LORISTA 50 mg. 28 tablets

WHAT LORISTA AND WHAT IT IS USED FOR?
Losartan belongs to a group of medicines known as angiotensin 11 receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. As a result, increases in blood pressure. Losartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels, and this in turn lowers the blood pressure. Losartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

LORISTA is used:
to treat patients with high blood pressure (hypertension) in adults and in children and adolescents 6-18 years.
protection of the kidney in hypertensive patients with type 2 diabetes with laboratory evidence of impaired renal function and proteinuria> 0,5 g per day (a condition in which urine contains an abnormal amount of protein).
to treat patients with chronic heart failure when therapy with specific medicines called angiotensin converting enzyme (ACE inhibitors - drugs used to lower blood pressure) is not considered suitable by your doctor. If your heart failure has been stabilized with an ACE inhibitor you should not be switched to losartan in patients with high blood pressure and a thickening of the left ventricle, losartan has been shown to decrease the risk of stroke (stroke) ("LIFE indication").

2. BEFORE YOU TAKE LORISTA
Do not take LORISTA
if you are allergic (hypersensitive) to losartan or to any of its ingredients, if your liver function is severely impaired,
if you are pregnant for more than 3 months (it is better to avoid LORISTA tablets in early pregnancy - see "Pregnancy and lactation").

Take special care with LORISTA
You should tell your doctor if you think you are (or might become) pregnant. LORISTA is not recommended in early pregnancy and must not be taken if you are pregnant more than three months, as it may cause serious harm to your baby if used at this stage (see "Pregnancy")

It is important to tell your doctor before taking LORISTA:
- If you have a history of angioedema (swelling of face, lips, throat and / or tongue) (see also section 4 "Possible Side Effects")
- 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 fluid in the kidneys) or are under dietary restriction of salt, leading to an extreme loss of fluid and salt in your body (see section 3 'Dosage in special patient groups'),
- If you are known to have narrowing or blockage of blood vessels leading to your kidneys or if you have recently had a kidney transplant,
- If your liver function is impaired (see sections 2 "Do not take LORISTA" and 3 'Dosage in special patient groups'),
- If you suffer from heart failure, with or without renal impairment or concomitant severe life threatening cardiac arrhythmias. Special attention should be paid when co-treated with B-blocker,
- If you have problems with your heart valves or heart muscle,
- If you suffer from coronary heart disease (caused by a reduced blood flow in the blood vessels of the heart) or from cerebrovascular disease (caused by a reduced blood circulation in the brain)
- 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).

Taking 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 natural products.
Take special care if you are taking the following medicines while being treated with Larissa
other medications to lower blood pressure, because they can further decrease blood pressure. Blood pressure can be lowered by one of the following drugs / class of drugs: tricyclic antidepressants, antipsychotics, baclofen, amifostine, medicines which retain potassium or may increase potassium levels (eg. Potassium supplements, potassium-containing salt substitutes or potassium sparing drugs, such as certain diuretics [amiloride, triamterene, spironolactone] or heparin), NSAIDs such as indomethacin, including COX-2 inhibitors (drugs that inhibit inflammation and may be used for the relief of pain), as they may reduce the effect of blood pressure reduction of losartan.
If your kidney function is impaired, the concomitant use 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. May be appropriate precautions (eg. Blood tests).

Taking LORISTA with food and drink
LORISTA may be administered with or without food.

Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine. pregnancy
You should tell your doctor if you think you are (or might become ') pregnant. Your doctor will normally advise you to stop taking LORISTA before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of LORISTA. LORISTA is not recommended in early pregnancy and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

breastfeeding
Tell your doctor if you are breastfeeding or about to start breast-feeding. LORISTA is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you want to breastfeed, especially if your baby is newborn, or was born prematurely.

Use in children and adolescents
Losartan has been studied in children. For more information you should consult with your doctor.
Driving and using machines
No studies on the effects on the ability to drive and use machines.
LORISTA is unlikely to affect your ability to drive or operate machinery. As with many other drugs, however, used to treat high blood pressure, losartan may cause some people experience dizziness or drowsiness. If you experience dizziness or drowsiness, you should consult your doctor before attempting such activities.
LORISTA contains lactose monohydrate. If you know by your doctor that you have an intolerance to some sugars, you should know before taking this medicine.

3. HOW TO TAKE LORISTA?
Always take LORISTA exactly as your doctor tells you. Your doctor will decide the appropriate dose of LORISTA, depending on your condition and whether you are taking other medicines. It is important to continue taking LORISTA for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.
LORISTA is available in the following concentrations: 12,5 mg, 25 mg, 50 mg and 100 mg.

Adult patients with high blood pressure
Treatment usually starts with 50 mg losartan (one tablet LORISTA 50 mg) once daily. Maximum effect on lowering blood pressure should be reached 3-6 weeks after starting treatment. In some patients the dose may later be increased to 100 mg losartan (two tablets LORISTA 50 mg) once daily. If you feel that the effect of losartan is too strong or too weak, please talk to your doctor or pharmacist.

Use in children and adolescents (6-18 years of age ")
The recommended starting dose in patients who weigh between 20 and 50 kg is 0,7 mg / kg once daily losartan accepted (up to 25 mg of LORISTA). The doctor may increase the dose if blood pressure is not controlled.

Adult patients with high blood pressure and type 2 diabetes
Treatment usually starts with 50 mg losartan (one tablet LORISTA 50 mg) once daily. The dose may later be increased to 100 mg losartan (two tablets LORISTA 50 mg) once daily depending on your blood pressure.
Losartan may be administered with other blood pressure lowering drugs (e. Diuretics, calcium channel blockers, alpha- or beta-blockers and drugs acting on the central nervous system), as well as insulin, and other drugs commonly used to lower blood glucose level (e. sulfonylureas, glitazones and glucosidase inhibitors).

Adult patients with heart failure
Treatment usually starts with 12,5 mg losartan once daily.
Generally, the dose should be gradually increased weekly (i.e. 12,5 mg daily for the first week, 25 mg daily for the second week, 50 mg daily for the third week, 100 mg daily for the fourth week, 150 mg daily during the fifth week) to support determined by your doctor. Can be used a maximum dose of 150 mg losartan (LORISTA naprlri tablets 50 mg or one tablet of LORISTA 100 mg LORISTA 50 mg) once daily.
In the treatment of heart failure, losartan is usually combined with a diuretic (medication that increases the amount of fluid secreted by the kidneys) and / or digitalis (medicine that helps to make the heart stronger and more efficient) and / or beta-blocker.

Dosage in special patient groups
The doctor may recommend a lower dose, especially when starting treatment in certain patients such as those treated with diuretics in high doses, in patients with hepatic impairment, or patients older than 75 years. The use of losartan is not recommended in patients with severe hepatic impairment (see section "Do not take LORISTA").

application
The tablets should be swallowed with a glass of water. You should try to take the tablets at the same time each day. It is important to continue to take LORISTA until your doctor tells you otherwise.

If you take more dose LORISTA
If you accidentally take too many tablets, or a child swallows some, contact your doctor immediately. Symptoms of overdose include low blood pressure, increased heartbeat, possibly decreased heartbeat.

If you forget to take LORISTA
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for forgotten tablet.
If you have any questions about using this product, consult your doctor.

4. POSSIBLE SIDE EFFECTS
Like all medicines, LORISTA can cause side effects, although not everybody gets them.
If you get such a reaction, stop taking losartan tablets and tell your doctor immediately or go to the emergency room of the 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.
Adverse drug reactions are classified as follows:
Very common: May occur in more than 1 in 10 patients
Common: may occur in 1 in 100 to 1 in 10 patients
Uncommon: may occur in 1 in 1,000 to 1 in 100 patients
Rare may occur in 1 in 10,000 to 1 in 1000 patients
Very rare: may occur in less than 1 in 10,000 patients
Not known: can not be estimated from the available data
The following adverse reactions have been reported with LORISTA:
Common: dizziness, dizziness, low blood pressure, weakness, fatigue, too low blood sugar (hypoglycaemia), too high level of potassium in your blood (hyperkalemia), changes in renal function, including renal failure, decreased red blood cells (anemia), elevation of blood urea, serum creatinine and serum potassium in patients with heart failure.

Uncommon: somnolence, headache, sleep disturbances, feeling of increased heart beat (palpitations), severe chest pain (angina), low blood pressure (especially after excessive loss of fluid from the circulating blood in the body, eg. In patients with severe heart failure or under treatment with high doses of diuretics), dose-related orthostatic effects such as lowering of blood pressure when rising from a lying or sitting position, shortness of breath (dyspnea), abdominal pain, persistent constipation, asthenia, fatigue, diarrhea, nausea, vomiting, hives (urticaria), itching (pruritus), rash, localized swelling (edema) cough.

Rare: angioedema hypersensitivity, inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura), numbness or tingling (paraesthesia), fainting (syncope),, very rapid and irregular heartbeat (atrial fibrillation) stroke (stroke), inflammation of the liver (hepatitis), elevated blood alanine aminotransferase (ALT), usually resolved upon discontinuation of treatment.
Not known: reduced number of platelets migraine, liver function abnormalities, muscle and joint pain, flu-like symptoms, back pain and urinary tract infection, increased sensitivity to the sun (photosensitivity), unexplained muscle pain with dark (like tea colored) urine (rhabdomyolysis), impotence, inflammation of the pancreas (pancreatitis), low sodium levels in the blood (hyponatraemia), depression, malaise (anxiety), ringing, buzzing, roaring, or clicking in the ears (tinnitus).

Adverse reactions in children are similar to those in adults.
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE LORISTA?
Keep out of the reach and sight of children.
Do not use LORISTA after the expiry date stated on the box after "EXP". The expiry date refers to the last day of the month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What LORISTA?
The active substance is losartan strap (losartan potassium). Each tablet contains 12,5 mg, 25 mg, 50 mg or 100 mg of losartan potassium, respectively equivalent to 11,4 mg, 22,9 mg, 45.8 mg and 91,5 mg losartan.
The other ingredients of LORISTA 12.5 mg / 25 mg: corn starch, pregelatinized corn starch, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, tselaktoza (cellulose and lactose monohydrate) in the tablet core and hypromellose, talc, propylene glycol, titanium dioxide (E 171) and quinoline yellow (E104) in the film coating.
The other ingredients of LORISTA 50 mg / 100 mgea: corn starch, prezhelatiniziratso with corn starch, microcrystalline cellulose, silica, colloidal anhydrous, magnesium stearate, tselaktoza (cellulose and lactose monohydrate) in the tablet core and hypromellose, talc, propylene glycol and titanium dioxide (E 171) in the film coating.