Losartan Potassium 50 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
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Losartan Potassium 25 mg Film-coated Tablets Losartan Potassium 50 mg Film-coated Tablets Losartan Potassium 100 mg Film-coated Tablets
Losartan potassium
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 your 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.
What is in this leaflet:
1 What Losartan Potassium is and what it is used for
2 What you need to know before you take Losartan Potassium
3 How to take Losartan Potassium
4 Possible side effects
5 How to store Losartan Potassium
6 Contents of the pack and other information
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.
• medicines which retain potassium or may increase potassium levels in blood (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.
If your kidney function is impaired, the concomitant use of these medicines may lead to a further worsening of the kidney function.
Losartan Potassium is used
• to treat high blood pressure (hypertension) in adults and 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).
• to treat patients with chronic heart failure when therapy with specific medicines called ACE inhibitors (angiotensin-converting-enzyme inhibitors, medicine used to lower high blood pressure) is not considered suitable by your doctor. If your heart failure has been stabilised with an ACE inhibitor you should not be switched to losartan.
• in patients with high blood pressure and a thickening of the left ventricle, Losartan Potassium has been shown to decrease the risk of stroke ("LIFE indication”).
Do not take Losartan Potassium
• if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6.1).
• if your liver function is severely impaired.
• if you are more than 3 months pregnant (it is also better to avoid Losartan Potassium in early pregnancy - see pregnancy section).
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.
Taking Losartan Potassium with food and drink
Losartan Potassium 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 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. Losartan Potassium 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 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Losartan Potassium.
You must tell your doctor if you think you are (or might become) pregnant. Losartan Potassium 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).
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. Losartan Potassium is unlikely to 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.
It is important to tell your doctor before taking Losartan Potassium:
• if you have had a history of angiooedema (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) 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" 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 with your 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).
Children and adolescents
Losartan Potassium has been studied in children. For more information, talk to your doctor.
Losartan Potassium is not recommended for use in children suffering from kidney or liver problems, or children under 6 years old, as limited data are available in these patient groups.
Other medicines and Losartan Potassium
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:
• 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,
Losartan Potassium 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.
Always take this medicine exactly as your doctor or pharmacist 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, 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 of your blood pressure.
Adult Patients with high blood pressure Treatment usually starts with 50 mg losartan (2 tablets - 25 mg /1 tablet - 50 mg // tablet -100 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 (4 tablets - 25 mg / 2 tablets - 50 mg /1 tablet -100 mg) once daily. If you have the impression that the effect of losartan is too strong or too weak, please talk to your doctor or pharmacist.
Use in children or adolescents (6 to 18 years old) The recommended starting dose in patients 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 of Losartan Potassium). The doctor may increase the dose if blood pressure is not controlled.
Adult Patients with high blood pressure and type 2 diabetes
Treatment usually starts with 50 mg losartan (2 tablets - 25 mg /1 tablet - 50 mg / / tablet -100 mg) once a day. The dose may later be increased to 100 mg losartan (4 tablets - 25 mg / 2 tablets -50 mg /1 tablet -100 mg) once daily depending on your blood pressure response.
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 of glucose in the blood (e.g. sulfonylureas, glitazones and glucosidase inhibitors).
Adult Patients with heart failure Treatment usually starts with 12.5 mg* losartan (/ tablet - 25 mg) once a day. Generally, the dose should be increased weekly step-by-step (i.e.,
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 during the fifth week) up to the maintenance dose as determined by your doctor. A maximum dose of 150 mg losartan (6 tablets -25 mg / 3 tablets - 50 mg /1 and / tablet -100 mg) once daily may be used.
* In order to achieve these lower doses there are tablets with 12.5 mg and 25 mg (breakable tablet) losartan per tablet available.
In the treatment of heart failure, losartan is usually combined with a diuretic (medicine that increases the amount of water that you pass out through your kidneys) and/or digitalis (medicine that helps to make the heart stronger and more efficient) and/or a beta-blocker.
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").
Method of administration
The tablets 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 until your doctor tells you otherwise.
Note for dividing Losartan Potassium 25 mg and 50 mg film-coated tablets:
The film-coated tablets can be divided into equal halves.
Note for dividing Losartan Potassium 100 mg film-coated tablets:
The film-coated tablets can be divided into equal quarters.
If you take more Losartan Potassium than you should
If you accidentally take too many tablets, contact your doctor immediately. Symptoms of overdose are low blood pressure, increased heartbeat, possibly decreased heartbeat.
If you forget to take Losartan Potassium
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 product, ask your doctor or pharmacist.
• low levels of sodium in the blood (hyponatraemia),
• depression,
• generally feeling unwell (malaise),
• ringing, buzzing, roaring, or clicking in the ears (tinnitus),
• distortion of the sense of taste.
Side effects in children are similar to those seen in adults.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Keep out of the reach and sight of children.
Do not use Losartan Potassium tablets after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the product in the outer package, in order to protect from light.
Do not open the blister pack until you are ready to take the 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.
Bottles:
After first opening:
Do not store above 25°C.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you 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 hospitalization.
The following side effects have been reported with Losartan Potassium:
Common (may affect up to 1 in 10 people):
• dizziness,
• 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 (may affect up to 1 in 100 people):
• 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),
• abdominal pain,
• obstipation,
• diarrhoea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• rash,
• localised swelling (oedema),
• cough.
Rare (may affect up to 1 in 1,000 people):
• inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura),
• numbness or tingling sensation (paraesthesia),
• fainting (syncope),
• very rapid and irregular heartbeat (atrial fibrillation), brain attack (stroke),
• inflammation of the liver (hepatitis),
• elevated blood alanine aminotransferase (ALT laboratory test to check liver function) 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 the sun (photosensitivity), maybe with reddening of skin after sun exposure,
• unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
What Losartan Potassium contains
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 microcrystalline cellulose, macrogol 4000, povidone K25, colloidal silicon dioxide, magnesium stearate, lactose monohydrate, hypromellose, titanium dioxide, sodium starch glycolate (type A), propylene glycol, indigo carmine. These tablets may also contain titanium dioxide (E171).
Losartan Potassium 25 mg, 50 mg and 100 mg contain potassium in the following amounts:
2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq) respectively.
What Losartan Potassium looks like and contents of the pack
Losartan Potassium 25 mg film-coated tablets white, oval, brake notch on both sides, embossment 2. The film-coated tablet can be divided into equal halves.
Losartan Potassium 50 mg film-coated tablets white, oval, brake notch on both sides, embossment 3. The film-coated tablet can be divided into equal halves.
Losartan Potassium 100 mg film-coated tablets white, oblong, three brake notches on both sides, embossment 5. The film-coated tablet can be divided into equal quarters.
Losartan Potassium is supplied in the following packages:
PVC/PVDC/Aluminium blister and HDPE bottles with a PP screw cap.
Blisters: 7, 10, 14, 20, 21,28, 30, 50, 56, 60, 84, 90, 98, 100 film-coated tablets.
Unit dose blisters: 10x5, 14x4 film-coated tablets.
Bottles: 250 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,39179 Barleben, Germany
or
Salutas Pharma GmbH,
Dieselstrasse 5, 70839 Gerlingen,
Germany
or
LEK S.A.,
Ul. Podlipie 16, 95 010 Strykow,
Poland
or
Lek Pharmaceuticals d.d.,
Verovskova 57, 1526 Ljublana,
Slovenia
or
Lek Pharmaceuticals d.d.,
Trimlini 2D, 9220 Lendava,
Slovenia.
This leaflet was last revised in 11/2012.
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