12.5 mg film-coated tablets
losartan potassium
What Losartan Teva 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 type 2 diabetes.
Losartan Teva is used:
- to treat 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 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 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 Teva may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you take Losartan Teva
Do not take Losartan Teva
- 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 Teva, see section 2; 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, pharmacist, or nurse before taking Losartan Teva.
If you think you may be pregnant or become pregnant during treatment, consult your doctor. Losartan Teva is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects (see section 2; Pregnancy and breastfeeding).
It is important to tell your doctor before starting treatment with Losartan Teva:
- if you have a history of angioedema (swelling of the face, lips, throat and / or tongue) (see 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 Teva, 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 Teva”).
Children and young people
Losartan has been studied in children. For more information, talk to your doctor.
Losartan Teva is not recommended for children with kidney or liver problems, or children under 6 years of age, as limited data are available in these patient groups.
Other medicines and Losartan Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you are taking potassium supplements, salt substitutes containing potassium, potassium-sparing medicines such as certain diuretics (amiloride, triamterene, spironolactone ), or other medicines that may increase the concentration of potassium in your blood (eg heparin or medicines containing trimethoprim), as use of these together with Losartan Teva is not recommended.
Take special care with any of the following medicines while you are being treated with Losartan Teva:
- 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
- non-steroidal anti-inflammatory drugs such as indomethacin, including COX-2 inhibitors (anti- inflammatory and analgesic drugs ) 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 Teva” 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.
Losartan Teva with food and drink
Losartan Teva can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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 Teva before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you.
Losartan Teva should not be used in early pregnancy and should not be used during the last 6 months of pregnancy as it may cause fetal harm.
Breast-feeding
Tell your doctor if you are breastfeeding or planning to start breastfeeding. Losartan Teva 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.
Driving and using machines
No studies have been performed. Losartan Teva 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 Teva contains lactose
Losartan Teva contains lactose monohydrates. 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 Teva
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 Teva, depending on your medical condition and whether you are taking other medicines. You must continue to take Losartan Teva 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 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 once daily. If you have the impression that the effect of losartan is too strong or too weak, talk to your doctor or pharmacist.
Use in children and adolescents (aged 6 to 18 years)
The recommended starting dose for patients weighing between 20 and 50 kg is 0.7 mg losartan per kg body weight once daily. Your doctor may need to increase the dose in case of insufficient blood pressure control.
Another dosage form 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 once daily. Dose one can then be increased to 100 mg losartan once daily depending on your blood pressure response.
Losartan Teva 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 glucoside).
Adult patients with heart failure
Treatment is usually started with 12.5 mg losartan 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 maintenance dose determined by your doctor. A maximum dose of 150 mg losartan 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 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 Teva).
Administration
Losartan Teva 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 Teva according to your doctor’s prescription.
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) ( angioedema ).
This is a serious but rare side effect, occurring in more than 1 in 10,000 and less than 1 in 1,000 patients. You may need emergency medical care or hospitalization.
The following side effects have been reported with Losartan Teva:
Common (may affect less than 1 user in 10):
- dizziness
- 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 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 urea in the blood and increase in serum creatinine and serum potassium in patients with heart failure .
Uncommon (may affect less than 1 user in 100):
- 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
- local swelling ( edema )
- cough.
Rare (may affect less than 1 in 1,000 people):
- hypersensitivity
- inflammation of the blood vessels ( vasculitis including Henoch Schönlein’s purpura)
- numbness or tingling ( paresthesias )
- fainting ( syncope )
- fast and irregular heartbeat ( atrial fibrillation )
- stroke
- inflammation of the liver ( hepatitis )
- 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
- migraine
- abnormal liver function
- muscle and joint pain
- flu-like symptoms
- back pain and urinary tract infection
- increased sensitivity to sunlight ( photosensitivity )
- unexplained muscle pain with dark (tea-colored) urine ( rhabdomyolysis )
- impotence
- inflammation of the pancreas ( pancreatitis )
- low levels of sodium in the blood ( hyponatremia )
- Depression
- general malaise
- ringing, buzzing, throbbing or clicking in the ears ( tinnitus )
- taste disorder ( dysgeusia ).
The side effects in children are similar to the side effects in adult patients.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information.
How to store Losartan Teva
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. day. or EXP. The expiration date is the last day of the specified month.
PVC / PVdC / Al blister and PVC / PE / PVdC / Al blister:
Do not store above 25 ° C.
OPA / Alu / PVC / Al blister:
No special storage instructions.
White opaque HDPE cans with white opaque polypropylene screw caps with safety closure or polypropylene screw caps with safety closure / senior-friendly closure with desiccant bag:
No special storage instructions.
HDPE jar: Shelf life after first opening: 6 months.
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 Losartan Teva 12.5 mg tablet contains 12.5 mg of losartan potassium.
The other ingredients are lactose monohydrate, microcrystalline cellulose (E460i), pregelatinized maize starch, magnesium stearate (E470b) in the tablet core, and polyvinyl alcohol, titanium dioxide (E171), macrogol, and talc in the tablet shell.
What the medicine looks like and contents of the pack
Losartan Teva 12.5 mg film-coated tablets are white, round slightly curved film-coated tablets, with “L” debossed on one side and smooth on the other.
Each tablet has a diameter of about 5 mm and is 3 mm thick.
Losartan Teva 12.5 mg film-coated tablets are available in pack sizes of 7, 21, 28, 30, and 100 film-coated tablets in blister packs.
Losartan Teva 12.5 mg film-coated tablets are available in pack sizes of 30, 100, and 250 film-coated tablets in cans.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer
Teva Pharmaceutical Works Private Limited Company
Debrecen, Hungary
Pharmachemie BV
Haarlem, The Netherlands
Merckle GmbH
Blaubeuren, Germany
Teva Pharma SLU
Zaragoza, Spain