Losartan Normon 12.5 mg starting film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Losartán Normon 12.5 mg Initiation film-coated tablets EFG

potassium losartan

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Losartán Normon is and what it is used for
2. What you need to know before taking Losartán Normon
3. How to take Losartán Normon
4. Possible side effects
5. How to store Losartán Normon
6. Contents of the pack and other information

1. What Losartán Normon 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 present in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartan blocks angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels and, consequently, a reduction in blood pressure. Losartan slows the progression of impaired kidney function in patients with high blood pressure and type 2 diabetes.

Losartán Normon is used

• to treat patients with high blood pressure (hypertension) in adults and in children and adolescents aged 6 to 18 years.
• to protect the kidneys in hypertensive patients with type 2 diabetes whose laboratory tests indicate renal insufficiency and proteinuria ≥ 0.5 g per day (a condition in which urine contains an abnormally high amount of protein).
• to treat patients with chronic heart failure, when their doctor considers treatment with specific medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to lower high blood pressure) to be unsuitable. 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 starting to take Losartán Normon

Do not take Losartán Normon

• if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6),
• if your liver function is severely impaired,
• if you are more than 3 months pregnant. (It is also advisable to avoid Losartán Normon in early 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 Normon.

Inform your doctor if you are pregnant (or suspect you might be). Use of Losartán Normon is not recommended during early pregnancy, and must under no circumstances be administered after the third month of pregnancy, as it may cause severe harm to your baby when used from that stage onward (see Pregnancy section).

Before taking Losartán Normon, it is important to inform your doctor:

• if you have previously experienced angioedema (swelling of the face, lips, tongue, and/or throat) (see also section 4. Possible side effects),
• if you have excessive vomiting or diarrhea, leading to 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 cause 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 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 Normon 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 attention is required if you are also being treated with a beta-blocker,
• if you have heart valve problems or issues with your 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 excessive secretion of the hormone aldosterone by the adrenal gland due to adrenal gland dysfunction),
• if you are taking any of the following medicines 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 medicines that may increase serum potassium (see section 2 “Other medicines and Losartán Normon”).

Your doctor may monitor your kidney function, blood pressure, and blood levels of electrolytes (e.g., potassium) at regular intervals.

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

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

Children and adolescents

Losartán Normon has been studied in children. For further information, speak with your doctor.

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

Other medicines and Losartán Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform 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 Normon is not recommended.

While being treated with Losartán Normon, take special care if you take 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 inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Losartán Normon” and “Warnings and precautions”).

If you have impaired kidney function, concomitant use of these medicines may lead to worsening of kidney 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 Normon with food and drink

Losartán Normon can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will generally advise you to stop taking Losartán Normon before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Losartán Normon. Use of Losartán Normon is not recommended during early pregnancy, and must under no circumstances be administered after the third month of pregnancy, as it may cause severe harm to your baby when used from that point onward.

Breastfeeding

Inform your doctor if you are breastfeeding or intend to start breastfeeding. Use of Losartán Normon is not recommended for breastfeeding mothers, and your doctor will choose an alternative 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 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 Normon 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 Normon contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Losartán Normon

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the appropriate dose of losartan depending on your condition and whether you are taking other medicines. It is important to keep taking losartan as prescribed by your doctor to maintain consistent blood pressure control.

Adult patients with high blood pressure

Treatment usually starts with 50 mg of losartan once daily. The maximum blood pressure-lowering effect is reached within 3–6 weeks after starting treatment. Afterwards, in some patients, the dose may be increased to 100 mg of losartan once daily.

If you feel that the effect of Losartán 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 its effectiveness has not been demonstrated 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 daily (up to 25 mg of losartan). Your doctor may increase the dose if blood pressure is not adequately controlled.

Other pharmaceutical forms 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 once daily. Afterwards, the dose may be increased to 100 mg of losartan once daily, depending on your blood pressure response.

Losartan tablets can be taken together 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 commonly used medications to reduce blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Adult patients with heart failure

Treatment usually starts with 12.5 mg of losartan once daily. The dose is usually increased gradually 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 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 pump more strongly and efficiently) 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 treated with 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 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 continue taking Losartán Normon unless your doctor tells you otherwise.

If you take more Losartán Normon than you should

If you accidentally take too many tablets, contact your doctor immediately. Symptoms of overdose may 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 91 562 04 20, stating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Losartán Normon

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

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

4. Possible adverse effects

Like all medicines, Losartán Normon can cause adverse effects, although not everyone experiences them.

If you experience the following, stop taking losartan tablets immediately and contact your doctor or go to the nearest hospital emergency department:

A severe allergic reaction (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 people):

• dizziness,
• low blood pressure (especially after excessive loss of fluid from the blood vessels, 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 (hypoglycaemia),
• high potassium levels in the blood (hyperkalaemia),
• changes in kidney function, including kidney failure,
• reduced number of red blood cells (anaemia),
• increased blood urea, serum creatinine and serum potassium levels in patients with heart failure.

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

• drowsiness,
• headache,
• sleep disorders,
• sensation of rapid heartbeat (palpitations),
• severe chest pain (angina pectoris),
• difficulty breathing (dyspnoea),
• abdominal pain,
• constipation,
• diarrhoea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• rash,
• localized swelling (oedema),
• cough.

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

• hypersensitivity,
• angioedema,
• inflammation of blood vessels (vasculitis, including Schönlein-Henoch purpura),
• numbness or tingling sensation (paraesthesia),
• 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,
• intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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

• reduced platelet count,
• migraine,
• abnormalities in 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-coloured urine (tea-coloured) (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in blood (hyponatraemia),
• depression,
• generally feeling 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 can also report them directly via 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 Normon

Keep out of sight and reach of children.

Do not use Losartán Normon after the expiry date stated on the packaging after EXP. The expiry date refers to 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 pack until ready to take the medicine.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Losartán Normon

The active substance in Losartán Normon is losartan potassium.

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

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

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

Appearance of the product and contents of the pack

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

Losartán Normon is available in the following pack sizes:

Aluminum-PE/PVDC blisters, 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 most recent revision of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address:

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