Leaflet: information for the user

Losartán Pharma Combix 100 mg film-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 give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Losartán Pharma Combix 100 mg tablets are and what they are used for

2. What you need to know before taking Losartán Pharma Combix 100 mg tablets

3. How to take Losartán Pharma Combix 100 mg tablets

4. Possible side effects

5. Storage of Losartán Pharma Combix 100 mg tablets

6. Contents of the pack and additional information.

Losartán belongs to a group of medicines 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 kidney function in patients with high blood pressure and type 2 diabetes.

Losartán 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 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 medicines, called angiotensin-converting enzyme inhibitors (ACE inhibitors, medicines used to lower high blood pressure) are not suitable. If their heart failure has been stabilized with an ACE inhibitor, they should not switch to losartán.

• in patients with high blood pressure and left ventricular hypertrophy of the heart, losartán has been shown to reduce the risk of stroke (LIFE indication).

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 are 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 medicine that contains aliskiren.

Warnings and precautions

Before taking Losartán Pharma Combix, it is important that you 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 diarrhoea, 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-salt diet that causes excessive loss of fluids or salt from your body (see section 3. Dosage in special patient groups)

• if you know that you have narrowing or blockage of the blood vessels that go to your kidneys or if you have recently had a kidney transplant

• if your liver function is altered (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 potentially fatal cardiac arrhythmias. Special attention is required when you are 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 high 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):

• a converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may need to monitor your kidney function, blood pressure and blood levels of electrolytes (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 diarrhoea after taking losartan. Your doctor will decide whether to continue treatment. Do not stop taking losartan on your own.

Use of losartan with other medicines

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

While you are being treated with 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 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 medicines, such as indometacin, 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 modify 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 Pharma Combix” and “Warnings and precautions”).

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

Taking Losartán Pharma Combix with food and drink

Losartan can be taken with or without food.

Pregnancy, breastfeeding and fertility

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

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

You should not take losartan if you are breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

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

It is unlikely that Losartán Pharma Combix 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 performing these activities.

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

Patients with high blood pressure

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

If you estimate that the action 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

Typically, treatment begins with 50 mg of losartan (1 Losartán Pharma Combix 50 mg tablet) once a day. Subsequently, the dose may be increased to 100 mg of losartan (2 Losartán Pharma Combix 50 mg tablets or 1 Losartán Pharma Combix 100 mg tablet) once a day, depending on your blood pressure response.

Losartan may be administered 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 medications frequently used to decrease blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Adult 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 for the first week, 25 mg per day for the second week, and 50 mg per day for the third week), up to a maintenance dose of 50 mg of losartan (1 Losartán Pharma Combix 50 mg tablet) once a day, depending on your condition.

In the treatment of heart failure, losartan is typically 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 heart failure, or patients over 75 years old. Losartan is not recommended for use in patients with severe liver failure (see "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 essential to continue taking Losartán Pharma Combix until your doctor tells you otherwise.

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 Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Losartán Pharma Combix

If you accidentally forget a dose, simply take the next dose as usual. Do not take a double dose to compensate for the missed tablet. If you have any additional questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Losartán Pharma Combix may cause side effects, although not everyone will experience them.

If you experience any of the following, stop taking the losartan 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: occurring in more than 1 in 10 patients

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

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

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

Very rare: occurring in fewer 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,

• 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 those receiving 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,

• diarrhea,

• nausea

• vomiting,

• itching (pruritus),

• skin rash,

• localized swelling (edema),

Rare:

• 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),

• elevated levels of alanine aminotransferase (ALT) in the blood, which usually resolves upon discontinuing treatment.

• intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown:

• reduced red blood cell count (anemia),

• reduced platelet count,

• migraine,

• cough,

• liver function abnormalities,

• muscle and joint pain,

• changes in kidney function (may be reversible upon discontinuing treatment), including kidney failure,

• flu-like symptoms,

• increased urea in the blood, creatinine, and plasma potassium in patients with heart failure,

• back pain and urinary tract infection,

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 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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

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, cornstarch, microcrystalline cellulose, hydroxypropyl cellulose of low substitution degree, anhydrous colloidal silica, potato starch glycolate type A, magnesium stearate, Opadry 03F58991 White (composed of: HPMC 2910/Hypromellose 6 Cp, titanium dioxide -E171-, macrogol, talc).

Appearance of the product and content of the packaging

Coated tablets with a film coating, white or almost white in color, in the shape of a capsule, with the engraving “Z18” on one face and smooth on the other.

PVDC/PVC-Aluminum blister.

Packaging of 28 tablets.

Losartán Pharma Combix is also available in packaging of 28 tablets of 50 mg.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Combix Laboratories, S.L.U.

C/ Badajoz, 2. Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet February 2025

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