PATIENT INFORMATION LEAFLET

Losartán ALMUS50 mgfilm-coated tablets

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2.What you need to know before you start taking Losartán Almus

3.How to take Losartán Almus

4.Possible side effects

5Storage of Losartán Almus

6. Contents of the pack and additional information

Losartán 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 results in an increase in blood pressure. Losartán prevents the binding of angiotensin II to these receptors, causing blood vessels to relax, which in turn reduces blood pressure. Losartán reduces the worsening of renal function in patients with high blood pressure and type 2 diabetes.

Losartán Almusis used

• to treat patients with elevated 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 proteins).
• 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 reduce elevated blood pressure) are not suitable. If their heart failure has been stabilized with an ACE inhibitor, they should not switch to losartan.
• in patients with elevated blood pressure and left ventricular hypertrophy of the heart, losartan has demonstrated that it reduces the risk of stroke (LIFE indication).

Do not take Losartán 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 more than 3 months pregnant. (It is also best to avoid Losartán Almus during the early months of pregnancy – see Pregnancy section).
• 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 Losartán Almus.

Inform your doctor if you are pregnant (or if you suspect you may be). Losartán Almus is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from that point onwards (see Pregnancy section).

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

Before taking Losartán Almus, it is essential to inform your doctor:

• if you have had 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 cause 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 following a low-sodium diet that causes excessive loss of fluids or salt from your body (see section 3. Posology in special patient groups),
• if you know you have narrowing or blockage of the blood vessels leading to your kidneys or if you have recently undergone a kidney transplant,
• if your liver function is altered (see sections 2. Do not take Losartán Almus and 3. Posology in special patient groups),
• if you have heart failure with or without kidney failure or potentially fatal cardiac arrhythmias. Special attention is required when being treated at the same time with a beta-blocker,
• if you have problems with your heart valves or heart muscle,
• if you have coronary heart disease (caused by reduced blood flow in the heart's blood vessels) or cerebrovascular disease (caused by reduced blood circulation in the brain),
• if you have primary aldosteronism (a syndrome associated with elevated secretion of the hormone aldosterone by the adrenal gland due to an alteration 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 renal function, blood pressure, and blood electrolyte levels (e.g. potassium), at regular intervals.

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

Losartán Almus with other medicines

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

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

• other medicines that lower blood pressure, as they may produce additional blood pressure reduction. Blood pressure may also decrease with 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 containing potassium, or potassium-sparing medicines such as certain diuretics [amiloride, triamterene, spironolactone] or heparin),
• non-steroidal anti-inflammatory drugs (NSAIDs), such as indometacin, 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 other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Losartán Almus” and “Warnings and precautions”).

If your renal function is impaired, the concomitant use of these medicines may cause a worsening of renal function.

Lithium-containing medicines should not be used in combination with losartan without your doctor's careful monitoring. It may be necessary to take special precautions (e.g. blood tests).

Losartán Almus with food and drinks

Losartán Almus can be taken with or without food.

Pregnancy and breastfeeding

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

Pregnancy

Your doctor will usually recommend that you stop taking Losartán Almus before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of Losartán Almus. Losartán Almus is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Losartán Almus is not recommended for use during breastfeeding, and your doctor will choose another 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 operating machinery

No studies have been conducted on the effects on the ability to drive and use machines.

It is unlikely that Losartán Almus will affect your ability to drive or use machines. However, as 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 engaging in these activities.

Important information about some of the components of Losartán Almus

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

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

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

Hypertensive patients

Typically, treatment begins with 50 mg of losartan (one Losartán Almus 50 mg tablet) once a day. The maximum blood pressure-lowering effect is achieved within 3-6 weeks of starting treatment. Afterwards, in some patients, the dose may be increased to 100 mg of losartan (two Losartán Almus 50 mg tablets) once a day.

If you estimate that the action of Losartán is too strong or too weak, please inform your doctor or pharmacist.

Hypertensive patients with type 2 diabetes

Typically, treatment begins with 50 mg of losartan (one Losartán Almus 50 mg tablet) once a day. Afterwards, the dose may be increased to 100 mg of losartan (two Losartán Almus 50 mg tablets) once a day, depending on your blood pressure response.

Losartan tablets can be taken with other medications that lower blood pressure (e.g., diuretics, calcium channel blockers, alpha or beta blockers, and central-acting medications), as well as with insulin and other frequently used medications to decrease blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Patients with heart failure

Typically, treatment begins with 12.5 mg of losartan once a day. Typically, 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 (one Losartán Almus 50 mg tablet) once a day, according to 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 be stronger and more efficient) and/or a beta blocker.

Posology in special patient groups

Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those treated with high doses of diuretics, patients with liver insufficiency, or patients over 75 years old. Losartan is not recommended for use in patients with severe liver insufficiency (see "Do not take Losartán Almus").

Administration

Tablets should be taken with a glass of water. Try to take your daily dose approximately at the same time each day. It is essential to continue taking Losartán Almus until your doctor tells you otherwise.

If you take more Losartán 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Losartán Almus

If you accidentally forget a dose, simply take the next dose normally. Do not take a double dose to compensate for the missed tablet.

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

Like all medicines, Losartán Almus can cause side effects, although not everyone will experience them.

If you experience any of the following, stop taking the losartán tablets and inform your doctor immediately or go to the emergency service of your nearest hospital:

A severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth, or throat that may cause difficulty swallowing or breathing).

This is a serious but rare side effect that affects more than 1 in 10,000 patients, but fewer than 1 in 1,000. You may need urgent medical attention or hospitalization.

Medicine side effects are classified as follows:

Very common:can affect more than 1 in 10 people

Common:can affect up to 1 in 10 people

Uncommon:can affect up to 1 in 100 people

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

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

Frequency not known:cannot be estimated from available data.

The following side effects have been reported with losartán:

Common:

• Dizziness,
• Dizziness,
• Low blood pressure,
• Weakness,
• Fatigue,
• Low blood sugar (hypoglycemia),
• High potassium levels in the blood (hyperkalemia),
• Changes in kidney function, including renal insufficiency,
• Reduced red blood cell count (anemia),
• A high level of urea in the blood, creatinine, and potassium in patients with heart failure.

Uncommon:

• Drowsiness,
• Headache,
• Sleep disorders,
• Sensation of very rapid heartbeats (palpitations),
• Severe chest pain (angina pectoris),
• Low blood pressure (especially after excessive loss of body water from the blood vessels, e.g. in patients with severe heart failure or in patients treated with high doses of diuretics),
• Orthostatic effects related to the dose, such as a decrease in blood pressure after standing up from lying down or sitting,
• Difficulty breathing (dyspnea),
• Abdominal pain,
• Chronic constipation,
• Diarrea,
• 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 may cause difficulty swallowing or breathing (angioedema),
• Inflammation of the blood vessels (vasculitis, Schonlein-Henoch purpura),
• Numbness or tingling (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 when treatment is stopped.
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown:

• Reduced platelet count,
• Migraine,
• Abnormal liver function,
• Muscle and joint pain,
• Symptoms similar to the flu,
• Back pain and urinary tract infection,
• Increased sensitivity to sunlight (photosensitivity),
• Muscle pain of unknown origin with dark-colored urine (tea-colored),
• Impotence,
• Inflammation of the pancreas (pancreatitis),
• Low sodium levels in the blood (hyponatremia),
• Depression,
• Generally feeling unwell (malaise),
• Ringing, buzzing, or clicking in the ears (tinnitus),
• Alteration of taste (dysgeusia).

The side effects in children are similar to those observed in adults.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use Losartán Almus after the expiration date that appears 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 the original packaging.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of LosartánAlmus

The active ingredient of Losartán Almus is losartan potassium.

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

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

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

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

Appearance of the product and contents of the packaging

Losartán Almus is supplied as film-coated, oblong, white tablets, scored on one side, containing 50 mg of losartan potassium.

Losartán Almus is supplied in the following packaging sizes:

PVC white – Aluminum blister pack, in packs of 28 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible manufacturer:

ATLANTIC PHARMA - PRODUÇOES FARMACEUTICAS, S.A.

Rua da Tapada Grande, No 2

Abrunheira, Sintra-Portugal

This leaflet was revised in February 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/