LOSARTAN TEVA-RATIO 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Losartan Teva-ratio 100 mg Film-Coated Tablets EFG

Potassium Losartan

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

3. How to take Losartan Teva-ratio

4. Possible side effects

5. Storage of Losartan Teva-ratio

6. Contents of the pack and other information

1. What is Losartan Teva-ratio and what is it 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 in blood vessels, causing them to narrow. This results in an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, which causes the blood vessels to relax, thereby lowering blood pressure. Losartan reduces the worsening of kidney function 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 from 6 to 18 years.
• to protect the kidneys in hypertensive patients with type 2 diabetes and laboratory results indicating kidney failure 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 medications called angiotensin-converting enzyme inhibitors (ACE inhibitors, medications 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 increased thickness 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 you take Losartan Teva-ratio

Do not take Losartan 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 recommended to avoid Losartan 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 containing aliskiren.

Warnings and precautions

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

You should inform your doctor if you think you are pregnant (or might be). Losartan Teva-ratio is not recommended at the beginning of pregnancy, and it 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 Losartan 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 side effects'),
• if you have excessive vomiting or diarrhea, which causes 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 on a low-salt diet that causes excessive loss of fluid 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 supply your kidneys or if you have recently undergone a kidney transplant,
  • if your liver function is impaired (see sections 2. "Do not take Losartan Teva-ratio" and 3. 'Posology in special patient groups'),
  • if you have heart failure with or without kidney failure or life-threatening heart rhythm disorders. Special attention is needed when you are being treated at the same time with a beta-blocker,
  • if you have problems with the valves in your heart or with the heart muscle,
  • 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 circulation in the brain),
  • if you have primary hyperaldosteronism (a syndrome associated with high 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 (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 Losartan Teva-ratio”.

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

Children and adolescents

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

Losartan Teva-ratio is not recommended for use in children with kidney or liver problems, as there is limited data available in these patient groups. Losartan Teva-ratio is not recommended for use in children under 6 years of age, as it has not been shown to work in this age group.

Taking Losartan Teva-ratio with other medicines

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

Tell your doctor if you are taking potassium supplements, salt substitutes that contain potassium, or potassium-sparing diuretics (e.g., amiloride, triamterene, spironolactone) or other medicines that may increase serum potassium (e.g., heparin, trimethoprim-containing medicines), as combination with Losartan Teva-ratio is not recommended.

While you are being treated with Losartan Teva-ratio, be particularly cautious if you take 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 medicines, 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 the information under the headings “Do not take Losartan Teva-ratio” and “Warnings and precautions”).

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

Medicines containing lithium should not be used in combination with losartan without your doctor performing careful monitoring. It may be appropriate to take special precautions (e.g., blood tests).

Taking Losartan Teva-ratio with food and drinks

Losartan Teva-ratio can 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking Losartan Teva-ratio before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan Teva-ratio.

Losartan Teva-ratio is not recommended at the beginning of pregnancy, and it 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

Tell your doctor if you are breastfeeding or about to start breastfeeding. Losartan Teva-ratio is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you want 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.

Losartan is unlikely to affect your ability to drive or use machines. However, as with 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 these activities.

Losartan Teva-ratio contains lactose

Losartan Teva-ratio contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Losartan Teva-ratio

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. 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-ratio as long as your doctor prescribes it to maintain constant control of your blood pressure.

Losartan Teva-ratio is available in 2 doses: 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

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

If you think the effect of Losartan Teva-ratio is too strong or too weak, please inform your doctor or pharmacist.

Use in children and adolescents

Children under 6 years

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

Children from 6 to 18 years

The recommended starting dose in patients who weigh between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, given once a day (up to 25 mg of Losartan Teva-ratio). Your doctor may increase the dose if blood pressure is not controlled.

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

Adult patients with high blood pressure and type 2 diabetes

Normally, treatment starts with 50 mg of losartan (one Losartan 50 mg tablet) once a day. After that, 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 Teva-ratio can be taken 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 frequently used to lower blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Adult patients with heart failure

Normally, treatment starts with 12.5 mg of losartan (one Losartan Teva-ratio 12.5 mg tablet) once a day. Normally, 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), up to a maintenance dose determined by your doctor. A maximum dose of 150 mg of losartan (e.g., three Losartan Teva-ratio 50 mg tablets) once a day may be used.

In the treatment of heart failure, losartan is normally combined with a diuretic (a medicine that increases the amount of water that passes through your kidneys) and/or digitalis (a medicine that helps your heart be 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 treated with high-dose diuretics, patients with liver failure, or patients over 75 years of age. Losartan is not recommended for use in patients with severe liver failure (see section "Do not take Losartan 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 Losartan Teva-ratio until your doctor tells you to stop.

If you take more Losartan Teva-ratio than you should

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

If you forget to take Losartan Teva-ratio tablets

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

If you have any further questions on 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 all people suffer from them.

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

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

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

The following adverse 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 water from the body within the blood vessels, e.g., in patients with severe heart failure or on high doses of diuretics),
• dose-related orthostatic effects, such as decreased 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 kidney failure,
• reduced number of red blood cells (anemia),
• increased urea, creatinine, and potassium levels in the blood in patients with heart failure.

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

• somnolence,
• headache,
• sleep disorders,
• sensation 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):

• hypersensitivity,
• inflammation of the blood vessels (vasculitis, including Schönlein-Henoch purpura),
• numbness or tingling sensation (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 discontinuation of treatment.

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

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

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

Reporting Adverse Effects

If you experience any of the adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Losartan Teva-ratio

Keep out of sight and reach of children.

Do not use this medicine after the expiration date stated on the carton and blister pack after "EXP". 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.

High-density polyethylene (HDPE) container with a polypropylene (PP) desiccant cap, tamper-evident (TE) or tamper-evident/senior-friendly (TE/SF).

This medicine does not require special storage conditions.

Once opened, expiration date is 6 months

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Losartan Teva-ratio

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

• The other ingredients 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 Losartan Teva-ratio and Package Contents

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

Each tablet is approximately 14 mm long, 8 mm wide, and 5 mm thick.

Losartan 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.

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

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

Not all package sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta,

Alcobendas, 28108 - Madrid

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 medicine is authorized in the Member States under the following names:

Germany: Losartan-ratiopharm 100 mg Filmtabletten

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

Finland: Losatrix

France: Losartan Ratio 100 mg, film-coated tablet

Luxembourg: Losartan-ratiopharm 100 mg Filmtabletten

Netherlands: Losartankalium 100 mg ratiopharm, film-coated tablets

Date of the last revision of this leaflet: October 2024

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

You can access detailed and updated information on 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