Losartan Potassium 50 Mg Film-Coated Tablets
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
Read all of this leaflet carefully before taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Losartan Potassium is and what it is used for
2. Before you take Losartan Potassium
3. How to take Losartan Potassium
4. Possible side effects
5. How to store Losartan Potassium
6. Further information
1. WHAT LOSARTAN POTASSIUM IS AND WHAT IT IS USED FOR
Losartan Potassium 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 Potassium prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Losartan Potassium slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Losartan Potassium is 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).
• to treat patients with chronic heart failure when therapy with specific medicines called angiotensin-converting-enzyme inhibitors (ACE 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 potassium.
• 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”).
2. BEFORE YOU TAKE LOSARTAN POTASSIUM Do NOT take Losartan Potassium:
• if you are allergic (hypersensitive) to losartan potassium or to any of its other ingredients
• 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.)
• if you have diabetes or impaired kidney function and you are treated with a blood pressure
Page 2 of 9
lowering medicine containing aliskiren
Take special care with Losartan Potassium:
You must tell your doctor if you think you are (ormightbecome) 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).
It is important to tell your doctor before taking Losartan Potassium:
• if you have had a history of angio-oedema (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 h-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).
• 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 Losartan Potassium”.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines and natural products.
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,
• 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, triamteren, spironolactone] or heparine),
• 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 Potassium.
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” 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 potassium 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 (ormightbecome) 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.
Breastfeeding
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 newborn, or was born prematurely. Ask your doctor or pharmacist for advice before taking any medicine.
Use in children and adolescents
Losartan Potassium has been studied in children. For more information, talk to your doctor.
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 Potassium may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, you should consult your doctor before attempting such activities.
Important information about some of the ingredients of Losartan Potassium
Losartan Potassium Tablets contain 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
Always take Losartan Potassium exactly as your doctor has instructed you. 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.
AdultpatientswithHighBloodPressure
Treatment usually starts with 50 mg losartan potassium (one Losartan Potassium 50 mg Film-Coated Tablet) 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 potassium (two tablets Losartan Potassium 50 mg Film-Coated Tablets) once daily.
If you have the impression that the effect of losartan potassium is too strong or too weak, please talk to your doctor or pharmacist.
Useinchildrenoradolescents(6to18yearsold)
The recommended starting dose in patients who weigh between 20 and 50 kg is 0.7 mg of losartan potassium 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.
AdultpatientswithhighbloodpressureandType2diabetes
Treatment usually starts with 50 mg losartan potassium (one Losartan Potassium 50 mg Film-Coated Tablet) once a day. The dose may later be increased to 100 mg losartan potassium (two Losartan Potassium 50 mg Film-Coated Tablets) once daily depending on your blood pressure response.
Losartan Potassium 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).
AdultpatientswithHeartFailure
Treatment usually starts with 12.5 mg losartan potassium (one Losartan Potassium 12.5 mg Film-Coated Tablet) 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 physician. A maximum dose of 150 mg losartan potassium (for example, three tablets of Losartan Potassium 50 mg or one tablet each of Losartan Potassium 100 mg and Losartan Potassium 50 mg) once daily may be used.
Losartan Potassium 50 mg tablets can be divided into equal doses (to provide a dose of 25 mg). For the doses not achievable with Losartan Potassium, other medicinal products containing losartan potassium in appropriate dose should be prescribed by your doctor.
In the treatment of heart failure, losartan potassium 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 potassium is not recommended in patients with severe hepatic impairment (see section "Do not take losartan potassium ").
Administration
The tablets should be swallowed whole 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.
If you take more Losartan Potassium than you should
If you accidentally take too many tablets, or a child swallows some, contact your doctor immediately.
Page 5 of 9
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Losartan Potassium 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 hospitalisation.
Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown which can be life-threatening and lead to kidney problems (rhabdomyolysis)
This side effect is of a not known frequency (frequency cannot be estimated from the available data).
The side effects of medicines are classified as follows:
very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1000
rare: affects 1 to 10 users in 10000
very rare: affects less than 1 users in 10000 patients
not known: frequency cannot be estimated from the available data
The following side effects have been reported with Losartan Potassium:
Common:
• dizziness,
• spinning sensation (vertigo)
• 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 resulting in a dizzy spell
• debility
• fatigue
• too little sugar in the blood (hypoglycaemia)
• too much potassium in the blood (hyperkalaemia).
• changes in kidney function including kidney failure
• a condition in which the amount of oxygen-carrying pigment (haemoglobin) in the blood is below normal, with the following symptoms; tiredness, headaches, being short of breath when exercising, dizziness and looking pale (anaemia)
• increase in blood urea, serum creatinine and serum potassium in patients with heart failure
Uncommon:
• feeling drowsy (somnolence)
• headache
• sleep disorders
• feeling of increased heart rate (palpitations)
• a pain or uncomfortable feeling in the chest, often spreading to the arms or neck and sometimes to the shoulders and back. This may be caused by too little blood and oxygen getting to the heart. (angina pectoris)
• shortness of breath (dyspnoea),
• stomach pain
• severe constipation (obstipation)
• diarrhoea
• feeling sick (nausea),
• being sick (vomiting)
• hives (urticaria)
• itching (pruritus)
• rash
• accumulation of fluid resulting in localised swelling (oedema).
• Cough
Rare:
• narrowage or blockage of blood vessels (vasculitis including Henoch-Schonlein purpura)
• numbness or tingling sensation (paraesthesia)
• fainting (syncope)
• very rapid and irregular heartbeat (artrial fibrillation)
• damage to part of the brain caused by an interruption to its blood supply (stroke)
• inflammation of the liver with the following symptoms; nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, light coloured bowel
• motions, dark coloured urine (hepatitis)
• elevated levels of liver enzyme (blood alanine aminotransferase (ALT)), usually resolved upon discontinuation of treatment.
Not known:
• low blood platelet count which can lead to bleeding or bruising more easily than normal (thrombocytopenia)
• migraine
• liver function abnormalities
• muscle and joint pain
• flu-like symptoms
• back pain
• urinary tract infection
• increased sensitivity to the sun (photosensitivity)
• impotence
• inability to develop or maintain an erection of the penis (erectile dysfunction)
• inflammation of the pancreas with the following symptoms; severe upper stomach pain, often with nausea and vomiting (pancreatitis)
• low levels of sodium in the blood (hyponatraemia)
• depression
• generally feeling unwell (malaise)
• ringing, buzzing, roaring, or clicking in the ears (tinnitus).
• taste disturbance or loss of taste
Side effects in children are similar to those seen in adults.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE LOSARTAN POTASSIUM:
Keep out of the reach and sight of children.
Do not use Losartan Potassium after the expiry date which is stated on the carton after EXP. The
Page 7 of 9
expiry date refers to the last day of that month.
Losartan Potassium does not require any special storage conditions.
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.
6. FURTHER INFORMATION
What Losartan Potassium Film-Coated Tablets 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 lactose monohydrate, microcrystalline cellulose (PH102), pregelatinized maize starch, magnesium stearate, hydroxypropyl cellulose (E463), hypromellose (E464), titanium dioxide (E171).
What Losartan Potassium Film-Coated Tablets looks like and contents of the pack
Losartan Potassium 25 mg tablet is supplied as a white, oval shaped, biconvex, film coated tablets debossed with “LN25” on one side and ‘M’ on the other side.
Losartan Potassium 50 mg tablet is supplied as a white, oval shaped, biconvex, beveled edge, film coated tablet debossed with “LN” and “50” on either side of score line on one side of the tablet and ‘M’ on the other side. The tablet can be divided into equal doses.
Losartan Potassium 100 mg tablet is supplied as a white, tear drop shaped, biconvex, film coated tablets debossed with “LN100” on one side and ‘M’ on the other side.
The blister pack comprises of white opaque PVC film on one side and aluminum foil coated with heat seal lacquer on the other side.
The white opaque HDPE bottle comprises of a round wide mouth HDPE heat seal lined bottle with white opaque polypropylene cap.
Losartan Potassium tablets are supplied in blisters containing 7, 10, 14, 21, 28, 30, 38, 56, 60, 84, 90, 98, 99 and 100 tablets and bottles containing 500, 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan Potters Bar Hertfordshire EN6 1TL United Kingdom
Manufacturer
McDermott Laboratories Ltd. t/a Gerard Laboratories,
35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13 Ireland
Mylan Hungary Kft. H-2900, Komarom Mylan utca 1, Hungary
This medicinal product is authorized in the Member States of the EEA under the following Names:
NO/H/0185/001 -004/DC
Austria
Belgium
Cyprus
Czech Republic
Denmark
Finland
France
Germany
Hungary
Italy
Luxembourg
Norway
Netherlands
Poland
Portugal
Romania
Slovenia
Spain
Sweden
United Kingdom
Arcalos xx mg Filmtabletten Losartan Mylan Pharma Losartan Mylan
Losartan Mylan xx mg potahovane tablety
Solartan
Solartan
LOSARTAN MYLAN PHARMA xx mg, comprime pellicule Losartan Mylan xx mg Filmtabletten
Losartan Mylan xx mg Filmtabletta Ireland Losartan Mylan Losartan Mylan Losartan Mylan Pharma Losartan Mylan
Losartankalium Mylan xx mg, filmomhulde tabletten
Tenlosar
Tenlosarian
Losartan Mylan xx mg comprimate filmate Losartan Generics xx mg filmsko oblozene tablete
Losartan MYLAN Pharmaceuticals 12,5 mg inicio comprimidos recubiertos con pelicula EFG
Losartan MYLAN Pharmaceuticals 25 mg comprimidos recubiertos con pelicula Losartan MYLAN Pharmaceuticals 50 mg, 100 mg comprimidos recubiertos con pelicula EFG Solartan
Losartan Potassium xx mg Film-coated Tablets
NO/H/0186/001 -004/DC
Norway Solamyl
This leaflet was last updated in
October 2016
Page 9 of 9