Package Insert: Information for the User

Losartán/Hidroclorotiazida Aurovitas 100 mg/25 mg Film-Coated Tablets EFG

Losartan potassium and hydrochlorothiazide

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

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

Angiotensin II is a substance produced in the body that binds to receptors present in blood vessels, causing them to constrict. This results in an increase in blood pressure. Losartán prevents the binding of angiotensin II to these receptors, causing blood vessels to relax, which in turn reduces blood pressure. Hidroclorotiazida causes the kidneys to eliminate a greater amount of water and salts. This also helps to reduce blood pressure.

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

Do not take Losartán/Hidroclorotiazida Aurovitas

• if you are allergic to losartan, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to other sulfonamide-derived substances (e.g. other thiazides, some antibacterials such as cotrimoxazole, ask your doctor if you are unsure),
• if you are more than 3 months pregnant. It is also best to avoid Losartán/Hidroclorotiazida Aurovitas at the beginning of pregnancy (see the 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 or 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 blood pressure lowering medicine that contains aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Losartán/Hidroclorotiazida Aurovitas:

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with 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 losartan/hydrochlorothiazide.
• 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 and may occur within a few hours to weeks after taking this medicine. Without treatment, this can lead to permanent loss of vision. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk.

• 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.

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

It is essential to inform your doctor before taking Losartán/Hidroclorotiazida Aurovitas:

• if you have previously experienced swelling of the face, lips, tongue or throat,
• if you are taking diuretics (urine-producing medicines),
• if you are following a low-sodium diet,
• if you have had excessive vomiting and/or diarrhea,
• if you have heart failure,
• if your liver function is altered (see section 2 ‘Do not take Losartán/Hidroclorotiazida Aurovitas’),
• if you have narrowed arteries (arterial stenosis), angina (chest pain due to heart dysfunction),
• if you have mitral or aortic valve stenosis (narrowing of the heart valves) or hypertrophic cardiomyopathy (a disease that causes thickening of the heart muscle),
• 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 calcium levels or low potassium levels or if you are following a low-potassium diet,
• if you need anesthesia (even for dental procedures) or before surgery, or if you are undergoing tests to determine your parathyroid function, inform your doctor or healthcare professional 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 an alteration 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 kidney problems related to diabetes,
• aliskiren.

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

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

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

Children and adolescents

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

Other medicines and Losartán/Hidroclorotiazida Aurovitas

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

Diuretics such as hydrochlorothiazide in Losartán/Hidroclorotiazida Aurovitas may 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 levels (e.g. trimethoprim-containing medicines), as the combination with Losartán/Hidroclorotiazida is not recommended.

Lithium preparations should not be taken with losartan/hydrochlorothiazide without your doctor's careful monitoring.

You may need to take special precautions (e.g. blood tests) if you are taking diuretics (urine-producing medicines), some laxatives, medicines for gout treatment, heart rhythm control medicines or diabetes medicines (oral or insulin).

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

• other medicines to lower your blood pressure,
• steroids,
• medicines for cancer treatment,
• pain medicines,
• medicines for fungal infections,
• medicines for arthritis,
• cholesterol-lowering resins such as cholestyramine,
• muscle relaxants,
• sleeping pills,
• 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 ACE inhibitor or aliskiren (see also the information under the headings “Do not take Losartán/Hidroclorotiazida Aurovitas” and “Warnings and precautions”).

Please inform your doctor when you plan to have a contrast agent with iodine.

Taking Losartán/Hidroclorotiazida Aurovitas with food, drinks and alcohol

It is recommended not to drink alcohol while taking these tablets: alcohol and losartan/hydrochlorothiazide tablets may increase the effects of each other.

Excessive salt in the diet may counteract the effect of losartan/hydrochlorothiazide tablets.

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

It is best to avoid grapefruit juice while taking Losartán/Hidroclorotiazida Aurovitas.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant (or could be), consult your doctor or pharmacist before using this medicine.

Pregnancy
You must inform your doctor if you think you may be pregnant (or could be). Normally, your doctor will advise you to stop taking losartan and hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medicine. Losartán/Hidroclorotiazida Aurovitas is not recommended during pregnancy and should not be used if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period.

Breastfeeding
Inform your doctor if you are breastfeeding or plan to start breastfeeding. Losartán/Hidroclorotiazida Aurovitas is not recommended for breastfeeding mothers and your doctor may choose another treatment if you wish to breastfeed.

Use in elderly patients

Losartán/Hidroclorotiazida Aurovitas acts with equal efficacy and is equally well tolerated by most elderly patients and young patients. Most elderly patients require the same dose as younger patients.

Driving and operating machinery

When starting treatment with this medicine, 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 medicine.

Losartán/Hidroclorotiazida Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose oflosartán and hidroclorotiazida, depending on your condition and if you are taking other medications. It is essential to continue takinglosartán and hidroclorotiazidaas prescribed by your doctor to maintain a constant control of blood pressure.

This medication is available in three doses: 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg.

High Blood Pressure

For most patients with high blood pressure, the recommended dose is 1 tablet oflosartán and hidroclorotiazida50 mg/12.5 mgper day to control your blood pressure for 24 hours. It can be increased to 2 tablets coated with film of50 mg/12.5 mgper day or changed to 1 tablet coated with film of100 mg/25 mg(a stronger dose) per day. The maximum daily dose is 2 tablets coated with film of50 mg/12.5 mgper day or 1 tablet coated with film of100 mg/25 mgper day.

Method of Administration

Losartán/Hidroclorotiazida Aurovitas tablets should be swallowed whole with a glass of water.

If you take more Losartán/Hidroclorotiazida Aurovitas than you should

In case of an overdose, contact your doctor immediately for immediate medical attention. An overdose may cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.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.

If you forgot to take Losartán/Hidroclorotiazida Aurovitas

Try to take losartán/hidroclorotiazida daily as prescribed. However, if you forget a dose, do not take an extra dose. Simply return to your regular schedule. Do not take a double dose to compensate for missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of the following, stop taking Losartán/Hidroclorotiazida Aurovitas tablets and inform 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 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 (may affect up to 1 in 10 people):

• Cough, upper respiratory tract infection, nasal congestion, sinusitis, breast tenderness,
• 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,
• Changes in renal function, including renal insufficiency,
• Low blood sugar (hypoglycemia).

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

• 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, reduced platelet count,
• Loss of appetite, elevated uric acid levels or manifest 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,
• Sharp pains or similar sensations, pain in the extremities, tremors, migraine, fainting,
• Blurred vision, burning or stinging in the eyes, conjunctivitis, worsening vision, seeing things in yellow,
• Ringing, buzzing, sounds, or crackling in the ears, vertigo,
• 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,
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which causes difficulty breathing), nasal bleeding, runny nose, congestion,
• Constipation, chronic 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 renal function, including kidney inflammation, urinary tract infection, sugar in the urine,
• Decreased libido, impotence,
• Swelling of the face, localized swelling (edema), fever.

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

• Hepatitis (liver inflammation), abnormal liver function tests.

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

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

Frequency unknown (cannot be estimated from available data):

• Symptoms similar to the flu,
• Muscle pain of unknown origin with dark-colored urine (rhabdomyolysis),
• Low sodium levels in the blood (hyponatremia),
• Generally feeling unwell,
• Alteration of taste (dysgeusia),
• Skin cancer and lip cancer (non-melanoma skin cancer),
• Sudden decrease in distant vision (acute myopia),Decreased vision or eye pain due to high eye pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma).

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 this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging/label. The expiration date is the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition of Losartán/Hidroclorotiazida Aurovitas

• The active principles are losartan potassium and hidroclorotiazida.

Losartán/Hidroclorotiazida Aurovitas100 mg/25 mg tablets contain100 mg of losartan potassium and 25 mg of hidroclorotiazida as active principles.

• The other components are:

Tablet core:microcrystalline cellulose, lactose monohydrate (lactose), pregelatinized cornstarch (cornstarch), anhydrous colloidal 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 package

Film-coated tablet.

Film-coated tablets, yellow, oval, beveled edges, biconvex, engraved with ‘E’ on one side and ‘49’ on the other side.

Losartán/Hidroclorotiazida Aurovitas film-coated tablets are available in blisterswhite opaque PVC/PE/PVDC- aluminium foil and high-density polyethylene (PEAD) bottles with polypropylene closures.

Package sizes:

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

Only some package sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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 member states of the European Economic Area with the following names:

Spain:Losartán/Hidroclorotiazida Aurovitas 100 mg/25 mg film-coated tablets EFG

Malta:Losartan /HydrochlorothiazideAurobindo100 mg/25 mg film-coated tablets

Portugal:Losartan + Hidroclorotiazida Aurovitas

Last review date of this leaflet: September 2023

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