LOSARTAN TARBIS FARMA 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Losartan Tarbis Farma 25 mg film-coated tablets EFG

Losartan Tarbis Farma 50 mg film-coated tablets EFG

Losartan Tarbis Farma 100 mg film-coated tablets EFG

potassium losartan

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Losartan Tarbis Farma and what is it used for
2. What you need to know before taking Losartan Tarbis Farma
3. How to take Losartan Tarbis Farma
4. Possible side effects
5. Storage of Losartan Tarbis Farma
6. Package contents and additional information

1. What is Losartan Tarbis Farma and what is it used for

Losartan belongs to a group of medications 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 constrict. This leads to an increase in blood pressure. Losartan prevents the binding of angiotensin II to these receptors, resulting in the relaxation of blood vessels, which in turn decreases blood pressure. Losartan reduces the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Potassium losartan 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 with clinical analyses indicating renal insufficiency 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 left ventricular thickness, losartan has been shown to reduce the risk of stroke ("LIFE indication").

2. What you need to know before taking Losartan Tarbis Farma

Do not take Losartan Tarbis Farma:

• if you are allergic to losartan or any of the other components of this medication (listed in section 6),
• if you are pregnant for more than 3 months (it is also recommended to avoid losartan at the beginning of pregnancy - see Pregnancy),
• if your liver function is severely impaired,
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure medication containing aliskiren.

Warnings and precautions

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Losartan Tarbis Farma. Your doctor will decide on the treatment to follow. Do not stop taking Losartan Tarbis Farma on your own.

Consult your doctor, pharmacist, or nurse before starting to take losartan.

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

It is essential 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 may cause excessive loss of fluid and/or salt from your body,
• if you are taking diuretics (medications that increase the amount of water that passes through your kidneys) or if you follow a low-salt diet that may cause excessive loss of fluids and salt in your body (see section 3 "Posology in special patient groups"),
• if you know you have narrowing or blockage of the blood vessels that go to your kidneys or if you have recently undergone a kidney transplant,
• if your liver function is impaired (see sections 2 "Do not take Losartan Tarbis Farma" and 3 "Posology in special patient groups"),
• if you have heart failure with or without kidney insufficiency or potentially life-threatening cardiac arrhythmias. Special attention is necessary when being treated simultaneously 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 medications used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially 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 Tarbis Farma".

• if you are taking other medications that may increase serum potassium levels (see section 2 "Taking losartan with other medications").

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

Taking losartan with other medications

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

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

While being treated with losartan, be especially cautious if you take any of the following medications:

• other medications that lower blood pressure, as they may produce an additional reduction in blood pressure. Blood pressure may also be lowered by some of the following medications/classes of medications: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory medications, such as indomethacin, including COX-2 inhibitors (medications that reduce inflammation and can be used to relieve pain), as they may decrease 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 ACE inhibitor or aliskiren (see also the information under the headings "Do not take Losartan Tarbis Farma" and "Warnings and precautions").

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

Medications containing lithium should not be taken in combination with losartan without close medical supervision. Special precautions may be necessary (e.g., blood tests).

Taking losartan with food and drinks

Losartan can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking losartan before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medication instead of losartan. Losartan is not recommended at the beginning of pregnancy, and it should not be taken if you are pregnant for more than 3 months, 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 is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to continue breastfeeding. Especially if your child is a newborn or premature.

Consult your doctor or pharmacist before using this medication.

Driving and using machines

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

It is unlikely that losartan will affect your ability to drive or use machines. However, like many medications 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 contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Losartan Tarbis Farma

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will decide on the appropriate dose of losartan, depending on your condition and whether you are taking other medications. It is essential to continue taking losartan as prescribed by your doctor to maintain constant blood pressure control.

Adult patients with high blood pressure

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

If you think the effect of losartan is too strong or too weak, 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 be effective in this age group.

Children between 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, administered once a day (up to 25 mg of losartan). The doctor may increase the dose if blood pressure is not controlled.

Other pharmaceutical forms of this medication 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 50 mg losartan tablet) once a day. Afterward, the dose may be increased to 100 mg of losartan (two 50 mg losartan tablets or one 100 mg losartan tablet) once a day, depending on the response of your blood pressure.

Losartan can be administered with other medications that lower blood pressure (e.g., diuretics, calcium antagonists, alpha or beta blockers, and centrally acting medications), as well as with insulin and other medications 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 12.5 mg losartan tablet) once a day. Normally, the dose should be gradually increased weekly (i.e., 12.5 mg/day during the first week, 25 mg/day during the second week, 50 mg/day during the third week, 100 mg/day during the fourth week, 150 mg/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 50 mg losartan tablets or one 100 mg losartan tablet and one 50 mg losartan tablet) once a day can be used.

In the treatment of heart failure, losartan is normally combined with a diuretic (a medication that increases the amount of water that passes through your kidneys) and/or digitalis (a medication that helps your heart be stronger and more efficient) and/or a beta-blocker.

Posology 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 insufficiency, or patients over 75 years of age. Losartan is not recommended for use in patients with severe liver insufficiency (see section "Do not take losartan").

Administration

The tablets should be swallowed whole with a glass of water. You should try to take your daily dose at approximately the same time each day. It is essential to continue taking losartan until your doctor tells you to stop.

The tablet can be divided into equal doses (only for 25 mg and 50 mg).

If you take more losartan than you should

If you accidentally take too many tablets, 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 medication and the amount ingested.

If you forget to take losartan

If you accidentally miss a dose, simply take the next dose as usual. Do not take a double dose to make up for missed doses. If you have any other questions about the use of this medication, 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).

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 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 renal function, including renal failure,
• reduced number of red blood cells (anemia),
• increased urea in blood, serum creatinine, and serum potassium 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),
• rash,
• localized swelling (edema),
• cough.

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

• hypersensitivity,
• angioedema,
• 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,
• inflammation of the liver (hepatitis),
• elevation of alanine aminotransferase (ALT) levels in blood, which usually resolves upon discontinuation of treatment.
• Intestinal angioedema: an inflammation in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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),
• muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in blood (hyponatremia),
• depression,
• generally feeling unwell (malaise),
• ringing, buzzing, noise, or clicking in the ears (tinnitus),
• alteration of 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, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Losartan Tarbis Farma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Losartan Tarbis Farma

The active ingredient is losartan potassium.

Each 25mg losartan tablet contains 25mg of losartan potassium.

Each 50mg losartan tablet contains 50mg of losartan potassium.

Each 100mg losartan tablet contains 100mg of losartan potassium.

The other components are:

Microcrystalline cellulose (PH 102 & PH 200), lactose monohydrate, pregelatinized corn starch, low-substituted hydroxypropylcellulose, crospovidone (type A), magnesium stearate, hypromellose 2910 6cP (E-464), titanium dioxide (E-171), and carnauba wax.

Appearance of the Product and Package Contents

Losartan Tarbis Farma 25mg film-coated tablets EFG

White to off-white, oval, biconvex film-coated tablets, 8.3 x 4.5 mm (approx.), engraved with "I" on one side and "5" on the other side with a score line.

The tablet can be divided into equal doses.

Losartan Tarbis Farma 50mg film-coated tablets EFG

Oval, white to off-white film-coated tablets, 10.4 x 5.5 mm (approx.), engraved with "I" on one side and "6" on the other side with a score line.

The tablet can be divided into equal doses.

Losartan Tarbis Farma 100mg film-coated tablets EFG

White to off-white, tear-drop shaped film-coated tablets, 11.8 x 7.2 mm (approx.), engraved with "H" on one side and "145" on the other side.

Aluminum-PVC/PVdC blister pack containing 28, 30, 56, 90, 98, and 250 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Losartan-Kalium Amarox 25mg/50mg/100mg film-coated tablets

Spain: Losartán Tarbis Farma 25mg/50mg/100mg film-coated tablets EFG

Netherlands: Losartankalium Amarox 25mg/50mg/100mg film-coated tablets

Date of the Last Revision of this Leaflet:

December 2024

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