Losartan 50mg Film-Coated Tablets
Out of date information, search anotherPATIENT INFORMATION LEAFLET LOSARTAN POTASSIUM 25, 50 & 100 mg FILM-COATED TABLETS
The name of this medicine is Losartan Potassium 25, 50 & 100 mg Film-coated Tablets which will be referred to as
Losartan Tablets throughout this leaflet.
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 further questions, please 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.
What is in this:
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..
If you already have kidney problems then using these medicines together with losartan may worsen your 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 can be taken with or without food.
Pregnancy, breast-feeding and fertility
You should not take losartan in the first 12 weeks of pregnancy and you must not take them at all after the 13th week as their use during pregnancy may possibly be harmful to the baby. If you become pregnant while on losartan, tell your doctor immediately so that an alternative medicine may be taken instead. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.
You must not take losartan if you are 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Children and adolescents
Losartan may be prescribed for children and adolescents. For more information, talk to your doctor.
Driving and using machines
Losartan may cause dizziness or drowsiness in some people and so may affect the ability to drive or use machines. If you experience dizziness or drowsiness, you should consult your doctor before attempting such activities.
Losartan contains Lactose.
These tablets contain lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
1. WHAT LOSARTAN TABLETS ARE AND WHAT THEY ARE USED FOR
Losartan Tablets belong to a group of medicines known as angiotensin-II receptor blockers (ARBs). Losartan can reduce blood
pressure and improve the ability of the heart to pump blood.
Losartan is used
• to lower blood pressure in people with high blood pressure (hypertension)
• to protect the kidney in 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 angiotension-converting-enzyme inhibitors (ACE inhibitors) is not considered suitable by your doctor. If your heart failure has been stabilized with an ACE inhibitor you should not be switched to losartan.
• in patients with high blood pressure and thickened heart muscle, losartan has been shown to decrease the risk of stroke.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSARTAN TABLETS 1 2
3. HOW TO TAKE LOSARTAN TABLETS
Dosage
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 Tablets depending on your condition and whether you are taking other medicines. It is important to continue taking the tablets for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.
PATIENTS WITH HIGH BLOOD PRESSURE
Treatment usually starts with one 50 mg 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 tablets 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.
PATIENTS WITH HIGH BLOOD PRESSURE AND TYPE 2 DIABETES
Treatment usually starts with 50 mg losartan (one 50 mg tablet) once a day. The dose may later be increased to 100 mg losartan (two 50 mg tablets) 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) up to the usual maintenance dose of 50 mg losartan (one 50 mg tablet) once daily, according to your condition.
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 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 the tablets until your doctor tells you otherwise.
For the 50mg tablet there is a score line which is only there to help you break the tablet if you have difficulty swallowing it whole If you take more Losartan Tablets than you should
If you have accidentally taken more than your prescribed dose, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you. The most common signs and symptoms of overdose are a fall in blood pressure (causing dizziness and light headedness) accompanied by either a fast or slow heart rate.
If you forget to take Losartan Tablets
It is important that you take your medicine every day. However, if you forget to take one or more doses, take your next dose when it is due and then go on as prescribed. Do not take a double dose to make up for a forgotten dose.
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If you have any further questions about this product ask your doctor or pharmacist.
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6. CONTENTS OF THE PACK AND OTHER INFORMATION
4. POSSIBLE SIDE EFFECTS
Like all medicines, Losartan Tablets can cause side effects, although not everybody gets them.
The following side effects are important and will require immediate action if you experience them. You should stop taking Losartan Tablets and tell your doctor immediately or go to the casualty department of your nearest hospital if the following symptoms occur: A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing).
Rare side effects affecting fewer than 1 in 1,000 patients:
• swelling of the face, tongue and windpipe which can cause great difficulty in breathing
• a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure
• stroke
Uncommon, affecting fewer than 1 in 100 people:
• angina (heart pain)
The following side effects have also been reported:
Common affecting up to 1 in 10 people:
• dizziness, sensation of spinning
• weakness, lassitude
• low blood pressure,
• low blood sugar (hypoglycaemia),
• changes in blood test results that show how the liver and kidneys are working. Too much potassium in the blood (hyperkalaemia).
Uncommon affecting fewer than 1 in 100 people:
• sleepiness or other sleep disturbance
• skin rash, itch, hives
• headache,
• palpitations
• fainting on standing (caused by low blood pressure)
• low blood pressure (especially after excessive loss of water from the body from within blood vessels e.g. in patients with severe heart failure or under treatment with high dose diuretics).
• breathlessness or difficulty breathing
• diarrhoea, nausea, vomiting, constipation, abdominal pain
• fluid retention (causing, for example, swollen ankles)
Rare affecting fewer than 1 in 1000 people:
• tingling sensation in the skin
• fainting (syncope)
• allergic reactions
• inflammation of the small blood vessels
• liver problems
• stroke
• very rapid and irregular heart beat (atrial fibrillation)
Not known (cannot be estimated from the available data):
• anaemia causing shortness of breath or looking pale
• bleeding or bruising more easily than normal
• back pain
• urinary infection
• flu-like symptoms
• migraine
• kidney problems (more common in those known to be at risk of kidney problems)
• muscle pains, joint pains
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What Losartan Tablets contain:
The active ingredient is losartan potassium. Each tablet contains 25, 50 or 100 mg of losartan potassium, equivalent to 22.9 mg, 45.8 mg or 91.6 mg of losartan.
Tablet core: Microcrystalline cellulose, dibasic calcium phosphate, colloidal anhydrous silica, croscarmellose sodium, talc, magnesium stearate.
Film-coating: Opadry White 31F589142
*consists of Hypromellose (E464), lactose monohydrate, titanium dioxide (E171), polyethylene glycol 4000, sodium citrate dihydrate (E331).
What Losartan Tablets look like and the contents of the pack:
Losartan Potassium 25 mg Film-coated Tablets are white, round-shaped, film-coated tablets plain on both sides.
Losartan Potassium 50 mg Film-coated Tablets are white, oval-shaped, film-coated tablets with a central break line on one side and plain on the other.
Losartan Potassium 100 mg Film-coated Tablets are white, oval-shaped, film-coated tablets plain on both sides.
Losartan Potassium Film-coated Tablets are supplied in blister packs containing 28 tablets.
Marketing Authorisation Holder:
Neolab Ltd., 57 High Street, Odiham, Hants, RG29 1LF.
Manufacture responsible for batch release is Fannin (UK) Ltd., 42-46 Booth Drive, Park Farm South, Wellingborough, Northhamptonshire, NN8 6GT
This information is available in alternative formats upon request.
This leaflet was last approved in April 2013.
5. HOW TO STORE LOSARTAN TABLETS
Keep your tablets out of the reach and sight of children.
Store in the original package in order to protect from light and moisture. Do not store above 25°C.
Do not take this medicine after the expiry carton stated on the carton. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any signs of deterioration in the packaging or if the tablets do not match description given in section 6. (Contents of the pack and other information)
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you are no longer use. These measures will help protect the environment.
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Do not take Losartan Tablets if you:
• are allergic (hypersensitive) to losartan or any of the other ingredients in the tablets (these are listed in Section 6, Further Information),
• are pregnant, think you may be pregnant or are planning to become pregnant, (see also “Pregnancy and breast-feeding”),
• are breast-feeding
• have severe liver problems
Take special care to "Warnings and precautions"
Before you Take Losartan Tablets
It is important to tell your doctor before taking Losartan Tablets if you:
• have ever had a history of angioedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 “Possible side effects”),
• suffer from excessive vomiting or diarrhoea leading to an extreme loss of fluid and/or salt in your body,
• receive diuretics (medicines that increase the amount of water that you pass out through your kidneys) or are under dietary salt restriction,
• are known to have narrowing or blockage of the blood vessels leading to your kidneys or if you have received a kidney transplant,
• if you have heart problems - caution is needed if you are treated with medicines known as beta-blockers
• If you have ever had a stroke,
• suffer from primary hyperaldosteronism (a hormone imbalance),
have liver problems.
Other medicines and Losartan Tablets
Talk to your doctor or pharmacist or nurse before taking 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. This list of medicines includes baclofen, amifostine and medicines used for mental health such as amitriptyline and chlorpromazine,
• medicines that affect potassium e.g. potassium supplements or certain diuretics (“water pills”) such as amiloride, triamterene, spirinolactone or medicines containing potassium such as heparin,
• pain relieving medicines such as indomethacin and medicines known as “Cox-2-inhibitors” because they may reduce the blood pressure lowering effect of losartan,