LOSARTAN TECNIGEN 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Losartan TecniGen 50 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you:

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Losartan TecniGen 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, causing the blood vessels to relax, which in turn lowers blood pressure. Losartan reduces the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Losartan TecniGen is used

• to treat patients with high blood pressure (hypertension).
• to protect the kidney in hypertensive patients with type 2 diabetes and laboratory results showing renal insufficiency and proteinuria = 0.5 g per day (a condition in which the urine contains an abnormal amount of protein).
• to treat patients with chronic heart failure, when your 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 TecniGen

Do not take Losartan TecniGen

• if you are allergic to the active substance 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 TecniGen during the first months of pregnancy – see section on Pregnancy).
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren

Warnings and precautions

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

Tell your doctor if you are pregnant (or think you may be). Your doctor will normally advise you to stop taking Losartan TecniGen before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan TecniGen. It is not recommended to take Losartan TecniGen at the start of pregnancy, and in no case should it be taken after the third month of pregnancy, as it may cause serious harm to your baby when taken from that time on.

Before taking Losartan TecniGen, 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 (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 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 supply your kidneys or if you have recently had a kidney transplant,
• if your liver function is altered (see sections 2. Do not take Losartan TecniGen and 3. Dosage in special patient groups),
• if you have heart failure with or without kidney insufficiency 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 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 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

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking losartan. Your doctor will decide whether to continue treatment. Do not stop taking losartan on your own.

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

See also the information under the heading “Do not take Losartan TecniGen”

Using Losartan TecniGen with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, herbal medicines, and natural products.

While you are being treated with Losartan TecniGen, be particularly careful if you take any of the following medicines:

• other medicines that lower blood pressure, as they may cause additional blood pressure reduction. Blood pressure may also be lowered by some of the following medicines/classes of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• medicines that retain potassium or may increase potassium levels (e.g., potassium supplements, salt substitutes containing potassium, or potassium-sparing diuretics [e.g., amiloride, triamterene, spironolactone] or heparin),
• non-steroidal anti-inflammatory medicines, 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 the information under the headings “Do not take Losartan TecniGen” and “Warnings and precautions”)

If your kidney function is impaired, concomitant use of these medicines may cause worsening of kidney function.

Medicines containing lithium should not be used in combination with losartan without your doctor performing careful monitoring. It may be appropriate to take special precautions (e.g., blood tests).

Taking Losartan TecniGen with food, drinks, and alcohol

Losartan TecniGen can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before taking any medicine.

Pregnancy

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

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. It is not recommended to use Losartan TecniGen during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Paediatric population

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

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 TecniGen will 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 TecniGen contains lactose.

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

3. How to take Losartan TecniGen

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again

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

Patient with high blood pressure

Normally, treatment starts with 50 mg of losartan (one Losartan TecniGen 50 mg tablet) 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 (2 Losartan TecniGen 50 mg tablets or 1 Losartan TecniGen 100 mg tablet) once a day.

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

Patient with high blood pressure and type 2 diabetes

Normally, treatment starts with 50 mg of losartan (one Losartan TecniGen 50 mg tablet) once a day. After that, the dose may be increased to 100 mg of losartan (2 Losartan TecniGen 50 mg tablets or 1 Losartan TecniGen 100 mg tablet) once a day, depending on your blood pressure response.

Losartan tablets can be taken 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 medicines commonly used to lower blood sugar levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Patient 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, and 50 mg per day during the third week), up to a maintenance dose of 50 mg of losartan (1 Losartan TecniGen 50 mg tablet) once a day, depending on your condition.

In the treatment of heart failure, losartan is normally 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 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-dose diuretics, patients with liver insufficiency, or patients over 75 years of age. It is not recommended to use losartan in patients with severe liver insufficiency (see section "Do not take Losartan TecniGen").

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 keep taking Losartan TecniGen until your doctor tells you to stop.

If you take more Losartan TecniGen than you should

If you accidentally take too many tablets, or if a child swallows some, contact your doctor immediately. The symptoms of overdose are low blood pressure, increased heart rate, and possibly decreased heart rate.

If 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 medicine and the amount taken.

If you forget to take Losartan TecniGen

If you accidentally forget 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 (skin 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, affecting more than 1 patient in 10,000 but less than 1 patient in 1,000. You may need urgent medical attention or hospitalization.

Side effects of medicines are classified as follows:

Very common:may affect more than 1 in 10 people.

Common:may affect up to 1 in 10 people.

Uncommon:may affect up to 1 in 100 people.

Rare:may affect up to 1 in 1,000 people.

Very rare:may affect up to 1 in 10,000 people.

Not known:frequency cannot be estimated from the available data.

The following side effects have been reported with losartan:

Common:

• dizziness,
• low blood pressure,
• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• high potassium levels in the blood (hyperkalemia).

Uncommon:

• drowsiness,
• headache,
• sleep disorders,
• sensation of rapid heartbeats (palpitations),
• severe chest pain (angina pectoris),
• 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-dose diuretic therapy),
• dose-related orthostatic effects, such as decreased blood pressure after standing up from lying down or sitting,
• difficulty breathing (dyspnea),
• abdominal pain,
• chronic constipation,
• diarrhea,
• nausea
• vomiting,
• hives (urticaria),
• itching (pruritus),
• skin rash,
• localized swelling (edema).

Rare:

• inflammation of blood vessels (vasculitis, Schonlein-Henoch purpura),
• numbness or tingling (paresthesia),
• fainting (syncope),
• rapid and irregular heartbeats (atrial fibrillation), stroke (cerebrovascular accident),
• 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.

Not known:

• reduced number of red blood cells (anemia),
• reduced number of platelets,
• migraine,
• cough,
• abnormalities in liver function,
• muscle and joint pain,
• changes in kidney function (may be reversible upon discontinuation of treatment), including kidney failure,
• flu-like symptoms,
• increased urea, creatinine, and potassium levels in the blood in patients with heart failure,
• back pain and urinary tract infection.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use. Website: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Losartan TecniGen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

No special storage conditions are required.

Store Losartan TecniGen in the original package.

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

Medicines should not be disposed of via wastewater or household waste. Return the packages and any unused medicines to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of packages and unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Losartán TecniGen 50 mg tablets

The active ingredient of Losartán TecniGen is losartan potassium.

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

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

Losartán TecniGen 50 mg contains potassium in the following amount: 4.24 mg (0.108 mEq)

Losartán TecniGen 50 mg tablets also contain hypromellose, titanium dioxide (E171), and macrogol 400.

Product Appearance and Container Content

Losartán TecniGen is supplied as film-coated, oblong, white tablets, scored on one side.

Losartán TecniGen is supplied in the following package sizes:

White PVC/Aluminum blister pack, in packages of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

TECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA, S.A.

Avda. de Bruselas, 13, 3º D.Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas, Spain

Manufacturer:

Atlantic Pharma Produçoes Farmaceuticas, S.A.

Rua da Tapada Grande, 2

Abrunheira. Sintra CP: 2710-089

PORTUGAL

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/