Losartan PensA 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Losartan Pensa 100 mg film-coated tablets EFG

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; do not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Losartan Pensa is and what it is used for
2. Before you take Losartan Pensa
3. How to take Losartan Pensa
4. Possible side effects
5. How to store Losartan Pensa
6. Further information

1. What Losartán Pensa is and what it is 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 present in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels and consequently lowering blood pressure. Losartan reduces the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Losartán Pensa is used

• to treat patients with high blood pressure (hypertension).
• to protect the kidney 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 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 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. Before taking Losartán Pensa

Do not take Losartán Pensa

• if you are allergic (hypersensitive) to losartan or to any of the other ingredients of Losartán Pensa,
• if your liver function is severely impaired,
• if you are more than 3 months pregnant. (It is also advisable to avoid Losartán Pensa during the first months of pregnancy – see Pregnancy section).
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Take special care with Losartán Pensa

Inform your doctor if you are pregnant (or suspect you may be pregnant). Use of Losartán Pensa 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 this stage onward (see Pregnancy section).

Before taking Losartán Pensa, it is important to 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 adverse effects),
• if you have excessive vomiting or diarrhoea, causing excessive loss of fluid and/or salt 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 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 supplying your kidneys or if you have recently had a kidney transplant,
• if you have impaired liver function (see sections 2. Do not take Losartán Pensa and 3. Dosage in special patient groups),
• if you have heart failure with or without kidney failure or potentially life-threatening concomitant cardiac arrhythmias. Special attention is required when you are being treated simultaneously 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 heart's blood vessels) 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):
  1. an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,
  2. Aliskiren.

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

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

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

Use of other medicines

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

While being treated with Losartán Pensa, take particular 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,
• medicines that retain potassium or may increase potassium levels (e.g. potassium supplements, salt substitutes containing potassium, 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 Pensa” and “Take special care with Losartán Pensa”).

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 without careful monitoring by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate.

Taking Losartán Pensa with food and drink

Losartán Pensa can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

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

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Use of Losartán Pensa is not recommended during breastfeeding, and your doctor will choose another 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.

Use in children and adolescents

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 Pensa 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.

Important information about some of the ingredients of Losartán Pensa

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

3. How to take Losartán Pensa

Follow exactly the instructions for using Losartán Pensa as given by your doctor.

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

Patients with high blood pressure

Treatment usually starts with 50 mg of losartan (one Losartán Pensa 50 mg tablet) 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 Losartán Pensa 50 mg tablets) 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 Losartán Pensa 50 mg tablet) once daily. Afterwards, the dose may be increased to 100 mg of losartan (two Losartán Pensa 50 mg tablets) 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 agents), as well as with insulin and other commonly used medications 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 (one Losartán Pensa 12.5 mg Inicio tablet) 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 Losartán Pensa 50 mg tablet) 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 fluid 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 receiving 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 Pensa").

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 Pensa unless your doctor tells you otherwise.

If you take more Losartán Pensa 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Losartán Pensa

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 other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

If you experience the following, stop taking losartan tablets immediately and contact your doctor right away 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 in 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: affects more than 1 in 10 patients
Common: affects 1 to 10 in 100 patients
Uncommon: affects 1 to 10 in 1,000 patients
Rare: affects 1 to 10 in 10,000 patients
Very rare: affects less than 1 in 10,000 patients
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 from the blood vessels, e.g. in patients with severe heart failure or on high-dose diuretic therapy),
• 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 upon discontinuation of treatment,
• intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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.

Reporting of adverse effects:

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Losartán Pensa

Keep out of the reach and sight of children.

Do not use Losartán Pensa 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 Pensa 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 at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional Information

Composition of Losartán Pensa

The active substance is potassium losartan.

Each Losartán Pensa 100 mg tablet contains 100 mg of potassium losartan.

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

Losartán Pensa 100 mg contains potassium in the following amount: 8.48 mg (0.216 mEq).

Losartán Pensa 100 mg tablets also contain hydroxypropylcellulose, hydroxypropylmethylcellulose, and titanium dioxide (E-171).

Appearance of the product and contents of the package

Losartán Pensa 100 mg is supplied as white, film-coated, unmarked tablets.

Losartán Pensa 100 mg is available in the following pack sizes:

Aluminum-PVC/PE/PVDC blisters, packs of 28 tablets

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Liconsa, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Date of the most recent revision of this leaflet: December 2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/