Losartan Tecnigen 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Losartán TecniGen 100 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you:

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

Leaflet contents:

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

1. What Losartán TecniGen 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, which in turn lowers blood pressure. Losartan slows the progression of renal impairment in patients with high blood pressure and type 2 diabetes.

Losartán TecniGen is used

• to treat patients with high blood pressure (hypertension).
• to protect the kidneys in hypertensive patients with type 2 diabetes and laboratory test results indicating renal impairment and proteinuria ≥ 0.5 g per day (a condition in which the urine contains an abnormally high amount of protein).
• to treat patients with chronic heart failure, when your doctor considers that treatment with specific medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines 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 left ventricular hypertrophy (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 taking Losartán TecniGen

Do not take Losartán TecniGen

• if you are allergic to the active substance 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 TecniGen during the first trimester of pregnancy – see Pregnancy section.)
• if you have diabetes or renal impairment and are being treated with an antihypertensive medicine containing aliskiren

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Losartán TecniGen.

Inform your doctor if you are pregnant (or suspect you might be). The use of Losartán TecniGen is not recommended during early pregnancy, and must be avoided after the third month of pregnancy, as it may cause serious harm to your baby when used from that stage onward (see Pregnancy section).

Before taking Losartán TecniGen, it is important to 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 are experiencing excessive vomiting or diarrhea, which may lead 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 fluid or salt loss (see section 3. Dosage in special patient populations),

• 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 TecniGen and 3. Dosage in special patient populations),

• 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 heart muscle disease,

• 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 dysfunction 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.

Contact 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 monotherapy without medical advice.

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 medicines

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

While being treated with Losartán TecniGen, take particular care if you are taking 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,
• medicines that retain potassium or may increase potassium levels (e.g., potassium supplements, potassium-containing salt substitutes, or potassium-sparing medicines such as certain diuretics [amiloride, triamterene, spironolactone] or heparin),
• 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 TecniGen” and “Warnings and precautions”).

If you have impaired kidney function, concomitant use of these medicines may lead to worsening of renal function.

Medicines containing lithium should not be used in combination with losartan without careful monitoring by your doctor. Special precautionary measures (e.g., blood tests) may be appropriate.

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 medicine.

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will generally advise you to stop taking Losartán TecniGen before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. The use of Losartán TecniGen is not recommended during early pregnancy, and must be avoided after the third month of pregnancy, as it may cause serious harm to your baby when used from that stage onward.

Breastfeeding

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

Paediatric population

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

Driving and using machines

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

It is unlikely that Losartán TecniGen 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 performing such activities.

Losartán TecniGen contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult him or her before taking this medicine.

3. How to take Losartán TecniGen

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

Your doctor will decide the appropriate dose of Losartán TecniGen, depending on your condition and whether you are taking other medicines. It is important to continue taking Losartán TecniGen as prescribed by your doctor to maintain consistent blood pressure control.

Patients with high blood pressure

Treatment usually starts with 50 mg of losartan (one tablet of Losartán TecniGen 50 mg) once daily. The maximum blood pressure-lowering effect is reached within 3 to 6 weeks after starting treatment. Afterwards, in some patients, the dose may be increased to 100 mg of losartan (two tablets of Losartán TecniGen 50 mg or one tablet of Losartán TecniGen 100 mg) once daily.

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

Patients with high blood pressure and type 2 diabetes

Treatment usually starts with 50 mg of losartan (one tablet of Losartán TecniGen 50 mg) once daily. Afterwards, the dose may be increased to 100 mg of losartan (two tablets of Losartán TecniGen 50 mg or one tablet of Losartán TecniGen 100 mg) once daily, depending on your blood pressure response.

Losartan tablets may be taken together with other medicines that lower blood pressure (e.g. diuretics, calcium antagonists, alpha or beta blockers, and centrally-acting medicines), as well as with insulin and other medicines commonly used to reduce blood glucose levels (e.g. sulfonylureas, glitazones, and glucosidase inhibitors).

Patients with heart failure

Treatment usually starts with 12.5 mg of losartan once daily. The dose is usually gradually increased on a weekly basis (i.e. 12.5 mg daily during the first week, 25 mg daily during the second week, and 50 mg daily during the third week), up to a maintenance dose of 50 mg of losartan (one tablet of Losartán TecniGen 50 mg) once daily, depending on your condition.

In the treatment of heart failure, losartan is usually combined with a diuretic (a medicine that increases the amount of water passing through your kidneys) and/or digitalis (a medicine that helps your heart become 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 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 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 continue taking Losartán TecniGen unless 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 any, contact your doctor immediately. Symptoms of overdose include 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 at 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Losartán TecniGen

If you accidentally miss a dose, simply take the next dose as usual. 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, this medicine can cause adverse effects, although not everyone experiences them.

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

A severe allergic reaction (skin 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.

Adverse 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 available data.

The following adverse effects have been reported with losartan:

Common:

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

Uncommon:

• drowsiness,
• headache,
• sleep disorders,
• sensation of very rapid heartbeat (palpitations),
• severe chest pain (angina pectoris),
• low blood pressure (especially after excessive loss of fluid in the blood vessels, e.g. in patients with severe heart failure or receiving high doses of diuretics),
• dose-related orthostatic effects, such as drop in blood pressure upon standing up from a lying or sitting position,
• difficulty breathing (dyspnoea),
• abdominal pain,
• chronic constipation,
• diarrhoea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• skin rash,
• localized swelling (oedema).

Rare:

• inflammation of blood vessels (vasculitis, Schönlein-Henoch purpura),
• numbness or tingling sensation (paraesthesia),
• fainting (syncope),
• very rapid and irregular heartbeat (atrial fibrillation), stroke (cerebrovascular accident),
• liver inflammation (hepatitis),
• increased blood levels of alanine aminotransferase (ALT), which usually resolves when treatment is stopped.

Not known:

• reduced number of red blood cells (anaemia),
• 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 renal failure,
• flu-like symptoms,
• increased blood urea, creatinine and plasma potassium levels in patients with heart failure,
• back pain and urinary tract infection,
• intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, 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: Website: www.notificaRAM.es.

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

5. Storage of Losartán TecniGen

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

Do not use this medicine 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 TecniGen in its original packaging.

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

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

6. Contents of the pack and other information

Composition of Losartán TecniGen

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

Monohydrate lactose (lactose), microcrystalline cellulose, hydroxypropyl cellulose, pregelatinized corn starch (corn starch), magnesium stearate, hypromellose, titanium dioxide (E171) and macrogol 400.

Appearance of the medicinal product and contents of the pack

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

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 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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/