LOSARTAN ALTER 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Losartan Alter 100 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Losartan belongs to a group of medications called 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 leads to an increase in blood pressure.

Losartan prevents the binding of angiotensin II to these receptors, resulting in the relaxation of blood vessels, which in turn decreases blood pressure. Losartan reduces the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Losartan Alter is used

• to treat patients with high blood pressure (hypertension) in adults and in children and adolescents from 6 to 18 years of age.
• to protect the kidneys in hypertensive patients with type 2 diabetes and laboratory test results indicating kidney failure and proteinuria ≥ 0.5 g/day (a condition in which the urine contains an abnormal amount of protein).

• 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 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 increased thickness 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 Alter

Do not take Losartan Alter

• if you are allergic to losartan or any of the other ingredients of this medication (listed in section 6),
• if you are pregnant for more than 3 months. (It is also recommended to avoid Losartan Alter at the beginning of pregnancy - see Pregnancy),
• if your liver function is severely impaired.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medication that contains aliskiren.
• Losartan Alter contains soy lecithin. It should not be used in case of peanut or soy allergy.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Losartan Alter.

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

Before taking Losartan Alter, it is essential that you inform your doctor:

• 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 have excessive vomiting or diarrhea, which may cause excessive loss of fluid and/or salt from your body,
• if you are taking diuretics (medications that increase the amount of water that passes through your kidneys) or if you are on a low-salt diet that may cause 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 undergone a kidney transplant,

• if your liver function is impaired (see sections 2. Do not take Losartan and 3. Dosage in special patient groups),
• if you have heart failure with or without kidney failure or life-threatening heart rhythm disorders. Special attention is necessary when 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 medications 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.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Losartan Alter. Your doctor will decide whether to continue treatment. Do not stop taking Losartan Alter on your own.

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 Alter”.

Children and Adolescents

Losartan has been studied in children. For more information, talk to 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 it has not been shown to be effective in this age group.

Taking Losartan Alter with Other Medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

While being treated with Losartan Alter, be particularly cautious if you take any of the following medications:

• other medications that lower blood pressure, as they may cause additional blood pressure reduction. Blood pressure may also be lowered by some of the following medications/classes of medications: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• medications that retain potassium or may increase potassium levels (e.g., potassium supplements, salt substitutes that contain potassium, or potassium-sparing diuretics [e.g., amiloride, triamterene, spironolactone] or heparin),
• non-steroidal anti-inflammatory medications, such as indomethacin, including COX-2 inhibitors (medications 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 ACE inhibitor or aliskiren (see also the information under the headings “Do not take Losartan Alter” and “Warnings and Precautions”).

If your kidney function is impaired, concomitant use of these medications may worsen kidney function.

Medications 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).

Taking Losartan Alter with Food and Drinks

Losartan 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 medication.

Pregnancy

You should inform your doctor if you are pregnant (or might be). Normally, your doctor will advise you to stop taking losartan before becoming pregnant or as soon as you know you are pregnant and recommend a different medication. Losartan is not recommended at the beginning of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your child if used after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Losartan is not recommended for breastfeeding mothers, and your doctor may choose a different treatment for you if you wish to breastfeed. Especially if your child is a newborn or premature.

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, as with many medications 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 these activities.

Losartan Alter contains Lactose

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

3. How to Take Losartan Alter

Follow the administration instructions of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of Losartan Alter, depending on your condition and whether you are taking other medications. It is essential to continue taking Losartan Alter as prescribed by your doctor to maintain constant blood pressure control.

Adult patients with high blood pressure

Normally, treatment starts with 50 mg of losartan (one Losartan Alter 50 mg tablet) once a day. The maximum blood pressure-lowering effect is achieved within 3-6 weeks of starting treatment. Afterward, in some patients, the dose may be increased to 100 mg of losartan (two Losartan Alter 50 mg tablets or one Losartan Alter 100 mg tablet) once a day.

If you think the effect of Losartan Alter is too strong or too weak, please inform your doctor or pharmacist.

Use in Children and Adolescents

Children under 6 years of age

Losartan Alter is not recommended for use in children under 6 years of age, as it has not been shown to be effective in this age group.

Children between 6 and 18 years of age

The recommended starting dose in patients who weigh between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, administered once a day (up to 25 mg of Losartan Alter). The doctor may increase the dose if blood pressure is not controlled.

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

Losartan can be administered with other medications that lower blood pressure (e.g., diuretics, calcium antagonists, alpha or beta blockers, and centrally acting agents), as well as with insulin and other medications 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 of losartan once a day. Normally, the dose is gradually increased weekly (i.e., 12.5 mg/day during the first week, 25 mg/day during the second week, 50 mg/day during the third week, 100 mg/day during the fourth week, 150 mg/day 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 Alter 50 mg tablets or one Losartan Alter 100 mg tablet and one Losartan Alter 50 mg tablet once a day) may be used.

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.

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 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 essential to continue taking this medication until your doctor tells you otherwise.

If you take more Losartan Alter than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Losartan Alter

If you accidentally miss a dose, simply take the next dose as usual. Do not take a double dose to make up for missed doses.

If you have any other questions about the use of this medication, 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 the losartan tablets 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 (it can affect up to 1 in 1,000 people). You may need urgent medical attention or hospitalization.

The following adverse effects have been reported with Losartan:

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

• dizziness,
• low blood pressure (especially after excessive loss of water from the body within the blood vessels, e.g., in patients with severe heart failure or being treated with high doses of diuretics),
• 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 people):

• drowsiness,
• headache,
• sleep disorder
• feeling of very rapid heartbeats (palpitations),
• severe chest pain (angina pectoris),
• difficulty breathing (dyspnea),
• abdominal pain,
• constipation,
• diarrhea,
• nausea
• vomiting,
• hives (urticaria)
• itching (pruritus),
• skin rash,
• localized swelling (edema),
• cough.

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

• hypersensitivity,
• angioedema,
• inflammation of the blood vessels (vasculitis, including Schoenlein-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 presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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),
• 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).

The adverse effects reported 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 does not appear in this prospectus. 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 Alter

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

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect it from light and moisture.

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 medicines you no longer need at the SIGRE point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Losartan Alter

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

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

Appearance of the Product and Package Contents

White, film-coated, oblong tablets.

Losartan Alter 100 mg is supplied in PVC/PE/PVDC-Aluminum blister packs, 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 Last Revision of this Prospectus: February 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.