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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Losartan/Hydrochlorothiazide Aurovitas 50 mg/12.5 mg film-coated tablets EFG

Losartan potassium and hydrochlorothiazide

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

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

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

Angiotensin II is a substance produced in the body that binds to receptors present in blood vessels, causing them to narrow. This results in an increase in blood pressure. Losartán prevents angiotensin II from binding to these receptors, causing blood vessels to relax, thereby reducing blood pressure. Hydrochlorothiazide causes the kidneys to eliminate increased amounts of water and salts. This also helps reduce blood pressure.

This medicine is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before taking Losartan/Hydrochlorothiazide Aurovitas

Do not take Losartan/Hydrochlorothiazide Aurovitas

• if you are allergic to losartan, hydrochlorothiazide, or any of the other components of this medicine (listed in section 6),
• if you are allergic to other sulfonamide-derived substances (e.g. other thiazides, certain antibiotics such as cotrimoxazole; ask your doctor if you are unsure),
• if you are more than 3 months pregnant. It is also advisable to avoid Losartan/Hydrochlorothiazide Aurovitas in early pregnancy (see section Pregnancy),
• 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 suffer from gout,
• if you have diabetes or kidney impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Losartan/Hydrochlorothiazide Aurovitas:

• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly 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 rays while taking losartan/hydrochlorothiazide.

• If you experience a decrease in vision 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 weeks after taking this medicine. Without treatment, this may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition.

• If you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking losartan/hydrochlorothiazide, seek medical attention immediately.

You should inform your doctor if you think you are pregnant (or could be). Losartan/Hydrochlorothiazide Aurovitas is not recommended during early pregnancy and must not be used if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see section Pregnancy).

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

• 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 your liver function is impaired (see section 2 ‘Do not take Losartan/Hydrochlorothiazide Aurovitas’),
• 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 (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 rashes, 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 your doctor or healthcare professional 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 adrenal dysfunction),
• 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), especially if you have kidney problems related to diabetes,
• aliskiren.

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

See also the information under the heading “Do not take Losartan/Hydrochlorothiazide Aurovitas”.

• if you are taking other medicines that may increase serum potassium (see section 2 “Other medicines and Losartan/Hydrochlorothiazide Aurovitas”).

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.

Children and adolescents

There is no experience with the use of Losartan/Hydrochlorothiazide Aurovitas in children. Therefore, Losartan/Hydrochlorothiazide Aurovitas must not be given to children.

Other medicines and Losartan/Hydrochlorothiazide Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Diuretics such as hydrochlorothiazide contained in Losartan/Hydrochlorothiazide Aurovitas can interact with other medicines.

Inform your doctor if you are taking potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, or other medicines that may increase serum potassium (e.g. medicines containing trimethoprim), as combination with losartan/hydrochlorothiazide is not recommended.

Lithium-containing preparations must not be taken with losartan/hydrochlorothiazide without careful monitoring by your doctor.

Special precautionary measures (e.g. blood tests) may be appropriate if you are taking diuretics (water tablets), certain laxatives, gout treatments, medicines to control heart rhythm, or diabetes medicines (oral agents or insulin).

It is also important that your doctor knows if you are taking:

• other medicines to lower your blood pressure,
• corticosteroids,
• 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,
• oral diabetes medicines or insulin.

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

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

Please inform your doctor when you plan to undergo iodinated contrast media procedures while taking Losartan/Hydrochlorothiazide Aurovitas.

Taking Losartan/Hydrochlorothiazide Aurovitas with food, drinks, and alcohol

You are advised not to drink alcohol while taking these tablets: alcohol and losartan/hydrochlorothiazide tablets may enhance each other's effects.

Excessive dietary salt intake may counteract the effect of losartan/hydrochlorothiazide tablets.

Losartan/Hydrochlorothiazide Aurovitas may be taken with or without food.

Grapefruit juice should be avoided while taking Losartan/Hydrochlorothiazide Aurovitas.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy You must inform your doctor if you think you are pregnant (or could be). Your doctor will usually advise you to stop taking losartan and hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Losartan and hydrochlorothiazide are not recommended during pregnancy and must not be taken if you are more than 3 months pregnant, as they may cause serious harm to your baby if used from the third month of pregnancy onward.

Breastfeeding Inform your doctor if you are breastfeeding or planning to breastfeed. Losartan/Hydrochlorothiazide Aurovitas is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.

Use in elderly patients

Losartan/Hydrochlorothiazide Aurovitas is equally effective and well tolerated in most elderly and younger patients. Most elderly patients require the same dose as younger patients.

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.

Losartan/Hydrochlorothiazide Aurovitas contains lactose

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

3. How to take Losartan/Hydrochlorothiazide Aurovitas

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the appropriate dose of losartan and hydrochlorothiazide based on your condition and whether you are taking other medicines. It is important to continue taking losartan and hydrochlorothiazide as prescribed by your doctor to maintain consistent blood pressure control.

This medicine is available in three strengths: 50 mg/12.5 mg, 100 mg/12.5 mg, and 100 mg/25 mg.

High blood pressure

For most patients with high blood pressure, the recommended dose is 1 tablet of losartan and hydrochlorothiazide 50 mg/12.5 mg daily to control blood pressure over 24 hours. This may be increased to 2 film-coated tablets of 50 mg/12.5 mg daily or changed to 1 film-coated tablet of 100 mg/25 mg (a stronger dose) daily. The maximum daily dose is 2 film-coated tablets of 50 mg/12.5 mg daily or 1 film-coated tablet of 100 mg/25 mg daily.

Method of administration

Losartan/Hydrochlorothiazide Aurovitas tablets should be swallowed whole with a glass of water.

If you take more Losartan/Hydrochlorothiazide Aurovitas than you should

In case of overdose, contact your doctor immediately to receive immediate medical attention. Overdose may cause low blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration. 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, stating the medicine and the amount ingested.

If you forget to take Losartan/Hydrochlorothiazide Aurovitas

Try to take losartan/hydrochlorothiazide daily as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your regular schedule. Do not take a double dose to make up for missed doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience the following, stop taking Losartán/Hidroclorotiazida Aurovitas tablets immediately and contact your doctor 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 rare but serious 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 (may affect up to 1 in 10 people):

• Cough, upper respiratory tract infection, nasal congestion, sinusitis, sinus disorder,
• diarrhoea, 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 haemoglobin levels,
• changes in kidney function including kidney failure,
• low blood sugar (hypoglycaemia).

Uncommon (may affect up to 1 in 100 people):

• Anaemia, red or brown spots on the skin (sometimes especially on the feet, legs, arms, and buttocks, with joint pain, swelling of hands and feet, and abdominal pain), bruising, reduced white blood cells, blood clotting problems, reduced platelet count,
• 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,
• muscle twitching or similar sensations, limb pain, tremor, migraine, fainting,
• blurred vision, burning or prickling sensations in the eyes, conjunctivitis, worsening of vision, seeing things in yellow,
• ringing, buzzing, noises, or crackling in the ears, dizziness,
• low blood pressure which may be associated with changes in posture (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (transient ischaemic 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 (causing difficulty breathing), nosebleed, runny nose, congestion,
• constipation, chronic constipation, flatulence, stomach disorders, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache,
• jaundice (yellowing of the eyes and skin), inflammation of the pancreas,
• urticaria, 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, localized swelling (oedema), fever.

Rare (may affect up to 1 in 1,000 people):

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

Very rare (may affect up to 1 in 10,000 people):

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

Frequency not known (cannot be estimated from available data):

• Flu-like symptoms,
• muscle pain of unknown origin with dark-coloured urine (tea-coloured) (rhabdomyolysis),
• low sodium levels in blood (hyponatraemia),
• generally feeling unwell (malaise),
• altered taste (dysgeusia),
• skin and lip cancer (non-melanoma skin cancer),
• sudden decrease in distance vision (acute myopia), decreased vision or eye pain due to high intraocular pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects 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/Hydrochlorothiazide Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging/label. The expiry date refers to the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Losartan/Hydrochlorothiazide Aurovitas

• The active substances are potassium losartan and hydrochlorothiazide.

Losartan/Hydrochlorothiazide Aurovitas 50 mg/12.5 mg tablets contain 50 mg of potassium losartan and 12.5 mg of hydrochlorothiazide as active substances.

• Other components are:

Tablet core: microcrystalline cellulose, monohydrate lactose (lactose), pregelatinized corn starch (corn starch), colloidal anhydrous silica, magnesium stearate.

Tablet coating: hydroxypropyl cellulose (E463), hypromellose 6cP (E464), titanium dioxide (E171), quinoline yellow aluminium lake (E104).

Appearance of the product and contents of the container

Film-coated tablet.

Film-coated, yellow, oval, bevel-edged, biconvex tablets, engraved with ‘E’ on one side and ‘48’ on the other.

Losartan/Hydrochlorothiazide Aurovitas film-coated tablets are available in opaque white PVC/PE/PVDC - aluminium foil blisters and high-density polyethylene (HDPE) bottles with polypropylene cap.

Pack sizes:

Blister packs: 14, 28, 30, 50, 56, 60, 90, 98, 100, 280 and 500 film-coated tablets.

Bottles: 14 and 500 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Losartan/Hydrochlorothiazide Aurovitas 50 mg/12.5 mg film-coated tablets EFG

Malta: Losartan /Hydrochlorothiazide Aurobindo 50 mg/12.5 mg film-coated tablets

Portugal: Losartan + Hydrochlorothiazide Aurovitas

Date of the most recent review of this leaflet: August 2025

Detailed 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/).