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

Introduction

PATIENT INFORMATION LEAFLET

Losartan/Hydrochlorothiazide SUN 50 mg/12.5 mg

film-coated tablets EFG

losartan potassium / hydrochlorothiazide

Read this 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

1. What is Losartan/Hydrochlorothiazide SUN and what is it used for

Losartan/Hydrochlorothiazide SUN is a combination of an angiotensin II receptor antagonist (losartan) 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 leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, which causes the blood vessels to relax, thereby decreasing blood pressure. Hydrochlorothiazide causes the kidneys to eliminate more water and salts. This also helps to reduce blood pressure.

Losartan/Hydrochlorothiazide is indicated for the treatment of essential hypertension (high blood pressure).

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

Do not take Losartan/Hydrochlorothiazide 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, some antibacterial medications such as cotrimoxazole; ask your doctor if you are not sure).
• if you are more than 3 months pregnant. (It is also recommended to avoid Losartan/Hydrochlorothiazide during the first months of pregnancy – see section Pregnancy).
• if you have severe hepatic impairment
• if you have severe renal impairment or your kidneys do not produce urine.
• if you have low potassium or sodium levels, high calcium levels that cannot be corrected with treatment
• if you have 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, pharmacist, or nurse before starting to take this medicine.

You should inform your doctor if you are pregnant (or think you might be). Losartan/Hydrochlorothiazide is not recommended during the first trimester of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby (see section Pregnancy).

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

Consult your doctor before starting to take Losartan/Hydrochlorothiazide:

• if you have previously experienced 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 you have narrow arteries that supply blood to the kidneys (renal artery stenosis), if you have only one working kidney, or if you have recently had a kidney transplant
• if you have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function)
• if you have narrowing of the heart valves (aortic or mitral stenosis) 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 disease that causes 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 need to have anesthesia (even at the dentist) or before surgery, or if you are going to have tests to determine your parathyroid function, you should inform your doctor or healthcare provider that you are taking losartan potassium and hydrochlorothiazide tablets
• if you have primary hyperaldosteronism (a syndrome associated with high secretion of aldosterone hormone by the adrenal gland due to an alteration of this gland).
• if you have had skin cancer or if you 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Losartan/Hydrochlorothiazide.
• if you are taking any of the following medicines used to treat high blood pressure:
• 1. - an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have diabetic kidney problems.
  2. - aliskiren

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

• If you are taking other medicines that may increase potassium levels in the blood (see section 2 "Other medicines and Losartan/Hydrochlorothiazide SUN");
• 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 increased pressure in the eye, and may occur within hours to weeks after taking Losartan/Hydrochlorothiazide. This can lead to permanent vision loss if not treated. You may be at greater risk of developing this if you are at risk of developing a condition called glaucoma or if you have previously been allergic 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 Losartan/Hydrochlorothiazide, seek medical attention immediately.

See also the section under the heading "Do not take Losartan/Hydrochlorothiazide SUN".

Other medicines and Losartan/Hydrochlorothiazide SUN:

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

Tell your doctor if you are taking potassium supplements, salt substitutes that contain potassium, potassium-sparing medicines, or other medicines that may increase potassium levels in the blood (e.g., trimetoprim-containing medicines), as combination with Losartan/Hydrochlorothiazide is not recommended.

Diuretics like hydrochlorothiazide in Losartan/Hydrochlorothiazide may interact with other medicines.

Lithium-containing preparations should not be taken with Losartan/Hydrochlorothiazide without close medical supervision.

Special precautions (e.g., blood tests) may be necessary if you are taking potassium supplements, salt substitutes that contain potassium, potassium-sparing medicines, diuretics (water pills), certain laxatives, gout treatments, heart rhythm or diabetes medicines (oral or insulin).

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

• other medicines to lower your blood pressure,
• corticosteroids,
• cancer medicines,
• painkillers,
• antifungal medicines
• arthritis medicines,
• cholesterol-lowering resins such as cholestyramine,
• muscle relaxants,
• sleeping pills;
• opioid medicines like morphine,
• "pressor amines" like adrenaline or other medicines of the same group;
• oral diabetes medicines or insulins.

Please inform your doctor when you are scheduled to have a contrast medium with iodine.

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

If you are taking an ACE inhibitor or aliskiren (see also information under the headings "Do not take Losartan/Hydrochlorothiazide SUN" and "Take special care with Losartan/Hydrochlorothiazide SUN".

Taking Losartan/Hydrochlorothiazide SUN with food and drinks

It is recommended that you do not drink alcohol while taking these tablets: alcohol and Losartan/Hydrochlorothiazide tablets may increase each other's effects.

Excessive salt in your diet may counteract the effect of Losartan/Hydrochlorothiazide tablets.

Losartan/Hydrochlorothiazide can be taken with or without food.

Grapefruit juice should be avoided while taking losartan/hydrochlorothiazide.

Pregnancy and breastfeeding:

Pregnancy

You should inform your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking Losartan/Hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan/Hydrochlorothiazide. Losartan/Hydrochlorothiazide is not recommended during the first trimester of pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. Losartan/Hydrochlorothiazide is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

Consult your doctor or pharmacist before taking any medicine.

Children and adolescents:

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

Use in elderly patients:

Losartan/Hydrochlorothiazide works as well and is as well tolerated by most elderly patients as it is 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 SUN contains lactose

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

Losartan/Hydrochlorothiazide SUN contains soy lecithin

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

Use in athletes

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

3. How to take Losartan/Hydrochlorothiazide SUN

Follow exactly the administration instructions of Losartan/Hydrochlorothiazide SUN given by your doctor. Your doctor will decide the appropriate dose of Losartan/Hydrochlorothiazide SUN, depending on your condition and whether you are taking other medicines. It is important to keep taking Losartan/Hydrochlorothiazide SUN as long as your doctor prescribes it to maintain constant control of your blood pressure.

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 over 24 hours. This may 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 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 Losartan/Hydrochlorothiazide SUN than you should:

In case of overdose, contact your doctor immediately or go directly to the hospital 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, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Losartan/Hydrochlorothiazide SUN:

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

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/Hydrochlorothiazide 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, 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,

-High levels of potassium (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 problems, and bruising,

-Loss of appetite, high levels of uric acid 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,

-Tingling or similar sensations, pain in the limbs, tremors, migraine, fainting,

-Blurred vision, eye irritation or itching, 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, often associated with a skin rash or bruising,

-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, skin redness, sensitivity to light, dry skin, flushing, sweating, hair loss,

-Pain in the arms, shoulders, hips, knee, 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):

• Hepatitis (liver inflammation), 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 (signs include severe difficulty breathing, fever, weakness, and confusion).

Unknown (frequency cannot be estimated from available data):

• -Decreased platelet count in blood,
• muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis);

-Pancreatitis (pancreas inflammation),

-Generally feeling unwell (malaise),

-Flu-like symptoms,

-Low sodium levels in blood (hyponatremia).

-Taste disturbance (dysgeusia)

-Skin 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 effusion) or acute angle-closure glaucoma]

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. 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/Hydrochlorothiazide SUN

Keep Losartán/Hydrochlorothiazide SUN out of sight and reach of children.

Do not use Losartán/Hydrochlorothiazide SUN after the expiration date stated 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 pack in the original packaging.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Losartán/Hydrochlorothiazide SUN

The active ingredients are losartan potassium and hydrochlorothiazide.

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

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

Appearance and Packaging of the Product

Losartán/Hydrochlorothiazide 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 side and smooth on the other side.

Losartán/Hydrochlorothiazide SUN 50 mg/12.5 mg is supplied in the following package sizes: 28 tablets

Polyamide/Al/PVC blister pack - Al and Al-Al strip blister pack, in packages of 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands

Manufacturer:

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 Laboratories, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona.

Spain

Tel.:+34 93 342 78 90

Date of the Last Revision of this Prospectus: December 2024

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