12.5 mg, 25 mg, 50 mg, 100 mg film-coated tablets
losartan potassium
What Losartan Mylan is and what it is used for
Losartan Mylan contains the active substance losartan which 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 type 2 diabetes.
Losartan Mylan is used:
- to treat patients with high blood pressure ( hypertension ) in adults and children and adolescents aged 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 Mylan may also be approved for the treatment of other conditions not mentioned in this product information. 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 take Losartan Mylan
Do not take Losartan Mylan:
- 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
- during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Losartan Mylan, see Pregnancy and breast-feeding)
- if you have diabetes or kidney problems and are being treated with a blood pressure lowering medicine containing aliskiren.
Warnings and cautions
Talk to your doctor or pharmacist before taking Losartan Mylan
- 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 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 Mylan” 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.
- if you are taking other medicines that may increase the concentration of potassium in your blood (see section 2 “Other medicines and Losartan Mylan”).
If you think you may be pregnant or become pregnant during treatment, consult your doctor. Losartan Mylan is not recommended in early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects, see Pregnancy and breastfeeding.
Children and young people
Losartan has been studied in children. Talk to a doctor for more information.
Losartan Mylan is not recommended for use in children with kidney or liver problems, as limited data are available in these patient groups.
Losartan Mylan is not recommended for use in children below 6 years of age, as it has not been shown to work in this age group.
Other medicines and Losartan Mylan
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 you are being treated with Losartan Mylan:
- other antihypertensive drugs as they can lower your blood pressure further. Blood pressure can also be lowered with any of the following drugs / drug group: tricyclic antidepressants, antipsychotics, baclofen, amifostine
- potassium-sparing medicines or medicines that increase potassium levels (potassium supplements, potassium-containing salt substitutes or potassium-saving medicines such as certain diuretics [amiloride, triamterene, spironolactone ] or other medicines that can increase the concentration of potassium in the blood (eg heparin or medicines containing trimethoprim) of these together with Losartan Mylan is not recommended.)
- 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 .
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 Mylan” and “Warnings and precautions”)
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.
Pregnancy and breastfeeding
Pregnancy
If you think you may be pregnant or become pregnant during treatment, consult your doctor. Your doctor will usually suggest that you stop taking Losartan Mylan before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Losartan Mylan 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.
Breast-feeding
Tell your doctor if you are breastfeeding or planning to start breastfeeding. Losartan Mylan is not recommended for breastfeeding and your doctor may choose another treatment for you if you want to breastfeed your baby, especially if your baby is newborn or born prematurely.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines:
No studies have been performed. Losartan Mylan 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. Description of these effects and side effects 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 Mylan 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 take Losartan Mylan
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will decide on the appropriate dose of Losartan Mylan, depending on your medical condition and whether you are taking other medicines.
You must continue to take Losartan Mylan according to your doctor’s prescription to maintain even control of your blood pressure.
Adult patients with high blood pressure
Treatment is usually started with 50 mg losartan (one Losartan Mylan 50 mg 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 of Losartan Mylan 50 mg) once daily.
If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.
Use for children and adolescents
Children under 6 years
Losartan Mylan is not recommended for use in children below 6 years of age, as it has not been shown to work in this age group.
Children aged 6 to 18 years
The recommended starting dose for patients weighing between 20 and 50 kg is 25 mg losartan once daily (up to a maximum of 50 mg losartan once daily). Your doctor may need to increase the dose in case of insufficient blood pressure control.
Other dosage forms of this medicine may be more suitable for children, consult a doctor or pharmacist
Adult patients with high blood pressure and type 2 diabetes
Treatment is usually started with 50 mg losartan (one Losartan Mylan 50 mg tablet ) once daily. Dose one can then be increased to 100 mg losartan (two tablets Losartan Mylan 50 mg) once daily depending on your blood pressure response.
Losartan Mylan 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).
Adult patients with heart failure
Treatment is usually started with 12.5 mg losartan (one Losartan Mylan 12.5 mg tablet ) 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 a maintenance dose determined by your doctor. A maximum dose of 150 mg losartan (eg three tablets Losartan Mylan 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/or digitalis (a medicine that helps the heart to function better and more efficiently) and/or a beta-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 Mylan”).
Administration
Losartan tablets should be swallowed with a glass of water. Try to take your daily dose at the same time each day. You must continue to take Losartan Mylan according to your doctor’s prescription.
Losartan Mylan can be taken with or without food.
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:
- Rash, itching , swelling of i.a. face, lips, mouth or throat that may cause difficulty swallowing and breathing. These may be signs of a severe allergic reaction including angioedema . This is a serious but rare side effect , which may affect up to 1 in 1,000 people.
- Unexplained muscle aches with dark (tea-colored) urine. These can be signs of muscle problems ( rhabdomyolysis ). This is a serious side effect but its frequency is not known (can not be calculated from the available data).
The following side effects have also been reported:
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
- decreased number of red blood cells ( anemia )
- low blood sugar ( hypoglycaemia )
- excess potassium in the blood ( hyperkalaemia )
- increase in urea in the blood
- increase in creatinine and potassium in the blood of patients with heart failure
- changes in kidney function including kidney failure which may cause changes in urination and pain in the lower back.
Uncommon (may affect up to 1 in 100 people):
- somnolence
- headache
- sleep disorders
- feeling that the heart is beating fast (palpitations)
- feeling of tightness in the chest or severe chest pain ( angina pectoris )
- shortness of breath ( dyspnoea )
- cough
- abdominal pain
- constipation
- diarrhea
- nausea
- vomiting
- hives ( urticaria )
- itching ( pruritus )
- rash
- local swelling ( edema ).
Rare (may affect up to 1 in 1,000 people):
- hypersensitivity
- inflammation of the blood vessels ( vasculitis including Henoch-Schönlein purpura)
- numbness or tingling ( paresthesia )
- fainting ( syncope )
- fast and irregular heartbeat ( atrial fibrillation )
- stroke
- liver inflammation ( hepatitis ) which may cause yellowing of the skin or eyes (jaundice)
- elevated alanine aminotransferase (S- ALAT ) levels, usually reversible after discontinuation of treatment.
No known frequency (can not be calculated from the available data):
- decreased platelet count
- ringing in the ears ( tinnitus )
- abnormal liver function
- increased sensitivity to sunlight ( photosensitivity )
- migraine
- taste disorder
- impotence
- Depression
- inflammation of the pancreas ( pancreatitis ) which can cause severe abdominal pain
- muscle and joint pain
- low levels of sodium in the blood detected by a blood test
- flu-like symptoms
- general malaise
- back pain and urinary tract infection.
The side effects in children are similar to the side effects in adult patients.
How to store Losartan Mylan
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 or jar after EXP. The expiration date is the last day of the specified month.
Store in the original package.
Do not open the blister pack until you are ready to take your medicine.
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 as losartan potassium
- Each tablet contains 12.5 mg, 25 mg, 50 mg or 100 mg of losartan potassium, corresponding to 11.44 mg, 22.88 mg, 45.76 mg and 91.52 mg of losartan, respectively .
- The other ingredients are lactose monohydrate (see section 2 “Losartan Mylan contains lactose”), pregelatinised starch , microcrystalline cellulose, magnesium stearate. The coating contains hydroxypropylcellulose, hypromellose, titanium dioxide E171 and brilliant blue E133 (12.5 mg tablets only).
What the medicine looks like and contents of the pack:
The film-coated tablet is round. The 12.5 mg tablet is blue and the 25 mg, 50 mg, 100 mg tablets are white.
Losartan Mylan tablets are available in blister packs of 7, 10, 14, 20, 21, 28, 28 ( calendar pack ), 30, 50 x 1, 56, 60, 84, 90, 98, 98 ( calendar pack ), 100, 210, 250, 280 and 500 tablets.
HDPE jars: 100 and 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Mylan AB, Box 23033, 104 35 Stockholm
08-555 227 50
08-555 227 51
inform@mylan.se
Manufacturer:
Liconsa , Avda. Miralcampo, No 7, Polígono Industrial Miralcampo, 19200 Azuqueca de Henares (Guadalajara) Spain
McDermott Laboratories to Gerard Laboratories , Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft. , Mylan utca 1., Komárom, H-2900, Hungary
This medicinal product is authorized under the European Economic Area under the names:
Belgium Losartan Mylan 12.5 mg, 25 mg, 50 mg, 100 mg film-coated tablets
Italy Losartan Mylan Generics 12.5 mg & 50 mg
Sweden Losartan Mylan 12.5 mg, 25 mg, 50 mg & 100 mg