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

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Losartan/Hydrochlorothiazide SUN 50 mg/12.5 mg

film-coated tablets EFG

losartan potassium / hydrochlorothiazide

Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Losartán/Hidroclorotiazida SUN 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 narrow. This leads to an increase in blood pressure. Losartán prevents angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels, thereby lowering blood pressure. Hidroclorotiazida causes the kidneys to eliminate increased amounts of water and salts. This also helps reduce blood pressure.

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

2. What you need to know before taking Losartán/Hidroclorotiazida SUN

Do not take Losartán/Hidroclorotiazida SUN:

• if you are allergic to losartan, hydrochlorothiazide, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to other sulfonamide-derived substances (e.g., other thiazides, certain antibacterial medicines such as cotrimoxazole; ask your doctor if you are unsure).
• if you are more than 3 months pregnant. (It is also advisable to avoid Losartán/Hidroclorotiazida during the first months of pregnancy – see Pregnancy section).
• if you have severe liver failure.
• if you have severe kidney failure 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 have gout.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting this medicine.

You must inform your doctor if you are pregnant (or suspect you might be). Use of Losartán/Hidroclorotiazida is not recommended during early pregnancy, and you must not take it after the third month of pregnancy, as it may cause severe harm to your baby when used from that stage onward (see Pregnancy section).

Contact your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Losartán/Hidroclorotiazida SUN. Your doctor will decide whether to continue treatment. Do not stop taking Losartán/Hidroclorotiazida SUN on your own.

Consult your doctor before starting Losartán/Hidroclorotiazida:

• if you have previously had swelling of the face, lips, tongue, or throat.
• if you are taking diuretics (medicines to increase urine output).
• if you are on a low-salt diet.
• if you have or have had excessive vomiting and/or diarrhea.
• if you have heart failure.
• if you have narrowed arteries supplying the kidneys (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant.
• if you have narrowed arteries (atherosclerosis), angina pectoris (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 disease causing joint pain, skin rashes, and fever (systemic lupus erythematosus).
• if you have high calcium levels or low potassium levels, or if you follow 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 the doctor or healthcare staff 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 gland dysfunction).
• 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 and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Losartán/Hidroclorotiazida.
• if you are taking any of the following medicines for high blood pressure (hypertension):
  1. • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
  2. • aliskiren.

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

• If you are taking other medicines that may increase serum potassium (see section 2 “Other medicines and Losartán/Hidroclorotiazida SUN”);
• If you experience vision changes or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to weeks after taking Losartán/Hidroclorotiazida. This may lead to permanent vision loss if not treated. You may be at higher risk, especially if you are predisposed to a condition called glaucoma or have previously had an allergy to penicillin or sulfonamides. If you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Losartán/Hidroclorotiazida, seek medical attention immediately.

See also the section under the heading “Do not take Losartán/Hidroclorotiazida SUN”.

Other medicines and Losartán/Hidroclorotiazida SUN:

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

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

Diuretics such as hydrochlorothiazide contained in Losartán/Hidroclorotiazida may interact with other medicines.

Lithium-containing preparations must not be taken with Losartán/Hidroclorotiazida unless your doctor closely monitors you.

Special precautionary measures (e.g., blood tests) may be appropriate if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, 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 blood pressure-lowering medicines,
• steroids,
• cancer treatment medicines,
• painkillers,
• 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.

Please inform your doctor if you are scheduled to receive iodinated contrast media while taking Losartán/Hidroclorotiazida.

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 Losartán/Hidroclorotiazida SUN” and “Take special care with Losartán/Hidroclorotiazida SUN”).

Taking Losartán/Hidroclorotiazida SUN with food and drinks

You are advised not to drink alcohol while taking these tablets: alcohol and Losartán/Hidroclorotiazida tablets may increase each other's effects.

Excessive dietary salt intake may counteract the effect of Losartán/Hidroclorotiazida tablets.

Losartán/Hidroclorotiazida can be taken with or without food.

Grapefruit juice should be avoided while taking losartan/hydrochlorothiazida.

Pregnancy and breastfeeding:

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking Losartán/Hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Losartán/Hidroclorotiazida is not recommended during early pregnancy, and must not be used from the third month of pregnancy onward, as it may cause severe harm to your baby from that stage.

Breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Children and adolescents:

There is no experience with the use of Losartán/Hidroclorotiazida in children. Therefore, Losartán/Hidroclorotiazida must not be given to children.

Use in elderly patients:

Losartán/Hidroclorotiazida 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 that require special attention (e.g., driving a car or operating dangerous machinery) until you know how you react to the medicine.

Losartán/Hidroclorotiazida SUN contains lactose

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

Losartán/Hidroclorotiazida SUN contains soya lecithin

This medicine contains soya lecithin. Do not use this medicine if you are allergic to peanuts or soy.

Use in athletes

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

3. How to take Losartán/Hidroclorotiazida SUN

Follow exactly the administration instructions for Losartán/Hidroclorotiazida SUN as indicated by your doctor. Your doctor will decide the appropriate dose of Losartán/Hidroclorotiazida SUN based on your condition and whether you are taking other medications. It is important to keep taking Losartán/Hidroclorotiazida SUN as prescribed by your doctor to maintain consistent blood pressure control.

High blood pressure

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

If you take more Losartán/Hidroclorotiazida SUN than you should:

In case of overdose, contact your doctor immediately or go directly to the hospital 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Losartán/Hidroclorotiazida SUN:

Try to take Losartán/Hidroclorotiazida SUN as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your regular dosing schedule.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

If you experience the following, stop taking Losartan/Hydrochlorothiazide tablets immediately and contact your doctor right away 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 serious but rare 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, respiratory infection, nasal congestion, sinusitis, sinus disorder,
• Diarrhea, abdominal pain, nausea, indigestion,
• Muscle pain or cramps, leg pain, back pain,
• Insomnia, headache, dizziness,
• Renal dysfunction, renal failure,
• Weakness, fatigue, chest pain,
• Elevated potassium levels (which may cause abnormal heart rhythm), decreased hemoglobin levels,
• Changes in kidney function including renal failure,
• Low blood sugar (hypoglycemia).

Uncommon (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 hands and feet, and abdominal pain), bruising, reduction in white blood cells, bleeding and bruising problems,
• 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 disorders, drowsiness, memory disturbance,
• Tingling or similar sensations, pain in the limbs, tremor, migraine, fainting,
• Blurred vision, burning or itching in the eyes, conjunctivitis, worsening of vision, seeing things in yellow,
• Ringing, buzzing, noises or clicking in the ears, vertigo,
• Low blood pressure which may be associated with postural changes (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (transient ischemic 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 (which may cause difficulty breathing), nosebleed, 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), inflammation of the pancreas,
• Hives, itching, skin inflammation, skin rash, redness of the skin, photosensitivity, 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 appetite, erectile dysfunction/impotence,
• Facial swelling, fever, localized swelling (edema).

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 presenting symptoms such as abdominal pain, nausea, vomiting and diarrhea.

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

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

Not known (frequency cannot be estimated from available data):

• Decrease in the number of platelets in the blood,
• Muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis),
• Inflammation of the pancreas (pancreatitis),
• Generally feeling unwell (malaise),
• Flu-like symptoms,
• Low sodium levels in the blood (hyponatremia),
• Altered taste (dysgeusia),
• Skin and lip cancer (non-melanoma skin cancer),
• Decreased vision or eye pain due to increased 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 type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect 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 SUN

Keep Losartan/Hydrochlorothiazide SUN out of the sight and reach of children.

Do not use Losartan/Hydrochlorothiazide SUN after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Keep the blister pack in the original packaging.

Do not open the blister pack until ready to take the medicine.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Losartan/Hydrochlorothiazide SUN

The active substances are losartan potassium and hydrochlorothiazide.

The other components (excipients) are: anhydrous lactose, microcrystalline cellulose, pregelatinized corn starch, magnesium stearate, colloidal anhydrous silica, talc, polyvinyl alcohol, titanium dioxide (E171), soybean lecithin (E322), quinoline yellow aluminum lake (E104), and xanthan gum.

Losartan/Hydrochlorothiazide SUN 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium.

Appearance of the product and contents of the pack

Losartan/Hydrochlorothiazide SUN 50 mg/12.5 mg is supplied as yellow, round, biconvex, film-coated tablets, engraved with the code “LH1” on one side and smooth on the other.

Losartan/Hydrochlorothiazide SUN 50 mg/12.5 mg is available in the following pack sizes: 28 tablets.

Packaged in Poliamide/Al/PVC – Al blisters or Al-Al strip blisters, containing 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.,
Polarisavenue 87,
2132JH Hoofddorp,
The Netherlands

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.,
Polarisavenue 87,
2132JH Hoofddorp,
The Netherlands

Or

Terapia S.A.
Str. Fabricii nr. 124,
Cluj-Napoca,
Romania

Local Representative

Sun Pharma Laboratorios, S.L.
Rambla de Catalunya, 53-55
08007 Barcelona,
Spain
Tel.: +34 93 342 78 90

Date of the most recent revision of this Patient Information Leaflet: December 2024

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