Losartan Alter 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Losartan Alter 100 mg film-coated tablets EFG

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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Losartán Alter 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 the binding of angiotensin II to these receptors, resulting in relaxation of the blood vessels, which in turn lowers blood pressure. Losartan slows down the progression of renal impairment in patients with high blood pressure and type 2 diabetes.

Losartán Alter 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 kidney 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 your doctor considers that treatment with specific medicines called angiotensin-converting enzyme (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 Losartán Alter

Do not take Losartán Alter

• 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. (It is also advisable to avoid Losartán Alter 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.
• Losartán Alter contains soybean lecithin. It must not be used if you are allergic to peanuts or soy.

Warnings and precautions

Talk to your doctor or pharmacist before taking Losartán Alter.

You should inform your doctor if you think you may be pregnant (or could become pregnant). Losartán Alter 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 unborn child (see section Pregnancy).

Before taking Losartán Alter, it is important to inform your doctor:

• if you have previously experienced angioedema (swelling of the face, lips, tongue, and/or throat) (see also section 4. Possible adverse effects),
• if you are experiencing excessive vomiting or diarrhea, which may lead 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 if you are on a low-salt diet that may cause excessive fluid or 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 undergone a kidney transplant,
• if you have impaired liver function (see sections 2. Do not take Losartán 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 a disorder of this gland),
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
  • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,
  • aliskiren.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Losartán Alter. Your doctor will decide whether to continue treatment. Do not stop taking Losartán Alter when used as monotherapy.

Your doctor may periodically monitor your kidney function, blood pressure, and blood levels of electrolytes (e.g., potassium).

See also the information under the heading “Do not take Losartán Alter”.

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 data in these patient groups are limited. Losartan is not recommended for use in children under 6 years of age, as efficacy has not been demonstrated in this age group.

Taking Losartán Alter with other medicines

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

While being treated with Losartán Alter, take particular care if you are 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,
• medicines that retain potassium or may increase potassium levels (e.g., potassium supplements, potassium-containing salt substitutes, or potassium-sparing medicines such as certain diuretics [amiloride, triamterene, spironolactone] or heparin),
• 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 additional precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Losartán Alter” 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 in combination with losartan without careful monitoring by your doctor. Special precautionary measures (e.g., blood tests) may be appropriate.

Taking Losartán Alter with food and drinks

Losartán Alter can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you are pregnant (or could be pregnant). Your doctor will usually 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 unborn child if used beyond the third month of pregnancy.

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 another treatment for you if you wish to breastfeed, particularly 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 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.

Losartán Alter contains lactose

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

3. How to take Losartán Alter

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of Losartán Alter depending on your condition and whether you are taking other medicines. It is important to continue taking Losartán Alter 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 tablet of Losartán Alter 50 mg) once daily. The maximum blood pressure-lowering effect is reached within 3 to 6 weeks after starting treatment. Afterwards, in some patients, the dose may be increased to 100 mg of losartan (two tablets of Losartán Alter 50 mg or one tablet of Losartán Alter 100 mg) once daily.

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

Use in children and adolescents

Children under 6 years of age

Losartán Alter 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 between 6 and 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 daily (up to 25 mg of Losartán Alter). Your doctor may increase the dose if blood pressure is not adequately controlled.

Other pharmaceutical forms may be more suitable for children; please ask your doctor or pharmacist.

Adult patients with high blood pressure and type 2 diabetes

Treatment usually starts with 50 mg of losartan (one tablet of Losartán Alter 50 mg) once daily. Afterwards, the dose may be increased to 100 mg of losartan (two tablets of Losartán Alter 50 mg or one tablet of Losartán Alter 100 mg) 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 of losartan once daily. The dose is usually 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 may be used (for example, three tablets of Losartán Alter 50 mg or one tablet of Losartán Alter 100 mg and one tablet of Losartán Alter 50 mg once daily).

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 to 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 receiving 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 Losartán Alter").

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 Losartán Alter 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 call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Losartán Alter

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 or pharmacist.

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 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 in swallowing or breathing).

This is a serious but rare adverse effect (may affect up to 1 in 1,000 people). 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 from the blood vessels, e.g. in patients with severe heart failure or on high doses of diuretics),
• dose-related orthostatic effects, such as a drop in blood pressure occurring after standing up from lying or sitting,
• weakness,
• fatigue,
• low blood sugar (hypoglycaemia),
• too much potassium in the blood (hyperkalaemia),
• changes in kidney function, including kidney failure,
• reduced number of red blood cells (anaemia),
• increased blood urea, serum creatinine and potassium levels in patients with heart failure.

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

• drowsiness,
• headache,
• sleep disorder,
• sensation of very rapid heartbeat (palpitations),
• severe chest pain (angina pectoris),
• difficulty breathing (dyspnoea),
• abdominal pain,
• constipation,
• diarrhoea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• skin rash,
• localized swelling (oedema),
• cough.

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

• hypersensitivity,
• angioedema,
• inflammation of blood vessels (vasculitis, including Henoch-Schönlein purpura),
• numbness or tingling sensation (paraesthesia),
• fainting (syncope),
• very rapid and irregular heartbeat (atrial fibrillation),
• stroke (cerebrovascular accident),
• liver inflammation (hepatitis),
• increased levels of alanine aminotransferase (ALT) in blood, which usually resolves when treatment is stopped,
• 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 levels of sodium in the blood (hyponatraemia),
• depression,
• general feeling of being unwell (malaise),
• ringing, buzzing, noise or clicking in the ears (tinnitus),
• altered taste (dysgeusia).

Adverse effects reported 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Losartan Alter

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.

Do not store above 30°C.

Keep in the original packaging to protect from light and moisture.

Do not open the blister pack until ready to take the medicine.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Losartán Alter

• The active substance is losartan. Each tablet contains 100 mg of potassium losartan.
• The other components are: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, anhydrous colloidal silica, magnesium stearate and Opadry II (polyvinyl alcohol, titanium dioxide, talc, macrogol 4000 and soy lecithin).

Losartán Alter 100 mg contains 8.48 mg of potassium (0.216 mEq).

Appearance of the product and contents of the container

Film-coated, white, oval tablets.

Losartán Alter 100 mg is supplied in PVC/PE/PVDC-Aluminum blisters, in packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

or

Laboratorios Alter, S.A

C/ Zeus 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

Date of the most recent review of this leaflet: February 2025

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/.