Losartan Teva-Ratio 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Losartan Teva-ratio 100 mg film-coated tablets EFG

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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

3.- How to take Losartan Teva-ratio

4.- Possible adverse effects

5.- How to store Losartan Teva-ratio

6.- Contents of the pack and other information

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

Losartan belongs 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 narrow. This leads to an increase in blood pressure. Losartan blocks the binding of angiotensin II to these receptors, resulting in relaxation of the blood vessels, thereby lowering blood pressure. Losartan slows the progression of renal impairment in patients with high blood pressure and type 2 diabetes.

Losartan Teva-ratio 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 abnormally high 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 starting to take Losartán Teva-ratio

Do not take Losartán Teva-ratio

• 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. (It is also advisable to avoid Losartán Teva-ratio in early pregnancy - see section 2: Pregnancy and breastfeeding),
• if you have diabetes or renal impairment and are being treated with an antihypertensive medicine containing aliskiren.

Warnings and precautions

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

You must inform your doctor if you think you are pregnant (or could be pregnant). Losartán Teva-ratio is not recommended during early pregnancy, and must not be used after the third month of pregnancy, as it may cause serious harm to your unborn child (see section 2: Pregnancy and breastfeeding).

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

• if you have a history of angioedema (swelling of the face, lips, tongue, and/or throat) (see section 4: 'Possible adverse effects'),
• if you have excessive vomiting or diarrhoea, leading to excessive loss of fluid and/or salt 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 cause excessive loss of fluid or salt from your body (see section 3: 'Dosage in special patient groups'),
  • if you know you have narrowing or blockage of the blood vessels supplying your kidneys or have recently undergone a kidney transplant,
  • if you have impaired liver function (see sections 2: 'Do not take Losartán Teva-ratio' 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 disorders,
  • if you have coronary heart disease (caused by reduced blood flow in the blood vessels of the heart) or cerebrovascular disease (caused by reduced blood flow to the brain),
  • if you have primary hyperaldosteronism (a syndrome associated with excessive secretion of the hormone aldosterone by the adrenal gland due to a disorder of this gland),
  • if you are taking any of the following medicines used to treat high blood pressure:
  • an ACE inhibitor (for example, 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 levels (see section 2: 'Taking Losartán Teva-ratio with other medicines').

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

Children and adolescents

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

Losartán Teva-ratio is not recommended for use in children with kidney or liver problems, as there is limited data available in these patient groups. Losartán Teva-ratio 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-ratio 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-ratio is not recommended.

While being treated with Losartán Teva-ratio, 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 II receptor antagonist (ARA) or aliskiren (see also information under the headings “Do not take Losartán Teva-ratio” and “Warnings and precautions”).

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

Medicines containing lithium should not be used in combination with losartan without careful monitoring by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate.

Taking Losartán Teva-ratio with food and drinks

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

Grapefruit juice should be avoided while taking losartan.

Pregnancy and Breastfeeding

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

Pregnancy

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

Losartán Teva-ratio 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.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Losartán Teva-ratio is not recommended for breastfeeding mothers, and your doctor may choose a different treatment for you if you wish to breastfeed, 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 performed.

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 performing such activities.

Losartán Teva-ratio contains lactose

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

3. How to take Losartán Teva-ratio

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

It is important to keep taking Losartán Teva-ratio as prescribed by your doctor to maintain consistent blood pressure control.

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

Adult patients with high blood pressure

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

If you feel that the effect 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 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 for 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 Losartán Teva-ratio). Your doctor may increase the dose if blood pressure is not controlled.

Another pharmaceutical form(s) 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 is usually started at 50 mg of losartan (one Losartán 50 mg tablet) once daily. Afterwards, the dose may be increased to 100 mg of losartan (two Losartán 50 mg tablets) once daily, depending on your blood pressure response.

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

Adult patients with heart failure

Treatment is usually started at 12.5 mg of losartan (one Losartán Teva-ratio 12.5 mg tablet) 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 Losartán Teva-ratio 50 mg tablets) 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 Losartán 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 important that you 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 915620420, indicating the medicine and the amount ingested. Symptoms of overdose include low blood pressure, increased heart rate, and possibly decreased heart rate.

If you forget to take Losartán Teva-ratio tablets

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

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 receiving 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),
• high potassium levels in the blood (hyperkalemia),
• changes in liver function, including renal failure,
• reduced number of red blood cells (anemia),
• increased blood urea, serum creatinine and potassium in patients with heart failure.

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

• drowsiness,
• headache,
• sleep disorders,
• sensation of rapid heartbeat (palpitations),
• severe chest pain (angina pectoris),
• difficulty breathing (dyspnea),
• abdominal pain,
• constipation,
• diarrhoea,
• 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 heartbeat (atrial fibrillation),
• stroke (cerebrovascular accident),
• intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea,
• inflammation of the liver (hepatitis),
• elevated levels of alanine aminotransferase (ALT) in blood, which usually resolves when treatment is discontinued.

Frequency not known (frequency cannot be estimated from the 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-coloured urine (tea-coloured) (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in blood (hyponatremia),
• depression,
• general feeling of being unwell (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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines, Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Losartan Teva-ratio

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and on the 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.

White opaque high-density polyethylene (HDPE) bottle with a screw cap and an opaque polypropylene (PP) desiccant, tamper-evident (TE) or tamper-evident/easy-open (TE/SF).

This medicine does not require any special storage conditions.

After first opening, discard after 6 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point in your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Losartán Teva-ratio

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

• 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 coating film.

Appearance of Losartán Teva-ratio and contents of the pack

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

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

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.

Losartán Teva-ratio 100 mg film-coated tablets are available in HDPE bottles containing 28 tablets.

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

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 medicinal product is authorised in Member States under 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

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

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): 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 packaging with your mobile phone (smartphone). You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/79922/P_79922.html