Losartan Potassium 25mg Film Coated Tablets
Out of date information, search anotherTEVA UK Ref: 231-30-87369-Z LEA LOSARTAN A/S TAB TUK Version: 2 19 February 2015
PAGE 1: FRONT FACE (INSIDE OF REEL)
Pharma code: 205
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Losartan Potassium 25 mg, 50 mg and 100 mg Film-Coated Tablets
Package leaflet: Information for the user
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 INTHIS LEAFLET:
1. What Losartan Potassium is and what it is used for
2. What you need to know before you take Losartan Potassium Film-Coated Tablets
3. How to take Losartan Potassium Film-Coated Tablets
4. Possible side effects
5. How to store Losartan Potassium Film-Coated Tablets
6. Contents of the pack and other information
What Losartan Potassium is and what it is 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 H high blood pressure andType 2 diabetes.
_Losartan Potassium isused:
• to treat patients with high blood pressure (hypertension)
• 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 ofthe left ventricle. Losartan Potassium has been shown to decrease the risk of stroke ("LIFE indication").
OWhat you need to know before you take Losartan Potassium Film-Coated Tablets Do not take Losartan Potassium Film-coated Tablets if:
• you are allergic to losartan or any ofthe other ingredients ofthis medicine (listed in section 6),
• your liver function is severly impaired
• you are more than 3 months pregnant. (It is also better to avoid Losartan Potassium Film-CoatedTablets in early pregnancy-see section 2: Pregnancyand breast-feeding).
• you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warnings and precautions
• Talkto your doctor or pharmacist before taking Losartan tablets.
• You musttell your doctor ifyou thinkyou are (or might become) pregnant. LosartanTablet are not recommended in early pregnancy, and must not be taken ifyou are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see section 2: Pregnancy and breast-feeding).
Take special care with Losartan Potassium Film-Coated Tablets It is important to tell your doctor before taking Losartan Potassium Film-CoatedTablets:
if you have hada history of angioedema (swelling ofthe face, lips, throat, and/or tongue) (see 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) or are under dietary salt restriction leading to an extreme loss of fluid and salt in your 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 Film-coatedTablets" 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 P-blocker concomitantly
if you have problems with your heart valves or heart muscle if you suffer from coronary heart disease (caused by reduced blood flow in the blood vessels ofthe heart) or from cerebrovascular disease (caused by a reduced blood circulation in the brain).
ifyou sufferfrom primary hyperaldosteronism (a syndrome associated with increased secretion ofthe hormone aldosterone by the adrenal gland, caused byan abnormality within thegland) if you aretaking any ofthe following medicines used to treat high blood pressure:
• an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular ifyou 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 Losartan potassium Film-coatedTablets'.
Children and adolescents
• Losartan Potassium has been studied in children. For more information, talkto your doctor.
Other medicines and Losartan Potassium Film-Coated Tablets
• Tell your doctor or pharmacist ifyou aretaking, have recently taken or might take any other medicines.
Take particular care ifyou are taking the following medicines while undertreatmentwith Losartan Potassium:
• 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
• your doctor may need to change your dose and/or to take other precautions: Ifyou are taking an ACE-inhibitor or aliskiren (see also information under the headings 'Do not take Losartan potassium Film-coatedTablets' and 'Warnings and precautions')
• medicines which retain potassium or may increase potassium levels (e.g. potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines such as certain diuretics [amiloride, triamterene, spironolactone] or heparin)
• non-steroidal anti-inflammatory drugs such as indometacin, 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.
Ifyour kidney function is impaired the concomitant use ofthese medicines may lead to a worsening ofthe 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 Film-Coated Tablets with food and drink
Losartan Potassium can be taken with or without food.
Pregnancy and breast-feeding
Ifyou are pregnant or breast-feeding, thinkyou may be pregnant or are planning to have a baby, askyour doctor or pharmacist for advice before taking this medicine.
Pregnancy
You must tell your doctor ifyou thinkyou are (or might become) pregnant. Your doctor will normally advise you to stop taking Losartan Potassium Film-CoatedTablets before you become pregnant or as soon as you know you are pregnant andwill advise you to take another medicine instead ofLosartan Potassium Film-CoatedTablets. Losartan Potassium Film-CoatedTablets are not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as they may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell you doctor ifyou are breast-feeding or about to start breast-feeding. Losartan Potassium Film-CoatedTabletsare 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 newborn, or was born prematurely.
Driving and using machines
No studies of the effects on the ability to drive and use machines have been performed.
Losartan Potassium is unlikely to directly affect your ability to drive or use machines. However, as with many other medicines used to treat high blood pressure, losartan 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 Film-Coated Tablets contain lactose monohydrate:
Losartan Potassium contains lactose monohydrate. Ifyou 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 Potassium Film-Coated Tablets
Your doctor will decide on the appropriate dose of Losartan Potassium, depending on your condition and whether you are taking other medicines. It is important to continue taking Losartan Potassium for as long as your doctor prescribes it in order to maintain smooth control ofyour blood pressure. Always take this medicine exactly asyour doctor hastold you. Checkwith your doctor or pharmacist ifyou are not sure.
Patients with high blood pressure
Treatment usually starts with 50 mg losartan (one tablet Losartan Potassium 50 mg) once a day.The maximal blood pressure 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 tablets Losartan Potassium 50 mg) once daily.
Ifyou have the impression that the effect of losartan is too strong or too weak, please talkto you doctor or pharmacist.
Patients with high blood pressure and Type 2 diabetes Treatment usually starts with 50 mg losartan (one tablet Losartan Potassium 50 mg) once a day.The dose may later be increased to 100 mg losartan (two tablets Losartan Potassium 50 mg) once daily depending on your blood pressure response.
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Losartan tablets 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 ofglucose in the blood (e.g. sulfonylureas, glitazones and glucosidase inhibitors). 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 2: "Do not take <Losartan potassium Film-coatedTablets>").
Use in children and adolescents (6 to 18 years old)
The recommended starting dose in patientswhoweigh between 20 and 50 kg is 25 mg of Losartan Potassium Film-CoatedTablets once a day. In patients who weigh more than 50 kg, the usual dose is 50 mg Losartan Potassium Film-CoatedTablets once daily.The doctor may increase the dose if blood pressure is not controlled. Losartan Potassium Film-CoatedTablets are not recommended for use in children under 6 years old.
Losartan Potassium Film-CoatedTablets are also not recommended in children with severe renal or hepatic impairment.
Administration
The tablets should be swallowed with a glass ofwater.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 until your doctor tells you otherwise.
If you take more Losartan Potassium Film-Coated Tablets than you should
Ifyou 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 Film-Coated Tablets
Ifyou 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. Ifyou have any further questions on the use ofthis product, askyour doctor or pharmacist.
Ifyou have any further questions on the use ofthis medicine, askyour doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Ifyou experience the following, stop taking Losartan 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 hospitalisation.
The side effects of medicines are classified as follows: very common: mayaffect morethan 1 in 10 people
common: may affect up to1 in 10 people
uncommon: may affect up to 1 in 100 people
rare: may affect up to 1 in 1,000 people
very rare: may affect up to 1 in 10,000 people
not known: frequency cannot be estimated from the available
data.
The following side effects have been reported with Losartan Potassium 25, 50 and 100 mg Film-CoatedTablets:
Common:
• dizziness
• vertigo
• low blood pressure
• debility
• fatigue
• too little sugar in the blood (hypoglycaemia),
• too much potassium in the blood (hyperkalaemia)
• 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:
• somnolence
• headache
• sleep disorders
• feeling of increased heart rate (palpitations)
• severe chest pain (angina pectoris)
• 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
• shortness of breath (dyspnoea)
• cough
• abdominal pain
• obstipation
• diarrhoea
• nausea (feeling sick)
• vomiting (being sick)
• hives (urticaria)
• itching (pruritus)
• rash
• localised swelling (oedema).
Rare:
• inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura)
• numbness or tingling sensation (paraesthesia)
• fainting (syncope)
• very rapid and irregular heartbeat (artrial fibrillation) brain attack (stroke)
• inflammation ofthe liver (hepatitis)
• elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation oftreatment.
Not known (cannot be estimated from the available data):
• reduced numberofthrombocytes
• migraine
• changes in the sense oftaste
• ringing, buzzing, roaring, or clicking in the ears (tinnitus)
• depression
• generally feeling unwell (malaise)
• liver function abnormalities
• muscle and joint pain
• unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis)
• increased sensitivity to the sun (photosensitivity)
• impotence
• inflammation of the pancreas (pancreatitis)
• low levels of sodium in the blood (hyponatraemia)
• flu-like symptoms
• backpain
• urinary tract infection.
Side effects in children are similar to those seen in adults.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
How to store Losartan Potassium Film-Coated Tablets
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 EXR The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 contains:
• Each Film-Coated tablet contains 25 mg, 50 mg or 100 mg of the active substance, losartan Potassium.
• The other ingredients are as follows:
Tablet core: lactose monohydrate, microcrystalline cellulose (E460a), pregelatinised starch, magnesium stearate (E572) Film-coat: polyvinyl alcohol (partially hydrolysed), titanium dioxide (E171), macrogol,talc.
What Losartan Potassium looks like and contents of the pack:
Losartan Potassium 25 mg Film-CoatedTablets are white, oval, slightly arched film-Coated tablets, debossed “2", scoreline and "5" on one side, scoreline on the other. Available in pack sizes of: 1, 14, 20, 28, 30, 56, 60, 90, 98 and 100. Hospital packs of 50 (50 x 1). Losartan Potassium 50 mg Film-CoatedTablets are white, oval, slightly arched film-Coated tablets, debossed "50" on one side, scoreline on the other. Available in pack sizes of: 1, 14, 20, 28, 30, 56, 60, 90, 98 and 100. Hospital packs of 50(50x 1)& 280 (10x 28 tablets).
Losartan Potassium 100 mg Film-CoatedTablets are white, oval, slightly arched film-Coated tablets, debossed "100" on one side, scoreline "on the other. Available in pack sizes of: 1, 14, 20, 28, 30, 56, 60, 90, 98 and 100. Hospital packs of 50(50x 1)& 280 (10x 28 tablets).
The tablets are packed in white opaque PVC/PVdC/AI blisters or in white opaque PVC/PE/PVdC/AI blisters or in OPA/Alu/PVC/AI blisters. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Eastbourne, BN22 9AG This leaflet was last revised in February 2015.
PL 00289/0963 PL 00289/0964 PL 00289/0965
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