LOSARTAN ALMUS 50 mg FILM-COATED TABLETS

Introduction

PATIENT INFORMATION LEAFLET

Losartan ALMUS50 mgfilm-coated tablets EFG

Read the entire leaflet carefully before starting to take this medication, as 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 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 leaflet. See section 4.

Contents of the leaflet:

1. What is Losartan Almus and what is it used for
2. What you need to know before taking Losartan Almus
3. How to take Losartan Almus
4. Possible side effects

5 Conservation of Losartan Almus

1. Package contents and additional information

1. What is Losartan Almus 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 angiotensin II from binding 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 Almus is used

• to treat patients with high 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 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 left ventricular wall thickness, losartan has been shown to reduce the risk of stroke (LIFE indication).

2. What you need to know before taking Losartan Almus

Do not take Losartan Almus

• if you are allergic to losartan or any of the other components of this medication (listed in section 6),
• if your liver function is severely impaired,
• if you are pregnant for more than 3 months. (It is also recommended to avoid Losartan Almus during the first months of pregnancy – see section Pregnancy).
• if you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.

Warnings and precautions

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

Inform your doctor if you are pregnant (or think you might be). It is not recommended to use Losartan Almus at the start of pregnancy, and in no case should it be administered if you are pregnant for more than three months, as it can cause serious harm to your baby when administered from that time on (see section Pregnancy).

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 Almus on your own.

Before taking Losartan Almus, 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 can cause excessive fluid and/or salt loss 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 can cause excessive fluid or salt loss 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 Almus and 3. Dosage in special patient groups),
• if you have heart failure with or without kidney insufficiency or potentially life-threatening cardiac arrhythmias. Special attention is necessary when being treated simultaneously 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

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 Almus".

Taking Losartan Almus with other medications

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

While being treated with Losartan Almus, 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 containing 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 angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings "Do not take Losartan Almus" 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. It may be appropriate to take special precautions (e.g., blood tests).

Taking Losartan Almus with food and drinks

Losartan Almus can be taken with or without food.

Pregnancy and breastfeeding

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

Pregnancy

Your doctor will usually advise you to stop taking Losartan Almus before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medication instead of Losartan Almus. It is not recommended to use Losartan Almus at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it can cause serious harm to your baby when administered from that time on.

Breastfeeding

Losartan Almus is not recommended during breastfeeding, and your doctor will choose an alternative treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Use in children and adolescents

Losartan has been studied in children. For more information, consult your doctor.

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 Almus 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.

Important information about some of the components of Losartan Almus

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 Almus

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

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

Patients with high blood pressure

Normally, treatment starts with 50 mg of losartan (one Losartan Almus 50 mg tablet) once a day. The maximum blood pressure-lowering effect is achieved within 3-6 weeks of starting treatment. After that, in some patients, the dose may be increased to 100 mg of losartan (2 Losartan Almus 50 mg tablets) once a day.

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

Patients with high blood pressure and type 2 diabetes

Normally, treatment starts with 50 mg of losartan (one Losartan Almus 50 mg tablet) once a day. After that, the dose may be increased to 100 mg of losartan (2 Losartan Almus 50 mg tablets) once a day, depending on your blood pressure response.

Losartan tablets 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).

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 per day during the first week, 25 mg per day during the second week, and 50 mg per day during the third week), up to a maintenance dose of 50 mg of losartan (1 Losartan Almus 50 mg tablet) once a day, depending on your condition.

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 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 insufficiency, or patients over 75 years old. The use of losartan is not recommended in patients with severe liver insufficiency (see section "Do not take Losartan Almus").

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 Losartan Almus until your doctor tells you to stop.

If you take more Losartan Almus 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.

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 Almus

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

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

4. Possible side effects

Like all medications, Losartan Almus can cause side effects, although not everyone will experience 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 side 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.

Medication side effects are classified as follows:

Very common:may affect more than 1 in 10 people

Common:may affect up to 1 in 10 people

Uncommon:may affect up to 1 in 100 people

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

Very rare:may affect up to 1 in 10,000 people

Frequency not known:cannot be estimated from the available data.

The following side effects have been reported with losartan:

Common:

• dizziness,
• vertigo,
• low blood pressure,
• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• high potassium levels in the blood (hyperkalemia),
• changes in kidney function, including kidney failure,
• reduced number of red blood cells (anemia),
• increased urea, creatinine, and potassium levels in the blood in patients with heart failure.

Uncommon:

• drowsiness,
• headache,
• sleep disorders,
• sensation of rapid heartbeats (palpitations),
• severe chest pain (angina pectoris),
• low blood pressure (especially after excessive fluid loss from the body, e.g., in patients with severe heart failure or on high-dose diuretics),
• dose-related orthostatic effects, such as decreased blood pressure after standing up from lying down or sitting,
• difficulty breathing (dyspnea),
• abdominal pain,
• chronic constipation,
• diarrhea,
• nausea
• vomiting,
• hives (urticaria),
• itching (pruritus),
• skin rash,
• localized swelling (edema),
• cough.

Rare:

• severe allergic reaction (hypersensitivity),
• swelling of the face, lips, or tongue and/or throat that can cause difficulty swallowing or breathing (angioedema),
• inflammation of the blood vessels (vasculitis, Schonlein-Henoch purpura),
• numbness or tingling (paresthesia),
• fainting (syncope),
• rapid and irregular heartbeats (atrial fibrillation),
• stroke (cerebral stroke),
• liver inflammation (hepatitis),
• elevated levels of alanine aminotransferase (ALT) in the blood, which usually resolves after discontinuing treatment.
• intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known:

• reduced platelet count,
• migraine,
• liver function abnormalities,
• 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 (rhabdomyolysis),
• impotence,
• pancreatitis (inflammation of the pancreas),
• low sodium levels in the blood (hyponatremia),
• depression,
• general feeling of being unwell (malaise),
• ringing, buzzing, noise, or clicking in the ears (tinnitus),
• altered taste (dysgeusia).

Side effects in children are similar to those observed in adults.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Losartan Almus

Keep out of sight and reach of children.

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

No special storage conditions are required.

Store Losartan Almus in its original packaging.

Do not open the blister pack until you are ready to take the medication.

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

6. Package Contents and Additional Information

Composition of Losartan Almus

The active ingredient of Losartan Almus is potassium losartan.

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

The other ingredients are microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, pregelatinized corn starch, and magnesium stearate.

Losartan Almus 50 mg contains potassium in the following amount: 4.24 mg (0.108 mEq).

The Losartan Almus 50 mg tablets also contain hydroxypropylmethylcellulose, polyethylene glycol 400, and titanium dioxide (E171).

Product Appearance and Package Contents

Losartan Almus is supplied as film-coated, oblong, white tablets with a score line on one side, containing 50 mg of potassium losartan.

Losartan Almus is supplied in the following package sizes:

White PVC-Aluminum blister pack, in packages of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua De Tapada Grande 2

Abrunheira, Sintra, 2710-228

Portugal

This leaflet was last revised in February 2025

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