Package Leaflet: Information for the User

Losartán/Hidroclorotiazida Combix 50 mg/12.5 mg Film-Coated Tablets EFG

Losartan potassium and hydrochlorothiazide

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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse.

1. What Losartan/Hydrochlorothiazide Combix is and what it is used for

2. What you need to know before you take Losartan/Hydrochlorothiazide Combix

3. How to take Losartan/Hydrochlorothiazide Combix

4. Possible side effects

5. Storage of Losartan/Hydrochlorothiazide Combix

6. Contents of the pack and additional information

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

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

Do not take Losartán/Hidroclorotiazida Combix

• If you are allergic (hypersensitive) to losartan, to hydrochlorothiazide, or to any of the other components of this medication.
• If you are allergic (hypersensitive) to sulfonamide-derived substances (for example, other thiazides, some antibacterials such as cotrimoxazole, ask your doctor if you have doubts).
• If you are more than 3 months pregnant (It is better to avoid Losartán/Hidroclorotiazida Combix during the first months of pregnancy - see Pregnancy section).
• If you have severe liver failure.
• If you have severe kidney failure or your kidneys do not produce urine.
• If you have low levels of potassium or sodium, high levels of calcium that cannot be corrected with treatment.

• If you have gout.
• If you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren.

Warnings and precautions

Inform your doctor if you are pregnant (or if you suspect that you may be). Losartán/Hidroclorotiazida Combix is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that point onwards (see Pregnancy section).

It is essential to 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 (medications to urinate)
• If you follow a low-sodium diet
• If you have excessive vomiting and/or diarrhea
• If you have heart failure
• If you have narrowed arteries (arterial stenosis), if you only have one functioning kidney, or if you have recently undergone a kidney transplant
• If you have atherosclerosis, angina pectoris (chest pain due to heart dysfunction)
• If you have aortic or mitral valve stenosis (narrowing of the heart valves) or hypertrophic cardiomyopathy (a disease that causes thickening of the heart valves)
• If you are diabetic
• If you have had gout
• If you have or have had an allergic reaction, asthma, or a condition that causes joint pain, skin eruptions, and fever (systemic lupus erythematosus)
• If you have high levels of calcium or low levels of potassium, or if you follow a low-potassium diet
• If you need anesthesia (even at the dentist) or before surgery, or if you are undergoing tests to determine your parathyroid function, inform your doctor or healthcare provider that you are taking losartan potassium and hydrochlorothiazide tablets
• If you have primary aldosteronism (a syndrome associated with an elevated secretion of aldosterone hormone by the adrenal gland due to a glandular alteration)
• If you are taking any of the following medications used to treat high blood pressure (hypertension):

• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (for example, enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

• Aliskiren. If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The use of hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Losartán/Hidroclorotiazida Combix.
• If you experience a decrease in vision or eye pain, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours to a week after taking Losartán/Hidroclorotiazida Combix.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Losartán/Hidroclorotiazida, seek medical attention immediately.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in the blood (such as 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 medications

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

Diuretics such as hydrochlorothiazide contained in Losartán/Hidroclorotiazida Combix may interact with other medications. Preparations containing lithium should not be taken with Losartán/Hidroclorotiazida Combix without your doctor's careful monitoring. Special precautions may be necessary (e.g., blood tests) if you take potassium supplements, potassium-sparing salt substitutes, or potassium-saving medications, diuretics (urine tablets), some laxatives, medications for gout treatment, medications to control heart rhythm or diabetes (oral medications or insulin). It is also essential that your doctor knows if you are taking other medications to lower your blood pressure, steroids, cancer medications, pain medications, fungal infection medications, or arthritis medications, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping pills; opioid medications such as morphine, "pressor amines" such as adrenaline, or other medications in the same group; (oral diabetes medications or insulin).

Your doctor may need to adjust 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/Hidroclorotiazida Combix” and “Warnings and precautions”).

Please inform your doctor when you plan to undergo a contrast medium with iodine while taking Losartán/Hidroclorotiazida Combix.

Losartán/Hidroclorotiazida Combix with food, drinks, and alcohol

It is recommended that you do not drink alcohol while taking these tablets: alcohol and Losartán/Hidroclorotiazida Combix tablets may increase the effects of each other.

Excessive salt in the diet may counteract the effect of Losartán/Hidroclorotiazida Combix tablets.

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

Pregnancy, breastfeeding, and fertility

Pregnancy:

You must inform your doctor if you are pregnant (or if you suspect that you may be). Your doctor will usually recommend that you stop taking Losartán/Hidroclorotiazida Combix before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Losartán/Hidroclorotiazida Combix. Losartán/Hidroclorotiazida Combix is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding:

Inform your doctor if you are breastfeeding or plan to start. Losartán/Hidroclorotiazida Combix is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

When starting treatment with this medication, you should not perform tasks that require special attention (e.g., driving a car or operating hazardous machinery) until you know how you tolerate your medication.

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

This medication contains lactose. If your doctor has indicated that you are intolerant to certain sugars, consult with them before taking this medication.

Use in athletes

This medication contains hydrochlorothiazide, which may produce a positive result in doping control tests.

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

Hypertension

For most patients with high blood pressure, the usual dose is 1 tablet of Losartán/Hidroclorotiazida 50 mg/12.5 mg per day to control blood pressure for 24 hours. It can be increased to 2 tablets of losartan/hidroclorotiazida 50 mg/12.5 mg per day or changed to 1 tablet of losartan/hidroclorotiazida 100 mg/25 mg (a higher dose) per day. The maximum daily dose is 2 tablets of 50 mg of losartan/12.5 mg of hidroclorotiazida per day or 1 tablet of 100 mg of losartan/25 mg of hidroclorotiazida per day.

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 acts with equal efficacy and is equally well tolerated by most elderly and young 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Overdose may cause a drop in 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 at the same time each day as prescribed. However, if you forget a dose, do not take an extra dose. Simply return to your regular schedule.

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

If you experience any of the following, stop taking Losartán/Hidroclorotiazida Combix 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.

The following side effects have been reported:

Frequent (affecting fewer than 1 in 10 but more than 1 in 100):

• Cough, respiratory infection, nasal congestion, sinusitis, breast discomfort,
• 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.

Less frequent (affecting fewer than 1 in 100 but more than 1 in 1,000):

• Anemia, red or brown spots on the skin, (sometimes especially on the feet, legs, arms, and buttocks, with joint pain, swelling of the hands and feet, and abdominal pain), hematoma, reduced white blood cell count, coagulation problems, and hematomas,
• Loss of appetite, elevated uric acid levels or overt gout, elevated blood glucose levels, abnormal electrolyte levels in the blood,
• Anxiety, nervousness, panic attacks (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory alteration,
• Tingling or similar sensations, pain in the extremities, tremors, migraine, fainting,
• Blurred vision, eye itching or stinging, conjunctivitis, worsening vision, seeing things in yellow,
• Decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma],
• Ringing, buzzing, sounds, or crackling in the ears,
• Low blood pressure that may be associated with changes in posture (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, transient ischemic attack (mini-stroke), heart attack, palpitations,
• Inflammation of blood vessels that often occurs with a skin rash or hematoma,
• Throat itching, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which may cause difficulty breathing), nasal bleeding, runny nose, congestion,
• Constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, salivary gland inflammation, tooth pain,
• Jaundice (yellow discoloration of the eyes and skin), pancreatitis inflammation,
• Hives, itching, skin inflammation, skin rash, redness of the skin, light sensitivity, dry skin, flushing, sweating, hair loss,
• Pain in the 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 libido, impotence,
• Swelling of the face, fever.

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

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

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

• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Frequency unknown

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting 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 out of the reach and sight of children.

Do not use Losartán/Hidroclorotiazida Combix after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above30°C.

Store Losartán/Hidroclorotiazida Combix in the original packaging.

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

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

Composition of Losartán/Hidroclorotiazida Combix

The active principles are losartan potassium and hydrochlorothiazide.

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

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

Appearance of the product and content of the packaging

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

Losartán/Hidroclorotiazida Combix is supplied in the following packaging sizes:

Aluminum-Aluminum blisters, in packs of 28 tablets.

Marketing Authorization Holder

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

Responsible for Manufacturing

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

This leaflet was last revised in February 2025

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