LOSAR-DENK 50 Tablet

Losar-Denk 50 is used:

- in the treatment of patients with high blood pressure (hypertension).

- to protect the kidneys of patients with high blood pressure and type-2 diabetes mellitus along with impaired kidney function proven by blood tests, with a urinary protein excretion of ≥0.5g/day (this disease is associated with pathologically high amounts of urinary protein).

- in the treatment of patients with heart failure when your doctor believes that treatment with ACE inhibitors (angiotensin conversion enzyme inhibitor which is a blood pressure reducing agent) is unsuitable. You should not be switched to treatment with losartan if your heart failure is stable with ACE inhibitors.

- in the treatment of patients with high blood pressure and left ventricular wall thickening. Losar-Denk 50 reduces the risk of stroke.

Dosage

Patients with high blood pressure

50mg once a day.

The maximum antihypertensive effect is achieved 3-6 weeks after treatment is initiated.

In some patients this dose may later be increased to 100mg losartan once a day.

Please talk to your doctor if you have the impression that the effect of losartan is too strong or too weak.

Patients with high blood pressure and type-2 diabetes mellitus

The usual initial dose is 50mg losartan once a day.

The dose may later be increased to 100mg losartan once a day depending on your blood pressure response.

Losartan tablets may be taken with other antihypertensive drugs, such as diuretics, calcium antagonists, alpha or beta blockers as well as central antihypertensive agents and also with insulin and other commonly used antidiabetic agents, such as sulfonylureas, glitazones and glucosidase inhibitors.

Patients with heart failure

The usual initial dose is 12.5mg once a day.

In general, the dose should be increased gradually on weekly bases (i.e. 12.5mg daily during the first week, 25mg daily during the second week, 50mg daily during the third week) up to the common maintenance dose of 50mg losartan daily depending on your condition.

For treatment of heart failure, losartan is usually administered with a diuretic (water pill to increase the amount of urine excreted via the kidneys) and/or digitalis and/or a beta blocker.

Dosage in special patient groups

The doctor may recommended a lower dose, particularly at the beginning of treatment, in patients receiving high doses of diuretics, in those with impaired liver function or in patients older than 75 years. The use of losartan is not recommended in patients with severe liver impairment.

Children and adolescents: See the package insert about the details.

Mode of administration

The tablets should be swallowed with a glass of water.

Try to take Losar-Denk 50 at the same time every day. It is important to continue taking Losar-Denk 50 until instructed otherwise by your doctor.

- if you are hypersensitive (allergic) to losartan or any of the other ingredients,

- if your liver function is seriously impaired,

- if you are pregnant or breast-feeding,

- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

If you experience the following symptoms, stop taking Losar-Denk 50 and inform your doctor immediately or go to the accident and emergency department of your nearest hospital: A severe allergic reaction that may cause rash, itching, swelling of the face, lips, mouth or throat that may be associated with difficulty swallowing or labored breathing.

Common:

- dizziness,

- low blood pressure,

- weakness,

- fatigue,

- abnormally low blood sugar (hypoglycaemia),

- increased potassium level in the blood (hyperkalaemia).

Uncommon:

- somnolence,

- headache,

- sleep disorders,

- palpitations or rapid heartbeat,

- severe pain and constricting feeling in the chest (angina pectoris),

- low blood pressure (particularly after severe volume depletion, e.g. in patients suffering from severe heart failure or receiving treatment with high doses of water pills),

- dose-related orthostatic effects, such as fall in blood pressure or circulatory complaints when you stand up after lying down or sitting,

- shortness of breath( dyspnoea),

- stomach pain,

- constipation,

- diarrhoea,

- nausea,

- vomiting,

- hives (urticaria),

- itching (pruritus),

- rash, restricted swelling on certain areas of the body (oedema).

Rare:

- inflammation of the vessels (angiitis, including Henoch-Schoenlein purpura),

- numbness or prickling (paresthesias),

- blackout (syncope),

- rapid heartbeat and arrhythmias (e.g. atrial fibrillation),

- stroke,

- inflammation of the liver (hepatitis),

- increased levels of alanine aminotransferase (ALT) in the blood. This usually recedes after treatment has been discontinued.

Not known:

- reduction in the number of red blood cells (anaemia),

- reduction in the number of platelets (thrombocytopenia),

- migraine,

- cough,

- impaired liver function,

- muscle and joint pain,

- impaired kidney function (may subside after treatment has been discontinued) including kidney failure,

- flu-like symptoms,

- increases in blood urea,

- increases in serum creatinine and serum potassium in patients with heart failure,

- back pain,

- urinary tract infections.

You should be particularly careful when taking any of the following medicines at the same time as Losar-Denk 50:

- other medicines to treat high blood pressure, as they may cause your blood pressure to drop even further. Your blood pressure to may also be reduced by one of the following medicines/classes of drugs: tricyclic antidepressants, antipsychotic agents, baclofen, amifostine.

- medicines that retain the potassium in your body or increase potassium levels in your blood (e.g. potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines, such as certain diuretics [water pills: amiloride, spironolactone, triamterene] or heparin).

- NSAIDs, such as indomethacine, including COX-2 inhibitors (anti-inflammatory drugs or painkillers), as they may reduce the antihypertensive effect of losartan.

If you have impaired kidney function, using these medicines may cause further deterioration of our kidney function.

Preparations containing lithium should not be taken with losartan without close medical supervision. Special precautionary measures (e.g. blood tests) may be appropriate.

Your doctor may need to change your dose and/or to take other precautions:

If you are taking an ACE-inhibitor or aliskiren.

Contraindicated: see the package insert about the details.

Consult your doctor before taking Losar-Denk 50

- if you have ever suffered from angioedema (hypersensitivity reaction manifested by swelling of the face, lips, throat and/or tongue),

- if you have severe vomiting or diarrhoea associated with severe volume and/or salt depletion of your body,

- if you are taking diuretics (water pills that increase the amount of urine excretion via the kidneys) or if you are on a low salt diet that may cause severe volume and salt depletion of your body,

- if the arteries to your kidneys are narrow or blocked (renal artery stenosis) or if you have recently undergone a kidney transplant,

- if you suffer from liver impairment,

- if you have heart failure with or without renal impairment or severe life threatening arrhythmias. Particular caution is required if you are also taking beta blockers,

- if you suffer from a heart value or heart muscle disorder,

- if you have coronary artery disease (caused by insufficient blood flow to the brain),

- if you suffer from primary hyperaldosteronism (a disease associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality of the adrenal gland),

- if you are taking any of the following medicines used to treat high blood pressure:

- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.

- aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

Losartan belongs to a class of drugs known as angiotensinⅡreceptor antagonists. The substance angiotensinⅡis formed in your body and binds to receptors in the blood vessels making them narrower. This causes your blood pressure to rise. Losartan prevents angiotensinⅡfrom binding to these receptors so that the blood vessels can relax and your blood pressure drops. Losartan slows down renal impairment in patients with high blood pressure and type-2 diabetes.

Pharmacotherapeutic group: AngiotensinⅡreceptor antagonist

Losartan is a synthetically produced oral angiotensinⅡreceptor (AT1 type) antagonist.

AngiotensinⅡ, a potent vasoconstrictor, is the primary active hormone of the renin-angiotensin system and an important determinant of the pathophysiology of hypertension. AngiotensinⅡbinds to the AT1 receptor present in many tissues (i.e. smooth vascular muscle, adrenal gland, kidneys and heart) and elicits important biological effects, such as vasoconstriction and the release of aldosterone for example. AngiotensinⅡalso stimulates smooth muscle cell proliferation.

Losartan selectively blocks the AT1 receptor. Losartan and its pharmacologically active carboxylic acid metabolite E-3174 block all physiologically relevant effects of angiotensinⅡin vitro and in vivo, regardless of its source or route of its synthesis.