Losartan Mabo 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Losartan MABO 50 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, consult your doctor or pharmacist.
• 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 or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Losartan MABO 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 blocks angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels, which in turn lowers blood pressure. Losartan slows down the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Losartan MABO is used:

• to treat adult patients and children and adolescents aged 6 to 18 years with high blood pressure (hypertension)
• 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 abnormally high amount of protein)
• to treat patients with chronic heart failure, when their 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 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 you need to know before taking Losartan MABO

Do not take Losartan MABO:

• if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6)
• if you have severely impaired liver function
• if you are more than 3 months pregnant. (Losartan MABO should also be avoided at the beginning of pregnancy – see pregnancy section)
• if you have diabetes or kidney failure and are being treated with an antihypertensive medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking Losartan MABO.

Tell your doctor if you think you may be pregnant (or could become pregnant). Losartan MABO is not recommended during early pregnancy, and must not be taken after the third month of pregnancy, as it may cause severe harm to your unborn child (see pregnancy section).

It is important that you inform your doctor before taking Losartan MABO:

• if you have previously experienced angioedema (swelling of the face, lips, tongue or throat) (see also section 4. Possible side effects)

• if you have excessive vomiting or diarrhoea, leading 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 (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 had a kidney transplant

• if you have impaired liver function (see sections 2. “Do not take Losartan MABO” 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 flow to the brain)

• if you have primary hyperaldosteronism (a syndrome associated with excessive secretion of the hormone aldosterone by the adrenal gland due to adrenal dysfunction)

• 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

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

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 MABO”.

Contact 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 MABO has been studied in children. For further information, speak with your doctor.

Losartan MABO is not recommended for use in children with kidney or liver problems, as there is limited data available in this patient group. Losartan MABO is not recommended for use in children under 6 years of age, as efficacy has not been demonstrated in this age group.

Taking Losartan MABO with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines, including those obtained without a prescription, herbal medicines or natural products.

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 MABO is not recommended.

While taking Losartan MABO, take particular care if you are also taking any of the following medicines:

• other medicines that lower blood pressure, as they may cause an additional decrease 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 Losartan MABO” 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 used together with losartan unless your doctor closely monitors you. Special precautions (e.g. blood tests) may be appropriate.

Taking Losartan MABO with food and drink

Losartan MABO may be taken with or without food.

Grapefruit juice should be avoided while taking Losartan MABO.

Pregnancy and breast-feeding

Pregnancy

You must inform your doctor if you think you may be pregnant (or could become pregnant).

Your doctor will usually advise you to stop taking Losartan MABO before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Losartan MABO is not recommended during early pregnancy, and must not be taken after the third month of pregnancy, as it may cause severe harm to your unborn child if used beyond the third month of pregnancy.

Breast-feeding

Inform your doctor if you are breast-feeding or planning to breast-feed. Losartan MABO is not recommended for breastfeeding mothers, and your doctor will choose another treatment for you if you wish to breast-feed, 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.

It is unlikely that Losartan MABO 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 performing such activities.

Losartan MABO contains lactose

Losartan MABO contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Losartan MABO

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor again. Your doctor will decide the appropriate dose of this medicine depending on your condition and whether you are taking other medicines. It is important to keep taking Losartan MABO 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 MABO 50 mg tablet) once daily. The maximum blood pressure-lowering effect is achieved between 3 and 6 weeks after starting treatment. Afterwards, in some patients, the dose may be increased to 100 mg of losartan (two Losartan MABO 50 mg tablets or one Losartan MABO 100 mg tablet) 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 of age

The use of losartan is not recommended in children under 6 years of age, as its effectiveness has not been demonstrated in this age group.

Children and adolescents aged 6 to 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 a maximum of 25 mg of losartan). The doctor may increase the dose if blood pressure is not controlled.

Other pharmaceutical forms 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 MABO 50 mg tablet) once daily. Afterwards, the dose may be increased to 100 mg of losartan (two Losartan MABO 50 mg tablets or one Losartan MABO 100 mg tablet) once daily, depending on your blood pressure response.

Losartan may be administered together 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 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 once daily.

Typically, the dose is 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, and 150 mg daily during the fifth week), until reaching the maintenance dose determined by your doctor. A maximum dose of 150 mg of losartan (e.g., three Losartan MABO 50 mg tablets or one Losartan MABO 100 mg tablet and one Losartan MABO 50 mg tablet) once daily may be used.

This medicine does not allow administration of a 12.5 mg dose. In cases where losartan 12.5 mg is prescribed, your doctor should choose another medicine.

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 pump more strongly and efficiently) 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 MABO").

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 this medicine until your doctor tells you otherwise.

If you take more Losartan MABO than you should

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

If you forget to take Losartan MABO

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 further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

If you stop taking Losartan MABO

If you have any other questions about the use of this product, 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 any of the following, stop taking Losartan MABO and contact your doctor immediately 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 MABO:

Common (may affect up to 1 in 10 patients):

• dizziness,
• low blood pressure (especially after excessive loss of fluid from blood vessels, e.g., in patients with severe heart failure receiving 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 renal failure,
• reduced number of red blood cells (anaemia),
• increased blood urea, creatinine, and serum potassium levels in patients with heart failure,

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

• drowsiness,
• headache,
• sleep disorders,
• sensation of 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 patients):

• 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),
• liver inflammation (hepatitis),
• elevated levels of alanine aminotransferase (ALT) in blood, which usually resolves upon discontinuation of treatment,
• intestinal angioedema: swelling in the intestine causing 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 MABO

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions. Do not open the blister pack until you are ready to take the medicine.

Medicines must not be disposed of via wastewater drains. Dispose of unused containers and medicines at the SIGRE Point at 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 Losartan MABO

The active substance is losartan potassium.

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

The other components are:

• core: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose and magnesium stearate.
• coating: hypromellose, hydroxypropylcellulose and titanium dioxide.

Appearance of the product and contents of the pack

Losartan MABO is supplied as white, round, film-coated tablets without a break line, containing 50 mg of losartan potassium.

Losartan MABO is available in the following pack sizes:

Losartan MABO 50 mg – PVC/PE/PVDC blisters with an aluminum foil lid, in packs of 7, 10, 14, 15, 21, 28, 30, 50, 56, 90, 98, 100, 210 or 280 tablets.

Losartan MABO 50 mg – HDPE bottles with a silica gel desiccant in the cap containing 250 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

MABO-FARMA, S.A.

Calle Vía de los Poblados 3,

Edificio 6, 28033, Madrid,

Spain.

Manufacturer:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

or

HEUMANN PHARMA GMBH & CO. GENERICA KG

Südwestpark 50

D-90449 Nürnberg, Germany

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

Denmark: Losartankalium "Liconsa" 50 mg filmovertrukne tablet

Netherlands: Losanox 50 mg filmomhulde tabletten

United Kingdom: Losartan potassium Liconsa 50 mg film-coated tablets

Germany: Losartan Liconsa 50 mg filmtabletten

France: Losartan potassium Liconsa

Spain: Losartan MABO 50 mg comprimidos recubiertos con película

Date of the most recent review of this leaflet: December 2024