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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
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
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.

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
Losartan potassium is used
extreme loss of fluid and salt in your body (see section 3 ‘Dosage in special
• to treat patients with high blood pressure (hypertension) in adults and in
patient groups’),
children and adolescents 6-18 years of age.
• if you are known to have narrowing or blockage of the blood vessels leading to
• 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 your kidneys or if you have received a kidney transplant recently,
• if your liver function is impaired (see sections 2 “Do not take Losartan
in which urine contains an abnormal amount of protein).
potassium” and 3 ‘Dosage in special patient groups’),
• to treat patients with chronic heart failure when therapy with specific
• if you suffer from heart failure with or without renal impairment or concomitant
medicines called angiotensin-converting-enzyme inhibitors (ACE inhibitors,
severe life threatening cardiac arrhythmias. Special caution is necessary when
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 you are treated with a ß-blocker concomitantly,
• if you have problems with your heart valves or heart muscle,
not be switched to losartan.
• if you suffer from coronary heart disease (caused by a reduced blood flow in the
• in patients with high blood pressure and a thickening of the left ventricle,
blood vessels of the heart) or from cerebrovascular disease (caused by a reduced
losartan has been shown to decrease the risk of stroke (“LIFE indication”).
blood circulation in the brain),
2. What you need to know before you take Losartan • if you suffer from primary hyperaldosteronism (a syndrome associated with
increased secretion of the hormone aldosterone by the adrenal gland, caused by
potassium
an abnormality within the gland).
• if you are taking any of the following medicines used to treat high blood
Do not take Losartan potassium:
pressure:
• if you are allergic to losartan or any of the other ingredients of this medicine
– an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if
(listed in section 6);
you have diabetes-related kidney problems.
• if your liver function is severely impaired;
– aliskiren
• if you are more than 3 months pregnant. (It is also better to avoid Losartan
potassium in early pregnancy – see pregnancy section.).
Your doctor may check your kidney function, blood pressure, and the amount of
• if you have diabetes or impaired kidney function and you are treated with a
electrolytes (e.g. potassium) in your blood at regular intervals.
blood pressure lowering medicine containing aliskiren
See also information under the heading “Do not take Losartan potassium”
Warnings and precautions
Children and adolescents
Talk to your doctor or pharmacist before taking Losartan potassium.
Losartan has been studied in children. For more information, talk to your doctor.
You must tell your doctor if you think that you are (or might become) pregnant
Losartan potassium is not recommended in early pregnancy, and must not be
Other medicines and Losartan potassium
taken if you are more than 3 months pregnant, as it may cause serious harm to
Tell your doctor or pharmacist if you are taking, have recently taken or might take
your baby if used at that stage (see pregnancy section).
any other medicines.
It is important to tell your doctor before taking Losartan potassium:
Take particular care if you are taking the following medicines while under
• if you have had a history of angiooedema (swelling of the face, lips, throat, and/ 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 potassiumsparing medicines such as certain diuretics [amiloride, triamterene,
spironolactone] or heparin),
• non-steroidal anti-inflammatory drugs such as indomethacin, 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.
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 take Losartan potassium” and “Warnings and precautions”)
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.
Breastfeeding
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.

Driving and using machines
No studies on the effects on the ability to drive and use machines have been
performed.
Losartan potassium 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 potassium 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 this medicine exactly as described in this leaflet or as your doctor or
pharmacist have told you. Check with your doctor or pharmacist if you are not
sure. 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.
Adult patients with high blood pressure
Treatment usually starts with 50 mg losartan (one tablet 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 Losartan potassium 50 mg or one
tablet of Losartan potassium 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 and adolescents aged 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 potassium). 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 50 mg losartan (one tablet Losartan potassium 50
mg) once a day. The dose may later be increased to 100 mg losartan (two tablets
Losartan potassium 50 mg or one tablet of Losartan potassium 100 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).
Adult patients with heart failure
Treatment usually starts with 12.5 mg losartan (one tablet 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, 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 potassium50 mg or one tablet each of Losartan potassium100 mg and
Losartan potassium50 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 potassium”).
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
Symptoms of overdose are low blood pressure, increased heartbeat, possibly
decreased heartbeat.

• sleep disorders,
• feeling of increased heart rate (palpitations),
• severe chest pain (angina pectoris),
• shortness of breath (dyspnoea),
If you have any further questions on the use of this medicine, ask your doctor or • abdominal pain,
pharmacist.
• obstipation,
• diarrhoea,
4. POSSIBLE SIDE EFFECTS
• nausea,
• vomiting,
Like Like all medicines, this medicine can cause side effects, although not
• hives (urticaria),
everybody gets them.
• itching (pruritus),
If you experience the following, stop taking losartan tablets and tell your doctor • rash,
• localised swelling (oedema),
immediately or go to the casualty department of your nearest hospital:
• cough.
A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat
Rare (may affect up to 1 in 1,000 people):
that may cause difficulty in swallowing or breathing).
• hypersensitivity,
This is a serious but rare side effect, which affects more than 1 out of 10,000
• angiooedema,
patients but fewer than 1 out of 1,000 patients. You may need urgent medical
• inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura),
• numbness or tingling sensation (paraesthesia),
attention or hospitalisation.
• fainting (syncope),
The following side effects have been reported with losartan:
• very rapid and irregular heartbeat (atrial fibrillation),
• brain attack (stroke),
Common (may affect up to 1 in 10 people):
• inflammation of the liver (hepatitis),
• dizziness,
• low blood pressure (especially after excessive loss of water from the body • elevated blood alanine aminotransferase (ALT) levels, usually resolved upon
within blood vessels e.g. in patients with severe heart failure or under
discontinuation of treatment.
treatment with high dose diuretics),
Not known (frequency cannot be estimated from the available data):
• dose-related orthostatic effects such as lowering of blood pressure appearing • reduced number of thrombocytes,
when rising from a lying or sitting position
• migraine,
• debility,
• liver function abnormalities,
• fatigue,
• muscle and joint pain,
• too little sugar in the blood (hypoglycaemia),
• flu-like symptoms,
• too much potassium in the blood (hyperkalaemia),
• back pain and urinary tract infection,
• changes in kidney function including kidney failure,
• increased sensitivity to the sun (photosensitivity),
• reduced number of red blood cells (anaemia),
• unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis),
• increase in blood urea, serum creatinine and serum potassium in patients with • impotence,
heart failure.
• inflammation of the pancreas (pancreatitis),
• low levels of sodium in the blood (hyponatraemia),
Uncommon (may affect up to 1 in 100 people):
• depression,
• somnolence,
• generally feeling unwell (malaise),
• headache,
If you forget to take Losartan potassium
Do not take a double dose to make up for a forgotten dose.
If you accidentally miss a daily dose, just take the next dose as normal.

• 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 Yellow Card Scheme
Website: 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 packaging
after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

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 doses.
Losartan potassium 50 mg: Round, convex, white film-coated, one-side-scored
tablet with bevelled edges. The score line is not intended for breaking the tablet.
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.

Do not throw away any medicines via wastewater or household waste. Ask your Losartan potassium 50 mg
pharmacist how to throw away medicines you no longer use. These measures will Polyethylene (HDPE) tablet container with polypropylene closure. Polyethylene
help protect the environment.
dessicator filled with silica gel.
Pack size: 250 film-coated tablets.

6. Contents of the pack and other 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.

Not all the pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Distributed by:
Consilient Health (UK) Ltd., No.1 Church Road, Richmond upon Thames, Surrey.
TW9 2QE.

This leaflet was last revised 10/2014.

P0309

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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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