Losartan/hydrochlorothiazide Combix 100 mg/25 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Losartán/Hidroclorotiazida Combix 100 mg/25 mg film-coated tablets EFG

Losartan potassium and hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine, as 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, pharmacist, or nurse.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.

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

• Leaflet Contents:

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

1. What Losartán/Hidroclorotiazida Combix is and what it is used for

Losartán/Hidroclorotiazida Combix is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).

Losartán/Hidroclorotiazida Combix is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before taking Losartán/Hidroclorotiazida Combix

Do not take Losartán/Hidroclorotiazida Combix

• If you are allergic (hypersensitive) to losartan, hydrochlorothiazide, or any of the other components of this medicine.

• if you are allergic (hypersensitive) to sulfonamide-derived substances (e.g., other thiazides, certain antibacterial agents such as cotrimoxazole; ask your doctor if you are unsure).

• if you are more than 3 months pregnant (Losartán/Hidroclorotiazida Combix should also be avoided during the first months of pregnancy—see Pregnancy section).

• if you have severe liver impairment.

• if you have severe renal impairment or your kidneys are not producing urine.

• if you have low levels of potassium or sodium, or high levels of calcium that cannot be corrected with treatment.

• if you have gout.

• if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Inform your doctor if you are pregnant (or suspect you might be pregnant). Use of Losartán/Hidroclorotiazida Combix is not recommended during early pregnancy, and you must not take it after the third month of pregnancy, as it may cause serious harm to your baby when used from this stage onward (see Pregnancy section).

It is important that you inform your doctor before taking Losartán/Hidroclorotiazida Combix:

• if you have previously experienced swelling of the face, lips, tongue, or throat

• if you are taking diuretics (medicines to increase urine production)

• if you are on a low-salt diet

• if you have had excessive vomiting and/or diarrhea

• if you have heart failure

• if you have narrowing of the arteries supplying the kidneys (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant

• if you have arterial narrowing (atherosclerosis), angina pectoris (chest pain due to poor heart function)

• if you have aortic or mitral valve stenosis (narrowing of heart valves) or hypertrophic cardiomyopathy (a condition causing thickening of the heart muscle)

• if you are diabetic

• if you have had gout

• if you have or have had an allergic disorder, asthma, or a condition causing joint pain, skin rash, and fever (systemic lupus erythematosus)

• if you have high calcium levels or low potassium levels, or if you are on a low-potassium diet

• if you require anesthesia (even at the dentist) or before surgery, or if you are undergoing tests to assess parathyroid function, you must inform the doctor or healthcare staff that you are taking losartan potassium and hydrochlorothiazide tablets

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

• if you are taking any of the following medicines for 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

• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Losartán/Hidroclorotiazida Combix.

• if you experience vision loss or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to a week after taking Losartán/Hidroclorotiazida Combix.

• if you have had respiratory or pulmonary problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop dyspnea or severe breathing difficulty after taking Losartán/Hidroclorotiazida, seek medical help immediately.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

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

See also the information under the heading “Do not take Losartán/Hidroclorotiazida Combix”.

Interaction of Losartán/Hidroclorotiazida Combix with other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Diuretics such as hydrochlorothiazide contained in Losartán/Hidroclorotiazida Combix may interact with other medicines. Lithium-containing preparations should not be taken with Losartán/Hidroclorotiazida Combix unless your doctor performs careful monitoring. Special precautionary measures (e.g., blood tests) may be required if you are taking potassium supplements, potassium-containing salt substitutes, or potassium-sparing medicines, diuretics (water tablets), certain laxatives, medicines for gout, medicines to control heart rhythm, or medicines for diabetes (oral agents or insulin). It is also important that your doctor knows if you are taking other blood pressure-lowering medicines, steroids, cancer treatments, pain medicines, antifungal medicines, arthritis medicines, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping tablets, opioid medicines such as morphine, "pressor amines" such as adrenaline or other medicines in the same group, or oral antidiabetic medicines or insulin.

Your doctor may need to adjust your dose and/or take additional precautions:

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

Please inform your doctor if you are scheduled to receive an iodinated contrast medium while taking Losartán/Hidroclorotiazida Combix.

Losartán/Hidroclorotiazida Combix with food, drinks, and alcohol

You are advised not to drink alcohol while taking these tablets: alcohol and Losartán/Hidroclorotiazida Combix tablets may increase each other's effects.

Excessive dietary salt intake may counteract the effect of Losartán/Hidroclorotiazida Combix tablets.

Losartán/Hidroclorotiazida Combix may be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnancy:

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking Losartán/Hidroclorotiazida Combix before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Losartán/Hidroclorotiazida Combix is not recommended during early pregnancy, and it must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when administered from this stage.

Breastfeeding:

Inform your doctor if you are breastfeeding or planning to breastfeed. Use of Losartán/Hidroclorotiazida Combix is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you wish to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

When starting treatment with this medicine, do not perform tasks that require special attention (e.g., driving a car or operating dangerous machinery) until you know how you tolerate the medicine.

Important information about some of the components of Losartán/Hidroclorotiazida Combix

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

Use in athletes

This medicine contains hydrochlorothiazide, which may lead to a positive result in doping control tests.

3. How to take Losartán/Hidroclorotiazida Combix

Follow exactly the administration instructions for Losartán/Hidroclorotiazida Combix given by your doctor. Your doctor will decide the appropriate dose of Losartán/Hidroclorotiazida depending on your condition and whether you are taking other medicines. It is important to keep taking Losartán/Hidroclorotiazida Combix as prescribed by your doctor to maintain consistent blood pressure control.

High blood pressure

For most patients with high blood pressure, the usual dose is 1 tablet of Losartán/Hidroclorotiazida 50 mg/12.5 mg once daily to control blood pressure over 24 hours. This dose may be increased to 2 tablets of losartán/hidroclorotiazida 50 mg/12.5 mg daily or changed to 1 tablet of losartán/hidroclorotiazida 100 mg/25 mg (a stronger dose) daily. The maximum daily dose is 2 tablets of 50 mg losartán/12.5 mg hydrochlorothiazide daily or 1 tablet of 100 mg losartán/25 mg hydrochlorothiazide daily.

Use in children and adolescents

There is no experience with the use of Losartán/Hidroclorotiazida Combix in children. Therefore, Losartán/Hidroclorotiazida Combix should not be administered to children.

Use in elderly patients

Losartán/Hidroclorotiazida Combix works with equal efficacy and is equally well tolerated in most elderly and younger patients. Most elderly patients require the same dose as younger patients.

If you take more Losartán/Hidroclorotiazida Combix than you should

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 medication and the amount ingested.

Overdose may cause low blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

If you forget to take Losartán/Hidroclorotiazida Combix

Try to take Losartán/Hidroclorotiazida Combix daily as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your regular dosing schedule.

4. Possible adverse effects

Like all medicines, Losartán/Hidroclorotiazida Combix may cause adverse effects, although not everyone experiences them.

If you experience any of the following, stop taking Losartán/Hidroclorotiazida Combix tablets immediately and contact your doctor right away 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.

The following adverse effects have been reported:

Common (affecting less than 1 in 10 but more than 1 in 100 people):

• Cough, respiratory infection, nasal congestion, sinusitis, sinus disorder,
• Diarrhea, abdominal pain, nausea, indigestion,
• Muscle pain or cramps, leg pain, back pain,
• Insomnia, headache, dizziness,
• Weakness, fatigue, chest pain,
• Elevated potassium levels (which may cause abnormal heart rhythm), decreased hemoglobin levels.

Uncommon (affecting less than 1 in 100 but more than 1 in 1,000 people):

• Anemia, red or brown spots on the skin (sometimes especially on feet, legs, arms, and buttocks, with joint pain, swelling of hands and feet, and abdominal pain), bruising, reduction in white blood cells, blood clotting problems and bruising,
• Loss of appetite, elevated uric acid levels or overt gout, elevated blood glucose levels, abnormal blood electrolyte levels,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory disturbance,
• Tingling or similar sensations, limb pain, tremor, migraine, fainting,
• Blurred vision, burning or itching in the eyes, conjunctivitis, worsening of vision, seeing things in yellow,
• Decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma],
• Ringing, buzzing, noises, or crackling in the ears,
• Low blood pressure which may be associated with postural changes (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (transient ischemic attack, "mini-stroke"), heart attack, palpitations,
• Inflammation of blood vessels, often associated with a skin rash or bruising,
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which may cause difficulty breathing), nosebleed, runny nose, congestion,
• Constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, swelling of a salivary gland, toothache,
• Jaundice (yellowing of eyes and skin), inflammation of the pancreas,
• Hives, itching, skin inflammation, skin rash, skin redness, photosensitivity, dry skin, flushing, sweating, hair loss,
• Pain in arms, shoulders, hips, knees, or other joints, joint swelling, stiffness, muscle weakness,
• Frequent urination, even at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in urine,
• Decreased sexual desire, impotence,
• Facial swelling, fever.

Rare (affecting more than 1 in 10,000 and less than 1 in 1,000 patients):

• Hepatitis (inflammation of the liver), abnormal liver function tests.
• Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Very rare (affecting up to 1 in 10,000 patients):

• Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion).

Frequency not known:

• Skin and lip cancer (non-melanoma skin cancer)

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 may 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/Hydrochlorothiazide Combix

Keep out of the reach and sight of children.

Do not use Losartan/Hydrochlorothiazide Combix after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Store Losartan/Hydrochlorothiazide Combix in the original container.

Keep the blister pack inside the outer packaging. Do not open the blister until you are ready to take the tablet.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Losartán/Hidroclorotiazida Combix

The active substances are losartan potassium and hydrochlorothiazide.

Each Losartán/Hidroclorotiazida Combix 100 mg/25 mg film-coated tablet contains, as active substances, 100 mg of losartan (potassium) and 25 mg of hydrochlorothiazide.

Losartán/Hidroclorotiazida Combix contains the following inactive ingredients: lactose monohydrate, corn starch, microcrystalline cellulose (E460i), low-substituted hydroxypropyl cellulose, anhydrous colloidal silica, sodium carboxymethyl potato starch (type A), magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol, and talc (E553b).

Appearance of the product and pack contents

Losartán/Hidroclorotiazida Combix 100 mg/25 mg tablets are supplied as white or almost white, capsule-shaped, film-coated tablets, marked with the code "ZD19" on one side and smooth on the other.

Losartán/Hidroclorotiazida Combix is available in the following pack sizes:

Aluminum-Aluminum blister packs containing 28 tablets.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz, 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Telephone: +34 91 490 42 51

Fax: +34 91 490 31 89

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d’activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Specialites Pharmaceutiques

ZAC du Suzot

35 rue de la Chapelle

63450 St Amant Tallende

France

The most recent revision of this leaflet was in February 2025

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