Losartan Pharma Combix 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Losartan Pharma Combix 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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. How to store Losartan Pharma Combix 100 mg tablets
6. Contents of the pack and other information

1. What Losartán Pharma Combix 100 mg tablets is and what it is 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 present in blood vessels, causing them to narrow. This leads to an increase in blood pressure.

Losartan prevents angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels, which in turn lowers blood pressure. Losartan reduces the progression of renal impairment 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 renal insufficiency 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 (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 thickening 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 Pharma Combix 100 mg tablets

Do not take Losartán Pharma Combix

• if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6)
• if you have severely impaired liver function
• 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 medicine containing aliskiren.

Warnings and precautions

Before taking Losartán Pharma Combix, it is important 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 are experiencing 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 if you are on a low-salt diet that may lead to excessive loss of fluids 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 undergone a kidney transplant
• if you have impaired liver function (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 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 in the brain)
• if you have primary hyperaldosteronism (a syndrome associated with excessive secretion of the hormone aldosterone by the adrenal gland due to adrenal gland dysfunction)
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
  • an angiotensin-converting enzyme (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 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

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

While being treated with Losartán Pharma Combix, 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, potassium-containing salt substitutes, or potassium-sparing medicines such as certain diuretics [amiloride, triamterene, spironolactone] or heparin)
• non-steroidal anti-inflammatory drugs (NSAIDs), 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 (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Losartán Pharma Combix” and “Warnings and precautions”).

If you have impaired kidney function, 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 closely monitors you. Special precautionary measures (e.g., blood tests) may be appropriate.

Taking Losartán Pharma Combix with food and drink

Losartan may be taken with or without food.

Pregnancy, breastfeeding and fertility

You must not take losartan during the first 12 weeks of pregnancy and under no circumstances from week 13 onwards, as its use during pregnancy may cause harm to your unborn 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 must not take losartan if you are breastfeeding.

Consult your doctor or pharmacist before using any medicine.

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 Pharma Combix 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 engaging in such activities.

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

3. How to take Losartán Pharma Combix 100 mg tablets

Follow exactly the instructions for use of this medicine as 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 medications. It is important to keep taking Losartán Pharma Combix as long as your doctor prescribes it to maintain consistent control of your blood pressure.

Patients with high blood pressure

Treatment usually starts with 50 mg of losartan (1 tablet of Losartán Pharma Combix 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 (2 tablets of Losartán Pharma Combix 50 mg or 1 tablet of Losartán Pharma Combix 100 mg) once daily.

If you feel that 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

Treatment usually starts with 50 mg of losartan (1 tablet of Losartán Pharma Combix 50 mg) once daily. Afterwards, the dose may be increased to 100 mg of losartan (2 tablets of Losartán Pharma Combix 50 mg or 1 tablet of Losartán Pharma Combix 100 mg) once daily, depending on your blood pressure response.

Losartan may be administered together 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 commonly used to reduce blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Adult patients with heart failure

Treatment usually starts with 12.5 mg of losartan once daily. The dose is usually gradually increased 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 (1 tablet of Losartán Pharma Combix 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 being 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 unless 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. Symptoms of overdose include 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. Telephone 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 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Losartán Pharma Combix can cause adverse effects, although not everyone experiences them.

If you experience the following, stop taking losartan tablets immediately and contact your doctor immediately 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: 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 available data

The following adverse effects have been reported with losartan:

Common:

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

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 doses of diuretics),
• dose-related orthostatic effects such as drop in blood pressure upon standing up from lying or sitting position,
• difficulty breathing (dyspnoea),
• abdominal pain,
• chronic constipation,
• diarrhoea,
• nausea,
• vomiting,
• itching (pruritus),
• skin rash,
• localized swelling (oedema),

Rare:

• 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:

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

Reporting of adverse effects

If you experience any adverse effect, consult 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 Losartan Pharma Combix 100 mg 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Losartan Pharma Combix 100 mg tablets

-The active substance is losartan. Each tablet contains 100 mg of potassium losartan.

-The other components (excipients) are: monohydrate lactose, 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 contents of the pack

Film-coated tablets, white or almost white, capsule-shaped, engraved with "Z18" on one side and smooth on the other.

PVDC/PVC-Aluminum blister pack.

Pack size: 28 tablets.

Losartan Pharma Combix is also available in packs 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 most recent review of this leaflet: February 2025

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