12.5 mg, 50 mg, 100 mg film-coated tablets
losartan potassium
What Losarstad 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 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.
Losarstad is used:
- to treat high blood pressure ( hypertension ) in adults and children and adolescents aged 6-18 years.
- to protect the kidneys of 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 angiotensin convertase enzyme inhibitors ( ACE inhibitors , blood pressure lowering 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 left ventricular thickening. Losarstad has been shown to reduce the risk of stroke (“LIFE indication”).
Losartan potassium found in Losarstad may also be approved for the treatment of other diseases 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 using Losarstad
Do not take Losarstad
- 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 during pregnancy, it is good to avoid Losarstad – see also “Pregnancy and breastfeeding”)
- if you have diabetes or renal impairment and are being treated with a blood pressure lowering medicine containing aliskiren.
Warnings and cautions
Talk to a doctor or pharmacist before taking Losarstad.
If you think you are (or might become) pregnant during treatment, consult your doctor. Losarstad is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects – see also “Pregnancy and breast-feeding”.
Tell your doctor before you start taking Losarstad:
- 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 suffer from 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 Losarstad” 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 beta-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 Losarstad”.
Children and young people
Losarstad has been studied in children. For further information, talk to your doctor.
Other medicines and Losarstad
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take special care with the following medicines during treatment with Losarstad:
- 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 (for the treatment of depression), antipsychotics (for the treatment of psychiatric illnesses), baclofen (muscle relaxants), amifostine (used in chemotherapy in cancer treatment)
- potassium-sparing drugs or drugs that increase potassium levels (eg 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 these may reduce the antihypertensive effect of losartan .
If your kidney function is impaired, concomitant use of these drugs may lead to further deterioration of kidney function.
Medicines containing lithium should not be used in combination with losartan without careful 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 Losarstad” and “Warnings and precautions”).
Losastad with food and drink
Losarstad 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. Usually, your doctor will suggest that you stop taking Losarstad before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Losarstad should not be used at the beginning of 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. Losarstad 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 on the effects on the ability to drive and use machines have been performed. Losarstad is not expected to affect your ability to drive or use machines. However, keep in mind that losartan, like many other medicines used to treat high blood pressure, can 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 attention. 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.
Losarstad 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 Losarstad
Always take Losarstad 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 Losarstad, depending on your medical condition and whether you are taking other medicines. You must continue to take Losarstad according to your doctor’s prescription to maintain even control of your blood pressure.
General dosing recommendations:
Losarstad film-coated tablets are available in three different strengths: 12.5 mg, 50 mg, and 100 mg.
Losarstad 50 mg
If your doctor has told you to take a smaller dose, Losarstad 50 mg film-coated tablet can be shared. It can be divided at the crossed break into two parts, both containing 25 mg losartan, or four parts each containing 12.5 mg losartan.
Losarstad 100 mg
If your doctor has told you to take a smaller dose, Losarstad 100 mg film-coated tablets can be shared. It can be divided at the breaking point into two parts, both of which contain 50 mg of losartan.
Adult patients with high blood pressure
Treatment is usually started with 50 mg losartan (one Losarstad 50 mg tablet or Los Losarstad 100 mg tablet) once daily. 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 Losarstad 50 mg tablets or one Losarstad 100 mg tablet) 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 (up to 25 mg losartan ). Your doctor may need to increase the dose in case of insufficient blood pressure control.
Adult patients with high blood pressure and type 2 diabetes
Treatment is usually started with 50 mg losartan (one Losarstad 50 mg tablet or Los Losarstad 100 mg tablet) once daily. Dose one can then be increased to 100 mg losartan (two tablets Losarstad 50 mg or one tablet Losarstad 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 medicines 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 Losarstad 12.5 mg tablet or Los Losarstad 50 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), up to the usual maintenance dose of 50 mg. mg losartan (one Losarstad 50 mg tablet or 1/2 Losarstad 100 mg tablet) once daily.
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. Losartan must not be used in the treatment of patients with severe hepatic impairment (see section “Do not take Losarstad”).
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 Losarstad 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 serious allergic reaction (rash, pruritus, skull nad of including the face, lips, mouth, or throat, which can cause swallowing or breathing).
This is a serious but rare side effect, which may affect up to 1 in 1,000 people. 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 / a feeling that it is spinning ( vertigo )
- low blood pressure (especially after heavy 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 urea in the blood and increase in serum creatinine and serum potassium in patients with heart failure .
Uncommon (may affect up to 1 in 100 people):
- somnolence
- headache
- sleep disorders
- feeling of heart beating (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 up to 1 in 1,000 people):
- hypersensitivity reaction er
- angioedema (severe allergic reaction that causes swelling, especially on face, mouth, tongue or throat)
- inflammation of the blood vessels ( vasculitis including Enoch ‑ Schönlein purpura)
- numbness or tingling ( paresthesias )
- fainting
- rapid and irregular heartbeat ( atrial fibrillation ) and stroke
- inflammation of the liver ( hepatitis )
- elevated alanine aminotransferase (S‑ ALAT ), levels, usually reversible after discontinuation of treatment.
No known frequency (affects the unknown number of users):
- decreased platelet count ( thrombocytopenia )
- 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.
The side effects in children are similar to the side effects in adult patients.
How Losarstad should be stored
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.
Do not store above 30 ° C. Store in the original package. Sensitive to light.
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 pack and other information
Content declaration
The active substance is losartan potassium.
One tablet Losarstad 12.5 mg contains 12.5 mg losartan potassium.
One Losarstad 50 mg tablet contains 50 mg of losartan potassium.
One tablet Losarstad 100 mg contains 100 mg losartan potassium.
The other ingredients in the tablet core are:
Lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, colloidal, anhydrous silica.
Other content topics in the film coating are:
Hypromellose, titanium dioxide E171, macrogol 400, carnauba wax.
What the medicine looks like and contents of the pack
Losarstad 12.5 mg film-coated tablets are white, round, biconvex, film-coated tablets.
Losarstad 50 mg film-coated tablets are white, round, biconvex, film-coated tablets with crossed breaks. The film-coated tablet can be divided into equal doses.
Losarstad 100 mg film-coated tablets are white, oval, biconvex, film-coated tablets with a scoreline. The film-coated tablet can be divided into equal doses.
Pack sizes:
Losarstad 12.5 mg – PVC / PVDC blister packs of 10, 10×1 (single dose blisters), 28, 28×1 (single dose blisters), 30, 30×1 (single dose blisters), 60, 60×1 (single dose blisters), 98, 98×1 (single dose blisters), 120 or 120×1 ( endosblister) film-coated tablets.
Losarstad 50 mg – PVC / PVDC blister packs of 10, 10×1 (single dose blister), 28, 28×1 (single dose blister), 30, 30×1 (single dose blister), 50, 50×1 (single dose blister), 60, 30×1 (single dose blister), 90, 90×1 (single dose blister) , 98, 98×1 (single-dose blisters), 120 or 120×1 (single-dose blisters) film-coated tablets.
Losarstad 100 mg – PVC / PVDC blister packs of 10, 10×1 (single dose blister), 28, 28×1 (single dose blister), 30, 30×1 (single dose blister), 60, 60×1 (single dose blister), 98, 98×1 (single dose blister) 120 or 120×1 (single dose blister) film coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2 – 18
61118 Bad Vilbel
Germany
Other manufacturers
Centrafarm Services BV
New Donk 9
PO Box 289
4870 AG Etten-Leur
Netherlands
Local representative
STADA Nordic ApS
Marielundsvej 46 A
2730 Herlev
Denmar