LOSARTAN POTASSIUM 25 MG FILM-COATED TABLETS

Active substance: LOSARTAN POTASSIUM

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Losartan potassium 12.5 mg
film-coated tablets

Losartan potassium 25 mg
film-coated tablets

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.
• 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. 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 note any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Losartan potassium is and what it is used for
2. Before you take Losartan potassium
3. How to take Losartan potassium
4. Possible side effects
5. How to store Losartan potassium
6. Further 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
• to treat patients with high blood pressure (hypertension)
• to protect 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).
• 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. Before you take Losartan potassium
Do not take Losartan potassium
• if you are allergic (hypersensitive) to losartan or to any of its other
ingredients;
• if your liver 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 section).
Take special care with Losartan potassium
It is important to tell your doctor before taking Losartan potassium:
• if you have had a history of angiooedema (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 ß-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).
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).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
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 potassium :
• 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 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.
Taking Losartan potassium with food and drink
Losartan potassium may be taken with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any 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 newborn, or was born prematurely.
Use in children and adolescents
Losartan has been studied in children. For more information, talk to your
doctor.
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.
Important information about some of the ingredients of Losartan
potassium
This product contains lactose. If you have been told by your doctor that you
have intolerance to some sugars, contact your doctor before taking this
medicinal product.
3. How to take Losartan potassium
Always take Losartan potassium exactly as your doctor has instructed you.
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.
Losartan-potassium containing medicinal products are available in the
following strengths: 12.5 mg, 25 mg, 50 mg and 100 mg.
Patients with High Blood Pressure
Treatment usually starts with 50 mg losartan (one tablet of 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 of 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.
Patients with high blood pressure and type 2 diabetes
Treatment usually starts with 50 mg losartan (one tablet of Losartan
potassium 50 mg) once a day. The dose may later be increased to 100 mg
losartan (two tablets of Losartan potassium 50 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).

4. POSSIBLE SIDE EFFECTS

Patients with Heart Failure
Treatment usually starts with 12.5 mg losartan (one tablet of Losartan
potassium 12.5 mg) 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 tablet of Losartan potassium
50 mg) once daily, according to your condition.

Like all medicines, Losartan potassium can cause side effects, although not
everybody gets them.

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. 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, 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 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 product, ask your doctor or
pharmacist.

Side effects may occur with certain frequencies, which are defined as follows:







Very common
Common
Uncommon
Rare
Very rare
Not known

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated from the available data

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 less than 1 out of 1,000 patients. You may need urgent medical
attention or hospitalisation.
The following side effects have been reported with losartan:
Common:
• dizziness,
• low blood pressure,
• debility,
• fatigue,
• too little sugar in the blood (hypoglycaemia),
• too much potassium in the blood (hyperkalaemia).
Uncommon:
• somnolence,
• headache,
• sleep disorders,



















feeling of increased heart rate (palpitations),
severe chest pain (angina pectoris),
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,
shortness of breath (dyspnoea),
abdominal pain,
obstipation,
diarrhoea,
nausea,
vomiting,
hives (urticaria),
itching (pruritus),
rash,
localised swelling (oedema).

Rare:
• 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 alanine aminotransferase (ALT) levels, usually resolved
upon discontinuation of treatment.
Not known:
• reduced number of red blood cells (anaemia),
• reduced number of thrombocytes,
• migraine,
• cough,
• liver function abnormalities,
• muscle and joint pain,
• changes in kidney function (may be reversible upon discontinuation of
treatment) including kidney failure,
• flu-like symptoms,

• increase in blood urea, serum creatinine and serum potassium in patients
with heart failure,
• back pain and urinary tract infection.
If any of the side effects gets serious or if you note any side effect not listed in
this leaflet, please tell your doctor or pharmacist.
5. How to store Losartan potassium
Keep out of the reach and sight of children.
Do not use Losartan potassium after the expiry date which is stated on the
carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via waste water or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
6. FURTHER INFORMATION
What Losartan potassium contains
• The active substance is Losartan potassium. Each film-coated tablet
contains 12.5 mg, 25 mg, 50 mg or 100 mg Losartan potassium, equivalent
to 11.4 mg, 22.9 mg, 45.8 mg and 91.5 mg losartan respectively.
• The other ingredients of Losartan potassium 12.5 mg/25 mg are: maize
starch, pregelatinised maize starch, microcrystalline cellulose, colloidal
anhydrous silica, magnesium stearate, cellactose (powdered cellulose and
lactose monohydrate) in the tablet core and hypromellose, talc, propylene
glycol, titanium dioxide (E171) and quinoline yellow (E104) in the film
coating.
• The other ingredients of Losartan potassium 50 mg/100 mg are: maize
starch, pregelatinised maize starch, microcrystalline cellulose, colloidal
anhydrous silica, magnesium stearate, cellactose (powdered cellulose and
lactose monohydrate) in the tablet core and hypromellose, talc, propylene
glycol and titanium dioxide (E171) in the film coating.

What Losartan potassium looks like and contents of the pack
Losartan potassium 12.5 mg: Oval, convex, yellow, film-coated tablet.
Losartan potassium 25 mg: Oval, convex, yellow, film-coated, one-side-scored
tablet. The tablet can be divided into equal halves.
Losartan potassium 50 mg: Round, convex, white film-coated, one-side-scored
tablet with bevelled edges. The tablet can be divided into equal halves.
Losartan potassium 100 mg: Oval, convex, white film-coated tablet.
Losartan potassium 12.5 mg/25 mg/50 mg/100 mg
PVC/PVDC blister of transparent foil, with aluminium foil used for covering;
box.
Pack sizes:
Losartan potassium 12.5 mg: 7, 10, 14, 15, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98,
100 film-coated tablets,
Losartan potassium 25 mg: 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100
film-coated tablets,
Losartan potassium 50 mg: 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100
film-coated tablets,
Losartan potassium 100 mg: 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100
film-coated tablets.
Losartan potassium 50 mg
Polyethylene (HDPE) tablet container with polypropylene closure. Polyethylene dessicator filled with silica gel.
Pack size: 250 film-coated tablets.
Not all the pack sizes may be marketed.
Marketing Authorisation Holder:
Krka d.d., Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufactured by:
1. KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
2. TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Distributed by:
Consilient Health (UK) Ltd., 500 Chiswick High Road, London, W4 5RG.
This leaflet was last revised in December 2011

P0141

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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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