Losartan Potassium 50mg Film-Coated Tablet
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Package leaflet: information for the user
Losartan potassium 25 mg film-coated tablets Losartan potassium 50 mg film-coated tablets Losartan potassium 100 mg film-coated tablets
Losartan potassium
The name of your medicine is Losartan potassium 25,50,100 mg film-coated tablets, which will be referred to as Losartan potassium tablets throughout the rest of this document.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Losartan potassium tablets are and what they are used for
2. What you need to know before you take Losartan potassium tablets
3. Howto take Losartan potassium tablets
4. Possible side effects
5. Howto store Losartan potassium tablets
6. Contents of the pack and other information
1. What Losartan potassium tablets are and what they are used for
Losartan belongs to a group of medicines known as angiotensin-II receptor antagonists.
Angiotensin-II is a substance produced in the body, which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Losartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Losartan potassium tablets are used
- to treat patients with high blood pressure (hypertension) in adults and in children and adolescents 6-18 years of age.
- to protect the kidney in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function and proteinuria > 0.5 g per day (a condition in which urine contains an abnormal amount of protein).
- in patients with high blood pressure and a thickening of the left ventricle, Losartan potassium tablets has been shown to decrease the risk of stroke (“LIFE indication”).
Losartan potassium tablets may also be authorised to treat other conditions which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions.
2. What you need to know before you take Losartan potassium tablets Do not take Losartan potassium tablets
- if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6)
- if you are more than 3 months pregnant. It is also better to avoid Losartan potassium tablets in early pregnancy (see also 'Pregnancy and breast-feeding')
- if your liver function is severely impaired
- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Losartan potassium tablets.
You must tell your doctor if you think you are (or might become) pregnant. Losartan potassium tablets is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
It is important to tell your doctor before taking Losartan potassium tablets:
- if you have had a history of angioedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 'Possible side effects')
- if you suffer from excessive vomiting or diarrhoea leading to an extreme loss of fluid and/or salt in your body
- if you receive diuretics (medicines that increase the amount of water that you pass out through your kidneys)
- if you are under dietary salt restriction leading to an extreme loss of fluid and salt inyour body (see section 3 'Dosage in special patient groups')
- if you are known to have narrowing or blockage of the blood vessels leading to your kidneys or if you have received a kidney transplant recently
- if your liver function is impaired (see sections 2 ‘Do not take Losartan potassium tablets’ and 3 ‘Dosage in special patient groups’)
- if you suffer from heart failure with or without renal impairment or concomitant severe life threatening cardiac arrhythmias. Special caution is necessary when you are treated with a beta-blocker concomitantly
- if you have problems withyour heart valves or heart muscle
- if you suffer from coronary heart disease (caused by a reduced blood flow in the blood vessels of the heart) or from cerebrovascular disease (caused by a reduced blood circulation in the brain)
- if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality within the gland)
- if you are taking any of the following medicines used to treat high blood pressure:
- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems
- aliskiren
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading “Do not take LosartanPotassium tablets”.
Children and adolescents
Losartan has been studied in children. For more information, talk to your doctor. Losartan potassium tablets is not recommended for use in children suffering from kidney or liver problems, as limited data are available in these patient groups.
Losartan potassium tablets is not recommended for use in children under 6 years old, as it has not been shown to work in this age group.
Other medicines and Losartan potassium tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Take particular care if you are taking the following medicines while under treatment with Losartan potassium tablets:
- other blood pressure lowering medicines as they may additionally reduce your blood pressure. Blood pressure may also be lowered by one of the following drugs/class of drugs: tricyclic antidepressants, antipsychotics, baclofen, amifostine;
- medicines which retain potassium or may increase potassium levels (e.g. potassium supplements, potassium-containing salt substitutes or potassiumsparing medicines such as certain diuretics [amiloride, triamterene, spironolactone] or heparin);
- non-steroidal anti-inflammatory drugs such as indomethacin, including cox-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain) as they may reduce the blood pressure lowering effect of losartan.
Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Losartan Potassium tablets” and “Warnings and precautions”).
If your kidney function is impaired, the concomitant use of these medicines may lead to a worsening of the kidney function.
Lithium containing medicines should not be taken in combination with losartan without close supervision by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate.
Losartan potassium tablets with food and drink
Losartan potassium tablets may be taken with or without food.
Pregnancy and Breast-feeding Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Losartan potassium tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan potassium tablets. Losartan potassium tablets is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Losartan potassium tablets is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed. Especially if your baby is a newborn, or born prematurely.
Askyour doctor or pharmacist for advice before taking this medicine.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. Losartan potassium tablets are unlikely to affect your ability to drive or use machines. However, as with many other medicines used to treat high blood pressure, Losartan potassium tablets may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, you should consult your doctor before attempting such activities.
Losartan potassium tablets contain lactose monohydrate
This medicine contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Losartan potassium tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will decide on the appropriate dose of Losartan potassium tablets, depending on your condition and whether you are taking other medicines. It is important to continue taking Losartan potassium tablets for as long as your doctor prescribes it in order to maintain smooth control of your bloodpressure.
Adult Patients with high blood pressure
Treatment usually starts with 50 mg losartan (one Losartan potassium tablet 50 mg) once a day. The maximal bloodpressure lowering effect should be reached 3-6 weeks after beginning treatment. In some patients the dose may later be increased to 100 mg losartan (two Losartan potassium tablets 50 mg) once daily.
If you have the impression that the effect of losartan is too strong or too weak, please talk to you doctor or pharmacist.
Use in children and adolescents Children below 6 years of age
Losartan potassium tablets is not recommended for use in children under 6 years old, as it has not been shown to work in this age group.
Children aged 6-18 years old
The recommended starting dose inpatients who weigh between 20 and 50 kg is 0,7 mg of losartan per kg of body weight administered once a day (up to 25 mg losartan). The doctor may increase the dose if the blood pressure could not be controlled.
Other form(s) of this medicine may be more suitable for children; ask your doctor or pharmacist.
Adult Patients with high blood pressure and type 2 diabetes
Treatment usually starts with 50 mg losartan (one Losartan potassium tablet 50 mg) once a day. The dose may later be increased to 100 mg losartan (two Losartan potassium tablets 50 mg or one tablet Losartan potassium tablets 100 mg) once daily depending on your blood pressure response.
Losartan may be administered with other blood pressure lowering medicines (e.g., diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used medicines that decrease the level of glucose in the blood (e.g., sulfonylureas, glitazones and glucosidase inhibitors).
Losartan potassium tablets is available in several strengths (25 mg, 50 mg and 100 mg) to simplify the administration per indication. Doses smaller than 25 mg can not be reached with Losartan potassium tablets.
Dosage in special patient groups
The doctor may advise a lower dose, especially when starting treatment in certain patients such as those treated with diuretics in high doses, in patients with liver impairment, or in patients over the age of 75 years.
The use of losartan is not recommended in patients with severe hepatic impairment (see section "Do not take Losartan potassium tablets").
Method of administration
The tablet should be swallowed with a glass of water. You should try to take your daily dose at about the same time each day. It is important that you continue to take Losartan potassium tablets until your doctor tells you otherwise.
If you take more Losartan potassium tablets than you should
If you accidentally take too many tablets, or a child swallows some, contact your doctor immediately.
Symptoms of overdose are low blood pressure, increased heartbeat, possibly decreased heartbeat.
If you forget to take Losartan potassium tablets
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following, stop taking Losartan potassium tablets and tell your doctor immediately or go to the casualty department of your nearest hospital:
A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing).
This is a serious but rare side effect, which affects more than 1 out of 10 000 patients but fewer than 1 out of 1 000 patients. You may need urgent medical attention or hospitalization.
The following side effects have been reported:
Common (may affect up to 1 in 10 people)
- dizziness
- low blood pressure (especially after excessive loss of water from the body within blood vessels e.g. in patients with severe heart failure or under treatment with high dose diuretics)
- dose-related orthostatic effects such as lowering of blood pressure appearing when rising from a lying or sitting position
- debility
- fatigue
- too little sugar in the blood (hypoglycaemia)
- too much potassium in the blood (hyperkalemia)
- changes in kidney function including kidney failure
- reduced number of red blood cells (anaemia)
- increase in blood urea, 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 increased heart rate (palpitations)
- severe chest pain (angina pectoris)
- shortness of breath (dyspnoea)
- abdominal pain
- obstipation
- diarrhoea
- nausea
- vomiting
- hives (urticaria)
- itching (pruritus)
- rash
- localised swelling (oedema)
- cough
Rare (may affect up to 1 in 1000 people)
- hypersensitivity
- angioedema
- inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura)
- numbness or tingling sensation (paraesthesia)
- fainting (syncope)
- very rapid and irregular heartbeat (arterial fibrillation)
- brain attack (stroke)
- inflammation of the liver (hepatitis)
- elevated blood alanine aminotransferase (ALT) levels usually resolved upon discontinuation of treatment
Not known (frequency cannot be estimated from the available data)
- reduced number of thrombocytes
- migraine
- liver function abnormalities
- 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
- generally feeling unwell (malaise)
- ringing, buzzing, roaring, or clicking in the ears (tinnitus)
- disturbed taste (dysgeusia)
The side effects in children are similar to those seen in adults.
Reporting ofside effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Losartan potassium tablets
Keep this medicine out of the sight and reach of children.
Do not use Losartan potassium tablets after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions. Store in the original package to protect from moisture.
Do not open the blister until you are ready to take the medicine.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Losartan potassium tablets contain
- The active substance is losartan potassium.
Each Losartan potassium 25 mg tablet contains 25 mg of losartan potassium.
Each Losartan potassium 50 mg tablet contains 50 mg of losartan potassium.
Each Losartan potassium 100 mg tablet contains 100 mg of losartan potassium.
- The other ingredients are:
Tablet core: Lactose monohydrate, microcrystalline cellulose (E460), pregelatinised starch and magnesium stearate (E572).
Tablet film-coating: Hypromellose (E464), titanium dioxide (E171) and hydroxypropylcellulose (E463).
What Losartan potassium tablets look like and contents of the pack
Appearance of the tablets:
Losartan potassium 25 mg film-coated tablets are white to off-white, oval shaped, film-coated tablets, debossed with “J” on one side and “25” on the other side.
Losartan potassium 50 mg film-coated tablets are white to off-white, oval shaped, film-coated tablets, debossed with “J” on one side and “50” on the other side.
Losartan potassium 100 mg film-coated tablets are white to off-white, capsule shaped, film-coated tablets, debossed with “J” on one side and “100” on the other side.
Pack sizes:
10,28,30,50,56,90,98 and 100 tablets in blisters of 10 or 14 tablets in a cardboard box. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Manufacturer
Jubilant Pharmaceuticals nv PSI supply nv
Axxes Business Park Axxes Business Park
Guldensporenpark 22 - Block C Guldensporenpark 22 - Block C
9820 Merelbeke 9820 Merelbeke
Belgium. Belgium.
This leaflet was last approved in 04/2015