Losartan Teva-Ratio 50 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Losartan Teva-ratio 50 mg film-coated tablets EFG

Please read all of 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 and must not be given to other people, even if they have the same symptoms as you, since it could 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 side 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 known as 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 prevents angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels, which in turn lowers blood pressure. Losartan slows the progression of declining kidney function in patients with high blood pressure and type 2 diabetes.

Losartán Teva-ratio is used

• to treat patients with high blood pressure (hypertension) in adults and in children and adolescents aged 6 to 18 years.
• to protect the kidneys 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 Sber needs to know before taking 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 you are more than 3 months pregnant. (It is also advisable to avoid losartan in early pregnancy – see Pregnancy section),
• if your liver function is severely impaired,
• if you have diabetes or renal impairment and are being treated with an antihypertensive medicine containing aliskiren.

Warnings and precautions

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

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

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 are experiencing excessive vomiting or diarrhoea, which may lead to 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 cause excessive fluid and salt loss 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 if you 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 disease,
• 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 excessive secretion of the hormone aldosterone by the adrenal gland due to adrenal gland dysfunction),
• if you are taking any of the following medicines used to treat high blood pressure:
• 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-ratio”.

• if you are taking other medicines that may increase serum potassium (see section 2 “Other medicines and Losartán Teva-ratio”).

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

Losartan has been studied in children. For further information, speak with 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 efficacy has not been demonstrated in this age group.

Other medicines and Losartán Teva-ratio

Tell 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 losartan is not recommended.

While being treated with losartan, 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 (NSAIDs), 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 (ACE) inhibitor or aliskiren (see also the information under the headings “Do not take Losartán Teva-ratio” and “Warnings and precautions”).

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

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

Taking Losartán Teva-ratio with food and drink

Losartan may be taken with or without food.

Grapefruit juice should be avoided while taking losartan.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are pregnant (or could be pregnant). Your doctor will usually advise you to stop taking losartan before becoming pregnant or as soon as you know you are pregnant and will recommend an alternative medicine instead of losartan. Losartan is not recommended during early pregnancy, and 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 onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Use of Losartán Teva-ratio is not recommended in breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to continue breastfeeding, especially if your baby is a newborn or was born prematurely.

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

It is unlikely that Losartán Teva-ratio 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-ratio contains lactose

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 use of this medicine provided 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 continue taking losartan as prescribed by your doctor to maintain consistent blood pressure control.

Patients with high blood pressure

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

If you feel that 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 its effectiveness has not been demonstrated in this age group.

Children aged 6–18 years

The recommended starting dose in patients weighing between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, given once daily (up to a maximum of 25 mg of losartan). 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.

Patients with high blood pressure and type 2 diabetes

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

Losartan may be administered together with other antihypertensive medicines (e.g. diuretics, calcium antagonists, alpha or beta blockers, and centrally-acting agents), as well as with insulin and other commonly used glucose-lowering medicines (e.g., sulfonylureas, glitazones, and alpha-glucosidase inhibitors).

Adult patients with heart failure

Treatment usually starts with 12.5 mg of losartan (one 12.5 mg losartan tablet "Inicio") once daily. The dose should usually be 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 dose determined by your doctor. A maximum daily dose of 150 mg of losartan (e.g., three 50 mg losartan 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 fluid 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 losartan unless your doctor tells you otherwise.

If you take more Losartán Teva-ratio than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Losartán Teva-ratio

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

If you have any questions 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 everyone experiences 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 (skin rash, itching, swelling of the face, lips, mouth or throat which may cause difficulty swallowing or breathing).

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
• 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 low blood pressure upon standing up from a lying or sitting position
• weakness
• fatigue
• low blood sugar (hypoglycaemia)
• high potassium levels in the blood (hyperkalaemia)
• changes in kidney function including kidney failure
• reduced number of red blood cells (anaemia)
• increased blood urea levels
• increased serum creatinine and serum potassium levels 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 (dyspnoea)
• abdominal pain
• constipation
• diarrhoea
• nausea
• vomiting
• hives (urticaria)
• itching (pruritus)
• skin rash
• localized swelling (oedema)
• cough

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

• hypersensitivity
• angioedema
• inflammation of blood vessels (vasculitis, Schönlein-Henoch purpura)
• numbness or tingling sensation (paraesthesia)
• 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)
• 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 platelet count
• 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 (hyponatraemia)
• depression
• generally feeling 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 adverse effects, consult your doctor or pharmacist, even if they are 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 packaging after EXP. The expiry date is the last day of the month indicated.

Store Losartan Teva-ratio in the original packaging.

Blister

No special storage conditions are required.

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

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

This medicine does not require special storage conditions.

After first opening, discard after 6 months.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Losartán Teva-ratio

• The active substance in Losartán Teva-ratio is potassium losartan.

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

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

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

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

Nature of the product and contents of the pack

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

Losartán Teva-ratio is available in the following pack sizes:

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

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.
C/ 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 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): http://www.gob.aemps.es/

You can access detailed and updated information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68944/P_68944.html