LOSARTAN NORMON 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Losartan Normon 50 mg film-coated tablets EFG

potassium losartan

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, 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. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. 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 Normon and what is it used for
2. What you need to know before you take Losartan Normon
3. How to take Losartan Normon
4. Possible side effects
5. Storing Losartan Normon
6. Contents of the pack and further information

1. What is Losartan Normon and what is it used for

Losartan belongs to a group of medicines called 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 results in an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, which causes the blood vessels to relax and thereby lowers the blood pressure. Losartan reduces the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Losartan Normon is used

• to treat patients with high blood pressure (hypertension) in adults and in children and adolescents from 6 to 18 years of age.
• to protect the kidneys in hypertensive patients with type 2 diabetes with clinical evidence of renal insufficiency and proteinuria ≥ 0.5 g/day (a condition in which the urine contains an abnormal amount of protein).
• to treat patients with chronic heart failure, when their doctor considers that treatment with specific medications called angiotensin-converting enzyme inhibitors (ACE inhibitors, medications 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 increased thickness 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 you take Losartan Normon

Do not take Losartan Normon

• if you are allergic to losartan or 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 Normon at the beginning of pregnancy - see section on Pregnancy).
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medication containing aliskiren.

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 think you may be pregnant). It is not recommended to use Losartan Normon at the start of pregnancy, and in no case should it be administered if you are pregnant for more than three months, as it may cause serious harm to your baby when administered from that time on (see section on Pregnancy).

Before taking Losartan Normon, it is important 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 causes excessive loss of fluid and/or salt from your body,
• if you are taking diuretics (medications that increase the amount of water that passes through your kidneys) or if you are on a low-salt diet that causes 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 go to your kidneys or if you have recently undergone a kidney transplant,
• if your liver function is altered (see sections 2. Do not take Losartan Normon and 3. Dosage in special patient groups),
• if you have heart failure with or without kidney failure or life-threatening cardiac arrhythmias. Special attention is necessary when 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 an alteration of this gland).
• if you are taking any of the following medications used to treat high blood pressure (hypertension):
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren.
  • If you are taking other medications that may increase serum potassium (see section 2 "Other medications and Losartan Normon").

Your doctor may monitor your kidney function, blood pressure, and blood 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 on your own.

See also the information under the heading "Do not take Losartan Normon".

Children and adolescents

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

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

Other medications and Losartan Normon

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

Tell your doctor if you are taking potassium supplements, salt substitutes that contain potassium, or potassium-sparing medications such as certain diuretics (amiloride, triamterene, spironolactone) or other medications that may increase serum potassium (e.g., heparin, medications that contain trimethoprim), as combination with Losartan Normon is not recommended.

While being treated with Losartan Normon, be especially careful if you take any of the following medications:

• other medications 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 medications/classes of medications: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory medications, such as indomethacin, 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 adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings "Do not take Losartan Normon" and "Warnings and precautions").

If your kidney function is impaired, concomitant use of these medications may worsen kidney function.

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

Taking Losartan Normon with food and drinks

Losartan Normon can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant (or if you think you may be pregnant). Your doctor will generally advise you to stop taking Losartan Normon before you become pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Losartan Normon. It is not recommended to use Losartan Normon at the start of pregnancy, and in no case should it be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby when administered from that time on.

Breastfeeding

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

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

It is unlikely that Losartan Normon will affect your ability to drive or use machines. However, as with 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 performing these activities.

Losartan Normon contains lactose

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

3. How to take Losartan Normon

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of losartan, depending on your condition and whether you are taking other medications. It is important to keep taking losartan while your doctor prescribes it to maintain constant control of your blood pressure.

Adult patients with high blood pressure

Normally, treatment starts with 50 mg of losartan 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 once a day.

If you think the effect of Losartan Normon 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 work in this age group.

Children between 6-18 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, administered 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 medication 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 once a day. After that, the dose may be increased to 100 mg of losartan once a day, depending on the response of your blood pressure.

Losartan tablets can be administered with other medications that lower blood pressure (e.g., diuretics, calcium antagonists, alpha or beta blockers, and centrally acting agents), as well as with insulin and other medications 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, and 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 once a day can be used.

In the treatment of heart failure, losartan is normally 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 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 Normon").

Administration

The 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 important that you keep taking Losartan Normon until your doctor tells you to stop.

If you take more Losartan Normon 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, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to take the package and the package leaflet of the medication to the healthcare professional.

If you forget to take Losartan Normon

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

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

4. Possible side effects

Like all medications, Losartan Normon can cause side effects, although not everybody gets 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 (rash, itching, swelling of the face, lips, mouth, or throat that can cause difficulty swallowing or breathing).

This is a serious but rare side effect, which affects more than 1 patient in 10,000, but less than 1 patient 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 water from the body within the blood vessels, e.g., in patients with severe heart failure or on 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 kidney function, including kidney failure
• reduced number of red blood cells (anemia)
• increased urea, creatinine, and potassium levels in the blood in patients with heart failure.

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

• drowsiness
• headache
• sleep disorders
• palpitations (feeling of rapid heartbeats),
• 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 the blood vessels (vasculitis, including Schonlein-Henoch purpura),
• numbness or tingling (paresthesia),
• fainting (syncope),
• rapid and irregular heartbeats (atrial fibrillation),
• stroke (cerebral attack),
• inflammation of the liver (hepatitis),
• elevation of alanine aminotransferase (ALT) levels in the blood, which usually resolves upon discontinuation of treatment.
• Intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known (frequency cannot be estimated from the 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 (tea-colored) (rhabdomyolysis)
• impotence
• inflammation of the pancreas (pancreatitis)
• 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).

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Losartán Normon

Keep out of sight and reach of children.

Do not use Losartán Normon 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 Normon in its original packaging.

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

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

6. Packaging Contents and Additional Information

Composition of Losartán Normon

The active ingredient of Losartán Normon is potassium losartan.

Each 50 mg Losartán Normon tablet contains 50 mg of potassium losartan.

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

The 50 mg Losartán Normon tablets also contain hydroxypropylcellulose, hydroxypropylmethylcellulose, and titanium dioxide (E-171).

Product Appearance and Packaging Contents

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

Losartán Normon is supplied in the following packaging sizes:

Aluminum-PE/PVDC blister packs, in packages containing 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the Last Revision of this Leaflet:February 2025 The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

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

https://cima.aemps.es/cima/dochtml/p/67912/P_67912.html