Losartan Potassium 100 Mg Film-Coated Tablets
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Losartan potassium 25 mg, 50
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.
• The full name of this medicine is Losartan potassium 25 mg, 50 mg and 100 mg film-coated tablets but within the leaflet it will be referred to as Losartan tablets.
What is in this leaflet:
1. What Losartan tablets are and what they are used for
2. What you need to know before you take Losartan tablets
3. How to take Losartan tablets
4. Possible side effects
5. How to store Losartan tablets
6. Contents of the pack and other information
1. WHAT LOSARTAN 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 also slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Losartan tablets are used
• to treat patients with high blood pressure (hypertension)
• to protect the kidneys in patients with high blood pressure and type 2 diabetes where tests have shown impaired kidney function and protein in the urine.
• 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.
• in patients with high blood pressure and a thickening of the muscle of the left ventricle (chamber in the heart), losartan has been shown to decrease the risk of stroke.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSARTAN TABLETS
Do not take Losartan tablets:
• if you are allergic (hypersensitive) to losartan or to any of the other ingredients,
• if your liver function is severely impaired,
• if you are more than 3 months pregnant. (It is also better to avoid losartan in early pregnancy - see pregnancy section.)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Losartan tablets.
You must tell your doctor if you think you are (or might become) pregnant. Losartan 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 tablets:
• if you have a history of allergic reactions such as 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 are taking diuretics (medicines that increase the amount of water that you pass out through your kidneys) or have a salt restricted diet 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 a blockage of the blood vessels leading to your kidneys or if you have recently received a kidney transplant,
• if your liver function is impaired (see sections 2 'Do not take Losartan tablets' and 3 'Dosage in special patient groups'),
• if you suffer from heart failure with or without impaired kidney function or severely abnormal heartbeat. Special caution is necessary when you are treated with a beta-blocker as well as Losartan tablets,
• if you have problems with your heart valves or heart muscle,
PACKAGE LEAFLET: INFORMATION FOR THE USER
mg & 100 mg film-coated tablets
(Losartan potassium)
• 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 tablets have been studied in children. For more information, talk to your doctor.
Losartan tablets are 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 tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 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 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 combination of losartan with these medicines may lead to a worsening of 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 tablets with food and drink
Losartan 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 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 tablets. Losartan tablets 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 your doctor if you are breast-feeding or about to start breast-feeding. Losartan tablets are 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.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
Losartan 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 may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, you should consult your doctor before attempting such activities.
3. HOW TO TAKE LOSARTAN TABLETS
Always take Losartan tablets exactly as your doctor has instructed. Your doctor will decide on the appropriate dose of Losartan tablets, depending on your condition and whether you are taking other medicines.
It is important to continue taking Losartan tablets 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 50 mg Losartan 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 (two 50 mg Losartan tablets) 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 and 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 tablet). 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 50 mg Losartan tablet) once a day. The dose may later be increased to 100 mg losartan (two 50 mg Losartan tablets) once daily depending on your blood pressure response.
Losartan tablets may be taken 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 (one
12.5 mg Losartan 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 doctor. A maximum dose of 150 mg Losartan (for example, three 50 mg Losartan tablets or one each of 100 mg and 50 mg Losartan tablets) 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 liver impairment (see section 'Do not take Losartan tablets').
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 tablets until your doctor tells you otherwise.
If you take more Losartan 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 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 everyone 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 hospitalisation.
The following side effects have been reported with Losartan tablets:
Common (may affect up to 1 in 10 people)
• dizziness,
• low blood pressure,
• a feeling of weakness,
• tiredness,
• low sugar levels in the blood (hypoglycaemia),
• high potassium levels in the blood (hyperkalaemia),
• dose-related orthostatic effects such as lowering of blood pressure appearing when rising from lying or sitting position,
• 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)
• drowsiness,
• headache,
• sleep disorders,
• feeling of increased heart rate (palpitations),
• severe chest pain (angina),
• 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),
• dizziness/light-headedness when rising from a lying or sitting position,
• shortness of breath (dyspnoea),
• abdominal pain,
• severe constipation,
• diarrhoea,
• feeling sick (nausea),
• being sick (vomiting),
• hives (urticaria),
• itching (pruritus),
• rash,
• localised swelling (oedema),
• cough
Rare (may affect up to 1 in 1,000 people)
• hypersensitivity,
• angioedema,
• 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 levels of alanine aminotransferase (ALT), usually resolved upon discontinuation of treatment.
Not known (frequency cannot be estimated from the available data)
• reduced number of red blood cells (anaemia),
• reduced number of platelets in the blood,
• migraine,
• distorted sense of taste (dysgeusia),
• liver problems,
• muscle and joint pain,
• changes in kidney function (may be reversible upon discontinuation of treatment) including kidney failure,
• flu-like symptoms,
• back pain 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),
• low levels of sodium in the blood (hyponatraemia),
• depression,
• generally feeling unwell (malaise),
• ringing, buzzing, roaring, or clicking in the ears (tinnitus).
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.
5. HOW TO STORE LOSARTAN POTASSIUM TABLETS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
Store in the original package.
25 mg Tablets: This medicinal product does not require any special storage conditions.
50 mg and 100 mg Tablets: Do not store above 25°C.
Do not remove the tablets from the blister pack 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 to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Losartan tablets contain
• The active substance (the ingredient that makes the tablet work) is losartan potassium. Each tablet contains either 25 mg, 50 mg or 100 mg losartan potassium per tablet.
• The other ingredients are mannitol (E 421), cellulose microcrystalline, croscarmellose sodium, povidone K-30, magnesium stearate, hypromellose 6, titanium dioxide (E 171), talc and propylene glycol.
What Losartan tablets look like and the contents of the pack
Losartan potassium 25 mg tablets are white, 8 mm round, biconvex, film-coated tablets marked "2L"
Losartan potassium 50 mg tablets are white, scored, 10 mm round, biconvex, film-coated tablets marked "3L"
Losartan potassium 100 mg tablets are white, scored, 18.3 mm x 9.2 mm oval, biconvex, film-coated tablets marked "4L"
Pack sizes
All strengths are supplied in blister packs of 5, 7, 10, 14, 15, 20, 21,28, 30, 50, 56, 60, 84, 98, 100, 210 and 280 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aptil Pharma Limited,
9th Floor, CP House,
97-107 Uxbridge Road,
Ealing, London W5 5TL
Manufacturer
Actavis Limited,
Reykjavikurvegur 78,
IS-220 Hafnarfjordur,
Iceland
This leaflet was last revised in June 2013.
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