LOSARTAN MABO 100 mg FILM-COATED TABLETS

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

Do not takeLosartan MABO:

• if you are allergic to losartan or any of the other ingredients of this medicine (listed in section 6)
• if your liver function is severely impaired. if you are more than 3 months pregnant. (It is also better to avoid Losartan MABO at the beginning of pregnancy – see section pregnancy)
• 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 or pharmacist before starting to take Losartan MABO.

Tell your doctor if you think you are pregnant (or might become pregnant). Losartan MABO is not recommended at the start of pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby (see section pregnancy).

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

• if you have previously suffered from angioedema (swelling of the face, lips, tongue or throat) (see also section 4. Possible side effects)
• if you have excessive vomiting or diarrhea, which causes 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 on a low-salt diet that causes excessive loss of fluids or 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 supply your kidneys or if you have recently had a kidney transplant,
• if your liver function is impaired (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 heart rhythm disorders. Special attention is needed when you are being treated at the same time 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 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 potassium levels in your blood (see section 2 “Taking Losartan MABO with other medicines”).

Your doctor may need to check 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”.

Talk to 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 MABO has 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 of age, as it has not been shown to work in this age group.

TakingLosartan MABOwith other medicines

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

Tell your doctor if you are taking potassium supplements, salt substitutes that contain potassium, or potassium-sparing diuretics (e.g. amiloride, triamterene, spironolactone) or other medicines that may increase potassium levels in your blood (e.g. heparin, trimethoprim-containing medicines), as combination with Losartan MABO is not recommended.

While being treated with Losartan MABO, be particularly cautious if you take 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
• non-steroidal anti-inflammatory medicines, such as indomethacin, 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 aliskiren (see also the information under the headings “Do not take Losartan MABO” and “Warnings and precautions”.

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

Medicines containing lithium should not be used in combination with losartan without careful monitoring by your doctor. Special precautions may be necessary (e.g. blood tests).

TakingLosartan MABOwith food and drinks

Losartan MABO can be taken with or without food.

Grapefruit juice should be avoided while taking losartan.

Pregnancy and breastfeeding

Pregnancy

You should tell your doctor if you think you are pregnant (or might become pregnant).

Normally, your doctor will advise you to stop taking Losartan MABO before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan MABO. Losartan MABO is not recommended during the first trimester of 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 after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Losartan MABO is not recommended for mothers who are breastfeeding, and your doctor will choose another treatment for you if you want to

continue breastfeeding. 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.

Losartan MABO is unlikely to affect your ability to drive or use machines. However, as with many medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, talk to your doctor before performing these activities.

Losartan MABOcontains lactose

Losartan MABO contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to take Losartan MABO

Follow exactly the administration instructions of this medicine given by your doctor. In case of 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 continue taking Losartan MABO as long as your doctor prescribes it to maintain constant control of your blood pressure.

Adult patients with high blood pressure

Normally, treatment starts 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 after 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 think the effect of losartan is too strong or too weak, please talk to your doctor or pharmacist.

Use in children and adolescents

Children under 6 years

Losartan is not recommended for children under 6 years, as it has not been shown to work in this age group.

Children and adolescents from 6 to 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 given once a day (up to a maximum of 25 mg of losartan). The doctor may increase the dose if blood pressure is not controlled.

Another pharmaceutical form of this medicine 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 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 given with other medicines that lower blood pressure (e.g. diuretics, calcium channel blockers, alpha or beta blockers, and centrally acting agents), as well as with insulin and other medicines 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 once a day.

Normally, the dose is gradually increased weekly (i.e. 12.5 mg per day during the first week, 25 mg per day during the second week, 50 mg per day during the third week, 100 mg per day during the fourth week, 150 mg per day during 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 can be used.

This medicine does not allow for the 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 normally combined with a diuretic (a medicine that increases the amount of water that passes 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 liver failure, or patients over 75 years of age. Losartan is not recommended for use in patients with severe liver failure (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 to stop.

If you take more Losartan MABOthan 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 miss a dose, simply take the next dose as normal. Do not take a double dose to make up for missed doses. If you have any other questions about the use of this medicine, ask your doctor or 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 all people suffer from them.

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

A severe allergic reaction (skin 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 MABO:

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

• dizziness,
• low blood pressure (especially after excessive loss of body water within the blood vessels, e.g., in patients with severe heart failure receiving high-dose diuretic treatment),
• 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, creatinine, and potassium levels in the blood in patients with heart failure,

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

• 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 patients):

• hypersensitivity,
• angioedema,
• inflammation of the blood vessels (vasculitis, including Schonlein-Henoch purpura),
• numbness or tingling sensation (paresthesia),
• fainting (syncope),
• 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 discontinuation of treatment,
• intestinal angioedema: swelling in the intestine that occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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 the sun (photosensitivity),
• muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in the 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 or pharmacist, even if it is a possible adverse effect that is not listed 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 MABO

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition ofLosartan MABO

The active ingredient is losartan potassium.

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

The other ingredients are:

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

Appearance of the Product and Packaging Contents

Losartan MABO is supplied as white, round, film-coated tablets without scoring, containing 100 mg of losartan potassium.

Losartan MABO is supplied in the following package sizes:

Losartan MABO 100 mg - PVC/PE/PVDC blister pack 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 100 mg - HDPE bottle with a desiccant silica gel cap, containing 250 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

MABO-FARMA, S.A.

Calle Rejas 2, 1st floor

28821, Coslada, Madrid.

Spain

Manufacturer:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, No. 7, Miralcampo Industrial Estate

19200 Azuqueca de Henares (Guadalajara)

Spain

or

HEUMANN PHARMA GMBH & CO. GENERICA KG

Südwestpark 50

D-90449 Nürnberg, Germany

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

Denmark Losartankalium "Liconsa" 100 mg film-coated tablets

Netherlands Losanox 100 mg film-coated tablets

United Kingdom Losartan potassium Liconsa 100 mg film-coated tablets

Germany Losartan Liconsa 100 mg film-coated tablets

France Losartan potassium Liconsa

Spain Losartan MABO 100 mg film-coated tablets

Date of the last revision of this leaflet:December 2024