Losartan Potassium 25mg Film-Coated Tablets
• stroke
• inflammation of the liver (hepatitis),
• elevated blood alanine aminotransferase (ALT) 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)
• 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),
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
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 carton and blister after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
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 contains
The active substance is losartan as losartan potassium.
Each Losartan potassium 25mg film-coated tablet contains 25mg of losartan potassium, equivalent to 22.9mg of losartan.
Each Losartan potassium 50mg film-coated tablet contains 50mg of losartan potassium, equivalent to 45.8mg of losartan.
Each Losartan potassium 100mg film-coated tablet contains 100mg of losartan potassium, equivalent to 91,6mg of losartan.
The other ingredients are:
Tablet core: lactose monohydrate, cellulose microcrystalline, maize starch, croscarmellose sodium and magnesium stearate.
Film-coat: OPADRY 20A58900 white: hydroxypropylcellulose, hypromellose, titanium dioxide E171.
What losartan looks like and contents of the pack
Losartan 25mg tablets are white, oval shaped with a score line on both sides.
Losartan 50mg tablets are white, oval shaped with a score line on both sides.
Losartan 100mg tablets are white, oval shaped with a score line on both sides.
The tablets can be divided into equal halves
Losartan potassium is available in blister packs of 7, 14, 15, 21,28, 30, 50, 56, 90, 98 280 (10x28) tablets or in plastic bottles of 30, 50, 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Zentiva,
One Onslow Street,
Guildford,
Surrey,
GU1 4YS,
UK.
Manufacturer:
Generis Farmaceutica, S.A, Rua Joao de Deus, no 19, Venda Nova, 2700-487 Amadora, Portugal Or
Winthrop Arzneimittel GmbH, BruningstraBe 50, 65926 Frankfurt am Main, Germany Or
Sanofi-Aventis Sp. z o.o., Drug Production and Distribution Plant, ul. Lubelska 52, 35-233 Rzeszow, Poland This leaflet was last revised in September 2014
LOSARTAN potassium 25mg, 50mg and 100mg film-coated tablets
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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 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
The name of your medicine is Losartan potassium film-coated tablets (referred to as losartan throughout this leaflet).
Losartan (the active ingredient of this medicine) belongs to a group of medicines known as angiotensin-ll receptor antagonists. Angiotensin-ll 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-ll to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Losartan slows the decrease in kidney function in patients with high blood pressure and type 2 diabetes.
Losartan is used:
• to treat 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 >0.5g per day (a condition in which urine contains abnormal amounts 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.
• in patients with high blood pressure and a thickening of the left ventricle, losartan 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
• if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6),
• if you are more than 3 months pregnant. (It is also better to avoid losartan in early pregnancy - see pregnancy section),
• if your liver function is severely impaired,
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor or pharmacist before taking losartan:
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:
• if you have had a history of angioedema (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" 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).
• 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".
Children and adolescents
Losartan has been studied in children. For more information, talk to your doctor.
Losartan is not recommended for use in children suffering from kidney or liver problems, as limited data are available in these patient groups. Losartan 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
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Take particular care if you are taking the following medicines while under treatment with losartan. Your doctor may need to change your dose and/or to take other precautions:
• 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, baclofene, 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 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.
• an ACE inhibitor or aliskiren (see also information under the headings "Do not take losartan" and "Warnings and precautions").
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 before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead. 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 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.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
Losartan 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 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, depending on your condition and whether you are taking other medicines. It is important to continue taking losartan 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 50mg losartan (one tablet losartan 50mg) 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 100mg losartan (two tablets 50mg or one 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 and adolescents
Children below 6 years of age
Losartan 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 6-18 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). 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 50mg losartan (one tablet of losartan 50mg) once a day. The dose may later be increased to 100mg losartan (two tablets of losartan 50mg or one tablet of losartan 100mg) 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 levels 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 half of tablet 25mg) once a day.
Generally, the dose should be increased weekly step-by-step (i.e., 12.5mg daily during the first week, 25mg daily during the second week, 50mg 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 50 mg or one tablet each of losartan 100 mg and losartan 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"). Administration
The tablets should be swallowed with a glass of water. Losartan may be taken with or without food.You should try to take your daily dose at about the same time each day. It is important that you continue to take losartan until your doctor tells you otherwise.
If you take more losartan 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
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 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 may affect up to 1 in 1,000 people. You may need urgent medical attention or hospitalisation.
The following side effects have been reported with losartan:
Common (may affect up to 1 in 10 people):
• dizziness
• 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,
• 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),
• shortness of breath (dyspnoea),
• abdominal pain,
• constipation,
• diarrhoea,
• nausea,
• 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 (artrial fibrillation),
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