LOSARTAN PENSA INICIO 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Losartan Pensa 12.5 mg Start coated tablets EFG

Read the package leaflet carefully before starting to take the medicine.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, inform your doctor or pharmacist. See section 4.

Contents of the package leaflet:

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

1. What is Losartan Pensa 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 leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, which causes the blood vessels to relax, resulting in a decrease in blood pressure. Losartan reduces the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Losartan 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 kidney failure 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 their 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. Before taking Losartan Pensa

Do not take Losartan Pensa

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

Be particularly careful with Losartan Pensa

Tell your doctor if you are pregnant (or if you think you might be). Your doctor will generally advise you to stop taking Losartan Pensa before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Losartan Pensa. Losartan Pensa should not be used at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time on (see section on Pregnancy).

Before taking Losartan Pensa, 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 (medications 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 undergone a kidney transplant,
• if your liver function is impaired (see sections 2. Do not take Losartan Pensa and 3. Dosage in special patient groups),
• if you have heart failure with or without kidney failure or potentially life-threatening heart rhythm disorders. Special attention is necessary when 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 a disorder of this gland).
• if you are taking any of the following medications 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

Tell your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Losartan Pensa. Your doctor will decide whether to continue treatment. Do not stop taking Losartan 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 the information under the heading “Do not take Losartan Pensa”

Use of other medications

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

While being treated with Losartan Pensa, be particularly cautious if you take any of the following medications:

• other medications that lower blood pressure, as they may cause additional blood pressure reduction. Blood pressure may also be lowered by some of the following medications/classes of medications: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• medications 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 medications, 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 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 Pensa” and “Be particularly careful with Losartan Pensa”).

If your kidney function is impaired, concomitant use of these medications may worsen kidney function.

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

Taking Losartan Pensa with food and drinks

Losartan Pensa can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant (or if you think you might be). Your doctor will generally advise you to stop taking Losartan Pensa before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Losartan Pensa. Losartan Pensa should not be used at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time on.

Breastfeeding

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

Consult your doctor or pharmacist before using any medication.

Use in children and adolescents

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

Driving and using machines

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

It is unlikely that Losartan Pensa will affect your ability to drive or use machines. However, as with 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 performing these activities.

Important information about some of the ingredients of Losartan Pensa

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Losartan Pensa

Follow the administration instructions of Losartan Pensa indicated by your doctor.

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

Patients with high blood pressure

Normally, treatment starts with 50 mg of losartan (one Losartan Pensa 50 mg tablet) once a day. The maximum blood pressure-lowering effect is achieved within 3-6 weeks of starting treatment. Afterward, in some patients, the dose may be increased to 100 mg of losartan (two Losartan Pensa 50 mg tablets) once a day.

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

Patients with high blood pressure and type 2 diabetes

Normally, treatment starts with 50 mg of losartan (one Losartan Pensa 50 mg tablet) once a day. Afterward, the dose may be increased to 100 mg of losartan (two Losartan Pensa 50 mg tablets) once a day, depending on your blood pressure response.

Losartan tablets can be administered with other blood pressure-lowering medications (e.g., diuretics, calcium antagonists, alpha or beta blockers, and centrally acting agents), as well as with insulin and other medications commonly used to lower blood sugar levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Patients with heart failure

Normally, treatment starts with 12.5 mg of losartan (one Losartan Pensa 12.5 mg Start tablet) 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 (one Losartan Pensa 50 mg tablet) once a day, depending on your condition.

In the treatment of heart failure, losartan is usually 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.

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 failure, or patients over 75 years old. The use of losartan is not recommended in patients with severe liver failure (see section "Do not take Losartan 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 Losartan Pensa until your doctor tells you to stop.

If you take more Losartan Pensa 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.

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 medication and the amount ingested.

If you forget to take Losartan 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 further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Losartan Pensa can cause side effects, although not everyone 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.

Medication side effects are classified as follows:

Very common:affect more than 1 in 10 patients

Common:affect 1 to 10 patients in 100

Uncommon:affect 1 to 10 patients in 1,000

Rare:affect 1 to 10 patients in 10,000

Very rare:affect less than 1 patient in 10,000

Unknownfrequency 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,
• palpitations (feeling of rapid heartbeats),
• chest pain (angina pectoris),
• low blood pressure (especially after excessive loss of water 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.

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 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 side effects:

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Losartan Pensa

Keep out of the reach and sight of children.

Do not use Losartan Pensa after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Store Losartan Pensa in its original packaging.

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

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Additional Information

Composition of Losartán Pensa

The active ingredient is losartan potassium.

Each Losartán Pensa 12.5 mg Initial tablet contains 12.5 mg of losartan potassium.

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

Losartán Pensa 12.5 mg Initial contains potassium in the following amount: 1.06 mg (0.027 mEq).

Losartán Pensa 12.5 mg Initial tablets also contain hydroxypropylcellulose, hydroxypropylmethylcellulose, titanium dioxide (E-171), and blue lake pigment.

Appearance of the Product and Packaging Contents

Losartán Pensa 12.5 mg Initial is supplied as blue, film-coated tablets without scoring.

Losartán Pensa is supplied in the following package sizes:

Aluminum-PVC/PE/PVDC blister pack, in packages of 7 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 Last Revision of this Leaflet:December 2022

Detailed 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/