12.5 mg, 25 mg, 50 mg and 100 mg film-coated tablets
losartan potassium
What Losartan Actavis is and what it is used for
Losartan Actavis 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 Actavis 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 Actavis 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 and 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 Actavis has been shown to reduce the risk of stroke (“LIFE indication”).
Losartan contained in Losartan Actavis 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 use Losartan Actavis
Do not use Losartan Actavis
- 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. Pregnant women should not use Losartan Actavis during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Losartan Actavis, 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 using Losartan Actavis.
Tell your doctor before using Losartan Actavis:
- if you have had 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 leads to large fluid loss and / or salt loss in your body
- if you use diuretics (medicines that increase the amount of water that passes through your kidneys) or if you are on a low-salt diet which can lead to severe salt and fluid loss (see section 3 “Dosage for special patient groups”)
- if you know 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 use Losartan Actavis” and section 3 “Dosage for special patient groups”)
- if you suffer from heart problems with or without impaired kidney function or concomitant life-threatening cardiac arrhythmia . Take special care if you are being treated with beta-blockers at the same time
- if you have problems with your heart valves or your heart muscle
- if you suffer from any heart disease (caused by impaired blood flow in the blood vessels of the heart) or by a cerebrovascular disease (caused by impaired blood flow in the brain)
- if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone et aldosterone from the adrenal gland, caused by a malformation of the adrenal gland)
- If you think you may be pregnant or become pregnant during treatment, consult your doctor. Losartan Actavis 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)
- 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 use Losartan Actavis”.
- if you are taking other medicines that may increase the concentration of potassium in your blood (see section 2 “Other medicines and Losartan Actavis”).
Children and young people
Losartan Actavis has been studied in children. For more information, talk to your doctor.
Losartan is not recommended for use in children with kidney or liver problems, as limited data are available in these patient groups. Losartan Actavis is not recommended for children under 6 years of age, as it has not been shown to work in this age group.
Other medicines and Losartan Actavis
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 Actavis are not recommended.
Take special care with the following medicines while taking Losartan Actavis:
- other antihypertensive drugs because they can lower 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 (drugs that reduce inflammation and can be used to relieve pain) as they may impair the blood pressure lowering 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 Actavis” and “Warnings and precautions”).
If you have impaired kidney function, concomitant treatment with these drugs may lead to further deterioration of your kidney function.
Medicines containing lithium should not be combined with Losartan Actavis without close medical supervision. Special precautions (eg blood tests) may be appropriate.
Losartan Actavis with food and drink
Losartan Actavis can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant and 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 Actavis before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Losartan Actavis 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 Actavis 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 on the ability to drive and use machines have been performed.
Losartan Actavis is unlikely to directly affect your ability to drive or use machines, but like many other antihypertensive drugs, Losartan Actavis may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, consult your doctor before performing any such activity.
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 Actavis contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
3. How to use Losartan Actavis
Always use 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 Actavis, depending on your condition and whether you are taking other medicines.
Adult patients with high blood pressure
Treatment is usually started with 50 mg losartan (a 50 mg tablet Losartan Actavis) once daily. Maximum blood pressure-lowering effect is obtained after 3-6 weeks after starting treatment. In some patients, the dose may need to be increased to 100 mg losartan (two Losartan Actavis 50 mg tablets or one Losartan Actavis 100 mg tablet ) once daily.
Use for children and adolescents
Children under 6 years of age
Losartan Actavis 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 0.7 mg losartan per kg body weight once daily (up to 25 mg Losartan Actavis). 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 Actavis 50 mg tablet ) once daily. Dose one can then be increased to 100 mg losartan (two tablets Losartan Actavis 50 mg or one tablet Losartan Actavis 100 mg) once daily depending on your blood pressure response.
Losartan tablets can be given with other antihypertensive drugs
(eg diuretic calcium channel blockers, alpha- or beta-blockers and centrally acting drugs) as well as 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 Losartan Actavis 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 Actavis 50 mg or one tablet of both Losartan Actavis 100 mg and Losartan Actavis 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 β-blocker.
Dosage for special patient groups
Doctors may prescribe lower doses, especially at the start of treatment for patients treated with high-dose diuretics, patients with hepatic impairment, and patients over 75 years of age. Losartan Actavis is not recommended for patients with severe hepatic impairment (see section “Do not use Losartan Actavis”).
Administration
The tablets should be swallowed with a glass of water. Try to take your daily dose at about the same time each day. You must continue to take Losartan Actavis until your doctor tells you otherwise
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 Actavis 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, which may affect up to 1 in 1,000 patients. 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 of 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
- inflammation of the blood vessels ( vasculitis including Henoch-Schönlein purpura)
- numbness or tingling ( paresthesias )
- fainting ( syncope )
- fast and irregular heartbeat ( atrial fibrillation )
- stroke
- inflammation of the liver ( hepatitis )
- elevated liver enzyme levels ( alanine aminotransferase (S- ALAT )), 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 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 changes ( dysgeusia ).
Side effects in children are similar to those reported in adults.
How to store Losartan Actavis
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 and label after EXP, or blisters after EXP. The expiration date is the last day of the specified month.
12.5 mg, 25 mg in blisters:
Store in the original package. Sensitive to light.
50 mg, 100 mg in blisters:
Do not store above 25 ° C. Store in the original package. Sensitive to light.
Can:
No special storage instructions.
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.Losartan Actavis 12.5 mg film-coated tablets: Each Losartan Actavis 12.5 mg film-coated tablet contains 12.5 mg of losartan potassium.Losartan Actavis 25 mg film-coated tablets: Each Losartan Actavis 25 mg film-coated tablet contains 25 mg of losartan potassium.Losartan Actavis 50 mg film-coated tablets: Each Losartan Actavis 50 mg film-coated tablet contains 50 mg of losartan potassium.Losartan Actavis 100 mg film-coated tablets: Each Losartan Actavis 100 mg film-coated tablet contains 100 mg of losartan potassium.
- Other ingredients are:Tablet core : mannitol, microcrystalline cellulose, croscarmellose sodium, povidone K29 / 32, magnesium stearate.Film coating : Hypromellose 6, titanium dioxide (E171), talc, propylene glycol
What the medicine looks like and contents of the pack
Losartan Actavis 12.5 mg film-coated tablets: white, round biconvex film-coated tablets, without the notch, labeled 1L, size: 6 mm
Losartan Actavis 25 mg film-coated tablets: white, round biconvex, film-coated tablets, without the notch, labeled 2L, size: 8 mm
Losartan Actavis 50 mg film-coated tablets: white, round biconvex, film-coated tablets, scored, marked 3L, size: 10 mm
Losartan Actavis 100 mg film-coated tablets: white, oval biconvex, film-coated tablets, scored, 4L, size: 18.3×9.2 mm
The 50 mg and 100 mg tablets can be divided into two equal doses.
Pack sizes:
Blister:
7, 10, 14, 15, 20, 21, 28, 30, 50, 56, 90, 98, 100, 210 tablets
Hospital packaging: 280 tablets
Can:
100, 250 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC EHF
Reykjavikurvegur 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Balkanpharma Dupnitsa AD
3 Samokovsko Schosse Str.
Dupnitsa 2600
Bulgaria