LOSARTAN NORMON 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Losartan Normon 12.5 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 other information

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

Losartan belongs to a group of medicines known as angiotensin II receptor antagonists.

Angiotensin II is a substance produced in the body which binds to receptors in blood vessels, causing them to narrow. This narrowing of blood vessels increases blood pressure. Losartan prevents the binding of angiotensin II to these receptors, which causes the blood vessels to relax and results in a lowering of blood pressure. Losartan also slows the progression of kidney disease 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 and laboratory tests indicating kidney problems and proteinuria ≥ 0.5 g/day (a condition where the urine contains an abnormal amount of protein).
• to treat patients with chronic heart failure, when your 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 stabilised 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 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 you have severely impaired liver function,
• if you are more than 3 months pregnant. (It is also better to avoid Losartan Normon at the start of pregnancy - see the section on Pregnancy).
• if you have diabetes or kidney problems and are being treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions

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

Tell your doctor if you are pregnant (or think you might be). Losartan Normon should not be used during the first trimester of pregnancy and should not be used at all after the third month of pregnancy, as it may cause serious harm to your baby when used after this point (see the section on Pregnancy).

Before taking Losartan Normon, it is important that you tell 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 diarrhoea, which causes 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 causes excessive loss of fluid 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 supply your kidneys or if you have recently had a kidney transplant,
• if your liver function is impaired (see sections 2. Do not take Losartan Normon and 3. Dosage in special patient groups),
• if you have heart failure with or without kidney problems or life-threatening heart rhythm disorders. Special attention is needed 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 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 problem with this gland).
• if you are taking any of the following medicines used to treat high blood pressure:
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
  • aliskiren.
  • If you are taking other medicines that may increase potassium levels in your blood (see section 2 "Other medicines 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 diarrhoea 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 experience 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 medicines and Losartan Normon

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 containing potassium or potassium-sparing diuretics (e.g. amiloride, triamterene, spironolactone) or other medicines that may increase potassium levels in your blood (e.g. heparin, trimetoprim-containing medicines), as this combination is not recommended.

While you are taking Losartan Normon, be particularly careful if you are taking any of the following medicines:

• other medicines that lower blood pressure, as they may cause additional lowering of 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 indometacin, 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 change 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, taking these medicines together may cause a worsening of kidney function.

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

Taking Losartan Normon with food and drink

Losartan Normon can be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking Losartan Normon before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan Normon. Losartan Normon should not be used during the first trimester of pregnancy and should not be used at all after the third month of pregnancy, as it may cause serious harm to your baby when used after this point.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Losartan Normon is not recommended for mothers who are breast-feeding, and your doctor will choose another treatment for you if you want to breast-feed, especially if your baby is a newborn or premature.

Consult your doctor or pharmacist 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 Normon 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 Normon contains lactose

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

3. How to take Losartan Normon

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will decide the appropriate dose of losartan, depending on your condition and whether you are taking other medicines. It is important to continue taking losartan as long as 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 this, the dose may be increased to 100 mg of losartan once a day in some patients.

If you feel that the effect of Losartan Normon is too strong or too weak, please talk to 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 aged 6-18 years

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 daily (up to 25 mg of losartan). Your doctor may increase the dose if your 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 once a day. The dose may then be increased to 100 mg of losartan once a day, depending on your blood pressure response.

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

Adult patients with heart failure

Normally, treatment starts with 12.5 mg of losartan once a day. The dose will usually be increased gradually, 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 can be used.

In the treatment of heart failure, losartan is usually 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 beat stronger and more efficiently) 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 impaired liver function or patients over 75 years of age. Losartan is not recommended for patients with severe liver impairment (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 the same time each day. It is important that you continue to take 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. 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 taken. It is recommended to take the packaging and the package leaflet of the medicine 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Losartan Normon can cause side effects, although not everybody gets them.

If you experience any of the following, stop taking the losartan tablets and tell your doctor immediately or go to the casualty department of your nearest hospital:

A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing).

This is a serious but rare side effect, which affects more than 1 in 10,000 patients but fewer than 1 in 1,000 patients. You may need urgent medical attention or hospitalisation.

The following side effects have been reported with losartan:

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

• dizziness,
• low blood pressure (especially after excessive loss of fluid 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 (hypoglycaemia)
• high potassium levels in the blood (hyperkalaemia)
• changes in kidney function, including kidney failure
• low red blood cell count (anaemia)
• 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
• fast heart rate (palpitations),
• severe chest pain (angina pectoris),
• difficulty breathing (dyspnoea),
• abdominal pain,
• constipation,
• diarrhoea,
• nausea
• vomiting,
• hives (urticaria),
• itching (pruritus),
• rash,
• localised swelling (oedema)
• 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 (paraesthesia),
• fainting (syncope),
• fast and irregular heart rhythm (atrial fibrillation),
• stroke (cerebral attack),
• inflammation of the liver (hepatitis),
• elevation of alanine aminotransferase (ALT) levels in the blood, which usually resolves when treatment is stopped.
• Intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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

• low platelet count,
• migraine,
• abnormal liver function,
• 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 urine (tea-coloured) (rhabdomyolysis)
• impotence
• inflammation of the pancreas (pancreatitis)
• low sodium levels in the blood (hyponatraemia)
• depression
• generally feeling unwell (malaise)
• ringing, buzzing, noise or clicking in the ears (tinnitus),
• disturbance of taste (dysgeusia).

Side effects in children are similar to those seen in adults.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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 medicines at the SIGRE collection point in 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. Packaging contents and additional information

Composition of Losartán Normon

The active ingredient of Losartán Normon is potassium losartan.

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

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

Losartán Normon 12.5 mg Initial tablets also contain hydroxypropylcellulose, hydroxypropylmethylcellulose, titanium dioxide (E-171), blue lake.

Appearance of the product and packaging contents

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

Losartán Normon is supplied in the following packaging sizes:

Aluminum-PE/PVDC blister pack, in packs containing 7 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

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 about 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/67910/P_67910.html