Losartan teva-ratio 100 mg comprimidos recubiertos con pelicula efg

Leaflet: information for the user

Losartán Teva-ratio 100mg 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 or pharmacist.

- This medicine has been prescribed for you only. Do not give it 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 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

Losartánbelongs 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.

Losartan Teva-ratio is used:

• to treat patients with elevated blood pressure (hypertension) in adults and in children and adolescents aged 6 – 18 years.
• to protect the kidneys in hypertensive patients with type 2 diabetes and laboratory test results indicating renal insufficiency and proteinuria ≥ 0.5 g per day (a situation 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 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 your liver function is severely impaired,
• if you are more than 3 months pregnant. (It is also best to avoid Losartán Teva-ratio at the beginning of pregnancy - see section 2: Pregnancy and breastfeeding),
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and precautions

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

You should inform your doctor if you think you are pregnant (or may be). Losartán Teva-ratio is not recommended at the beginning of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your child (see section 2: Pregnancy and breastfeeding).

Before taking Losartán Teva-ratio, it is essential that you inform your doctor:

• if you have had a history of angioedema (swelling of the face, lips, tongue and/or throat) (see 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 are following a low-sodium diet that causes excessive loss of fluids or salt from your body (see section 3.‘Posology 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 Teva-ratio" 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 aldosteronism (a syndrome associated with high secretion of the hormone aldosterone 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:
• an 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 Teva-ratio”.

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

Children and adolescents

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

Losartán Teva-ratio is not recommended for use in children with kidney or liver problems, as there are limited data available in these patient groups.Losartán Teva-ratio 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 Losartán Teva-ratio 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 that contain 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 trimetoprim), as the combination with Losartán Teva-ratio is not recommended.

While taking Losartán Teva-ratio, be particularly careful if you are taking 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/class of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory medicines, such as indometacin, 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 modify your dose and/or take other precautions: If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Losartán Teva-ratio” and “Warnings and precautions”).

If your kidney function is impaired, the concomitant use of these medicines may cause worsening of kidney function.

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

Taking Losartán Teva-ratio with food and drink

Losartán Teva-ratio can be taken with or without food.

It is recommended to avoid grapefruit juice while taking losartan.

Pregnancy and breastfeeding

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

Pregnancy

You should inform your doctor if you think you are pregnant (or may be). Normally, your doctor will recommend that you stop taking Losartán Teva-ratio before becoming pregnant or as soon as you know you are pregnant and advise you to take another medicine different from Losartán Teva-ratio.

Losartán Teva-ratio is not recommended at the beginning of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your child if used after the third month of pregnancy.

Breastfeeding

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

Driving and using machines

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.

Losartán Teva-ratio contains lactose

Losartán Teva-ratio contains lactose monohydrate. 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 the appropriate dose of losartan, depending on your condition and if you are taking other medications.

It is essential to continue taking Losartán Teva-ratio as prescribed by your doctor to maintain constant blood pressure control.

Losartán Teva-ratio is available in 2 doses:12.5mg and 100 mg film-coated tablets. The 100mg tablets can be divided into equal doses.

Adult patients with high blood pressure

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

If you estimate that the action of Losartán Teva-ratio is too strong or too weak, please inform your doctor or pharmacist.

Use in children and adolescents

Children under 6 years

Losartán Teva-ratio is not recommended for use in children under 6 years, as it has shown not to work in this age group.

Children 6 to 18 years

The recommended starting dose in patients weighing between 20 and 50kg is 0.7mg of losartan per kg of body weight, administered once a day (up to 25mg of Losartán Teva-ratio). The 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 50mg of losartan (one Losartán 50 mg tablet) once a day. After that, the dose may be increased to 100mg of losartan (two Losartán 50mg tablets) once a day, depending on your blood pressure response.

Losartán Teva-ratio 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 12.5mg of losartan (one Losartán Teva-ratio 12.5mg tablet) once a day. Typically, the dose is gradually increased, weekly (i.e., 12.5mg per day for the first week, 25mg per day for the second week, 50mg per day for the third week, 100mg per day for the fourth week, 150mg per day for the fifth week), to a maintenance dose determined by your doctor. A maximum dose of 150mg of losartan (e.g., three Losartán Teva-ratio 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, in patients with liver insufficiency, or in patients over 75 years old. Losartan is not recommended for use in patients with severe liver insufficiency (see "Do not takeLosartán Teva-ratio").

Administration

The tablets should be taken with a glass of water. You should try to take your daily dose at approximately the same time each day. It is essential to continue taking Losartán Teva-ratio until your doctor tells you otherwise.

If you take more Losartán Teva-ratio than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 915620420, indicating the medication and the amount ingested. The symptoms of overdose are low blood pressure, increased heart rate, and possibly decreased heart rate.

If you forget to take Losartán Teva-ratio tablets

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:

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

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,
• Vertigo,
• 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),
• Dose-related orthostatic effects, such as a decrease in blood pressure that occurs after standing up from a lying or sitting position,
• Weakness,
• Fatigue,
• Low blood sugar (hypoglycemia),
• High potassium levels in the blood (hyperkalemia),
• Liver function changes, including renal failure,
• Reduced red blood cell count (anemia),
• Increased urea, creatinine, and potassium levels in the blood in patients with heart failure.

Occasional (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),
• Rash,
• Localized swelling (edema),
• Cough.

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

• Hyperensitivity,
• Inflammation of blood vessels (vasculitis, including Schönlein-Henoch purpura),
• Numbness or tingling (paresthesia),
• Fainting (syncope),
• Very rapid and irregular heartbeats (atrial fibrillation),
• Stroke (cerebrovascular accident),
• Liver inflammation (hepatitis),
• Elevation of alanine aminotransferase (ALT) levels in the blood, which usually resolves upon discontinuing treatment.

Unknown frequency (frequency cannot be estimated from available data):

• Reduced platelet count,
• Migraine,
• Liver function anomalies,
• Muscle and joint pain,
• Symptoms similar to the flu,
• Back pain and urinary tract infection,
• Increased sensitivity to sunlight (photosensitivity),
• Muscle pain of unknown origin with dark-colored urine (tea-colored urine) (rhabdomyolysis),
• Impotence,
• Pancreatitis,
• Low sodium levels in the blood (hyponatremia),
• Depression,
• Generally 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 of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish System for 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 medicine after the expiration date that appears on the box and on the blister after "CAD". The expiration date is the last day of the month indicated.

PVC/PVdC/Al or PVC/PE/PVdC/Al blisters

Do not store above 25°C.

OPA/Alu/PVC/Al blisters

This medicine does not require special storage conditions.

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

This medicine does not require special storage conditions.

Once opened, expiration date of 6 months

Medicines should not be thrown down the drain or in the trash. Dispose of the containersand medicines that you do not need at the SIGRE pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you do not need. In this way, you will help protect the environment.

Composition of Losartán Teva-ratio

• The active ingredient is losartan potassium. Each Losartán Teva-ratio film-coated tablet contains 100 mg of losartan potassium.

• The other components are lactose monohydrate, microcrystalline cellulose (E 460i), pregelatinized starch, and magnesium stearate (E 470b) in the tablet core, and polyvinyl alcohol, titanium dioxide (E 171), macrogol, and talc in the film coating.

Appearance of Losartán Teva-ratio and contents of the package

• Losartán Teva-ratio 100 mg film-coated tablets are white, oval, slightly arched, and engraved with "100" on one side and a notch on the other side.

Each tablet has a diameter of approximately 14 mm, a length of 8 mm, and a thickness of 5 mm.

Losartán Teva-ratio 100 mg film-coated tablets are available in blister packs of 7, 14, 28, 30, 50, 56, 60, 90, 98, and 100 film-coated tablets.

Losartán Teva-ratio 100 mg film-coated tablets are also available in perforated blister packs of 28x1 and 50x1 film-coated tablets.

Losartan Teva-ratio 100 mg film-coated tablets are also available in HDPE bottles with a package of 28 film-coated tablets.

Only some package sizes may be marketed.

Holder of the Marketing Authorization

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor, 28108 - Madrid, Spain

Responsible for Manufacturing

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen, Hungary

OR

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany

OR

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem, Postbus 552, 2003 RN Haarlem, Netherlands

OR

Teva Pharma S.L.U.

C/C, n 4, Polígono Industrial Malpica, 50016 Zaragoza, Spain

This medicine is authorized in the Member States with the following names:

Germany: Losartán-ratiopharm 100 mg Filmtabletten

Spain: Losartán Teva-ratio 100 mg film-coated tablets EFG

Finland: Losatrix

France: Losartan Ratio 100 mg, comprimé pelliculé

Luxembourg: Losartan-ratiopharm 100 mg Filmtabletten

Netherlands: Losartankalium 100 mg ratiopharm, filmomhulde tabletten

Last review date of this leaflet: October 2024

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

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79922/P_79922.html