Prospecto: information for the user

Losartán TecniGen 100 mg film-coated tablets

Read this prospectus carefully before starting to take this medicine because it contains important information for you:

-Keep this prospectus, as you may need to read it again.

-If you have any doubts, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus. See section 4.

1.What is Losartán TecniGen and what is it used for.

2.What you need to know before starting to take Losartán TecniGen.

3.How to take Losartán TecniGen.

4.Possible adverse effects.

5.Storage of Losartán TecniGen.

6.Contents of the package and additional information.

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 TecniGen is used for

• treating patients with elevated blood pressure (hypertension).
• protecting the kidneys in hypertensive patients with type 2 diabetes and laboratory test results 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) are not suitable. If their heart failure has been stabilized with an ACE inhibitor, they should not switch to losartan.
• in patients with elevated blood pressure and left ventricular hypertrophy of the heart, losartan has been shown to reduce the risk of stroke (LIFE indication).

Do not take Losartán TecniGen

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6),
• if your liver function is severely impaired,
• if you are more than 3 months pregnant. (It is also best to avoid Losartán TecniGen during the first months of pregnancy – see Pregnancy section).
• if you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskirén

Warnings and precautions

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

Inform your doctor if you are pregnant (or if you suspect you may be). Losartán TecniGen is not recommended for use at the beginning of pregnancy, and in no case should it 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 TecniGen, 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 fluid and/or salt loss from your body,
• if you are taking diuretics (medications that increase the amount of water that passes through your kidneys) or if you are following a low-sodium diet that causes excessive fluid and/or salt loss from your body (see section 3. Dosage in special patient groups),
• if you know you have narrowing or blockage of the blood vessels leading to your kidneys or if you have recently undergone a kidney transplant,
• if your liver function is altered (see sections 2. Do not take Losartán TecniGen 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 being treated simultaneously with a beta-blocker,
• if you have heart valve problems or heart muscle problems,
• if you have coronary heart disease (caused by reduced blood flow in the heart's blood vessels) or cerebrovascular disease (caused by reduced blood flow in the brain),
• if you have primary aldosteronism (a syndrome associated with 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):

- an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

- aliskirén

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

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 Losartán TecniGen”

Use of Losartán TecniGen with other medications

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including over-the-counter medications, herbal remedies, and natural products.

While taking Losartán TecniGen, be particularly cautious if you are taking any of the following medications:

• other medications that lower blood pressure, as they may cause additional blood pressure reduction. Blood pressure may also decrease with some of the following medications/classes of medications: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• medications that retain potassium or that may increase potassium levels (e.g. potassium supplements, salt substitutes containing potassium, or potassium-sparing medications such as certain diuretics [amiloride, triamterene, spironolactone] or heparin),
• nonsteroidal anti-inflammatory drugs (NSAIDs), 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 dosage 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 TecniGen” and “Warnings and precautions”)

If your kidney function is impaired, the concomitant use of these medications may cause a worsening of kidney function.

Lithium-containing medications 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).

Taking Losartán TecniGen with food, drinks, and alcohol

Losartán TecniGen can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

Pregnancy

You should inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you stop taking Losartán TecniGen before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Losartán TecniGen. Losartán TecniGen is not recommended for use at the beginning of pregnancy, and in no case should it 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.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Losartán TecniGen is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Pediatric population

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

Driving and operating machinery:

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

It is unlikely that Losartán TecniGen 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.

Losartán TecniGen contains lactose.

If your doctor has told you that you have a certain sugar intolerance, 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 Losartán TecniGen, depending on your condition and if you are taking other medications. It is essential to continue taking Losartán TecniGen as prescribed by your doctor to maintain constant blood pressure control.

Patients with high blood pressure

Typically, treatment begins with 50 mg of losartan (one Losartán TecniGen 50 mg tablet) 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 (2 Losartán TecniGen 50 mg tablets or 1 Losartán TecniGen 100 mg tablet) once a day.

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

Patients with high blood pressure and type 2 diabetes

Typically, treatment begins with 50 mg of losartan (one Losartán TecniGen 50 mg tablet) once a day. Subsequently, the dose may be increased to 100 mg of losartan (2 Losartán TecniGen 50 mg tablets or 1 Losartán TecniGen 100 mg tablet) 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 decrease blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

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 for the first week, 25 mg per day for the second week, and 50 mg per day for the third week), up to a maintenance dose of 50 mg of losartan (1 Losartán TecniGen 50 mg tablet) once a day, depending on your condition.

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.

Posology 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 Losartán TecniGen").

Administration

Tablets should be taken with a glass of water. Try to take your daily dose at approximately the same time each day. It is essential to continue taking Losartán TecniGen until your doctor tells you otherwise.

If you take more Losartán TecniGen than you should

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

IfIn 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 taken.

If you forget to take Losartán TecniGen

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, this medicine can cause side effects, although not everyone will experience them

.

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

Severe allergic reaction (skin 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.

Medicine side effects are classified as follows:

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

Common:can affect up to 1 in 10 people.

Uncommon:can affect up to 1 in 100 people.

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

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

Unknown:the frequency cannot be estimated from 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 (hyperkalemia).

Uncommon:

• drowsiness,
• headache,
• sleep disorders,
• feeling of very rapid heartbeats (palpitations),
• severe chest pain (angina pectoris),
• low blood pressure (especially after excessive loss of body water from the blood vessels, e.g. in patients with severe heart failure or on high doses of diuretics),
• orthostatic effects related to the dose, such as a decrease in blood pressure after standing up from lying 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),
• syncope (fainting),
• very 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 when treatment is stopped.

Unknown:

• reduced number of red blood cells (anemia),
• reduced number of platelets,
• migraine,
• cough,
• liver function abnormalities,
• muscle and joint pain,
• changes in kidney function (may be reversible when treatment is stopped), 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,
• intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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. Website: www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication 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 TecniGen in the original packaging.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Losartán TecniGen

The active ingredient is losartan.Each tablet contains 100 mg of losartan potassium.The other components (excipients) are:

Lactose monohydrate (lactose), microcrystalline cellulose, hydroxypropyl cellulose, pregelatinized cornstarch (cornstarch), magnesium stearate, hypromellose, titanium dioxide (E171), and macrogol 400.

Appearance of the product and content of the packaging

Losartán TecniGen 100 mg EFG tablets are film-coated, oblong, white tablets with a notch on one side.They are presented in a blister pack of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

TECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA, S.A.

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

28108 Alcobendas, Spain

Responsible for manufacturing:

Atlantic Pharma Produçoes Farmaceuticas, S.A.

Rua da Tapada Grande, 2

Abrunheira. Sintra CP: 2710-089

PORTUGAL

Date of the last review 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 Medical Devices (AEMPS) http://www.aemps.gob.es/