PATIENT INFORMATION LEAFLET

SUN 50 mg/12.5 mg Losartan/Hydrochlorothiazide

Coated Tablets EFG

Losartan Potassium / Hydrochlorothiazide

Read this leaflet carefully before you start to take 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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 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.

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

Do not take Losartán/Hidroclorotiazida SUN:

Warnings and precautions

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

You must inform your doctor if you are pregnant (or if you suspect that you may be). Losartán/Hidroclorotiazida is not recommended for use at the start of pregnancy, and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that time (see Pregnancy section).

Consult 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 to take Losartán/Hidroclorotiazida:

• 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 or have had excessive vomiting and/or diarrhea
• if you have heart failure
• if you have narrow arteries leading to the kidney (renal artery stenosis), if you only have one functioning kidney or if you have recently had a kidney transplant
• if you have atherosclerosis (narrowing of the arteries), angina (chest pain due to poor heart function)
• if you have aortic or mitral 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 disease that causes joint pain, skin rashes and fever (systemic lupus erythematosus)
• if you have high levels of calcium or low levels of potassium or if you are following a low-potassium diet
• if you need anesthesia (even for dental procedures) or before surgery, or if you are having 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 a glandular alteration)
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The use of 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 Losartán/Hidroclorotiazida.
• if you are taking any of the following blood pressure-lowering medicines:
• 1. - an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  2. - aliskiren

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

• if you are taking other medicines that may increase serum potassium levels (see section 2 “Other medicines and Losartán/Hidroclorotiazida SUN”);
• 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 intraocular pressure and may occur within a few hours to several weeks after taking Losartán/Hidroclorotiazida. This may lead to permanent vision loss if not treated. You may be at higher risk of developing this if you are at risk of developing a condition called glaucoma or if you have previously had an allergy to penicillin or sulfonamides.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, see your doctor 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 taken recently or may need to take any other medicine.

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.

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

Lithium preparations should not be taken with Losartán/Hidroclorotiazida without close monitoring by your doctor.

Special precautions may be necessary (e.g. blood tests) if you take potassium supplements, salt substitutes containing potassium or potassium-sparing medicines, diuretics (urine-producing medicines), some laxatives, medicines for gout treatment, heart rhythm control medicines or diabetes medicines (oral or insulin).

It is also important for your doctor to know if you are taking:

• other blood pressure-lowering medicines,
• 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.

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

Your doctor may need to modify 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 “Be careful with Losartán/Hidroclorotiazida SUN”.

Losartán/Hidroclorotiazida SUN with food and drinks

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

Excessive salt in the diet may counteract the effect of Losartán/Hidroclorotiazida tablets.

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

It is recommended to avoid grapefruit juice while taking losartan/hydrochlorothiazide.

Pregnancy and breastfeeding:

Pregnancy

You must inform your doctor if you are pregnant (or if you suspect that you may be). Your doctor will usually recommend that you stop taking Losartán/Hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of Losartán/Hidroclorotiazida. Losartán/Hidroclorotiazida is not recommended for use at the start of pregnancy, and it should not be taken from the third month of pregnancy as it may cause serious harm to your baby when administered from that time.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Losartán/Hidroclorotiazida is not recommended for use during breastfeeding, and your doctor will choose another treatment for you 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 should not be administered to children.

Use in elderly patients:

Losartán/Hidroclorotiazida 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 may require special attention (e.g. driving a car or operating hazardous machinery) until you know how you tolerate your medicine.

Losartán/Hidroclorotiazida SUN contains lactose

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

Losartán/Hidroclorotiazida SUN contains soy lecithin

This medicine contains soy lecithin. Do not use this medicine in case of allergy to peanuts or soy.

Use in athletes

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

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 if you are taking other medications. It is essential to continue 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 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 higher 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: Losartán/Hidroclorotiazida SUN SUN

In case of overdose, contact your doctor immediately or go directly to the hospital for immediate medical attention. An overdose can cause low blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

In case of overdose or accidental ingestion, consult immediately with your doctor or pharmacist or call the Toxicological Information Service, phone 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 at the same time each day as prescribed. However, if you forget a dose, do not take an extra dose. Simply return to your regular schedule.

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

If you experience any of the following, stop taking Losartán/Hidroclorotiazida tablets and inform your doctor immediately or go to the nearest hospital emergency service:

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 less 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, respiratory infection, nasal congestion, sinusitis, breast disorder,

-Diarrhea, abdominal pain, nausea, indigestion,

-Muscle pain or cramps, leg pain, back pain,

-Insomnia, headache, dizziness,

-Renal dysfunction, renal insufficiency,

-Weakness, fatigue, chest pain,

-Elevated potassium levels (which may cause an abnormal heart rhythm), decreased hemoglobin levels,

-Changes in renal function that include renal insufficiency,

-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 cells, coagulation problems, and hematomas,

-Loss of appetite, elevated uric acid levels or manifest gout, elevated blood glucose levels, abnormal electrolyte levels in the blood,

-Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory alteration,

-Tingling or similar sensations, pain in the extremities, tremor, migraine, fainting,

-Blurred vision, eye itching or stinging, 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”) myocardial infarction, palpitations,

-Inflammation of blood vessels that often occurs with a skin rash or hematoma,

-Throat pain, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which may cause 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,

-Urticaria, itching, skin inflammation, skin rash, skin redness, 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 sexual appetite, erectile dysfunction/impotence,

-Swelling of the face, fever, localized swelling (edema).

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

• Jaundice (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 (may affect up to 1 in 10,000 people):

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

Unknown (frequency cannot be estimated from available data):

• Decreased platelet count in the blood,
• Unknown muscle pain with dark-colored urine (rhabdomyolysis);

– Pancreatitis inflammation,

– Generally feeling unwell (malaise),

– Flu-like symptoms,

– Low sodium levels in the blood (hyponatremia).

– Alteration of taste (dysgeusia)

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

– Decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma]

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 Losartán/Hydrochlorothiazide SUN out of the sight and reach of children.

Do not use Losartán/Hydrochlorothiazide SUN after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Keep the blister in its original packaging.

Do not open the blister until you are ready to take the medication.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Losartán/Hidroclorotiazida SUN

The active principles are losartan potassium and hydrochlorothiazide..

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

Losartán/Hidroclorotiazida SUN 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium.

Appearance of the product and content of the container

Losartán/Hidroclorotiazida SUN 50 mg/12.5 mg is supplied as film-coated tablets, yellow in color, circular, biconvex, and engraved with the text “LH1” on one face and smooth on the other face.

Losartán/Hidroclorotiazida SUN 50 mg/12.5 mg is supplied in the following container sizes: 28 tablets

Poliamide/Al/PVC – Al and Al-Al blister strips, in containers of 28 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the Marketing Authorization:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands

Responsible for manufacturing:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

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

Last review date of this leaflet: December 2024

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