Losartan Teva-Ratiopharm 25 mg film-coated tablets

Patient Information Leaflet

Introduction

Package Leaflet: Information for the User

Losartán Teva-ratiopharm 25 mg film-coated tablets

Losartan potassium

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you

• Keep this leaflet. 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 and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

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

3. How to take Losartán Teva-ratiopharm

4. Possible side effects

5. How to store Losartán Teva-ratiopharm

6. Contents of the pack and other information

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

Losartan belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that binds to receptors in the blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartan blocks angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels and consequently lowering blood pressure. Losartan slows the progression of renal impairment in patients with high blood pressure and type 2 diabetes.

Losartán 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 kidney in hypertensive patients with type 2 diabetes and laboratory test results indicating renal impairment and proteinuria ≥0.5 g per day (a condition in which the urine contains an abnormal amount of protein)
• to treat patients with chronic heart failure when your doctor considers that treatment with specific medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to lower high blood pressure) is not suitable. If your heart failure has been stabilized with an ACE inhibitor, you should not switch to losartan
• in patients with high blood pressure and thickening of the left ventricle of the heart, losartan has been shown to reduce the risk of stroke (“LIFE indication”)

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

Do not take Losartán Teva-ratiopharm

• if you are allergic to losartan or to 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. (Losartán Teva-ratiopharm should also be avoided during early pregnancy – see section 2: Pregnancy and breastfeeding),
  • if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Losartán Teva-ratiopharm.

You must inform your doctor if you think you may be pregnant (or could become pregnant). Losartán Teva-ratiopharm is not recommended during early pregnancy, and must not be taken if you are more than 3 months pregnant, as its use during this period may cause serious harm to your unborn child (see section 2: Pregnancy and breastfeeding).

Before taking Losartán Teva-ratiopharm, it is important to inform your doctor:

• if you have previously experienced angioedema (swelling of the face, lips, tongue, and/or throat) (see section 4: ‘Possible side effects’),
• if you are experiencing excessive vomiting or diarrhoea, which may cause excessive fluid and/or salt loss from your body,
• if you are taking diuretics (medicines that increase the amount of fluid passing through your kidneys) or are on a low-salt diet that may lead to excessive fluid or salt loss (see section 3: ‘Dosage in special patient groups’),
• if you know you have narrowing or blockage of the blood vessels supplying your kidneys or if you have recently undergone a kidney transplant,
• if your liver function is impaired (see sections 2: “Do not take Losartán Teva-ratiopharm” and 3: ‘Dosage in special patient groups’),
• if you have heart failure with or without renal impairment or potentially life-threatening concomitant cardiac arrhythmias. Special care is needed if you are also being treated with a beta-blocker,
• if you have heart valve problems or heart muscle disease,
• 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 excessive secretion of the hormone aldosterone by the adrenal gland due to adrenal dysfunction),
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
  • an angiotensin-converting enzyme (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 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 levels (see section 2: “Taking Losartán Teva-ratiopharm with other medicines”).

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

Children and adolescents

Losartán Teva-ratiopharm has been studied in children. For further information, speak with your doctor.

Losartán Teva-ratiopharm is not recommended for use in children with kidney or liver problems, as there is limited data available in these patient groups. Losartán Teva-ratiopharm is not recommended for use in children under 6 years of age, as efficacy has not been demonstrated in this age group.

Taking Losartán Teva-ratiopharm with other medicines

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

Inform your doctor if you are taking potassium supplements, salt substitutes containing 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 trimethoprim), as combination with Losartán Teva-ratiopharm is not recommended.

While being treated with Losartán Teva-ratiopharm, take particular care 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 be lowered by some of the following medicines/classes of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory drugs, such as indomethacin, 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 adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Losartán Teva-ratiopharm” and “Warnings and precautions”).

If you have impaired kidney function, concomitant use of these medicines may lead to worsening of kidney function.

Medicines containing lithium should not be used in combination with losartan unless your doctor performs careful monitoring. Special precautionary measures (e.g. blood tests) may be appropriate.

Taking Losartán Teva-ratiopharm with food and drinks

Losartán Teva-ratiopharm may be taken with or without food.

Grapefruit juice should be avoided while taking Losartán Teva-ratiopharm.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you think you are pregnant (or could be). Usually, your doctor will advise you to stop taking Losartán Teva-ratiopharm before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine to Losartán Teva-ratiopharm.

Losartán Teva-ratiopharm is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used beyond the third month of pregnancy.

Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding. Losartán Teva-ratiopharm is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is a newborn or was born prematurely.

Driving and using machines

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

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

Losartán Teva-ratiopharm contains lactose

Losartán Teva-ratiopharm contains lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Losartan Teva-ratiopharm

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will decide the appropriate dose of losartan, depending on your condition and whether you are taking other medicines.

It is important to continue taking Losartan Teva-ratiopharm as prescribed by your doctor in order to maintain consistent blood pressure control.

Losartan Teva-ratiopharm is available in three strengths: 25 mg, 50 mg, and 100 mg film-coated tablets. The 25 mg, 50 mg, and 100 mg tablets can be divided into equal doses.

Adult patients with high blood pressure

Treatment usually starts with 50 mg of losartan (one tablet of Losartan Teva-ratiopharm 50 mg) once daily. The maximum blood pressure-lowering effect is achieved within 3 to 6 weeks after starting treatment. Afterwards, in some patients, the dose may be increased to 100 mg of losartan (two tablets of Losartan Teva-ratiopharm 50 mg) once daily.

If you feel that the effect of Losartan 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

Losartan Teva-ratiopharm is not recommended for use in children under 6 years of age, as it has been shown not to be effective in this age group.

Children aged 6 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 daily (up to 25 mg of Losartan Teva-ratiopharm). Your doctor may increase the dose if blood pressure is not adequately controlled.

Other pharmaceutical forms of this medicine may be more suitable for children; please consult your doctor or pharmacist.

Adult patients with high blood pressure and type 2 diabetes

Treatment usually starts with 50 mg of losartan (one tablet of Losartan Teva-ratiopharm 50 mg) once daily. Afterwards, the dose may be increased to 100 mg of losartan (two tablets of Losartan Teva-ratiopharm 50 mg) once daily, depending on your blood pressure response.

Losartan Teva-ratiopharm may be administered together with other medicines that lower blood pressure (e.g. diuretics, calcium antagonists, alpha or beta-blockers, and centrally-acting agents), as well as with insulin and other medicines commonly used to reduce blood glucose levels (e.g. sulfonylureas, glitazones, and glucosidase inhibitors).

Adult patients with heart failure

Treatment usually starts with 12.5 mg of losartan once daily. The dose is usually gradually increased on a weekly basis (i.e., 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week, 100 mg daily during the fourth week, 150 mg daily during the fifth week), up to a maintenance dose determined by your doctor. A maximum dose of 150 mg of losartan (e.g., three tablets of Losartan Teva-ratiopharm 50 mg) once daily may be used.

In the treatment of heart failure, losartan is usually combined with a diuretic (a medicine that increases the amount of water passing through your kidneys) and/or digitalis (a medicine that helps your heart to become 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 receiving high-dose diuretics, patients with hepatic impairment, or patients over 75 years of age. The use of losartan is not recommended in patients with severe hepatic impairment (see section "Do not take Losartan Teva-ratiopharm").

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 important that you continue taking Losartan Teva-ratiopharm unless your doctor tells you otherwise.

If you take more Losartan Teva-ratiopharm than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 915620420, indicating the medicine and the amount ingested. Symptoms of overdose may include low blood pressure, increased heart rate, and possibly decreased heart rate.

If you forget to take Losartan Teva-ratiopharm tablets

If you accidentally miss a dose, simply take the next dose as usual. Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience the following, stop taking losartan tablets immediately and contact your doctor right away or go to the nearest hospital emergency department:

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

This is a serious but rare adverse effect, affecting more than 1 in 10,000 patients but less than 1 in 1,000. It may require urgent medical attention or hospitalization.

The following adverse effects have been reported with losartan:

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

• dizziness,
• vertigo,
• low blood pressure (especially after excessive loss of fluid from the blood vessels, e.g. in patients with severe heart failure or those on high doses of diuretics),
• dose-related orthostatic effects, such as a drop in blood pressure occurring after standing up from a lying or sitting position,
• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• too much potassium in the blood (hyperkalemia),
• changes in liver function, including kidney failure,
• reduced number of red blood cells (anemia),
• increased blood levels of urea, creatinine, and serum potassium in patients with heart failure.

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

• drowsiness,
• headache,
• sleep disorders,
• sensation of very rapid heartbeat (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,

• inflammation of blood vessels (vasculitis, including Schönlein-Henoch purpura),

• numbness or tingling sensation (paresthesia),

• fainting (syncope),

• very rapid and irregular heartbeats (atrial fibrillation),

• stroke (cerebrovascular accident),

  • intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea,

• inflammation of the liver (hepatitis),

• increased levels of alanine aminotransferase (ALT) in blood, which usually resolves when treatment is stopped.

Frequency not known (frequency cannot be estimated from available data):

• reduced number of platelets,
• migraine,
• abnormalities in liver function,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to sunlight (photosensitivity),
• unexplained muscle pain with dark-colored urine (tea-colored urine) (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low levels of sodium in blood (hyponatremia),
• depression,
• general malaise,
• ringing, buzzing, noise, or clicking in the ears (tinnitus),
• altered taste (dysgeusia).

Adverse effects in children are similar to those observed in adults.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products at: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Losartan Teva-ratiopharm

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to 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 any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Losartán Teva-ratiopharm

• The active substance is potassium losartan. Each Losartán Teva-ratiopharm film-coated tablet contains 25 mg of potassium losartan.
• The other components are lactose monohydrate, microcrystalline cellulose (E 460i), pregelatinized starch (from corn), and magnesium stearate (E 470b) in the tablet core; and polyvinyl alcohol, titanium dioxide (E 171), macrogol, and talc in the coating film.

Appearance of Losartán Teva-ratiopharm and contents of the pack

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

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 packs of 14, 28, 56, and 98 film-coated tablets in blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.
C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,
Alcobendas, 28108 - Madrid, Spain

Manufacturer

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 Polígono Industrial Malpica
50016 Zaragoza, Spain

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

Germany: Losartán-CT 25 mg Filmtabletten
Spain: Losartán Teva-ratiopharm 25 mg comprimidos recubiertos con película

Date of the most recent review of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) at http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicinal product by scanning the QR code included on the outer packaging with your mobile phone (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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