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LOSARTAN 25MG FILM-COATED TABLETS

Active substance(s): LOSARTAN POTASSIUM / LOSARTAN POTASSIUM

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PATIENT 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 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.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Losartan Tablets are and what they are used for.
What you need to know before you take Losartan Tablets.
How to take Losartan Tablets.
Possible side effects.
How to Store Losartan Tablets.
Contents of the pack and other information.

1. WHAT LOSARTAN TABLETS ARE AND WHAT THEY ARE USED FOR
Losartan Tablets be long t o a gr oup of medicines known a s 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 doc tor. I f your he art f ailure ha s be en s tabilized with a n A CE i nhibitor you
should not be switched to losartan.
in pa tients with hi gh bl ood pr essure a nd t hickened he art m uscle, l osartan ha s be en
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 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, breast-feeding and fertility”),
are breast-feeding.
have severe liver problems
If you have diabetes or impared kidney function and you are treated with a blood
pressure lowering medicine contacting aliskiren

Warnings and precautions
Talk to your doctor or pharmacist 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.
If you are taking any of the following medicines used to treat high blood pressure:
o an ACE -inhibitor (f or e xample e nalapril, l isinopril, ramipril), in p articular if
you have diabetes related kidney problems.
o 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 losartan tablets’
Other medicines and Losartan Tablets
Talk t o you r doc tor o r pharmacist or nur se be fore t aking any ot her medicines, i ncluding
medicines obtained without a prescription or herbal medicines and natural products.
Take pa rticular c are if you a re t aking t he f ollowing m edicines w hile u nder t reatment w ith
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 r elieving m edicines s uch a s indomethacin a nd m edicines know n a s “ Cox-2inhibitors” because they may reduce the blood pressure lowering effect of losartan, 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.

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 losartan” and “Warnings and precautions”)
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 be come pr egnant w hile on l osartan, t ell your doc tor immediately so t hat an al ternative
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 o r us e m achines. I f you e xperience d izziness or dr owsiness, you should c onsult 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.
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 us ually s tarts w ith one 5 0 mg t ablet onc e a da y. T he m aximal bl ood pr essure
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 i ncreased t o 100 mg l osartan ( two 50 mg t ablets) onc e da ily de pending on your bl ood
pressure response.
Losartan T ablets m ay be a dministered w ith ot her bl ood p ressure lowering m edicines ( e.g.
diuretics, c alcium c hannel bl ockers, a lpha- or be ta-blockers, a nd c entrally a cting a gents) a s
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 u sually s tarts w ith 12.5 mg l osartan onc e a da y. G enerally, t he do se s hould 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 t he a mount o f w ater t hat you pa ss out t hrough your ki dneys) a nd/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 allows the tablet to
be divided into equal doses.
If you take more Losartan Tablets than you should

If you ha ve 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 f orget to take one or
more doses, take your next dose when it is due and then go on a s prescribed. Do not take a
double dose to make up for a forgotten dose.
If you have any further questions about this product ask your doctor or pharmacist.
Note: This product is not available as a 12.5mg dose. Your doctor will prescribe an alternative
if necessary.
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, (may affect up to 1 in 100 people):
• angina (heart pain)
The following side effects have also been reported:
Common (may affect 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 (may affect up to 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 (may affect up to 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

distorted sense of taste

sensitivity to sunlight

erectile dysfunction/ impotence

depression

ringing in the ear
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 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 use this medicine if you not ice 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 t o t hrow aw ay m edicines y ou are n o l onger u se. T hese m easures will h elp p rotect t he
environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION

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 31F58914*
*consists o f H ypromellose (E464), l actose m onohydrate, titanium di oxide ( E171),
polyethylene glycol 4000, sodium citrate dihydrate (E331).
What Losartan Tablets look like and the contents of the pack:
Losartan Potassium 25 m g 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:
Cadila P harmaceuticals (E urope) Limited, Amba H ouse, 4 th Floor, K ings S uite, 15 C ollege
Road, Harrow, Middlesex - HA1 1BA, UK.
Manufacture responsible for batch release is Fannin (UK) Ltd., 42-46 Booth Drive, Park
Farm South, Wellingborough, Northamptonshire, NN8 6GT
This information is available in alternative formats upon request.
This leaflet was last approved in Jan 2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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