LOSARTAN PENSA 50 mg FILM-COATED TABLETS

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 especially 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 you become pregnant or as soon as you know you are pregnant and will advise you to 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 go to 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 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 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

Consult 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 you are 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 produce an additional reduction in blood pressure. 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 that 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 especially 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 performing careful monitoring. It may be appropriate to take special precautionary measures (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 you become pregnant or as soon as you know you are pregnant and will advise you to 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.

Losartan Pensa is unlikely to 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 instructions for administration 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 control of your blood pressure.

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. After that, 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. After that, 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 medications that lower blood pressure (e.g., diuretics, calcium antagonists, alpha or beta blockers, and centrally acting agents), as well as with insulin and other medications frequently 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 Initiation 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) 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 normally 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 other 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,
• sensation of rapid heartbeats (palpitations),
• severe 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 the blood vessels (vasculitis, Schonlein-Henoch purpura),
• numbness or tingling (paresthesia),
• fainting (syncope),
• rapid and irregular heartbeats (atrial fibrillation), stroke (cerebral stroke),
• liver inflammation (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 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 of 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 Medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storing 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 medications in the SIGRE point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Additional Information

Composition of Losartan Pensa

The active ingredient is losartan potassium.

Each Losartan Pensa 50 mg tablet contains 50 mg of losartan potassium.

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

Losartan Pensa 50 mg contains potassium in the following amount: 4.24 mg (0.108 mEq).

Losartan Pensa 50 mg tablets also contain hydroxypropylcellulose, hydroxypropylmethylcellulose, and titanium dioxide (E-171).

Appearance of the Product and Packaging Contents

Losartan Pensa 50 mg is supplied as white, film-coated tablets without scoring.

Losartan Pensa 50 mg is supplied in the following package sizes:

Aluminum-PVC/PE/PVDC blister pack, in packages 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 Last Review of this Prospectus:December 2024

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