplied in the following container sizes:

Losartán Teva-ratio 50 mg - is presented in a container with 28 and 500 film-coated tablets containing each tablet 50 mg of losartan potassium in a white opaque PVC/PVdC/Al blister or in an HDPE bottle (contains desiccant) with 28 film-coated tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas. Madrid. Spain

Responsible for manufacturing:

Teva Pharmaceutical Works Co. Ltd.

Pallagi út 13

Debrecen (Hungary)

or

Teva Pharma S.L.U.

C/ C, n 4 Industrial Estate Malpica

50016 Zaragoza

Spain

Date of the last review of this leaflet:February 2025

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

You can access detailed and updated information on this medicine by scanning with your smartphone the QR code included in the carton. You can also access this information on the following internet address: https://cima.aemps.es/cima/dochtml/p/68944/P_68944.html