LOSARTAN SUN 100 mg FILM-COATED TABLETS

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

Do not take Losartan SUN:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if your liver function is severely impaired,
• if you are pregnant for more than 3 months. (It is also recommended to avoid Losartan SUN during the first months of pregnancy – see section Pregnancy).
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you start taking Losartan SUN.

You should inform your doctor if you think you are pregnant (or might become pregnant). Losartan SUN is not recommended during the first trimester of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your child (see section Pregnancy).

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

Before taking Losartan SUN, it is essential that you inform your doctor:

• if you have a history of angioedema (swelling of the face, lips, tongue, and/or throat) (see also section 4. Possible side effects),
• if you have excessive vomiting or diarrhea, which may cause excessive loss of fluid and/or salt from your body,
• if you are taking diuretics (medicines that increase the amount of water that passes through your kidneys) or if you are on a low-salt diet that may cause excessive loss of fluids or salt in your body (see section 3. Dosage in special patient groups),
• if you know you have narrowing or blockage of the blood vessels that supply your kidneys or if you have recently undergone a kidney transplant,
• if your liver function is impaired (see sections 2. Do not take Losartan SUN and 3. Dosage in special patient groups),
• if you have heart failure with or without kidney failure or life-threatening heart rhythm disorders. Special attention is necessary when you are being treated at the same time with a beta-blocker,
• if you have problems with the valves in your heart or with the heart muscle,
• if you have coronary heart disease (caused by reduced blood flow in the blood vessels of the heart) or cerebrovascular disease (caused by reduced blood circulation in the brain),
• 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:
• 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 monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the section under the heading “Do not take Losartan SUN”.

• if you are taking other medicines that may increase serum potassium levels (see section 2 “Taking Losartan SUN with other medicines”).

Children and adolescents

Losartan has been studied in children. For more information, talk to your doctor.

Losartan is not recommended for use in children with kidney or liver problems, as there is limited data available in these patient groups. Losartan is not recommended for use in children under 6 years of age, as it has not been shown to be effective in this age group.

Taking Losartan SUN with other medicines:

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, or potassium-sparing medicines such as certain diuretics (amiloride, triamterene, spironolactone) or other medicines that may increase serum potassium levels (e.g., heparin, trimethoprim-containing medicines), as combination with Losartan is not recommended.

While you are being treated with Losartan SUN, be particularly cautious if you take any of the following medicines:

• other medicines that lower blood pressure, as they may produce an additional reduction in blood pressure. Blood pressure may also be lowered by some of the following medicines/classes of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory medicines, such as indomethacin, including COX-2 inhibitors (medicines that reduce inflammation and may be used to relieve pain), as they may reduce the blood pressure-lowering effect of losartan.

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 Losartan SUN” and “Warnings and precautions”.

If your kidney function is impaired, concomitant use of these medicines may cause a worsening of kidney function.

Medicines that contain lithium should not be used in combination with losartan without your doctor performing careful monitoring. It may be appropriate to take special precautions (e.g., blood tests).

Taking Losartan SUN with food and drinks:

Losartan SUN can be taken with or without food.

Grapefruit juice should be avoided while taking this medicine.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you think you are pregnant (or might become pregnant). Your doctor will generally advise you to stop taking Losartan SUN before you become pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of Losartan SUN. Losartan SUN is not recommended during the first trimester of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your child when administered from that time on.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. Losartan SUN is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed, especially if your child is newborn or premature.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:

No studies on the effects on the ability to drive and use machines have been performed.

Losartan SUN is unlikely to affect your ability to drive or use machines. However, as with many medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, consult your doctor before performing these activities.

Losartan SUN contains lactose

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

3. How to take Losartan SUN

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Your doctor will decide the appropriate dose of Losartan SUN, depending on your condition and whether you are taking other medicines. It is essential to keep taking Losartan SUN while your doctor prescribes it to maintain constant blood pressure control.

Adult patients with high blood pressure

Normally, treatment starts with 50 mg of losartan (one Losartan SUN 50 mg tablet) once a day. The maximum blood pressure-lowering effect is achieved within 3-6 weeks of starting treatment. After that, in some patients, the dose may be increased to 100 mg of losartan (two Losartan SUN 50 mg tablets or one losartan 100 mg tablet) once a day.

If you think the effect of Losartan is too strong or too weak, please inform your doctor or pharmacist.

Use in children and adolescents

Children under 6 years of age

Losartan is not recommended for use in children under 6 years of age, as it has not been shown to be effective in this age group.

Children between 6 and 18 years of age

The recommended starting dose in patients who weigh between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, given once a day (up to 25 mg of losartan). The doctor may increase the dose if blood pressure is not controlled.

Other pharmaceutical forms of this medicine may be more suitable for children; ask your doctor or pharmacist.

Adult patients with high blood pressure and type 2 diabetes

Normally, treatment starts with 50 mg of losartan (one Losartan SUN 50 mg tablet) once a day. After that, the dose may be increased to 100 mg of losartan (two Losartan SUN 50 mg tablets or one losartan 100 mg tablet) once a day, depending on the response of your blood pressure.

Losartan tablets can be taken with other medicines that lower blood pressure (e.g., diuretics, calcium antagonists, alpha or beta blockers, and centrally acting agents), as well as with insulin and other medicines frequently used to lower blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Adult patients with heart failure

Normally, treatment starts with 12.5 mg of losartan once a day. Normally, the dose is gradually increased weekly (i.e., 12.5 mg per day during the first week, 25 mg per day during the second week, 50 mg per day during the third week, 100 mg per day during the fourth week, 150 mg per day during the fifth week), up to a maintenance dose determined by your doctor. A maximum dose of 150 mg of losartan (e.g., three Losartan SUN 50 mg tablets or one 100 mg and one 50 mg tablet) may be used once a day.

In the treatment of heart failure, losartan is normally combined with a diuretic (a medicine that increases the amount of water that passes through your kidneys) and/or digitalis (a medicine that helps your heart be stronger and more efficient) and/or a beta-blocker.

Dosage in special patient groups

Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those treated with high-dose diuretics, patients with liver failure, or patients over 75 years of age. Losartan is not recommended for use in patients with severe liver failure (see section "Do not take Losartan SUN").

Administration

The tablets should be taken with a glass of water. You should try to take your daily dose at approximately the same time each day. It is essential to keep taking Losartan SUN until your doctor tells you to stop.

If you take more Losartan SUN than you should:

If you accidentally take too many tablets, contact your doctor immediately. The symptoms of overdose are low blood pressure, increased heart rate, and possibly decreased heart rate.

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 ingested.

If you forget to take Losartan SUN:

If you accidentally miss a dose, simply take the next dose as usual. Do not take a double dose to make up for missed doses.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, Losartán SUN can cause adverse effects, although not all people suffer from them.

If you experience the following, stop taking the losartan 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 with losartan:

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

• dizziness,

• low blood pressure, (especially after excessive loss of water from the body within the blood vessels, e.g., in patients with severe heart failure or being treated with high doses of diuretics),
• dose-related orthostatic effects, such as a decrease in blood pressure that occurs after standing up from lying down or sitting,

• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• high potassium levels in the blood (hyperkalemia).
• Changes in liver function, including kidney failure
• Reduced number of red blood cells (anemia)
• Increased urea, creatinine, and serum potassium levels in patients with heart failure

Infrequent (may affect up to 1 in 100 patients):

• somnolence,
• headache,
• sleep disorders,
• sensation of very rapid heartbeats (palpitations),
• severe chest pain (angina pectoris),
• difficulty breathing (dyspnea),
• abdominal pain,
• chronic constipation,
• diarrhea,
• nausea
• vomiting,
• hives (urticaria),
• itching (pruritus),
• skin rash,
• localized swelling (edema).
• cough

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

• hypersensitivity
• angioedema
• intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea,
• inflammation of the blood vessels (vasculitis, including Schonlein-Henoch purpura),
• numbness or tingling sensation (paresthesia),
• fainting (syncope),
• very rapid and irregular heartbeats (atrial fibrillation),
• stroke (cerebrovascular accident),
• liver inflammation (hepatitis),
• elevation of alanine aminotransferase (ALT) levels in blood, which usually resolves upon discontinuation of treatment.

Frequency not known (frequency cannot be estimated from available data):

• reduced platelet count,
• migraine,
• liver function abnormalities,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection.
• Increased sensitivity to sunlight (photosensitivity)
• Muscle pain of unknown origin with dark-colored urine (rhabdomyolysis)
• Impotence
• Pancreatitis (inflammation of the pancreas)
• Low sodium levels in the blood (hyponatremia)
• Depression
• Generally feeling unwell (malaise)
• Ringing, buzzing, noise, or clicking in the ears (tinnitus)
• Alteration of taste (dysgeusia)

Adverse effects in children are similar to those observed in adults.

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear 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 SUN

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

Do not use this medicine 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.

Store Losartán SUN in its 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 SUN

The active ingredient of Losartán SUN is losartan potassium.

Each Losartán SUN tablet contains 100 mg of losartan (as potassium salt).

The other ingredients are: microcrystalline cellulose, anhydrous lactose, pregelatinized corn starch, magnesium stearate, anhydrous colloidal silica, talc, hypromellose, titanium dioxide (E 171), propylene glycol (1,108 mg), and hydroxypropylcellulose.

Losartán SUN 100 mg contains potassium in the following amount: 8.48 mg (0.216 mEq)

Appearance of the Product and Package Contents

Losartán SUN 100 mg is supplied as biconvex, circular, white film-coated tablets with the text “L4” engraved on one face and flat on the other face.

Losartán SUN is supplied in the following package sizes:

Aluminum/polyamide-Al-PVC blister or aluminum blister, 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

TERAPIA, S.A.

124 Fabricii Street

400 632 Cluj Napoca, Romania

Or

SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.

Polarisavenue, 87

2132 JH Hoofddorp, Netherlands

You can request more information about this medicine by contacting the

local representative of the marketing authorization holder

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