LOSARTAN ALMUS 100 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Losartan ALMUS100 mgfilm-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

5 Storage of Losartan Almus

1. Contents of the pack and further information

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

Losartan belongs to a group of medicines called angiotensin II receptor antagonists.

Angiotensin II is a substance produced in the body that binds to receptors in blood vessels, causing them to narrow. This results in an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, which causes the blood vessels to relax, resulting in a decrease in 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 results that indicate kidney failure 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 your 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 you take Losartan Almus

Do not take Losartan Almus

• 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 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 failure and are being treated with a blood pressure-lowering medicine 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 if you think you might be pregnant). Your doctor will normally advise you to stop taking Losartan Almus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan Almus. Losartan Almus should not be used at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may 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 important 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 that causes excessive fluid loss and/or salt loss 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 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 altered (see sections 2. Do not take Losartan Almus 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 (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 medicines

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

While you are taking Losartan Almus, be particularly cautious if you take any of the following medicines:

• other medicines that lower blood pressure, as they may cause additional blood pressure reduction. 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 that 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 medicines, such as indomethacin, including COX-2 inhibitors (medicines that reduce inflammation and that 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 Almus” and “Warnings and precautions”.

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

Medicines that contain lithium should not be used in combination with losartan without your doctor performing careful monitoring. It may be appropriate to take special precautions (e.g., blood tests).

Taking Losartan Almus with food and drink

Losartan Almus can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Your doctor will normally advise you to stop taking Losartan Almus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan Almus. Losartan Almus should not be used at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may 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 another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Use in children and adolescents

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

Driving and using machines

No studies have been performed 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 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 these activities.

Important information about some of the ingredients of Losartan Almus

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

3. How to take Losartan Almus

Follow exactly the administration instructions of this medicine given 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 medicines. It is important to keep taking Losartan Almus while your doctor prescribes it to you to maintain constant control of your blood pressure.

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 (one Losartan Almus 100 mg tablet) 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 (one Losartan Almus 100 mg tablet) once a day, depending on your blood pressure response.

Losartan tablets can be administered with other blood pressure-lowering medicines (e.g., diuretics, calcium antagonists, 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).

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) to a maintenance dose of 50 mg of losartan (one Losartan Almus 50 mg tablet) once a day, depending on your condition.

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 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 in patients with severe liver failure (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 important that you keep 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, telephone 91 562 04 20, indicating the medicine 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Losartan Almus can cause side effects, although not everybody gets 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, which affects more than 1 patient in 10,000, but less than 1 patient in 1,000. You may need urgent medical attention or hospitalization.

Side effects of medicines 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 diuretic therapy),
• dose-related orthostatic effects, such as decreased blood pressure when standing up after 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 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 upon discontinuation of treatment.
• intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known:

• reduced number of platelets,
• 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,
• generally feeling 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 of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Losartán Almus

Keep out of sight and reach of children.

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

No special storage conditions are required.

Store Losartán 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 any unused medications. This will help protect the environment.

6. Packaging contents and additional information

Composition of Losartán Almus

The active ingredient of Losartán Almus is potassium losartan.

Each Losartán Almus 100 mg tablet contains 100 mg of potassium losartan.

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

Losartán Almus 100 mg contains potassium in the following amount: 8.48 mg (0.216 mEq).

The Losartán Almus 100 mg tablets also contain hydroxypropylmethylcellulose, polyethylene glycol 400, and titanium dioxide (E171).

Appearance of the product and packaging contents

Losartán Almus is supplied as film-coated, oblong, white tablets with a score line on one side, containing 100 mg of potassium losartan.

Losartán Almus is supplied in the following packaging 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/