LOSARTAN PHARMA COMBIX 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Losartán Pharma Combix 50 mg film-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:

1. What Losartán Pharma Combix 50 mg film-coated tablets are and what they are used for
2. What you need to know before you take Losartán Pharma Combix 50 mg film-coated tablets
3. How to take Losartán Pharma Combix 50 mg film-coated tablets
4. Possible side effects
5. Storage of Losartán Pharma Combix 50 mg film-coated tablets
6. Contents of the pack and other information

1. What Losartán Pharma Combix 50 mg film-coated tablets are and what they are 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 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 kidney failure 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 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 Losartán Pharma Combix 50 mg film-coated tablets

Do not take Losartán Pharma Combix

• 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, think you may be pregnant, or plan to become pregnant (see also “Pregnancy, breast-feeding, and fertility”)
• if you are breast-feeding
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and precautions

Before taking Losartán Pharma Combix, 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, which can 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 on a low-salt diet that causes excessive loss of fluids or salt in 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 Losartán Pharma Combix 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 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), especially 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 Pharma Combix”.

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 on your own.

Using losartan with other medicines

Tell your doctor or pharmacist that you are using or have recently used or may need to use any other medicines.

While you are taking Losartán Pharma Combix, be particularly careful if you take any of the following medicines:

• other medicines that lower blood pressure, as they may cause additional lowering of 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 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 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 Losartán Pharma Combix” and “Warnings and precautions”).

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

Medicines containing 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 Losartán Pharma Combix with food and drink

Losartan can be taken with or without food.

Pregnancy, breast-feeding, and fertility

You should not take losartan during the first 12 weeks of pregnancy and in no case after the 13th week, as its use during pregnancy may harm your baby.

If you become pregnant while taking losartan, inform your doctor immediately. A switch to an alternative treatment should be made before a planned pregnancy.

You should not take losartan if you are breast-feeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Losartán Pharma Combix is unlikely to 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.

Losartán Pharma Combix contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Losartán Pharma Combix 50 mg film-coated tablets

Follow exactly the instructions of administration of this medicine given by your doctor. Your doctor will decide the appropriate dose of Losartán Pharma Combix, depending on your condition and whether you are taking other medicines. It is important to continue taking Losartán Pharma Combix as long as your doctor prescribes it to maintain constant control of your blood pressure.

Patients with high blood pressure

Normally, treatment starts with 50 mg of losartan (1 tablet of Losartán Pharma Combix 50 mg) 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 tablets of Losartán Pharma Combix 50 mg) once a day.

If you think the effect of Losartán Pharma Combix 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 (1 tablet of Losartán Pharma Combix 50 mg) once a day. After that, the dose may be increased to 100 mg of losartan (2 tablets of Losartán Pharma Combix 50 mg) once a day, depending on your blood pressure response.

Losartan 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 sugar 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 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 (1 tablet of Losartán Pharma Combix 50 mg) 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 heart failure, 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 Pharma Combix").

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 Pharma Combix until your doctor tells you to stop.

If you take more Losartán Pharma Combix 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 medicine and the amount ingested.

If you forget to take Losartán Pharma Combix

If you accidentally miss a dose, simply take the next dose as normal. 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, Losartán Pharma Combix 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, affecting 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: occurring in more than 1 in 10 patients

Common: occurring in between 1 in 100 and 1 in 10 patients

Uncommon: occurring in between 1 in 1,000 and 1 in 100 patients

Rare: occurring in between 1 in 10,000 and 1 in 1,000 patients

Very rare: occurring in less than 1 in 10,000 patients

Not known: cannot be estimated from the available data

The following side effects have been reported with losartan:

Common:

• dizziness,
• low blood pressure,
• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• high potassium levels in the blood (hyperkalemia),

Uncommon:

• drowsiness,
• headache,
• sleep disorders,
• palpitations (feeling of rapid heartbeats),
• severe chest pain (angina pectoris),
• low blood pressure (especially after excessive loss of water 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 after standing up from lying down or sitting,
• difficulty breathing (dyspnea),
• abdominal pain,
• chronic constipation,
• diarrhea,
• nausea,
• vomiting,
• itching (pruritus),
• skin rash,
• localized swelling (edema),

Rare:

• inflammation of blood vessels (vasculitis, Schonlein-Henoch purpura),
• numbness or tingling (paresthesia),
• fainting (syncope),
• 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 with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Very rare:

• reduced number of red blood cells (anemia),
• reduced number of platelets,
• migraine,
• cough,
• liver function abnormalities,
• muscle and joint pain,
• changes in kidney function (may be reversible upon discontinuation of treatment), including kidney failure,
• flu-like symptoms,
• increased urea, creatinine, and potassium levels in the blood in patients with heart failure,
• back pain and urinary tract infection,

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects 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 Pharma Combix 50 mg film-coated tablets

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition of Losartan Pharma Combix 50 mg tablets

-The active ingredient is losartan. Each tablet contains 50 mg of losartan potassium.

-The other components (excipients) are: lactose monohydrate, corn starch, microcrystalline cellulose, low-substituted hydroxypropylcellulose, anhydrous colloidal silica, sodium starch glycolate type A potato, magnesium stearate, Opadry 03F58991 White (composed of: HPMC 2910/Hypromellose 6 Cp, titanium dioxide -E171-, macrogol, talc).

Appearance of the Product and Package Contents

Film-coated tablets, white or almost white in color, capsule-shaped, scored on one side and smooth on the other.

The tablet can be divided into equal doses.

PVDC/PVC-Aluminum blister pack.

Packages of 28 tablets.

Losartan Pharma Combix is also available in packages of 28 tablets of 100 mg.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz, 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

25, parc d’activités des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of the Last Revision of this Leaflet 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/