Losartan/hydrochlorothiazide Combix 50 mg/12.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Losartán/Hidroclorotiazida Combix 50 mg/12.5 mg film-coated tablets EFG

Losartan potassium and hydrochlorothiazide

Please read this 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 personally. Do not share it with others, 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 the side effects are 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 starting to take Losartán/Hidroclorotiazida Combix

Do not take Losartán/Hidroclorotiazida Combix

• If you are allergic (hypersensitive) to losartan, hydrochlorothiazide, or any of the other ingredients of this medicine.
• if you are allergic (hypersensitive) to sulfonamide-derived substances (e.g., other thiazides, certain antibacterial agents such as cotrimoxazole; consult your doctor if you have any doubts).
• if you are more than 3 months pregnant. (It is also advisable to avoid Losartán/Hidroclorotiazida Combix during the first months of pregnancy – see Pregnancy section.)
• if you have severe liver impairment.
• if you have severe renal impairment or your kidneys do not produce urine.
• if you have low levels of potassium or sodium, or high calcium levels that cannot be corrected with treatment.
• if you have gout.
• if you have diabetes or kidney 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). 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 severe harm to your baby when used from this point 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 or currently have 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 narrowing of arteries (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 are on a low-potassium diet

• if you require anesthesia (including 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 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 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 cancer and lip cancer. Protect your skin from exposure to sunlight and UV radiation 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 intraocular pressure, which may occur within hours to a week after taking Losartán/Hidroclorotiazida Combix.

• if you have previously experienced respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing 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 can interact with other medicines. Preparations containing lithium should not be taken with Losartán/Hidroclorotiazida Combix unless your doctor performs careful monitoring. Special precautionary measures (e.g., blood tests) may be necessary if you are taking potassium supplements, salt substitutes containing potassium, 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, "vasopressor 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 enhance 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 must not be used from the third month of pregnancy onward, as it may cause severe 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 intend to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

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

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

Use in athletes

This medicine contains hydrochlorothiazide, which may result in a positive doping test.

3. How to take Losartán/Hidroclorotiazida Combix

Follow exactly the instructions for taking Losartán/Hidroclorotiazida Combix as given by your doctor. Your doctor will decide the appropriate dose of Losartán/Hidroclorotiazida Combix 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 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) once 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 given to children.

Use in elderly patients

Losartán/Hidroclorotiazida Combix works with equal effectiveness and is equally well tolerated by 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 every day 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 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 in 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 people but more than 1 in 100):

• 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 an abnormal heart rhythm), decreased hemoglobin levels.

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

• Anemia, red or brown spots on the skin (sometimes particularly on the feet, legs, arms, and buttocks, with joint pain, swelling of the hands and feet, and abdominal pain), bruising, reduced white blood cell count, bleeding disorders 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 disturbances, drowsiness, memory impairment,
• Tingling or similar sensations, pain in the limbs, 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), nosebleeds, runny nose, congestion,
• Constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache,
• Jaundice (yellowing of the 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 the urine,
• Decreased sexual appetite, 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 (signs 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, talk to 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 Losartán/Hidroclorotiazida Combix

Keep out of the reach and sight of children.

Do not use Losartán/Hidroclorotiazida 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 Losartán/Hidroclorotiazida Combix in the original container.

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

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Losartán/Hidroclorotiazida Combix

The active substances are losartan potassium and hydrochlorothiazide.

Each Losartán/Hidroclorotiazida Combix 50 mg/12.5 mg film-coated tablet contains, as active substances, 50 mg of losartan (potassium) and 12.5 mg of hydrochlorothiazide.

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

Appearance of the product and contents of the container

Losartán/Hidroclorotiazida Combix 50 mg/12.5 mg tablets are supplied as film-coated tablets, white or almost white, capsule-shaped, with the code "ZD18" engraved on one side and smooth on the other.

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

Aluminum-Aluminum blisters, packs of 28 tablets.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz, 2. Building 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 medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/