el-GRen-US

 

Name of the medicinal product: LYOSAN

Content: Each film coated tablet contains 100 mg of Losartan potassium

Pharmaceutical Form: Film-coated tablets

Pharmacotherapeutic group: Angiotensin II receptor antagonists

Packaging Description: Carton containing 30 film-coated tablets placed in PVC / Aluminium blisters.

LYOSAN is cerebral circulation improver.
Losartan belongs to a class of medicines known as "angiotensin II receptor antagonists".
Angiotensin II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This leads to an increase in blood pressure. Losartan prevents the binding of angiotensin II to these receptors, causing relaxation of blood vessels, which lowers blood pressure. Losartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
The LYOSAN indicated for:
  • treating patients with high blood pressure (hypertension).
  • protecting the kidney in hypertensive patients with type 2 diabetes with bad renal function evidenced by laboratory parameters and proteinuria ≥ 0.5 g per day (a condition in which urine contains an abnormal amount of protein).
  • the treatment of patients with chronic heart failure when therapy with specific medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors, a medicine used to lower high blood pressure) is not considered suitable by your doctor. If heart failure has been stabilized with an ACE inhibitor, should not change the treatment in losartan. In patients with high blood pressure and thickening of the left ventricle it has been described that the LYOSAN reduces the risk of stroke (indicator "LIFE").

Do not take LYOSAN:

  • if you are allergic (hypersensitive) to losartan or to any other component
  • if you have severe hepatic impairment is not recommended concomitant administration of nimodipine orally and antiepileptics.
  • if you are, you think or plan to become pregnant (see also "Pregnancy and lactation")
  • if you are breast-feeding
  • if you have diabetes or impaired kidney function and you are treated with a drug that lowers blood pressure and containing aliskiren.
Take special care with LYOSAN:
It is important to tell your doctor before taking LYOSAN
  • if you have a history of swelling of the face, lips, throat and / or tongue, if you suffer from excessive vomiting or diarrhea leading to an extreme loss of fluid and / or salt in your body.
  • if you receive diuretics (medicines that increase the amount of water excreted through the kidneys) or are on a diet to reduce the salt, which leads to great loss of fluid and salt from your body.
  • if you have a narrowing or blockage of the blood vessels that lead to the kidneys or recently have had a kidney transplant.
  • if you have heart failure with or without renal impairment or life-threatening cardiac arrhythmias. Particular care is required when a beta blocker is also administered.
  • if you have problems with the heart valves or the heart muscles.
  • if you suffer from coronary heart disease (caused by a reduced blood flow in the blood vessels of the heart) or cerebrovascular disease (caused by decreased blood flow to the brain).
  • if you have had gout.
  • if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality within the gland).
  • if you are taking, any of the following medicines used to treat high blood pressure:
    • an ACE inhibitor (for example enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
    • alisikren
Your doctor may check your kidney function, your blood pressure and the amount of electrolytes (eg potassium) in your blood at regular intervals.

Taking / using other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. including medicines obtained without a prescription or herbal medicines and natural products. In particular, pay attention if you are taking any of the following drugs when you are treated with LYOSAN:

  • other medicines that lower blood pressure because they may further reduce blood pressure. Blood pressure can also be reduced by the following drugs: tricyclic antidepressants, antipsychotics, baclofen, amifostine
  • drugs that maintain or may increase potassium levels (eg potassium supplements, potassium-containing salt substitutes or medicines which retain potassium. such as certain diuretics (amiloride, triamterene, spironolactone or heparin)
  • nonsteroidal antiinflammatory drugs such as indomethacin, including cox 2- inhibitors (drugs that reduce inflammation, and are used in pain relief), because it can reduce the effect of losartan pressure reduction
  • If you have kidney dysfunction, concomitant administration of these drugs can lead to worsening of renal function
  • Lithium containing medicines should not be taken in combination with losartan without close supervision by your doctor. It is likely to require specific precautionary measures (eg blood tests)
  • Your doctor may need to change the dose of these other medicines or take other precautions
  • If you are taking an ACE-inhibitor or aliskiren
Taking LYOSAN with food and drink:
The LYOSAN can be taken with or without food.

Pregnancy and breast-feeding:
It would be better to not take losartan in the first 12 weeks of pregnancy and should not take them at all after the 13th week as their use during pregnancy may be harmful to the baby. If you become pregnant while on losartan, tell your doctor immediately. A switch to a suitable alternative treatment can be selected in advance of a planned pregnancy. You should not take losartan if you are breast feeding. Consult your doctor or pharmacist before taking any medicine.
Use in children and adolescents:
Losartan has been studied in children. For more information, contact your doctor.

Driving and using machines:
No studies on the effects on the ability to drive and use machines. LYOSAN is not likely to affect the ability to drive and use machines. However, as with many other medicines used to treat high blood pressure, losartan may cause some people feel dizzy or drowsy. If you experience dizziness or drowsiness should contact your doctor before attempting such activities.

Important information about some of the ingredients of LYOSAN:
LYOSAN contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Like all medicines, LYOSAN can cause side effects, although not everybody gets them. If you experience the following, stop taking losartan tablets and immediately contact your doctor or go to the first aids of your nearest hospital.
A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing). This is a serious but rare side effect, which affects more than 1 in 10,000 patients but less than 1 in 1000 patients. You may need urgent medical attention or hospitalization.
The following adverse reactions have been reported with LYOSAN:
Common (occurring in 1 in 100 to 1 in 10 patients):
  • dizziness
  • low blood pressure
  • weakness
  • weariness
  • very little amount of blood sugar (hypoglycemia)
  • too much potassium in the blood (hyperkalemia)

Uncommon (occurring in 1 in 1,000 to 1 in 100 patients):
  • drowsiness
  • headache
  • sleep disorders
  • feeling of increased heart rate (palpitations)
  • severe chest pain (angina)
  • low blood pressure (especially after the significant water loss from the body blood vessels eg in patients with severe heart failure or under treatment with high doses of diuretics)
  • dose-related orthostatic effects such as lowering blood pressure that occurs when someone gets up from a lying position or sitting position
  • rapid breathing (dyspnoea)
  • stomachache
  • persistent constipation
  • diarrhea
  • nausea
  • vomiting
  • hives (urticaria)
  • κνησμός
  • rash
  • localized swelling

Rare (occurring in 1 in 10,000 to 1 in 1000 patients):
  • inflammation of blood vessels (vasculitis including immovable purple Henoch Schoenlein)
  • tingling or numbness (paraesthesia)
  • fainting (syncope)
  • very fast or abnormal heart rhythm (atrial fibrillation), stroke
  • liver inflammation (hepatitis)
  • elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of therapy

Not known (can not be estimated from the available data):
  • reduced number of red blood cells (anemia)
  • reduced number of thrombocytes
  • migraine
  • cough
  • abnormal liver function
  • muscle and joint pain
  • changes in kidney function (may be reversible upon discontinuation of treatment) including kidney failure
  • sympoms similar to those of influenza
  • an increase in blood urea, serum creatinine and serum potassium in patients with heart failure
  • back pain and urinary tract infection

If any of the side effects gets serious, or if you notice any side effects not listed , please tell your doctor or pharmacist.
Reporting of suspected adverse reactions:

The reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

What's in LYOSAN:
The active substance is losartan potassium.
Each tablet LYOSAN 50 mg containing 50 mg losartan potassium.
Κάθε δισκίο LYOSAN 100 mg περιέχει 100 mg losartan potassium.

The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate and magnesium stearate.
Coating: hypromellose 6 cps, macrogol 400, titanium dioxide Cl 77891 E171,iron oxide yellow Cl77492 E172,yellow lake No.6 E110, Lactose Monohydrate