LOSARTAN SILANES 50 mg FILM-COATED TABLETS

Contents of the prospectus

1. What Losartan Silanes is and what it is used for
2. What you need to know before starting to take Losartan Silanes
3. How to take Losartan Silanes
4. Possible side effects
5. Storage of Losartan Silanes
6. Package contents and additional information

1. What is LOSARTAN SILANES and what is it used for

Losartan belongs to a group of medications 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 causes an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, which causes the blood vessels to relax, thereby decreasing blood pressure. Losartan reduces the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Losartan Silanes 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 situation 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).

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

2. BEFORE TAKING LOSARTÁN SILANES

Do not take Losartán Silanes

• if you are allergic (hypersensitive) to losartan or to any of the other components of Losartán Silanes,
• if your liver function is seriously damaged,
• if you are pregnant for more than 3 months. (It is also best to avoid Losartán Silanes during the first months of pregnancy – see the Pregnancy section).
• if you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.

Warnings and precautions

Tell your doctor if you are pregnant (or if you suspect you may be). Your doctor will generally advise you to 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 during 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 the Pregnancy section).

Consult your doctor before starting to take Losartán Silanes:

• 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. Posology 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 altered (see sections 2. Do not take Losartán Silanes and 3. Posology in special patient groups),
• if you have heart failure with or without kidney failure or potentially life-threatening cardiac arrhythmias. Special attention is necessary when being treated at the same time with a beta-blocker,
• if you have problems with the valves of 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 an alteration of this gland).
• if you are taking any of the following medications 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

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 Silanes”.

Use of Losartán Silanes with other medications

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

While being treated with Losartán Silanes, 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 that may increase potassium levels (e.g., potassium supplements, salt substitutes that contain 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 that may be used to relieve pain), as they may decrease the blood pressure-lowering effect of losartan.

If your kidney function is impaired, concomitant use of these medications may cause worsening of 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 precautions (e.g., blood tests).

Your doctor may need to modify 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 Losartán Silanes” and “Warnings and precautions”)”

Taking Losartán Silanes with food and drinks

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 you may be). Your doctor will generally 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 during 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. Losartán Silanes 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 Losartán Silanes will affect your ability to drive or use machines. However, like 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.

3. HOW TO TAKE LOSARTÁN SILANES

Follow your doctor's instructions for taking Losartán Silanes exactly. If you are in doubt, consult your doctor again.

Your doctor will decide 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 control of your blood pressure.

Patients with high blood pressure

Normally, treatment starts 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. After that, in some patients, the dose may be increased to 100 mg of losartan (2 Losartán Silanes 50 mg tablets) once a day.

If you think 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

Normally, treatment starts with 50 mg of losartan (one Losartán Silanes 50 mg tablet) once a day. After that, the dose may be increased to 100 mg of losartan (2 Losartán Silanes 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 medications with central action), 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 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 (1 Losartán Silanes 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 the section "Do not take Losartán Silanes").

Administration

Follow the administration instructions for the medication contained in this prospectus or as indicated by your doctor. In case of doubt, consult your doctor.

The tablets should be taken with a glass of water. You should try to take your daily dose at approximately the same time every day. It is essential to 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. 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 or nurse 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 as usual. Do not take a double dose to make up 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.

4. POSSIBLE SIDE EFFECTS

Like all medications, Losartán Silanes can cause side effects, although not everyone will experience 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, which affects 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: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 less than 1 patient in 10,000.

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 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 blood vessels (vasculitis, Schonlein-Henoch purpura),
• numbness or tingling (paresthesia),
• fainting (syncope),
• rapid and irregular heartbeats (atrial fibrillation), stroke (cerebrovascular accident),
• liver inflammation (hepatitis),

and elevation of alanine aminotransferase (ALT) levels in blood, which usually resolves upon discontinuation of treatment.

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 plasma levels in patients with heart failure,
• back pain and urinary tract infection.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es.

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

5. STORAGE OF LOSARTAN SILANES

Keep out of the 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 its original packaging.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Losartan Silanes

The active ingredient of Losartan Silanes is potassium losartan.

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

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

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

The other coating components are microcrystalline cellulose, hydroxypropyl methylcellulose, polyoxyethylene 40 stearate, and titanium dioxide (E171).

Appearance of the product and packaging content

Losartan Silanes 50 mg is supplied as film-coated tablets, white, oval, and biconvex with a score.

Losartan Silanes is supplied in the following package sizes:

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

Marketing authorization holder and manufacturer

Marketing Authorization Holder:

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

Retamar Street, 11,

28043 Madrid

Spain

Manufacturer:

Sofarimex Lda.

Industries Avenue, Alto do Colaride

Agualva 2735-213 Cacém – Portugal

Or

Chemical and Pharmaceutical Industry VIR, S.A.

Laguna Street 66-68-70

Urtinsa II Industrial Estate

28923 Alcorcón-Madrid (Spain)

This leaflet was approved in July 2017

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