LOSARTAN/HYDROCHLOROTHIAZIDE AUROVITAS 50 mg/12.5 mg FILM-COATED TABLETS

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

Do not take Losartan/Hydrochlorothiazide 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 not sure),
• if you are more than 3 months pregnant. It is also better to avoid Losartan/Hydrochlorothiazide Aurovitas at the beginning of pregnancy (see the section on Pregnancy),
• if you have severe hepatic 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 renal impairment 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 Losartan/Hydrochlorothiazide Aurovitas:

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular its 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 ray exposure while taking losartan/hydrochlorothiazide.
• If you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and can occur within hours to weeks after taking this medicine. Without treatment, this can lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamide, you may be at greater risk of developing this condition.

• 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 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 might be). Losartan/Hydrochlorothiazide Aurovitas is not recommended at the start 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 from the third month of pregnancy.

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

• 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 your liver function is impaired (see section 2 'Do not take Losartan/Hydrochlorothiazide Aurovitas'),
• 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 (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 had an allergic disorder, asthma, or a condition that causes joint pain, skin rash, and fever (systemic lupus erythematosus),
• if you have high levels of calcium or low levels of potassium or if you are on a low-potassium diet,
• if you need to have anesthesia (even at the dentist) or before surgery, or if you are to undergo 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.

Your doctor may need to check 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 levels (see section 2 “Other medicines and Losartan/Hydrochlorothiazide Aurovitas”).

Please inform your doctor when you are planning to undergo an iodine-containing contrast medium.

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

It is recommended that you do not 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.

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

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should inform your doctor if you think you are pregnant (or might be). Your doctor will normally advise you to stop taking losartan and hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead. Losartan and hydrochlorothiazide are not recommended during pregnancy and should 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.

Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding. Losartan/Hydrochlorothiazide Aurovitas is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment if you wish to breast-feed.

Use in elderly patients

Losartan/Hydrochlorothiazide Aurovitas works as well and is as well tolerated by most elderly patients as by younger patients. Most elderly patients require the same dose as younger patients.

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.

Losartan/Hydrochlorothiazide Aurovitas contains lactose

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

3. How to take Losartan/Hydrochlorothiazide Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Your doctor will decide the appropriate dose of losartan and hydrochlorothiazide, depending on your condition and whether you are taking other medicines. It is important to keep taking losartan and hydrochlorothiazide while your doctor prescribes it for you to maintain constant control of your blood pressure.

This medicine is available in three strengths: 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 one Losartan/Hydrochlorothiazide Aurovitas 50 mg/12.5 mg tablet per day to control blood pressure over 24 hours. This may be increased to two 50 mg/12.5 mg film-coated tablets per day or changed to one 100 mg/25 mg film-coated tablet per day. The maximum daily dose is two 50 mg/12.5 mg film-coated tablets per day or one 100 mg/25 mg film-coated tablet per day.

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 for immediate medical attention. 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 Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Losartan/Hydrochlorothiazide Aurovitas

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

If you have any further questions on 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 all people suffer from them.

If you experience the following, stop taking Losartán/Hidroclorotiazida Aurovitas 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 adverse effect, affecting more than 1 patient in 10,000, but less than 1 patient in 1,000. It may require urgent medical attention or hospitalization.

The following adverse effects have been reported:

Frequent (may affect up to 1 in 10 people):

• Cough, upper respiratory tract 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,
• changes in renal function including renal failure,
• low blood sugar (hypoglycemia).

Infrequent (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 disorders, reduced platelet count,
• loss of appetite, high uric acid levels or gout, high blood glucose levels, abnormal blood electrolyte levels,
• anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory impairment,
• muscle aches or similar sensations, pain in the limbs, tremor, migraine, fainting,
• blurred vision, burning or stinging in the eyes, conjunctivitis, worsening vision, seeing things in yellow,
• ringing, buzzing, noises, or clicking in the ears, vertigo,
• low blood pressure that may be associated with postural changes (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 hematoma,
• sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which can cause difficulty breathing), nasal bleeding, runny nose, congestion,
• constipation, chronic 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 renal function including kidney inflammation, urinary tract infection, sugar in the urine,
• decreased sexual appetite, 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 (signs include severe difficulty breathing, fever, weakness, and confusion).

Frequency Not Known (cannot be estimated from the available data):

• Flu-like symptoms,
• muscle pain of unknown origin with dark-colored urine (tea-colored urine) (rhabdomyolysis),
• low sodium levels in the blood (hyponatremia),
• generally feeling unwell (malaise),
• taste disturbance (dysgeusia),
• skin 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 effusion) or acute angle-closure glaucoma).

Reporting of Adverse Effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Losartán/Hidroclorotiazida Aurovitas

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

Do not use this medicine after the expiration date stated 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 via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Losartán/Hidroclorotiazida Aurovitas

• The active ingredients are losartan potassium and hydrochlorothiazide.

Losartán/Hidroclorotiazida Aurovitas 50 mg/12.5 mg film-coated tablets contain 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as active ingredients.

• The other ingredients are:

Core of the tablet:microcrystalline cellulose, lactose monohydrate (lactose), pregelatinized corn starch (corn starch), colloidal anhydrous silica, magnesium stearate.

Coating of the tablet:hydroxypropyl cellulose (E463), hypromellose 6cP (E464), titanium dioxide (E171), aluminum lake of quinoline yellow (E104).

Appearance and Package Contents

Film-coated tablet.

Yellow, oval, biconvex, film-coated tablets with beveled edges, engraved with 'E' on one side and '48' on the other side.

Losartán/Hidroclorotiazida Aurovitas film-coated tablets are available in white opaque PVC/PE/PVDC - aluminum foil blisters and high-density polyethylene (HDPE) bottles with polypropylene closures.

Package 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.

Not all package sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Losartán/Hidroclorotiazida Aurovitas 50 mg/12.5 mg film-coated tablets EFG

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

Portugal: Losartan + Hidroclorotiazida Aurovitas

Date of the Last Revision of this Leaflet:September 2023

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