LOSARTAN PHARMA COMBIX 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Losartan Pharma Combix 100 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package 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 package leaflet. See section 4.

Contents of the package leaflet:

1. What Losartan Pharma Combix 100 mg tablets are and what they are used for
2. What you need to know before taking Losartan Pharma Combix 100 mg tablets
3. How to take Losartan Pharma Combix 100 mg tablets
4. Possible side effects
5. Storage of Losartan Pharma Combix 100 mg tablets
6. Package contents and additional information.

1. What Losartan Pharma Combix 100 mg tablets are and what they are 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 the binding of angiotensin II 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 is used:

• to treat patients with high blood pressure (hypertension).
• to protect the kidneys 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 taking Losartan Pharma Combix 100 mg tablets

Do not take Losartan Pharma Combix

• if you are allergic to losartan or any of the other ingredients of this medication (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, breastfeeding, and fertility”)
• if you are breastfeeding
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medication containing aliskiren.

Warnings and precautions

Before taking Losartan Pharma Combix, 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 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 impaired (see sections 2. Do not take Losartan Pharma Combix and 3. Dosage in special patient groups)
• if you have heart failure with or without kidney failure or life-threatening cardiac arrhythmias. Special attention is necessary 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 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 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 medications

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

While taking Losartan Pharma Combix, 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 decrease 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 Pharma Combix” 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 your doctor's careful monitoring. It may be appropriate to take special precautions (e.g., blood tests).

Taking Losartan Pharma Combix with food and drinks

Losartan can be taken with or without food.

Pregnancy, breastfeeding, 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 breastfeeding.

Consult your doctor or pharmacist before using any medication.

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 Pharma Combix 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 engaging in such activities.

Losartan Pharma Combix 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 Pharma Combix 100 mg tablets

Follow your doctor's instructions for taking this medication exactly. Your doctor will decide the appropriate dose of Losartan Pharma Combix, depending on your condition and whether you are taking other medications. It is essential to continue taking Losartan Pharma Combix as long as your doctor prescribes it to maintain constant blood pressure control.

Patients with high blood pressure

Normally, treatment starts with 50 mg of losartan (1 tablet of Losartan Pharma Combix 50 mg) once a day. The maximum blood pressure-lowering effect is achieved within 3-6 weeks of starting treatment. Afterward, in some patients, the dose may be increased to 100 mg of losartan (2 tablets of Losartan Pharma Combix 50 mg or 1 tablet of Losartan Pharma Combix 100 mg) once a day.

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

Losartan 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 commonly 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 Losartan Pharma Combix 50 mg) 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 heart failure, or patients over 75 years old. The use of losartan is not recommended in patients with severe liver failure (see section "Do not take Losartan 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 essential to continue taking Losartan Pharma Combix until your doctor tells you otherwise.

If you take more Losartan 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 medication and the amount ingested.

If you forget to take Losartan Pharma Combix

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 about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Losartan Pharma Combix 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 rare but serious 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: occurring in more than 1 in 10 patients

Common: occurring in 1 in 100 to 1 in 10 patients

Uncommon: occurring in 1 in 1,000 to 1 in 100 patients

Rare: occurring in 1 in 10,000 to 1 in 1,000 patients

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

Unknown: cannot be estimated from 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 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,
• 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.

Unknown:

• 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package 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 Pharma Combix 100 mg tablets

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

No special storage conditions are required.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Losartán Pharma Combix 100 mg tablets

-The active ingredient is losartan. Each tablet contains 100 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 Packaging Content

Film-coated tablets, white or almost white in color, capsule-shaped, with the engraving “Z18” on one side and smooth on the other.

PVDC/PVC-Aluminum blister pack.

Packaging containing 28 tablets.

Losartán Pharma Combix is also available in packaging of 28 tablets of 50 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 Prospectus 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/