Package Leaflet: Information for the User

Losartán Normon 12.5 mg Film-Coated Tablets

losartan potassium

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Losartán belongs to a group of medications known as angiotensin II receptor antagonists.

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. Losartán reduces the worsening of renal function in patients with high blood pressure and type 2 diabetes.

Losartán Normon is used for

• treating patients with elevated blood pressure (hypertension) in adults and in children and adolescents aged 6 to 18 years.
• protecting the kidneys in hypertensive patients with type 2 diabetes and clinical tests indicating renal insufficiency and proteinuria ≥ 0.5 g per day (a situation in which the urine contains an abnormal amount of proteins).
• treating patients with chronic heart failure, when their doctor considers that treatment with specific medications, called angiotensin-converting enzyme inhibitors (ACE inhibitors, medications used to reduce elevated blood pressure) is not suitable. If their heart failure has been stabilized with an ACE inhibitor, they should not switch to losartán.
• in patients with elevated blood pressure and left ventricular hypertrophy of the heart, losartán has been shown to reduce the risk of stroke (LIFE indication).

Do not take Losartán Normon

• if you are allergic to losartan or any of the other ingredients of this medicine (including those listed in section 6),
• if your liver function is severely damaged,
• if you are more than 3 months pregnant. (It is also best to avoid Losartán Normon at the beginning of pregnancy - see Pregnancy section).
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medication that contains aliskirén.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Losartan Normon.

Inform your doctor if you are pregnant (or if you suspect you may be). Losartán Normon is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from that point onwards (see Pregnancy section).

Before taking Losartán Normon, it is essential that you inform your doctor:

• if you have had 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 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 follow a low-sodium diet that causes excessive loss of fluids or salt from your body (see section 3. Dosage in special patient groups),
• if you know you have narrowing or blockage of the blood vessels that go to your kidneys or if you have recently had a kidney transplant,
• if your liver function is altered (see sections 2. Do not take Losartán Normon and 3. Dosage in special patient groups),
• if you have heart failure with or without kidney failure or potentially fatal cardiac arrhythmias. Special attention is required when you are being treated at the same time with a beta-blocker,
• if you have problems with your heart valves or heart muscle,
• if you have coronary heart disease (caused by reduced blood flow in the heart's blood vessels) or cerebrovascular disease (caused by reduced blood circulation in the brain),
• if you have primary aldosteronism (a syndrome associated with an elevated secretion of the aldosterone hormone by the adrenal gland due to an alteration of this gland).
• if you are taking any of the following medications used to treat high blood pressure (hypertension):
• • a converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskirén.
  • if you are taking other medications that may increase serum potassium (see section 2 “other medications and Losartan Normon”).

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

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Losartan Normon. Your doctor will decide whether to continue treatment. Do not stop taking Losartan Normon in monotherapy.

See also the information under the heading “Do not take Losartán Normon”.

Children and adolescents

Losartan Normon has been studied in children. For more information, speak with your doctor.

Losartan Normon is not recommended for use in children with kidney or liver problems, as there are limited data available for these patient groups. Losartan Normon 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.

Other medications and Losartan Normon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take other medications.

Inform your doctor if you are taking potassium supplements, salt substitutes containing potassium, or potassium-sparing medications such as certain diuretics (amilorida, triamtereno, spironolactone) or other medications that may increase serum potassium (e.g. heparin, medications containing trimetoprim), as the combination with Losartan Normon is not recommended.

While taking Losartan Normon, be particularly cautious if you are taking any of the following medications:

• other medications that lower blood pressure, as they may cause an additional reduction in blood pressure. Blood pressure may also decrease with some of the following medications/classes of medications: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• nonsteroidal anti-inflammatory drugs, such as indometacina, including COX-2 inhibitors (medications 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 modify your dose and/or take other precautions:

if you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Losartán Normon” and “Warnings and precautions”).

if your renal function is altered, the concomitant use of these medications may cause a worsening of renal function.

Medications containing lithium should not be used in combination with losartan without your doctor's careful monitoring. It may be necessary to take special precautions (e.g. blood tests).

Losartan Normon with food and beverages

Losartan Normon can be taken with or without food.

Pregnancy and lactation

Pregnancy

You must inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you stop taking Losartan Normon before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Losartan Normon. Losartan Normon is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from that point onwards.

Lactation

Inform your doctor if you are breastfeeding or plan to start. Losartan Normon is not recommended for use in breastfeeding mothers, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is a newborn or premature.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery.

It is unlikely that Losartan Normon will affect your ability to drive or operate machinery. However, as many medications 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 these activities.

Losartan Normon contains lactose

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide on the appropriate dose of losartan, depending on your condition and if you are taking other medications. It is essential to continue taking losartan as prescribed by your doctor to maintain constant blood pressure control.

Adult patients with high blood pressure

Typically, treatment begins with 50 mg of losartan once a day. The maximum blood pressure-lowering effect is achieved within 3-6 weeks of starting treatment. Subsequently, in some patients, the dose may be increased to 100 mg of losartan once a day.

If you estimate that the action of Losartan Normon is too strong or too weak, please inform your doctor or pharmacist.

Use in children and adolescents

Children under 6 years old

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

Children aged 6-18 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 a day (up to 25 mg of losartan). Your doctor may increase the dose if your blood pressure is not controlled.

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

Adult patients with high blood pressure and type 2 diabetes

Typically, treatment begins with 50 mg of losartan once a day. Subsequently, the dose may be increased to 100 mg of losartan once a day, depending on your blood pressure response.

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

Adult patients with heart failure

Typically, treatment begins with 12.5 mg of losartan once a day. Typically, 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, and 150 mg per day during the fifth week), to a maintenance dose determined by your doctor. A maximum dose of 150 mg of losartan once a day may be used.

In the treatment of heart failure, losartan is typically combined with a diuretic (a medication that increases the amount of water that passes through your kidneys) and/or digitalis (a medication 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 doses of diuretics, patients with liver insufficiency, or patients over 75 years old. Losartan is not recommended for use in patients with severe liver insufficiency (see "Do not take Losartan Normon").

Administration

Tablets should be swallowed whole with a glass of water. You should try to take your daily dose at approximately the same time each day. It is essential to continue taking Losartan Normon until your doctor tells you otherwise.

If you take more Losartan Normon 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Losartan Normon

If you accidentally forget a dose, simply take the next dose as usual. Do not take a double dose to compensate for the missed tablet.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Losartán Normon can cause side effects, although not everyone will experience them.

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

Severe allergic reaction (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 fewer than 1 in 1,000. You may need urgent medical attention or hospitalization.

The following side effects have been reported with losartan:

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

• dizziness,
• low blood pressure (especially after excessive loss of body water within blood vessels, e.g., in patients with severe heart failure or those receiving high doses of diuretics),
• orthostatic effects related to the dose, 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 kidney function, including kidney failure
• reduced red blood cell count (anemia)
• increased urea in the blood, serum creatinine, and serum potassium in patients with heart failure.

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

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

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

• hypersensitivity
• angioedema
• inflammation of blood vessels (vasculitis, including Henoch-Schönlein purpura),
• numbness or tingling (paresthesia),
• syncope (fainting),
• rapid and irregular heartbeats (atrial fibrillation),
• stroke (cerebral infarction),
• inflammation of the liver (hepatitis),
• elevation of alanine aminotransferase (ALT) levels in the blood, which usually resolves upon discontinuing treatment.
• Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown frequency (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)
• unknown origin muscle pain with dark-colored urine (rhabdomyolysis)
• impotence
• inflammation of the pancreas (pancreatitis)
• low sodium levels in the blood (hyponatremia)
• depression
• usually feeling unwell (malaise)
• ringing, buzzing, ringing, or clicking in the ears (tinnitus),
• alteration of taste (dysgeusia).

The side effects in children are similar to those observed in adults.

Reporting of side effects:

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

Do not use Losartán Normon 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.

Store Losartán Normon in the original packaging.

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

Medicines should not be thrown down the drains or in the trash.Deposit the packaging and unused medicines at the SIGRE Pointof the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Losartán Normon

The active ingredient of Losartán Normon is losartan potassium.

Each Losartán Normon 12.5 mg Start tablet contains 12.5 mg of losartan potassium.

The other components are lactose monohydrate, maize pregelatinized starch, microcrystalline cellulose, magnesium stearate.

The Losartán Normon 12.5 mg Start tablets also contain hydroxypropylcellulose, hydroxypropylmethylcellulose, titanium dioxide (E-171), blue lac.

Appearance of the product and content of the packaging

Losartán Normon is supplied as blue-coated, round film-coated tablets.

Losartán Normon is supplied in the following packaging sizes:

Aluminum-PE/PVDC blister pack, in packs containing 7 blue-coated, film-coated tablets.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet:February 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gobs.es/.

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/67910/P_67910.html