LOSARTAN TEVA-RATIO 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Losartan Teva-ratio 50 mg film-coated tablets EFG

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.

• 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 and other information:

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. Storing 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 leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, causing blood vessels to relax, which in turn lowers 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 with clinical laboratory evidence of renal impairment and proteinuria ≥ 0.5 g/day (a disease in which the urine contains an abnormal amount of protein).
• 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 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 you are more than 3 months pregnant. (It is also better to avoid losartan at the beginning of pregnancy – see section Pregnancy),
• if your liver function is severely impaired,
• if you have diabetes or kidney disease and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Losartan Teva-ratio.

You should inform your doctor if you think you are pregnant (or might become pregnant). Losartan is not recommended at the beginning of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see section Pregnancy).

It is important that you inform your doctor before taking losartan:

• if you have a history of angioedema (swelling of the face, lips, tongue, and/or throat) (see also section 4. Possible side effects),
• if you have excessive vomiting or diarrhea, which can lead to 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 leads to excessive loss of fluids and salt in your body (see section 3. Dosage 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 had a kidney transplant,
• if your liver function is impaired (see sections 2. Do not take Losartan Teva-ratio and 3. Dosage in special patient groups),
• if you have heart failure with or without kidney impairment 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 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 Losartan Teva-ratio”.

• if you are taking other medicines that may increase potassium levels in your blood (see section 2 “Other medicines and Losartan Teva-ratio”).

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

Children and adolescents

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

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

Other medicines and Losartan Teva-ratio

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 potassium levels in your blood (e.g., heparin, trimethoprim-containing medicines), as this combination is not recommended.

While you are taking losartan, be particularly cautious if you take any of the following medicines:

• other medicines that lower blood pressure, as they may cause additional blood pressure reduction. 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 can 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 the information under the headings “Do not take Losartan Teva-ratio” and “Warnings and precautions”).

If your kidney function is impaired, taking these medicines together may lead to worsening of kidney function.

Medicines that contain lithium should not be used in combination with losartan without close monitoring by your doctor. Special precautions may be necessary (e.g., blood tests).

Taking Losartan Teva-ratio with food and drink

Losartan can be taken with or without food.

Grapefruit juice should be avoided while taking losartan.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you think you are pregnant (or might become pregnant). Normally, your doctor will advise you to stop taking losartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of losartan. Losartan is not recommended during the first trimester of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used from 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 use in breastfeeding mothers, and your doctor may choose another treatment if you wish to continue breastfeeding. Especially if your child is a newborn or was born prematurely.

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

Losartan Teva-ratio 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

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Losartan Teva-ratio

Follow exactly the administration instructions of this medicine given 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 whether you are taking other medicines. It is important to keep taking losartan while your doctor prescribes it to maintain constant blood pressure control.

Patient with high blood pressure

Normally, treatment starts with 50 mg of losartan (one losartan 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 50 mg tablets) once a day.

If you think the effect of losartan is too strong or too weak, please inform your doctor or pharmacist.

Use in children and adolescents

Children under 6 years

Losartan 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 aged 6-18 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). 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.

Patient 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 the response of your blood pressure.

Losartan can be given with other medicines that lower blood pressure (e.g., diuretics, calcium channel blockers, 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 patient with heart failure

Normally, treatment starts with 12.5 mg of losartan (one losartan 12.5 mg initiation tablet) once a day. Normally, the dose should be 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 dose determined by your doctor. A maximum dose of losartan of 150 mg (e.g., three losartan 50 mg tablets) once a day can 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 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 treated with high-dose diuretics, patients with liver impairment, or patients over 75 years of age. Losartan is not recommended for use in patients with severe liver impairment (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 keep taking losartan until your doctor tells you to stop.

If you take more Losartan Teva-ratio than you should

If you accidentally take too many tablets, or if a child swallows some, contact your doctor immediately. The symptoms of overdose are low blood pressure, increased heart rate, and possibly decreased heart rate.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Losartan Teva-ratio

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

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

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 (skin rash, itching, swelling of the face, lips, mouth, or throat that can cause difficulty swallowing or breathing).

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

The following adverse effects have been reported with losartan:

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

• dizziness
• 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 being treated with high doses of diuretics)
• dose-related orthostatic effects, such as decreased blood pressure after standing up from lying down or sitting
• weakness
• fatigue
• low blood sugar (hypoglycemia)
• high potassium levels in the blood (hyperkalemia)
• changes in renal function, including renal failure
• reduced number of red blood cells (anemia)
• increased urea in the blood
• increased serum creatinine and potassium levels in patients with heart failure.

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

• drowsiness
• headache
• sleep disorders
• feeling of very rapid heartbeats (palpitations)
• severe chest pain (angina pectoris)
• difficulty breathing (dyspnea)
• abdominal pain
• constipation
• diarrhea
• nausea
• vomiting
• hives (urticaria)
• itching (pruritus)
• skin rash
• localized swelling (edema)
• cough

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

• hypersensitivity
• angioedema
• inflammation of the blood vessels (vasculitis, Schonlein-Henoch purpura)
• numbness or tingling sensation (paresthesia)
• fainting (syncope)
• very rapid and irregular heartbeats (atrial fibrillation)
• stroke
• intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea
• 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 the 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
• low sodium levels in the blood (hyponatremia)
• depression
• generally feeling unwell (malaise)
• ringing, buzzing, noise, or clicking in the ears (tinnitus)
• disturbance of taste (dysgeusia).

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

Reporting of 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 Pharmacovigilance System for Human Use Medicines, Website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Losartán Teva-ratio

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Store Losartán Teva-ratio in its original packaging.

Blister

No special storage conditions are required.

Do not open the blister until you are ready to take the medicine.

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

This medicine does not require special storage conditions.

Once opened, the expiry date is 6 months

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

6. Packaging Contents and Additional Information

Composition of Losartán Teva-ratio

• The active ingredient of Losartán Teva-ratio is losartan potassium.

Each Losartán Teva-ratio 50 mg tablet contains 50 mg of losartan (as potassium salt).

• The other ingredients are: lactose monohydrate, microcrystalline cellulose, pregelatinized starch (derived from corn), and magnesium stearate in the core.

Losartán Teva-ratio 50 mg contains potassium in the following amount: 4.24 mg (0.108 mEq).

Losartán Teva-ratio 50 mg tablets also contain the following ingredients in the film coating: alcohol, partially hydrolyzed polyvinyl, titanium dioxide, macrogol, and talc.

Appearance and Packaging of the Product

Losartán Teva-ratio is supplied as film-coated tablets, white, oval, slightly arched, engraved with "50" on one side, scored on the other, containing 50 mg of losartan potassium.

Losartán Teva-ratio is supplied in the following packaging sizes:

Losartán Teva-ratio 50 mg - is presented in packaging containing 28 and 500 film-coated tablets, each containing 50 mg of losartan potassium, in white opaque PVC/PVdC/Al blister packs or in HDPE bottles (containing a desiccant) with 28 film-coated tablets.

Not all packaging sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas, Madrid, Spain

Manufacturer:

Teva Pharmaceutical Works Co. Ltd.

Pallagi út 13

Debrecen, Hungary

or

Teva Pharma S.L.U.

C/ C, n 4 Polígono Industrial Malpica

50016 Zaragoza, Spain

Date of the Last Revision of this Leaflet:February 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.gob.aemps.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/68944/P_68944.html