Losartan Potassium 50 Mg Film-Coated Tablets
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Package leaflet: Information for the user
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 pharmacist or nurse.
- 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
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
1. 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 high blood pressure and type-2 diabetes.
Losartan potassium is used
• totreatpatients with high blood pressure (hypertension) in adults and in children and adolescents 6-18 years of age.
• toprotect 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).
• totreatpatients 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.
• inpatients 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. What you need to know before you take Losartan potassium
Do not take Losartan potassium:
• ifyouare allergic to losartan potassium or any of the other ingredients of this medicine (listed in section 6).
• ifyourliver 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".),
• ifyouhave diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
Warnings and precautions
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)
It is important to tell your doctor before taking Losartan potassium:
• ifyouhave had a history of angio-oedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 'Possible side effects'),
• ifyousuffer from excessive vomiting or diarrhoea leading to an extreme loss of fluid and/or salt in your body,
• ifyoureceive 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'),
• ifyouare known to have narrowing or blockage of the blood vessels leading to your kidneys or if you have received a kidney transplant recently,
• ifyourliver function is impaired (see sections 2 "Do not take Losartan potassium " and 3 "Dosage in special patient groups"),
• ifyousuffer 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 U-blocker concomitantly,
• ifyouhave problems with your heart valves or heart muscle,
• ifyousuffer 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),
• ifyousuffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality within the gland).
• ifyouare taking any of the following medicines used to treat high blood pressure:
- an “ACE-inhibitor” (for example enalapril, lisinopril, ramipril, etc.), 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”
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, as limited data are available in these patient groups. Losartan potassium 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
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:
• otherblood 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, 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 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.
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”).
Losartan potassium with food and drink and alcohol
Losartan potassium may be taken with or without food.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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.
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.
Losartan potassium contains lactose monohydrate
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.
3. How to take Losartan potassium
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 (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. 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 Children below 6 years of age
Losartan potassium 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 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. The doctor may increase the dose if blood pressure is not 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 tablet Losartan potassium 50 mg) once a day. The dose may later be increased to 100 mg losartan (two tablets Losartan potassium 50 mg or one tablet of Losartan potassium 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 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 (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. .
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 potassium ").
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Cyprus:
Czech Republic: Denmark:
France:
Germany:
Italy:
Ireland:
Malta:
The Netherlands: Spain:
Sweden:
The United Kingdom:
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.
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 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 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,
• lowblood 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,
• toolittlesugar in the blood (hypoglycaemia),
• toomuch potassium in the blood (hyperkalaemia),
• changesin kidney function including kidney failure,
• reducednumber of red blood cells (anaemia),
• increasein blood urea, serum creatinine and serum potassium in patients with heart failure.
Uncommon (may affect up to 1 in 100 people):
• somnolence,
• headache,
• sleepdisorders,
• feelingof increased heart rate (palpitations),
• severechest 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 1,000 people):
• hypersensitivity,
• angiooedema,
• inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura),
• numbness or tingling sensation (paraesthesia),
• fainting(syncope),
• veryrapid and irregular heartbeat (atrial fibrillation)
• brainattack (stroke),
• inflammation of the liver (hepatitis),
• elevatedblood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment.
Not known (frequency cannot be estimated from the available data):
• reducednumber of thrombocytes,
• migraine,
• liverfunction abnormalities,
• muscleand joint pain,
• flu-likesymptoms,
• backpain and urinary tract infection,
• increased sensitivity to the sun (photosensitivity),
• unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• lowlevels of sodium in the blood (hyponatraemia),
• depression,
• generally feeling unwell (malaise),
• ringing,buzzing, roaring, or clicking in the ears (tinnitus),
• disturbed taste (dysgeusia).
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Malta
ADR Reporting The Medicines Authority Post-Licensing Directorate 203 Level 3, Rue D'Argens GZR-1368 Gzira
Website: www.medicinesauthority.gov.mt e-mail: postlicensing.medicinesauthority@gov.mt
5. How to store Losartan potassium
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 label, carton and blister after EXP. 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
• Theactive substances is losartan potassium.
Each Losartan potassium 50 mg tablet contains 50 mg losartan potassium, equivalent to 45.8 mg of losartan.
Each Losartan potassium 100 mg tablet contains 100 mg losartan potassium, equivalent to 91.7 mg of losartan.
• Theother ingredients are:
Tablet core: Cellulose, microcrystalline, lactose monohydrate, starch, pregelatinised (maize starch), low substituted hydroxypropyl cellulose, magnesium stearate.
Tablet coat: Hydroxypropyl cellulose, hypromellose and titanium dioxide (E171).
What Losartan potassium looks like and contents of the pack
Film-coated tablet.
Losartan potassium 50 mg film-coated tablets:
White to off-white, oval shaped, biconvex film-coated tablets debossed with 'E' on one side and '4' and '6' separated by score line on the other side. The tablet can be divided into equal doses.
Losartan potassium 100 mg film-coated tablets:
White to off-white, oval shaped, biconvex film-coated tablets debossed with 'E' on one side and '47' on other side.
Blister pack of white opaque PVC/PVdC- Aluminium:
Pack size: 28, 56, 98 and 100 film-coated tablets HDPE bottle with polypropylene closure Pack size: 30 and 1000 film-coated tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder
Marketing Authorisation Holder UK_ Milpharm Limited
Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom
MT_ Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront Floriana FRN 1913 Malta
Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
^ocapTaH KanuM Aypo6nH,qo 50 mg OurnMuipaHH TaSneTKH Losartan Aurobindo 50 mg rmKaAujijieva |j£ Aehto ujievio 5iaKa Losartan Aurobindo 50 mg/ 100 mg potahovane tablety Losartan “Aurobindo”
LOSARTAN ARROW LAB 50 mg, comprime pellicule secable LOSARTAN ARROW LAB 100 mg, comprime pellicule Losartan Aurobindo 50 mg/ 100 mg Filmtabletten Losartan Aurobindo
Losartan potassium Milpharm 50 mg/ 100 mg film-coated tablets Losartan potassium 50 mg/ 100 mg film-coated tablets Losartankalium Aurobindo 50 mg/ 100 mg, filmomhulde tabletten Losartan Aurobindo 50 mg/ 100 mg comprimidos recubiertos con pelfcula EFG
Losartan Aurobindo 50 mg/ 100 mg filmdragerade tabletter Losartan potassium 50 mg/ 100 mg film-coated tablets
This leaflet was last revised in 08/2015.
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