12.5 mg, 50 mg, 100 mg film-coated tablets losartan
What Losartan Krka is and what it is used for
Losartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is a body-specific substance that binds to receptors in blood vessels and causes them to constrict. This causes the blood pressure to rise. Losartan prevents the binding of angiotensin II to these receptors, which causes the blood vessels to dilate and the blood pressure to drop. Losartan prevents further renal impairment in patients with high blood pressure and types 2 diabetes
Losartan Krka is used:
- to treat patients with high blood pressure ( hypertension ) in adults and in children and adolescents between 6-18 years.
- to protect the kidney in patients with high blood pressure and type 2 diabetes who have laboratory values indicating renal impairment and proteinuria ≥0.5 g / day (a condition in which the urine contains abnormal amounts of protein)
- to treat patients with chronic heart failure , when treatment with specific drugs called ACE inhibitors (antihypertensive drugs) is not considered appropriate by your doctor. If your heart failure is stabilized with an ACE inhibitor , you should not switch to losartan
- to treat patients with high blood pressure and a thickening of the heart wall. Losartan has been shown to reduce the risk of stroke (“LIFE indication”).
Losartan contained in Losartan Krka may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Losartan Krka
Do not use Losartan Krka
- if you are allergic to losartan or any of the other ingredients of this medicine (listed in section 6).
- if you have severe hepatic impairment
- if you are pregnant during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Losartan Krka, see Pregnancy and breast-feeding).
- if you have diabetes or renal impairment and are being treated with a blood pressure lowering medicine containing aliskiren
Warnings and cautions
Talk to your doctor or pharmacist before taking Losartan Krka.
If you think you may be pregnant (or become pregnant) during treatment, consult your doctor. Losartan Krka is not recommended during early pregnancy and should not be used during the last 6 months of pregnancy as it may cause serious harm to your baby (see Pregnancy and breast-feeding).
- if you have a history of angioedema (swelling of the face, lips, throat and / or tongue) (see also section 4; Possible side effects )
- if you have been sick with severe vomiting or diarrhea, which has caused severe salt and / or dehydration
- if you are being treated with diuretics (medicines that increase the excretion of urine from your kidneys) or eat a low-salt diet which can lead to severe salt and fluid loss (see section 3; Dosage in special patient groups)
- if you have a narrowing or blockage in the blood vessels leading to your kidneys or if you have recently had a kidney transplant
- if you have impaired liver function (see section 2; Do not take Losartan Krka, and section 3; Dosage in special patient groups)
- if you suffer from heart failure with or without impaired kidney function or at the same time severe life-threatening cardiac arrhythmia . Particular caution should be exercised if you are being treated with a β-blocker at the same time
- if you have problems with your heart valves or your heart muscle
- if you suffer from coronary heart disease (caused by a decrease in blood flow in the blood vessels of the heart) or from cerebrovascular disease (caused by a decrease in blood circulation in the brain)
- if you suffer from primary hyperaldosteronism (a syndrome in which your adrenal glands produce too much of the hormone et aldosterone , caused by a disorder of the adrenal gland).
- if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (eg enalapril , lisinopril, ramipril), especially if you have diabetes-related kidney problems.
- aliskiren
Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.
See also the information under the heading “Do not take Losartan Krka”.
Children and young people
Losartan has been studied in children. Ask your doctor for more information.
Other medicines and Losartan Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important to tell your doctor if you are taking any of the following medicines while taking Losartan Krka:
other antihypertensive drugs as they can lower your blood pressure further. Blood pressure can also be lowered with any of the following drugs/drug groups: tricyclic antidepressants, antipsychotics, baclofen, amifostine
potassium-sparing drugs, or drugs that increase potassium levels (potassium supplements, potassium-containing salt substitutes, or potassium-sparing drugs such as certain diuretics (amiloride, triamterene, spironolactone ) or heparin )
non-steroidal anti-inflammatory drugs such as indomethacin, including COX-2 inhibitors (medicines for inflammation and pain) as they may reduce the antihypertensive effect of losartan If you have renal impairment, concomitant use of these drugs may lead to impaired renal function. Medicines containing lithium should not be used in combination with losartan without close monitoring by your doctor. Special precautions (eg blood tests) may be appropriate.
Your doctor may need to change your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Losartan Krka” and “Warnings and precautions”).
Losartan Krka with food, drink and alcohol
Losartan Krka can be taken with or without food.
Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
If you think you may be pregnant (or become pregnant) during treatment, consult your doctor. Usually, your doctor suggests that you stop taking Losartan Krka before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Losartan Krka should not be used in early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects.
Breastfeeding
Tell your doctor if you are breastfeeding planning to start breastfeeding Breastfeeding of a newborn baby, especially premature babies, is not recommended when using Losartan Krka.
Driving and using machines
No studies have been performed. Losartan Krka is not expected to affect your ability to drive or use machines. However, keep in mind that, as with many other medicines used to treat high blood pressure losartan may cause dizziness and drowsiness in some patients. If you experience dizziness or drowsiness, consult your doctor before performing any of these activities.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Losartan Krka contains excipients
This medicine contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Losartan Krka
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Your doctor will decide on the appropriate dose of Losartan Krka, depending on your medical condition and whether you are taking other medicines. you must continue to take Losartan Krka according to your doctor’s prescription to maintain even control of your blood pressure
Losartan Krka is available in strengths of 12.5 mg, 50 mg, and 100 mg.
Adult patients with high blood pressure
Treatment is usually started with 50 mg losartan (one 50 mg Losartan Krka tablet ) once daily. The maximum blood pressure-lowering effect is achieved within 3-6 weeks after starting treatment. In some patients, the dose may then be increased to 100 mg losartan (two tablets Losartan Krka 50 mg, or one tablet Losartan Krka 100 mg) once daily.
If you have the impression that the effect of losartan is too strong or too weak, talk to your doctor or pharmacist.
Adult patients with high blood pressure and type 2 diabetes
Treatment is usually started with 50 mg losartan (one 50 mg Losartan Krka tablet ) once daily. Dose one can then be increased to 100 mg losartan (two tablets Losartan Krka 50 mg, or one tablet Losartan Krka 100 mg) once daily depending on your blood pressure response.
Losartan tablets can be given with other antihypertensive drugs (eg diuretics calcium channel blockers, alpha- or beta-blockers, and centrally acting drugs) as well as with insulin and other commonly used drugs that lower blood glucose levels (eg sulphonylureas, glitazones, and glucosidase inhibitors).
Adult patients with heart failure
Treatment is usually started with 12.5 mg losartan (one tablet Losartan Krka 12.5 mg) once daily. Depending on your condition, the dose should be increased step by step, weekly (ie 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week, 100 mg daily during the fourth week 150 mg daily for the fifth week), up to the usual maintenance dose determined by your doctor. A maximum dose of 150 mg losartan (eg three tablets Losartan Krka 50 mg or one tablet of both Losartan Krka 100 mg and Losartan Krka 50 mg) once daily can be used.
In the treatment of heart failure, losartan is often combined with a diuretic (a medicine that increases the excretion of urine from your kidneys) and/digitalis (a medicine that helps the heart to function better and more efficiently) and/or β-blocker.
Dosage in special patient groups
Your doctor may prescribe a lower dose especially for initial treatment in some patients, such as in patients treated with high-dose diuretics, in patients with hepatic impairment, or patients over 75 years of age. The use of losartan is not recommended in patients with severe hepatic impairment (see section: Do not take Losartan Krka).
Administration
The tablets should be swallowed together with a glass of water. Try to take your daily dose at the same time each day. you must continue to take Losartan Krka according to your doctor’s prescription
Use for children and adolescents
Use for children and adolescents (6-18 years)
The recommended starting dose for patients with a body weight of 20-50 kg is 0.7 mg losartan/body weight once daily (maximum 25 mg losartan ). If the desired blood pressure effect is not achieved, the doctor may increase the dose one.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following, stop taking losartan tablets and talk to your doctor immediately or seek medical attention:
A severe allergic reaction (rash, itching swelling of the face, lips, mouth, or throat, which can cause difficulty swallowing and breathing).
This is a serious but rare side effect affecting more than 1 in 10,000 people and less than 1 in 1,000 users. You may need emergency medical care or hospitalization.
The following side effects have been reported with losartan:
Common (may affect up to 1 in 10 people)
- dizziness
- low blood pressure (especially after severe fluid loss from the body, eg in patients with severe heart failure or during treatment with high-dose diuretics)
- dose- related orthostatic effects such as a drop in blood pressure when getting up quickly from a lying or sitting position
- impotence
- fatigue
- low blood sugar ( hypoglycaemia )
- excess potassium in the blood ( hyperkalaemia ).
- change in renal function including renal failure
- decreased number of red blood cells ( anemia )
- increase in blood urea, serum creatinine and serum potassium in patients with heart failure
Uncommon (may affect up to 1 in 100 people)
- somnolence
- headache
- sleep disorders
- feeling that the heart is beating fast (palpitations)
- severe chest pain ( angina pectoris )
- shortness of breath ( dyspnoea )
- abdominal pain
- constipation
- diarrhea
- nausea
- vomiting
- hives ( urticaria )
- itching ( pruritus )
- rash
- swelling ( edema )
- cough
Rare (may affect up to 1 in 1,000 people)
- hypersensitivity
- angioedema
- inflammation of the blood vessels ( vasculitis including Henoch-Schönlein purpura)
- numbness or tingling
- fainting
- fast and irregular heartbeat ( atrial fibrillation )
- stroke
- inflammation of the liver ( hepatitis )
- elevated alanine aminotransferase ( ALT ) levels in the blood, usually reversible after discontinuation of treatment.
Has been reported (occurs in an unknown number of users)
- decreased platelet count
- migraine
- abnormal liver function
- muscle and joint pain
- flu-like symptoms
- back pain and urinary tract infection
- increased sensitivity to the sun ( photosensitivity )
- unexplained muscle pain with dark (tea-colored) urine ( rhabdomyolysis )
- impotence
- pancreatitis ( pancreatitis )
- low levels of sodium in the blood ( hyponatremia )
- Depression
- general malaise
- ringing, buzzing, throbbing or clicking in the ears ( tinnitus )
- altered sense of taste ( dysgeusia )
The side effects in children are similar to the side effects in adults.
How to store Losartan Krka
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Polyethylene (HDPE) tablet jar with safety-sealed polypropylene closure
Losartan Krka 12.5 mg: The product should be used within 250 days of fthe irst opening.
Losartan Krka 100 mg: The product should be used within 100 days of fthe irst opening.
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.
Contents of the package and other information
Content declaration
- The active substance is losartan potassium. One film-coated tablet contains 12.5 mg, 50 mg or 100 mg of losartan potassium, equivalent to 11.4 mg, 45.8 mg or 91.6 mg of losartan .
- The other ingredients in Losartan Krka 12.5 mg are maize starch , pregelatinised starch , microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, cell lactose (a mixture of cellulose and lactose monohydrate ) in the tablet core and hypromellose, talc, propylene glycol17 (propylene glycol1) E104) in the film coating.
- The other ingredients of Losartan Krka 50 mg and Losartan Krka 100 mg are maize starch , pregelatinised starch , microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, cell lactose (a mixture of cellulose and lactose monohydrate ) in the tablet core and hypromellose (E1), propylene glycol, talc, talc the film coating.
What the medicine looks like and contents of the pack
Losartan Krka 12.5 mg: oval, convex, yellow film-coated tablets
Losartan Krka 50 mg: round, convex, white film-coated tablets with bbevelededges and a notch on one side. The notch is not intended for splitting the tablet.
Losartan Krka 100 mg: oval, convex, white film-coated tablets.
Blister (PVC / PVDC blister with transparent foil with aluminum foil as cover, cardboard)
Losartan Krka 12.5 mg: 7, 10,14, 15, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112 film-coated tablets.
Losartan Krka 50 mg: 10, 14, 15,20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112 film-coated tablets.
Losartan Krka 100 mg: 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98,100, 112 film-coated tablets.
Polyethylene (HDPE, white) tablet jar with polypropylene closure. Polyethylene drying capsule filled with silica gel
Losartan Krka 50 mg: 250 film-coated tablets, in a carton.
Polyethylene (HDPE, white) tablet jar with safety-sealed polypropylene closure
Losartan Krka 12.5 mg: 250 film-coated tablets, in a carton.
Losartan Krka 100 mg: 100 film-coated tablets, in a carton.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer
KRKA dd Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany