Package Leaflet: Information for the User

Losartan MABO 50 mg Film-Coated Tablets

losartan potassium

Read 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1. What Losartan MABO is and what it is used for

2. What you need to know before you take Losartan MABO

3. How to take Losartan MABO

4. Possible side effects

5. Storage of Losartan MABO

6. Contents of the pack and additional information

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

Losartan MABOis used:

• to treat adult and pediatric patients aged 6 to 18 years with elevated blood pressure (hypertension)
• to protect the kidney in hypertensive patients with type 2 diabetes and laboratory test results indicating renal insufficiency and proteinuria ≥0.5 g per day (a situation in which the urine contains an abnormal amount of proteins)
• 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 reduce elevated blood pressure) are not suitable. If their heart failure has been stabilized with an ACE inhibitor, they should not switch to losartan
• in patients with elevated blood pressure and left ventricular hypertrophy, losartan has been shown to reduce the risk of stroke (“LIFE indication”).

Do not takeLosartan MABO:

• if you are allergic to losartan or any of the other ingredients in this medicine.(listed in section 6)
• if your liver function is severely impaired. if you are more than 3 months pregnant. (It is also best to avoidLosartan MABOat the beginning of pregnancy– see pregnancy section)
• if you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeLosartan MABO.

Inform your doctor if you think you are pregnant (or could be). Losartan MABO is not recommended at the beginning of pregnancy, and it should not be taken if you are more than three months pregnant, as it may cause serious harm to your child (see pregnancy section).

It is essential to inform your doctor before takingLosartan MABO:

• if you have previously suffered from angioedema (swelling of the face, lips, tongue, or throat)(also see section 4. Possible side effects)
• if you have excessive vomiting or diarrhea, which cause 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 following a low-sodium diet that causes 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 that go to your kidneys or if you have recently had a kidney transplant,
• if your liver function is altered (see sections 2. “Do not take LosartanMABO”and 3. “Dosage in special patient groups”)
• if you have heart failure with or without kidney failure or potentially fatal cardiac arrhythmias. Special attention is required when being treated at the same time with a beta-blocker
• if you have problems with your heart valves or heart muscle
• if you have coronary heart disease (caused by reduced blood flow in the heart's blood vessels) or cerebrovascular disease (caused by reduced blood circulation in the brain)
• if you have primary aldosteronism (a syndrome associated with high secretion of the hormone aldosterone by the adrenal gland due to an alteration of this gland),
• if you are taking any of the following blood pressure medications:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskirén
• if you are taking other medicines that may increase serum potassium (see section 2 “Taking Losartan MABO with other medicines”).

Your doctor may monitor your kidney function, blood pressure, and serum electrolyte levels (e.g., potassium) at regular intervals.

Also see the information under the heading “Do not takeLosartan MABO”.

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

Losartan MABO is not recommended for use in children with kidney or liver problems, as there is limited data in this patient group. Losartan MABO is not recommended for use in children under 6 years old, as it has not been shown to be effective in this age group.

TakingLosartan MABOwith other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those obtained without a prescription or herbal and natural products.

Inform your doctor if you are taking potassium supplements, salt substitutes containing potassium, or potassium-sparing medicines such as certain diuretics (amilorida, triamtereno, spironolactone) or other medicines that may increase serum potassium (e.g., heparin, medicines containing trimetoprim), as the combination with Losartan MABO is not recommended.

While takingLosartan MABObe particularly cautious if you are taking any of the following medicines:

• other medicines that lower blood pressure, as they may cause additional lowering of blood pressure. Blood pressure may also be lowered by some of the following medicines/classes of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine
• nonsteroidal anti-inflammatory drugs (NSAIDs), such as indometacina, 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 ACE inhibitor or aliskirén (also see the information under the headings“Do not takeLosartan MABO”and“Warnings and precautions”).

if your kidney function is impaired, the concomitant use of these medicines may cause worsening of kidney function.

Medicines containing lithium should not be used in combination with losartan without your doctor's careful monitoring. It may be necessary to take special precautions (e.g., blood tests).

Taking Losartan MABOwith food and drinks

Losartan MABOcan be taken with or without food.

It is recommended to avoid grapefruit juice while taking Losartan MABO.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you think you are pregnant (or could be).

Normally, your doctor will advise you to stop takingLosartan MABObefore becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead ofLosartan MABO.Losartan MABO is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your child if used after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start breastfeeding. Losartan MABO is not recommended for use in breastfeeding mothers, and your doctor will choose another treatment for you if you wish to continue breastfeeding.

Especially if your baby is a newborn or premature.

Driving and operating machines

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

It is unlikely thatLosartan MABOwill affect your ability to drive or use machines. However, as 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 these activities.

Losartan MABO contains lactose

Losartan MABOcontains lactosemonohydrate. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.Your doctor will decide the appropriate dose of this medication depending on your condition and if you are taking other medications. It is important to continue taking Losartan MABO as prescribed by your doctor to maintain constant blood pressure control.

Adult patients with high blood pressure

Normally, treatment begins with 50 mg of losartan (one Losartan MABO 50 mg tablet) once a day.The maximum blood pressure-lowering effect is achieved between 3 to 6 weeks of starting treatment. After that, 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 a day.

If you estimate that the losartan action 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, as it has not been shown to be effective in this age group.

Children and adolescents from 6 to 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 administered once a day (up to a maximum of 25 mg of losartan). Your 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 begins with 50 mg of losartan (one Losartan MABO 50 mg tablet) once a day. After that, the dose may be increased to 100 mg of losartan (two Losartan MABO 50 mg tablets or one Losartan MABO 100 mg tablet) once a day depending on your blood pressure response.

Losartan can be taken with other medications that lower blood pressure (e.g., diuretics, calcium channel blockers, alpha or beta blockers, and central-acting medications), as well as with insulin and other medications commonly used to reduce blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Adult patients with heart failure

Normally, treatment begins with 12.5 mg once a day.

Normally, the dose is gradually increased weekly (i.e., 12.5 mg per day for the first week, 25 mg per day for the second week, 50 mg per day for the third week, 100 mg per day for the fourth week, 150 mg per day for the fifth week), until the maintenance dose determined by your doctor is reached.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 a day may be used.

This medication does not allow for a dose of 12.5 mg. In cases where losartan 12.5 mg is prescribed, your doctor must choose another medication.

In the treatment of heart failure, losartan is usually 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 doses of diuretics, patients with liver insufficiency, or patients over 75 years old. Losartan is not recommended for use in patients with severe liver insufficiency (see "Do not take Losartan MABO").

Administration

The tablets should be taken with a glass of water. You should try to take your daily dose approximately at the same time each day. It is essential that you continue taking this medication 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.The symptoms of overdose are low blood pressure, increased heart rate, and possibly decreased heart rate.

If you forget to take Losartan MABO

If you accidentally forget a dose, simply take the next dose as usual.Do not take a double dose to compensate for the missed doses. If you have any other questions about the use of this medication, ask your doctor or pharmacist, or nurse.

If you interrupt treatment with Losartan MABO

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following, stop taking Losartan MABO and inform your doctor immediately or go to the nearest hospital emergency service:

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

This is a serious but rare side effect that affects more than 1 in 10,000 patients but fewer than 1 in 1,000. You may need urgent medical attention or hospitalization.

The following side effects have been reported with Losartan MABO:

Frequent (can affect up to 1 in 10 patients):

• dizziness,
• low blood pressure (especially after excessive water loss within blood vessels, for example, in patients with severe heart failure who receive high-dose diuretics),
• orthostatic effects related to the dose, such as a decrease in 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 kidney function, including kidney failure,
• reduced red blood cell count (anemia),
• increased urea, creatinine, and potassium levels in the blood in patients with heart failure,

Occasional (can affect up to 1 in 100 patients):

• drowsiness,
• headache,
• sleep disturbances,
• sensation 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 (can affect up to 1 in 1,000 patients):

• hypersensitivity,
• angioedema,
• inflammation of blood vessels (vasculitis, including Schonlein-Henoch purpura),
• numbness or tingling (paresthesia),
• syncope (fainting),
• very rapid and irregular heartbeats (atrial fibrillation),
• stroke (cerebrovascular accident),
• inflammation of the liver (hepatitis),
• elevation of alanine aminotransferase (ALT) levels in the blood, which usually resolves upon discontinuing treatment,
• intestinal angioedema: swelling in the intestine accompanied by symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency unknown (the frequency cannot be estimated from available data):

• reduced platelet count,
• migraine,
• liver function abnormalities,
• muscle and joint pain,

• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to the sun (photosensitivity),
• unknown muscle pain with dark-colored urine (rhabdomyolysis),
• impotence,
• pancreatitis,
• low sodium levels in the blood (hyponatremia),
• depression,
• usually feeling unwell (malaise),
• ringing, buzzing, or clicking sounds in the ears (tinnitus).
• alteration of taste (dysgeusia).

The side effects in children are similar to those observed in adults.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

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

Medications should not be disposed of through drains. Dispose of packaging and unused medications at the SIGRE point of your pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition ofLosartan MABO

The active ingredient is losartan potassium.

Each Losartan MABO 50 mg tablet contains 50 mg oflosartan potassium.

The other components are:

• core:lactose monohydrate,maize pregelatinized starch,microcrystalline celluloseandmagnesium stearate.
• Coating: hypromellose,hydroxypropyl celluloseandtitanium dioxide.

Appearance of the product and contents of the package

Losartan MABOis supplied as white, round, film-coated tablets, without score, containing 50 mgoflosartan potassium.

Losartan MABOis supplied in the following package sizes:

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

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

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder:

MABO-FARMA, S.A.

Calle Rejas 2, planta 1

28821, Coslada, 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 member states of the European Economic Area with the following names:

DenmarkLosartankalium "Liconsa" 50 mg filmovertrukne tablet

NetherlandsLosanox 50 mg filmomhulde tabletten

United KingdomLosartan potassium Liconsa 50 mg film-coated tablets

GermanyLosartan Liconsa 50 mg filmtabletten

FranceLosartan potassium Liconsa

SpainLosartan MABO 50 mg comprimidos recubiertos con película

Last review date of this leaflet:December 2024