Losartan Sun 100 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Losartán SUN 100 mg film-coated tablets EFG
Please read this 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 and should not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Losartán SUN is and what it is used for.
- What you need to know before taking Losartán SUN.
- How to take Losartán SUN.
- Possible side effects.
- How to store Losartán SUN.
- Contents of the pack and other information.
1. What Losartán SUN is and what it is used for
Losartan belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that binds to receptors in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartan blocks the binding of angiotensin II to these receptors, resulting in relaxation of the blood vessels, thereby lowering blood pressure. Losartan slows the progression of impaired kidney function in patients with high blood pressure and type 2 diabetes.
Losartán SUN is used
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to treat patients with high blood pressure (hypertension) in adults and children and adolescents aged 6 to 18 years.
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to protect the kidney in hypertensive patients with type 2 diabetes and laboratory test results indicating renal impairment and proteinuria ≥ 0.5 g per day (a condition in which the urine contains an abnormally high amount of protein).
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to treat patients with chronic heart failure, when their doctor considers that treatment with specific medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors, medicines used to lower high blood pressure) is not suitable. If your heart failure has been stabilized with an ACE inhibitor, you should not switch to losartan.
In patients with high blood pressure and thickening of the left ventricle of the heart, losartan has been shown to reduce the risk of stroke (LIFE indication).
2. What you need to know before taking Losartán SUN
Do not take Losartán SUN:
- if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6),
- if you have severely impaired liver function,
- if you are more than 3 months pregnant. (It is also advisable to avoid Losartán SUN during the first months of pregnancy – see Pregnancy section),
- if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to take Losartán SUN.
You must inform your doctor if you think you may be pregnant (or could become pregnant). Use of Losartán SUN is not recommended during early pregnancy, and must not be initiated after the third month of pregnancy, as it may cause serious harm to your unborn child (see Pregnancy section).
Contact your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Losartán SUN. Your doctor will decide whether to continue treatment. Do not stop taking Losartán SUN on your own.
Before taking Losartán SUN, it is important to 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 fluid and/or salt loss from your body,
- if you are taking diuretics (medicines that increase the amount of fluid passing through your kidneys) or are on a low-salt diet that may lead to excessive fluid or salt loss (see section 3. Dosage in special patient groups),
- if you know you have narrowing or blockage of the blood vessels supplying your kidneys or if you have recently undergone a kidney transplant,
- if you have impaired liver function (see sections 2. Do not take Losartán SUN and 3. Dosage in special patient groups),
- if you have heart failure with or without renal impairment or potentially life-threatening concomitant cardiac arrhythmias. Special care is needed if you are also being treated with a beta-blocker,
- if you have heart valve problems or heart muscle disease,
- 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 excessive secretion of the hormone aldosterone by the adrenal gland due to adrenal dysfunction),
- if you are taking any of the following medicines used to treat high blood pressure (hypertension):
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- an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,
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- aliskiren.
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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 Losartán SUN”.
- if you are taking other medicines that may increase serum potassium levels (see section 2 “Taking Losartán SUN with other medicines”).
Children and adolescents
Losartan has been studied in children. For further information, speak with your doctor.
Losartan is not recommended for use in children with kidney or liver problems, as data in these patient groups are limited. Losartan is not recommended for use in children under 6 years of age, as efficacy has not been demonstrated in this age group.
Taking Losartán SUN with other medicines:
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, salt substitutes containing potassium, or potassium-sparing medicines such as certain diuretics (amiloride, triamterene, spironolactone), or other medicines that may increase serum potassium (e.g., heparin, medicines containing trimethoprim), as combination with Losartán is not recommended.
While being treated with Losartán SUN, take particular care if you are taking any of the following medicines:
- other medicines that lower blood pressure, as they may cause 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 drugs (NSAIDs), 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 (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Losartán SUN” and “Warnings and precautions”).
If you have impaired kidney function, concomitant use of these medicines may lead to worsening of renal function.
Medicines containing lithium should not be used in combination with losartan unless your doctor closely monitors you. Special precautionary measures (e.g., blood tests) may be appropriate.
Taking Losartán SUN with food and drink:
Losartán SUN may be taken with or without food.
Grapefruit juice should be avoided while taking this medicine.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are pregnant (or could be pregnant). Your doctor will usually advise you to stop taking Losartán SUN before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Losartán SUN is not recommended during early pregnancy, and must not be used after the third month of pregnancy, as it may cause serious harm to your unborn child when used from this stage onward.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Use of Losartán SUN is not recommended during breastfeeding. Your doctor will choose an alternative treatment for you if you intend to breastfeed, especially if your baby is a newborn or premature.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines:
No studies on the effects on the ability to drive and use machines have been conducted.
It is unlikely that Losartán SUN will affect your ability to drive or use machines. However, like 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 engaging in such activities.
Losartán SUN contains lactose
This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Losartán SUN
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. Your doctor will determine the appropriate dose of Losartán SUN depending on your condition and whether you are taking other medications. It is important to continue taking Losartán SUN as prescribed by your doctor in order to maintain consistent blood pressure control.
Adult patients with high blood pressure
Treatment usually starts with 50 mg of losartan (one Losartan SUN 50 mg tablet) once daily. The maximum blood pressure-lowering effect is achieved within 3–6 weeks after starting treatment. Afterwards, in some patients, the dose may be increased to 100 mg of losartan (two Losartán SUN 50 mg tablets or one losartan 100 mg tablet) once daily.
If you feel that the effect of Losartán 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 its effectiveness has not been demonstrated in this age group.
Children aged between 6 and 18 years
The recommended starting dose in patients weighing between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, administered once daily (up to 25 mg of losartan). Your doctor may increase the dose if blood pressure is not adequately controlled.
Another pharmaceutical form(s) of this medicine may be more suitable for children; please consult your doctor or pharmacist.
Adult patients with high blood pressure and type 2 diabetes
Treatment usually starts with 50 mg of losartan (one Losartán SUN 50 mg tablet) once daily. Afterwards, the dose may be increased to 100 mg of losartan (two Losartán SUN 50 mg tablets or one losartan 100 mg tablet) once daily, depending on your blood pressure response.
Losartan tablets may be taken together with other blood pressure-lowering medicines (e.g., diuretics, calcium antagonists, alpha or beta blockers, and centrally acting agents), as well as with insulin and other commonly used glucose-lowering medicines (e.g., sulfonylureas, glitazones, and alpha-glucosidase inhibitors).
Adult patients with heart failure
Treatment usually starts with 12.5 mg of losartan once daily. The dose is usually gradually increased on a weekly basis (i.e., 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week, 100 mg daily during the fourth week, and 150 mg daily during the fifth week), until a maintenance dose determined by your doctor is reached. A maximum dose of 150 mg of losartan (e.g., three 50 mg losartan tablets or one 100 mg and one 50 mg tablet) once daily may be used.
In the treatment of heart failure, losartan is usually combined with a diuretic (a medicine that increases the amount of fluid passing through your kidneys), and/or digitalis (a medicine that helps your heart become stronger and more efficient), and/or a beta-blocker.
Dosage in special patient populations
Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those receiving high-dose diuretics, patients with hepatic impairment, or patients over 75 years of age. The use of losartan is not recommended in patients with severe hepatic impairment (see section "Do not take Losartán 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 important that you continue taking Losartán SUN until your doctor tells you otherwise.
If you take more Losartán SUN than you should:
If you accidentally take too many tablets, contact your doctor immediately. Symptoms of overdose include low blood pressure, increased heart rate, and possibly decreased heart rate.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Losartán SUN:
If you accidentally miss a dose, simply take the next dose as scheduled. Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, Losartán SUN may cause adverse effects, although not everyone experiences them.
If you experience the following, stop taking losartan tablets immediately and inform 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 with losartan:
Common (may affect up to 1 in 10 patients):
- dizziness,
- low blood pressure (especially after excessive loss of fluid from the bloodstream, e.g. in patients with severe heart failure or receiving high doses of diuretics),
- dose-related orthostatic effects, such as a drop in blood pressure occurring after standing up from a lying or sitting position,
- weakness,
- fatigue,
- low blood sugar (hypoglycemia),
- too much potassium in the blood (hyperkalemia),
- changes in liver function, including renal failure,
- reduced number of red blood cells (anemia),
- increased blood urea, creatinine and serum potassium levels in patients with heart failure.
Uncommon (may affect up to 1 in 100 patients):
- drowsiness,
- headache,
- sleep disorders,
- sensation of very rapid heartbeat (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 causing symptoms such as abdominal pain, nausea, vomiting and diarrhea,
- inflammation of blood vessels (vasculitis, including Schönlein-Henoch purpura),
- numbness or tingling sensation (paresthesia),
- fainting (syncope),
- very rapid and irregular heartbeat (atrial fibrillation),
- stroke (cerebrovascular accident),
- liver inflammation (hepatitis),
- increased levels of alanine aminotransferase (ALT) in blood, which usually resolves upon discontinuation of treatment.
Frequency not known (frequency cannot be estimated from available data):
- reduced number of platelets,
- migraine,
- abnormalities in liver function,
- muscle and joint pain,
- flu-like symptoms,
- back pain and urinary tract infection,
- increased sensitivity to sunlight (photosensitivity),
- unexplained muscle pain with dark-colored urine (tea-colored) (rhabdomyolysis),
- impotence,
- inflammation of the pancreas (pancreatitis),
- low sodium levels in blood (hyponatremia),
- depression,
- general feeling of being unwell (malaise),
- ringing, buzzing, noise or clicking in the ears (tinnitus),
- taste disturbance (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 not listed in this leaflet. You may also report them directly through 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 Losartán SUN
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
No special storage conditions are required.
Store Losartán SUN 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 empty containers and unused medicines at a SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of LosartánSUN
The active substance in Losartán SUN is potassium losartan.
Each Losartán SUN tablet contains 100 mg of losartan (as potassium salt).
The other components are: microcrystalline cellulose, anhydrous lactose, pregelatinized corn starch, magnesium stearate, colloidal anhydrous 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 contents of the pack
Losartán SUN 100 mg is supplied as white, biconvex, circular, film-coated tablets, with the code "L4" engraved on one side and plain on the other.
Losartán SUN is available in the following pack sizes:
Al/polyamide-Al-PVC blisters or aluminum blisters, in packs of 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
TERAPIA, S.A.
124 Fabricii Street
400 632 Cluj Napoca, Romania
OR
SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.
Polarisavenue, 87
2132 JH Hoofddorp, The Netherlands
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder
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 leaflet: December 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/