Losartan Almus 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Losartan ALMUS 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. 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 must not be given to other people, 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 such effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Losartán Almus 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 the progression of renal impairment in patients with high blood pressure and type 2 diabetes.

Losartán 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 impairment and proteinuria ≥ 0.5 g per day (a condition 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 medicines called angiotensin-converting enzyme inhibitors (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 left ventricular hypertrophy (thickening of the wall 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 Almus

Do not take Losartán Almus

• if you are allergic to losartan or to 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 advisable to avoid Losartán Almus during the first months of pregnancy – see Pregnancy section).
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking Losartán Almus.

Tell your doctor if you are pregnant (or think you might be). Use of Losartán Almus is not recommended in early pregnancy, and must not be initiated if you are more than three months pregnant, as it may cause serious harm to your baby when used from that stage onward (see Pregnancy section).

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

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

• if you have ever had angioedema (swelling of the face, lips, tongue, and/or throat) (see also section 4. Possible side effects),

• if you have excessive vomiting or diarrhoea, which may cause 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 are on a low-salt diet that may lead to excessive loss of fluid 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 supplying your kidneys or if you have recently had a kidney transplant,

• if your liver function is impaired (see sections 2. Do not take Losartán Almus 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 to the brain),

• if you have primary hyperaldosteronism (a syndrome associated with excessive secretion of the hormone aldosterone by the adrenal gland due to gland dysfunction),

• 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 Losartán Almus”.

Taking Losartán Almus with other medicines

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

While being treated with Losartán Almus, 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, salt substitutes containing potassium, or potassium-sparing medicines such as certain diuretics [amiloride, triamterene, spironolactone] or heparin),
• non-steroidal anti-inflammatory drugs, 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 other precautions:

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

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

Medicines containing lithium should not be used in combination with losartan unless your doctor carefully monitors you. Special precautions (e.g. blood tests) may be appropriate.

Taking Losartán Almus with food and drink

Losartán Almus may 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

Your doctor will usually advise you to stop taking Losartán Almus before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Losartán Almus is not recommended in early pregnancy, and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when used from that stage.

Breast-feeding

Use of Losartán Almus is not recommended during breast-feeding. Your doctor will choose an alternative treatment for you if you wish to breastfeed, especially if your baby is a newborn or premature.

Use in children and adolescents

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

Driving and using machines

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

It is unlikely that Losartán Almus 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 carrying out such activities.

Important information about some of the ingredients of Losartán Almus

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

3. How to take Losartán Almus

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the appropriate dose of Losartán Almus based on your condition and whether you are taking other medications. It is important to continue taking Losartán Almus as prescribed by your doctor to maintain consistent blood pressure control.

Patients with high blood pressure

Treatment usually starts with 50 mg of losartan (one tablet of Losartán Almus 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 (one tablet of Losartán Almus 100 mg) once daily.

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

Patients with high blood pressure and type 2 diabetes

Treatment usually starts with 50 mg of losartan (one tablet of Losartán Almus 50 mg) once daily. Afterwards, the dose may be increased to 100 mg of losartan (one tablet of Losartán Almus 100 mg) once daily, depending on your blood pressure response.

Losartan tablets may be taken together with other antihypertensive medicines (e.g., diuretics, calcium antagonists, alpha or beta blockers, and centrally acting agents), as well as with insulin and other medicines commonly used to lower blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Patients with heart failure

Treatment usually starts with 12.5 mg of losartan once daily. The dose is usually increased gradually on a weekly basis (i.e., 12.5 mg daily during the first week, 25 mg daily during the second week, and 50 mg daily during the third week), up to a maintenance dose of 50 mg of losartan (one tablet of Losartán Almus 50 mg) once daily, depending on your condition.

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 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 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 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 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. Symptoms of overdose may include low blood pressure, increased heart rate, and possibly decreased heart rate.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Losartán Almus

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

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

4. Possible adverse effects

Like all medicines, Losartán Almus may cause adverse effects, although not everyone experiences them.

If you experience the following, stop taking losartan tablets immediately and contact your doctor 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 swallowing or breathing).

This is a serious but rare adverse effect, affecting more than 1 in 10,000 patients but less than 1 in 1,000. It may require urgent medical attention or hospitalization.

Adverse 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
Not known frequency: cannot be estimated from available data.

The following adverse effects have been reported with losartan:

Common:

• dizziness,
• vertigo,
• low blood pressure,
• weakness,
• fatigue,
• low blood sugar (hypoglycaemia),
• high potassium levels in blood (hyperkalaemia),
• changes in kidney function including renal failure,
• reduced number of red blood cells (anaemia),
• increased blood urea, creatinine and plasma potassium levels in patients with heart failure.

Uncommon:

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

Rare:

• severe allergic reaction (hypersensitivity),
• swelling of the face, lips, tongue and/or throat which may cause difficulty swallowing or breathing (angioedema),
• inflammation of blood vessels (vasculitis, Schönlein-Henoch purpura),
• numbness or tingling sensation (paraesthesia),
• fainting (syncope),
• very rapid and irregular heartbeat (atrial fibrillation),
• stroke (cerebrovascular accident),
• liver inflammation (hepatitis),
• increased blood levels of alanine aminotransferase (ALT), which usually resolves upon discontinuation of treatment,
• intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Not known frequency:

• 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) indicating muscle breakdown (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in blood (hyponatraemia),
• depression,
• general feeling of being unwell (malaise),
• ringing, buzzing, noise or clicking in the ears (tinnitus),
• altered taste (dysgeusia).

Adverse effects 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 Medicines: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Store Losartán Almus in the original container.

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to your pharmacy’s SIGRE point. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Package contents and other information

Composition of Losartán Almus

The active substance in 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).

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

Appearance of the product and contents of the pack

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

Losartán Almus is available in the following pack sizes:

White PVC – Aluminium blisters, packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 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 up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/