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PATIENT INFORMATION LEAFLET

Losartán SILANES 50 mg film-coated tablets

Read this leaflet carefully before you start taking this medicine because 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 or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Contents of the leaflet:

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

Losartan 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. Losartan prevents the binding of angiotensin II to these receptors, causing blood vessels to relax, which in turn reduces blood pressure. Losartan reduces the worsening of renal function in patients with high blood pressure and type 2 diabetes.

Losartan Silanes is used for

• to treat patients with elevated blood pressure (hypertension).
• to protect the kidney 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).
• 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 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 demonstrated that it reduces the risk of stroke (LIFE indication).

They should consult a doctor if it worsens or does not improve

Do not take Losartán Silanes

• if you are allergic (hypersensitive) to losartan or any of the other components of Losartán Silanes,
• if your liver function is severely damaged,
• if you are more than 3 months pregnant. (It is also best to avoid Losartán Silanes 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 aliskiren.

Warnings and precautions

Inform your doctor if you are pregnant (or if you suspect that you may be). Losartán Silanes is not recommended for use at the beginning of pregnancy, and in any case, it should not 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).

Consult your doctor before starting to take Losartán Silanes:

• 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 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 following a low-sodium diet that causes excessive loss of fluids or salt from your body (see section 3. Dosage in special patient groups),
• if you know that 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 altered (see sections 2. Do not take Losartán Silanes 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 at the same time with a beta-blocker,
• if you have problems with your heart valves or heart muscle,
• 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 aldosteronism (a syndrome associated with high secretion of the hormone aldosterone 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):
• • a converting enzyme inhibitor (ACEI) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren

Your doctor may monitor your renal function, blood pressure, and blood electrolyte levels (for example, potassium), at regular intervals.

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

Use of Losartán Silanes 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 Silanes, be particularly cautious if you are taking any of the following medications:

• other medications that lower blood pressure, as they may produce 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),
• non-steroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, including COX-2 inhibitors (medications that reduce inflammation and that may be used to relieve pain), as they may reduce the blood pressure-lowering effect of losartan.

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

Medications containing lithium 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).

Your doctor may need to adjust your dosage and/or take other precautions:

If you are taking an ACEI or aliskiren (see also the information under the headings “Do not take Losartán Silanes” and “Warnings and precautions”)

Taking Losartán Silanes with food and beverages

Losartán Silanes can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant (or if you suspect that you may be). Your doctor will usually recommend that you stop taking Losartán Silanes before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Losartán Silanes. Losartán Silanes is not recommended for use at the beginning of pregnancy, and in any case, it should not 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 are about to start. Losartán Silanes 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.

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 operating machinery

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

It is unlikely that Losartán Silanes will affect your ability to drive or use machines. 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.

Follow exactly the administration instructions for Losartán Silanes as indicated by your doctor. In case of doubt, consult your doctor again.

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

Hypertensive patients

Typically, treatment begins with 50 mg of losartan (one Losartán Silanes 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 (two Losartán Silanes 50 mg tablets) once a day.

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

Hypertensive patients with type 2 diabetes

Typically, treatment begins with 50 mg of losartan (one Losartán Silanes 50 mg tablet) once a day. Subsequently, the dose may be increased to 100 mg of losartan (two Losartán Silanes 50 mg tablets) 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 frequently used medications to reduce 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. Normally, 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 (one Losartán Silanes 50 mg tablet) once a day, depending on your condition.

In heart failure treatment, 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.

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 patients with severe liver insufficiency (see "Do not take Losartán Silanes").

Administration

Follow exactly the administration instructions contained in this leaflet or those indicated by your doctor. In case of doubt, consult your doctor.

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

If you take more Losartán Silanes 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.

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 Losartán Silanes

If you accidentally forget a dose, simply take the next dose normally. Do not take a double dose to compensate for the missed tablet.

If you interrupt treatment with Losartán Silanes

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Losartán Silanes can cause side effects, although not everyone will experience them.

If you experience any of the following, stop taking the losartan tablets and inform your doctor immediately or go to the emergency service 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.

Medication side effects are classified as follows:

Very common:Affects 1 in 10 patients.

Common:Affects 1 to 10 patients in 100.

Uncommon:Affects 1 to 10 patients in 1,000.

Rare:Affects 1 to 10 patients in 10,000.

Very rare:Affects fewer than 1 in 10,000 patients.

Unknown:The frequency 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 (hyperkalemia).

Uncommon:

• Drowsiness,
• Headache,
• Sleep disturbances,
• 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),
• Dose-related orthostatic effects, such as decreased blood pressure after standing up from lying or sitting,
• Difficulty breathing (dyspnea),
• Abdominal pain,
• Chronic constipation,
• Diarrea,
• 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),
• 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,
• Renal function changes (may be reversible when treatment is stopped), including kidney failure,
• Symptoms similar to the flu,
• Increased urea in the blood, creatinine, and plasma potassium in patients with heart failure,
• Back pain and urinary tract infection.

Reporting of side effects

If you experience any type of side effect, consult your doctor or 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 Medicinal Products for Human Use:www.notificaRAM.es.

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

Keep out of reach and sight of children.

Do not use Losartán Silanes 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 Silanes in the original packaging.

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

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of unused packaging and medicines. In this way, you will help protect the environment.

Composition of Losartán Silanes

The active ingredient of Losartán Silanes is losartan potassium.

Each Losartán Silanes 50 mg tablet contains 50 mg of losartan potassium.

The other components of the core are microcrystalline cellulose, stearate of sodium fumarate, sodium croscarmellose, and anhydrous colloidal silica.

Losartán Silanes 50 mg contains potassium in the following amount: 4.24 mg (0.108 mEq).

The other components of the coating are microcrystalline cellulose, hydroxypropylmethylcellulose, polyoxyl 40 stearate, and titanium dioxide (E171).

Appearance of the product and contents of the package

Losartán Silanes 50 mg is supplied as film-coated tablets, white, oval, biconvex, with a notch.

Losartán Silanes is supplied in the following package sizes:

PVC/PE/PVDC/Al blister pack, in packages of 28 film-coated tablets.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

SILANES I.D.F., S.L.

Calle Retamar, 11,

28043 Madrid

Spain

Responsible Manufacturer:

Sofarimex Lda.

Av. Indústrias, Alto do Colaride

Agualva 2735-213 Cacém – Portugal

Ó

Industrial and Pharmaceutical Company VIR, S.A.

C/ Laguna 66-68-70

Polígono Industrial Urtinsa II

28923 Alcorcón-Madrid (Spain)

This leaflet was approved in July 2017

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es