LOSARTAN/HYDROCHLOROTHIAZIDE COMBIX 100 mg/25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

Potassium losartan and hydrochlorothiazide

Read all of this 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

• Contents of the pack and other information
• 1. What is Losartan/Hydrochlorothiazide Combix and what is it 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. How to store Losartan/Hydrochlorothiazide Combix
• 6. Contents of the pack and further information

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

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

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

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

Do not take Losartan/Hydrochlorothiazide 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, some antibacterials such as cotrimoxazole; ask your doctor if you have doubts).
• If you are pregnant for more than 3 months (it is also recommended to avoid Losartan/Hydrochlorothiazide Combix during the first months of pregnancy - see section Pregnancy).
• If you have severe hepatic impairment.
• If you have severe renal impairment or your kidneys do not produce urine.
• If you have low potassium or sodium levels, high calcium levels 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 that contains aliskiren.

Warnings and precautions

Tell your doctor if you are pregnant (or think you may be). Losartan/Hydrochlorothiazide Combix is not recommended during the first trimester of pregnancy and must not be taken if you are pregnant more than 3 months, as it may cause serious harm to your baby when administered from that time on (see section Pregnancy).

It is important that you inform your doctor before taking Losartan/Hydrochlorothiazide Combix:

• If you have previously suffered from swelling of the face, lips, tongue, or throat
• If you are taking diuretics (water pills)
• 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 narrow arteries supplying the kidneys (renal artery stenosis), if you only have one functioning kidney, or if you have recently had a kidney transplant
• If you have narrowing of the arteries (arteriosclerosis), angina pectoris (chest pain due to poor heart function)
• If you have narrowing of the aortic or mitral valve (valve stenosis) or hypertrophic cardiomyopathy (a disease that causes thickening of the heart valves)
• If you are diabetic
• If you have had gout
• If you have had an allergic disorder, asthma, or a condition that causes joint pain, skin rashes, and fever (systemic lupus erythematosus)
• If you have high calcium levels or low potassium levels or are on a low-potassium diet
• If you need to have anesthesia (even at the dentist) or before surgery, or if you are going to have tests to determine your parathyroid function, you should inform your doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets
• If you have primary hyperaldosteronism (a syndrome associated with high 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 used to treat high blood pressure (hypertension):

• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have diabetes-related kidney problems.
• Aliskiren.

• If you have had skin cancer or if you 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Losartan/Hydrochlorothiazide Combix.
• If you experience vision loss or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within hours to a week after taking Losartan/Hydrochlorothiazide Combix.
• If you have had respiratory or lung 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 Losartan/Hydrochlorothiazide Combix, go to the doctor 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 Losartan/Hydrochlorothiazide Combix”.

Interaction of Losartan/Hydrochlorothiazide Combix with other medicines

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

Diuretics like hydrochlorothiazide contained in Losartan/Hydrochlorothiazide Combix may interact with other medicines. Preparations containing lithium should not be taken with Losartan/Hydrochlorothiazide Combix without your doctor's careful monitoring. Special precautions may be necessary (e.g., blood tests) if you take potassium supplements, salt substitutes containing potassium, or potassium-sparing medicines, diuretics (water pills), some laxatives, medicines for gout, medicines to control heart rhythm or for diabetes (oral or insulin), or other blood pressure-lowering medicines.

It is also important that your doctor knows if you are taking other medicines to lower your blood pressure, steroids, cancer medicines, painkillers, antifungal medicines, or arthritis medicines, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping pills; opioid medicines like morphine, "pressor amines" like adrenaline or other medicines in the same group; (oral diabetes medicines or insulins).

Your doctor may need to change your dose and/or take other precautions:

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

Please, when taking Losartan/Hydrochlorothiazide Combix, inform your doctor when you are scheduled to have an iodine contrast medium.

Losartan/Hydrochlorothiazide Combix with food, drinks, and alcohol

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

Excessive salt in the diet may counteract the effect of Losartan/Hydrochlorothiazide Combix tablets.

Losartan/Hydrochlorothiazide Combix can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnancy:

You should inform your doctor if you are pregnant (or think you may be). Your doctor will generally advise you to stop taking Losartan/Hydrochlorothiazide Combix before you become pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of Losartan/Hydrochlorothiazide Combix. Losartan/Hydrochlorothiazide Combix is not recommended during the first trimester of pregnancy and must not be taken if you are pregnant more than 3 months, as it may cause serious harm to your baby when administered from that time on.

Breastfeeding:

Tell your doctor if you are breastfeeding or plan to start breastfeeding. Losartan/Hydrochlorothiazide Combix is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

When you start treatment with this medicine, you should not perform tasks that require special attention (e.g., driving a car or using hazardous machinery) until you know how your medicine affects you.

Important information about some of the ingredients of Losartan/Hydrochlorothiazide Combix

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Use in athletes

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

3. How to take Losartan/Hydrochlorothiazide Combix

Follow exactly the administration instructions of Losartan/Hydrochlorothiazide Combix given by your doctor. Your doctor will decide the appropriate dose of Losartan/Hydrochlorothiazide, depending on your condition and whether you are taking other medicines. It is important to continue taking Losartan/Hydrochlorothiazide Combix as long as your doctor prescribes it to maintain constant control of your blood pressure.

High blood pressure

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

Use in children and adolescents

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

Use in elderly patients

Losartan/Hydrochlorothiazide Combix works with equal efficacy and is equally well tolerated by most elderly patients and younger patients. Most elderly patients require the same dose as younger patients.

If you take more Losartan/Hydrochlorothiazide Combix than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

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

If you forget to take Losartan/Hydrochlorothiazide Combix

Try to take Losartan/Hydrochlorothiazide Combix as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your usual schedule.

4. Possible side effects

Like all medicines, Losartan/Hydrochlorothiazide Combix can cause side effects, although not everybody gets them.

If you experience the following, stop taking Losartan/Hydrochlorothiazide Combix tablets and inform your doctor immediately or go to the emergency department of your nearest hospital:

A severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth, or throat that can cause difficulty swallowing or breathing).

This is a serious but rare side effect that affects more than 1 patient in 10,000 but less than 1 patient in 1,000. You may need urgent medical attention or hospitalization.

The following side effects have been reported:

Frequent (affecting less than 1 in 10 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,
• High potassium levels (which can cause an abnormal heart rhythm), decreased hemoglobin levels.

Uncommon (affecting less 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), bruising, reduced white blood cells, coagulation problems, and bruising,
• Loss of appetite, high uric acid levels or gout, high blood sugar levels, abnormal blood electrolyte levels,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory impairment,
• Numbness or similar sensations, pain in the limbs, tremor, migraine, fainting,
• Blurred vision, eye irritation or itching, 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 effusion) or glaucoma],
• Ringing, buzzing, noises, or clicking 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, stroke (transient stroke, "mini-stroke"), heart attack, palpitations,
• Inflammation of blood vessels that is often associated with a skin rash or bruising,
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which can 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), pancreatitis,
• Hives, itching, skin inflammation, skin rash, redness of the skin, sensitivity to light, 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 sexual desire, impotence,
• Swelling of the face, fever.

Rare (affecting more than 1 patient in 10,000 but less than 1 patient in 1,000):

• Hepatitis (inflammation of the liver), 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 patient in 10,000):

• Acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).

Frequency not known

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

If you think any of the side effects you are experiencing is serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Losartan/Hydrochlorothiazide Combix

Keep out of the reach and sight of children.

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

Do not store above 30°C.

Store Losartan/Hydrochlorothiazide Combix in its original packaging.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Losartan/Hydrochlorothiazide Combix

The active ingredients are losartan potassium and hydrochlorothiazide.

Each Losartan/Hydrochlorothiazide Combix 100 mg/25 mg film-coated tablet contains, as active ingredients, 100 mg of losartan (potassium) and 25 mg of hydrochlorothiazide.

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

Product Appearance and Container Content

Losartan/Hydrochlorothiazide Combix 100 mg/25 mg tablets are supplied as film-coated tablets, white or almost white in color, capsule-shaped, with the letters "ZD19" engraved on one side and smooth on the other.

Losartan/Hydrochlorothiazide Combix is supplied in the following container sizes:

Aluminum-Aluminum Blister, in packages of 28 tablets.

Marketing Authorization Holder

Combix Laboratories, S.L.U.

C/ Badajoz, 2. Building 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Phone: + 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 last revision of this prospectus was in February 2025

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