50 mg, 100 mg film-coated tablets
losartan potassium
What Losartan Sandoz 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 Sandoz is used:
- to treat high blood pressure ( hypertension ) in adults and children and adolescents aged 6‑18 years
- 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 Sandoz has been shown to reduce the risk of stroke (“LIFE indication”).
Losartan contained in Losartan Sandoz 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 Sandoz
Do not take Losartan Sandoz
- 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 Sandoz, 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 Sandoz.
If you think you may be pregnant (or may become pregnant) during treatment, consult your doctor. Losartan Sandoz is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects (see Pregnancy and breast-feeding).
Tell your doctor before starting treatment;
- 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 Sandoz”, 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 Sandoz”.
Children and young people
Losartan Sandoz has been studied in children. For more information, talk to your doctor.
Losartan Sandoz is not recommended for use in children with kidney or liver problems or children under 6 years of age, as data for this patient group are limited.
Other medicines and Losartan Sandoz
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:
- 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 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 Sandoz” and “Warnings and precautions”)
Losartan Sandoz with food and drink
Losartan Sandoz can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
If you think you may be pregnant (or may become pregnant) during treatment, consult your doctor. Your doctor will usually suggest that you stop taking Losartan Sandoz before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Losartan Sandoz 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 Sandoz 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 any medicine.
Driving and using machines
No studies have been performed. Losartan Sandoz 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 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.
Losartan Sandoz 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.
Losartan Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take Losartan Sandoz
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 Sandoz, depending on your medical condition and whether you are taking other medicines. You must continue to take Losartan Sandoz as prescribed by your doctor to maintain even control of your blood pressure.
Adult patients with high blood pressure
Treatment is usually started with 50 mg losartan (one tablet Losartan Sandoz 50 mg or Los tablet Losartan Sandoz 100 mg) once daily. The maximum blood pressure-lowering effect is reached within 3-6 weeks after starting treatment. In some patients, the dose may then be increased to 100 mg losartan (2 tablets Losartan Sandoz 50 mg or one tablet Losartan Sandoz 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.
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 Sandoz). Your doctor may need to increase the dose in case of insufficient blood pressure control.
Other dosage forms with losartan may be more suitable for children, consult a doctor or pharmacist.
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 a maintenance dose determined by your doctor. A maximum dose of 150 mg losartan (3 tablets Losartan Sandoz 50 mg or 1 Los tablets Losartan Sandoz 100 mg) once daily can be used.
* If you have been prescribed 12.5 mg, it is not possible to take that dose with this medicine. Instead, another medicine containing losartan should 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 Sandoz”).
Administration
Losartan Sandoz 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 Sandoz as your doctor prescribes it.
Sharing Losartan Sandoz 50 mg film-coated tablets:
The film-coated tablet can be divided into two equal parts.
Dividing Losartan Sandoz 100 mg film-coated tablets:
The film-coated tablet can be divided into four equal parts.
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, 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 Sandoz:
Common (may affect more than 1 user in 10):
- 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 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 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 up to 1 in 1,000 people):
- hypersensitivity
- angioedema
- inflammation of the blood vessels ( vasculitis including Enoch ‑ Schönlein 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 (laboratory tests to check liver function), usually reversible after discontinuation of treatment
Has been reported (occurs in the 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 sunlight ( photosensitivity ), may cause skin redness after sun exposure
- 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.
How to store Losartan Sandoz
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 blister, jar, and carton after “EXP”. or “EXP”.
The expiration date is the last day of the specified month.
Store in the original package. Sensitive to light.
Burk :
After opening the jar for the first time:
Do not store above 25 ° C.
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.
Each film-coated tablet of Losartan Sandoz 50 mg contains 50 mg of losartan potassium.
Each Losartan Sandoz 100 mg film-coated tablet contains 100 mg of losartan potassium.
The other ingredients are microcrystalline cellulose, macrogol 4000, povidone K 25, colloidal anhydrous silica, magnesium stearate, lactose (as monohydrate), hypromellose, titanium dioxide (E171), sodium starch glycolate (type A).
What the medicine looks like and contents of the pack
Losartan Sandoz 50 mg film-coated tablet: White, oval, film-coated tablet, scored on both sides, and imprinted with “3” on one side.
The film-coated tablets are packaged in aluminum blisters in polyvinyl chloride (PVC) and polyvinylidene chloride (PVDC) and stored in a carton, or packaged in a high-density polyethylene (HDPE) jar with a polypropylene screw cap.
Losartan Sandoz 100 mg film-coated tablet: White, oblong, film-coated tablet with three notches on both sides and imprint “5” on one side.
The film-coated tablets are packaged in aluminum blisters in polyvinyl chloride (PVC) and polyvinylidene chloride (PVDC) and stored in a carton, or packaged in a high-density polyethylene (HDPE) jar with a polypropylene screw cap.
Pack sizes:
Blisters: 7, 10, 14, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98, 100, 104, 120 film-coated tablets
Single-dose blisters: 10×5, 14×4 film-coated tablets
Jar: 250 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder :
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
Lek Pharmaceuticals dd, Trimline 2 D, 9220 Lendava, Slovenia