Losartan teva-ratiopharm 25 mg comprimidos recubiertos con pelicula

Leaflet: information for the user

Teva-ratiopharm Losartan 25 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 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 Losartan Teva-ratiopharm is and what it is used for

2.- What you need to know before you start taking Losartan Teva-ratiopharm

3.- How to take Losartan Teva-ratiopharm

4.- Possible side effects

5.- Storage of Losartan Teva-ratiopharm

6.- Contents of the pack and additional information

Losartánbelongs 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 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 kidney function in patients with high blood pressure and type 2 diabetes.

Losartan Teva-ratiopharm is used:

-to treat patients with high 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 medicines, called angiotensin-converting enzyme inhibitors (ACE inhibitors, medicines used to reduce high 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 high blood pressure and left ventricular hypertrophy, losartan has been shown to reduce the risk of stroke (“LIFE indication”).

Do not take Losartán Teva-ratiopharm

-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-ratiopharm at the beginning of pregnancy - see section 2: Pregnancy and lactation),

• 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-ratiopharm.

You must inform your doctor if you think you are pregnant (or may be). Losartán Teva-ratiopharm 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 lactation).

Before taking Losartán Teva-ratiopharm, 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-salt diet that causes excessive loss of fluids or salt from your body (see section 3. ‘Dosage in special patient groups’),
• if you know that 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-ratiopharm" and 3. ‘Dosage 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 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 medicines used to treat high blood pressure (hypertension):
  -an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril),particularly if you have kidney problems related to diabetes.
  -aliskiren

Your doctor may need to 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-ratiopharm”

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

Children and adolescents

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

Losartán Teva-ratiopharm is not recommended for use in children with kidney or liver problems, as there are limited data available in these patient groups. Losartán Teva-ratiopharm 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-ratiopharm 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 it is not recommended to take Losartán Teva-ratiopharm with these medicines.

While taking Losartán Teva-ratiopharm, 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/classes of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,

-non-steroidal anti-inflammatory drugs, 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.

Youmay need to modify your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Losartán Teva-ratiopharm” 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-ratiopharm with food and drinks

Losartán Teva-ratiopharmcan be taken with or without food.

It is recommended to avoid grapefruit juice while taking Losartán Teva-ratiopharm.

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 must inform your doctor if you think you are pregnant (or may be). Normally, your doctor will recommend that you stop taking Losartán Teva-ratiopharm before becoming pregnant or as soon as you know you are pregnant and advise you to take a different medicine instead of Losartán Teva-ratiopharm.

Losartán Teva-ratiopharm 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. Losartán Teva-ratiopharm is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you want to breastfeed, especially if your baby is a newborn or premature.

Driving and operating 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-ratiopharm contains lactose

Losartán Teva-ratiopharm contains lactose monohydrate. 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. If in 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 Losartán Teva-ratiopharm as prescribed by your doctor to maintain constant blood pressure control.

Losartán Teva-ratiopharm is available inthree doses:25 mg, 50mg and 100 mg film-coated tablets. The 25 mg, 50mg, and 100 mg tablets can be divided into equal doses.

Adult patients with high blood pressure

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

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

Special populations

Use in children and adolescents

Children under 6 years

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

Children from6 to 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 Losartán Teva-ratiopharm). 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 Losartán Teva-ratiopharm 50 mg tablet) once a day. Subsequently, the dose may be increased to 100 mg of losartan (two Losartán Teva-ratiopharm 50 mg tablets) once a day, depending on your blood pressure response.

Losartán Teva-ratiopharm 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 once a day. Typically, the dose is gradually increased 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 Losartán Teva-ratiopharm 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 take Losartán Teva-ratiopharm").

Administration

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

If you take more Losartán Teva-ratiopharm 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-ratiopharm tablets

If you accidentally forget a dose, simply take the next dose normally. 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 nearest hospital emergency service:

-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 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,

-Vertigo,

-Low blood pressure (especially after excessive loss of body water within blood vessels, e.g., in patients with severe heart failure or on 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 liver function, including renal failure,

-Reduced red blood cell count (anemia),

-Increased urea, creatinine, and potassium levels in the blood in patients with heart failure

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

-Drowsiness,

-Headache,

-Sleep disorders,

-Palpitations,

-Severe chest pain (angina pectoris),

-Difficulty breathing (dyspnea),

-Abdominal pain,

-Constipation

-Diarrhea,

-Nausea

-Vomiting,

-Hives (urticaria)

-Itching (pruritus),

-Rash,

-Localized swelling (edema),

-Tinnitus.

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

-Hypersensitivity,

-Vasculitis, including Henoch-Schönlein purpura,

-Numbness or tingling (paresthesia),

-Syncope,

-Atrial fibrillation,

-Cerebral attack (stroke),

-Heptatitis,

-Elevated levels of alanine aminotransferase (ALT) in the blood, which usually resolves when treatment is discontinued.

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

-Reduced platelet count,

-Migraine,

-Liver function anomalies,

-Muscle and joint pain,

-Flu-like symptoms,

-Back pain and urinary tract infection,

-Sensitivity to sunlight (photosensitivity)

-Dark-colored urine (tea-colored) due to muscle damage (rhabdomyolysis),

-Impotence,

-Pancreatitis

-Low sodium levels in the blood (hyponatremia),

-Depression,

-General malaise,

-Ringing, buzzing, or clicking in the ears (tinnitus)

-Alteration of taste (dysgeusia).

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

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use, Website:www.notificaRAM.es. By reporting adverse reactions, 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 box and on the blister pack 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 at a temperature above 25°C.

OPA/Alu/PVC/ Al blisters

This medication does not require special storage conditions.

Medicines should not be disposed of through the drains or in the trash. Dispose of the packagingand the medication that you no longer need at the SIGREpoint at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medication that you no longer need. By doing so, you will help protect the environment.

Composition of Losartán Teva-ratiopharm

-The active ingredient is losartan potassium. Each film-coated tablet of Losartán Teva-ratiopharm film-coated tablets contains 25 mg of losartan potassium

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

Appearance of Losartán Teva-ratiopharm and contents of the package

-Losartán Teva-ratiopharm 25 mg film-coated tablets are white, oval, slightly arched, film-coated tablets with “2”, scored and “5” on one side, scored on the other side.

Each tablet is approximately 9 mm long, 5 mm wide and 3 mm thick.

Losartán Teva-ratiopharm 25 mg film-coated tablets are available in blister packs of 14, 28, 56 and 98 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,

Alcobendas, 28108 - Madrid

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

Teva Pharma S.L.U.

C/ C n 4 Industrial Estate Malpica

50016 Zaragoza

Spain

This medicinal product is authorized in the Member States with the following names:

Germany:Losartan-CT 25 mg Filmtabletten

SpainLosartán Teva-ratiopharm 25 mg film-coated tablets

Last review date of this leaflet:March 2024

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/

You can access detailed and updated information on this medicinal product 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/78475/P_78475.html

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