Losartan Tarbis Farma 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Losartán Tarbis Farma 25 mg film-coated tablets EFG

Losartán Tarbis Farma 50 mg film-coated tablets EFG

Losartán Tarbis Farma 100 mg film-coated tablets EFG

potassium losartan

Read the entire 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, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Losartán Tarbis Farma is and what it is used for
2. What you need to know before taking Losartán Tarbis Farma
3. How to take Losartán Tarbis Farma
4. Possible adverse effects
5. How to store Losartán Tarbis Farma
6. Contents of the pack and other information

1. What Losartán Tarbis Farma 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 located in the 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, which in turn lowers blood pressure. Losartan slows the progression of renal impairment 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 aged 6 to 18 years.
• to protect the kidneys in hypertensive patients with type 2 diabetes who have laboratory test results indicating kidney failure 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 inhibitors (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 be switched 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 Tarbis Farma

Do not take Losartán Tarbis Farma:

• 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 (losartan should also be avoided in early pregnancy – see Pregnancy),
• if you have severely impaired liver function,
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Losartán Tarbis Farma. Your doctor will decide on the appropriate course of action. Do not stop taking Losartán Tarbis Farma on your own.

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

You must 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 after the third month of pregnancy, as it may cause serious harm to your baby if used at this stage (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 are experiencing excessive vomiting or diarrhea, 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 fluids and 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 if you have recently undergone a kidney transplant,

• if you have impaired liver function (see sections 2 “Do not take Losartán Tarbis Farma” and 3 “Dosage in special patient groups”),

• if you have heart failure with or without kidney failure 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 dysfunction 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 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 Tarbis Farma.”

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

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.

Taking losartan with other medicines

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

Tell 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 special 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 inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Losartán Tarbis Farma” and “Warnings and precautions”).

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

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

Taking losartan with food and drink

Losartan can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are pregnant (or could be pregnant). Usually, your doctor will advise you to stop taking losartan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Losartan 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 from the third month of pregnancy onward.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Losartan is not recommended for 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 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 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 carrying out such activities.

Losartán contains lactose

This medicine 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 Tarbis Farma

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 medicines. It is important to keep taking losartan as prescribed by your doctor to maintain consistent blood pressure control.

Adult patients with high blood pressure

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

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

Use in children and adolescents

Children under 6 years of age

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 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 losartan). Your doctor may increase the dose if blood pressure is not adequately 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 usually starts with 50 mg of losartan (one losartan 50 mg tablet) once daily. Afterwards, the dose may be increased to 100 mg of losartan (two losartan 50 mg tablets or one losartan 100 mg tablet) once daily, depending on your blood pressure response.

Losartan 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 alpha-glucosidase inhibitors).

Adult patients with heart failure

Treatment usually starts with 12.5 mg of losartan (one Losartán 12.5 mg tablet) 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 maintenance dose determined by your doctor. A maximum dose of 150 mg of losartan (e.g., three losartan 50 mg tablets or one losartan 100 mg tablet plus one losartan 50 mg tablet) 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 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 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 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 important that you continue taking losartan unless your doctor tells you otherwise.

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

If you take more losartan than you should

If you accidentally take too many tablets, contact your doctor immediately. Symptoms of overdose include low blood pressure, increased heart rate, and possibly decreased heart rate.

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

If you forget to take losartan

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 experiences them.

If you experience the following, stop taking losartan tablets immediately and inform your doctor 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).

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 in the blood vessels, e.g. in patients with severe heart failure or on high-dose diuretic therapy),
• 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 (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, 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),
• rash,
• localized swelling (oedema),
• cough.

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

• hypersensitivity,
• angioedema,
• inflammation of blood vessels (vasculitis, including Schönlein-Henoch purpura),
• numbness or tingling sensation (paraesthesia),
• fainting (syncope),
• very rapid and irregular heartbeat (atrial fibrillation),
• stroke (cerebrovascular accident),
• inflammation of the liver (hepatitis),
• elevated levels of alanine aminotransferase (ALT) in blood, which usually resolve upon discontinuation of treatment,
• intestinal angioedema: inflammation in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Frequency not known (frequency cannot be estimated from 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 (hyponatraemia),
• 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, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry 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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Losartán Tarbis Farma

The active substance is losartan potassium.

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

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

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

Other components:

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 contents of the container

Losartán Tarbis Farma 25 mg film-coated tablets EFG

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

The tablet can be divided into equal doses.

Losartán Tarbis Farma 50 mg film-coated tablets EFG

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

The tablet can be divided into equal doses.

Losartán Tarbis Farma 100 mg film-coated tablets EFG

Tear-shaped, white to off-white film-coated tablets, approximately 11.8 x 7.2 mm, marked with "H" on one side and "145" on the other.

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

Only certain 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

The Netherlands

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Losartan-Kalium Amarox 25 mg/50 mg/100 mg Filmtabletten

Spain: Losartán Tarbis Farma 25 mg/50 mg/100 mg comprimidos recubiertos con película EFG

The Netherlands: Losartankalium Amarox 25 mg/50 mg/100 mg, filmomhulde tabletten

Date of the most recent review of this leaflet:

December 2024

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.aemps.gob.es/