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LOSARTAN POTASSIUM 12.5 MG FILM-COATED TABLETS

Active substance(s): 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.

• 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
Losartan potassium is used
an
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),

if you suffer from primary hyperaldosteronism (a syndrome associated with
2. What you need to know before you take Losartan
increased secretion of the hormone aldosterone by the adrenal gland, caused
potassium
by 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
your baby if used at that stage (see pregnancy section).
take 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
treatment with 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’),

• 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.

Uncommon (may affect up to 1 in 100 people):
• somnolence,
• headache,
If you forget to take Losartan potassium
• sleep disorders,
Do not take a double dose to make up for a forgotten dose.
• feeling of increased heart rate (palpitations),
If you accidentally miss a daily dose, just take the next dose as normal.
• severe chest pain (angina pectoris),
Losartan tablets may be administered with other blood pressure lowering
If you have any further questions on the use of this medicine, ask your doctor or • shortness of breath (dyspnoea),
medicines (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers,
pharmacist.
• abdominal pain,
and centrally acting agents) as well as with insulin and other commonly used
• obstipation,
medicines that decrease the level of glucose in the blood (e.g. sulfonylureas,
4. POSSIBLE SIDE EFFECTS
• diarrhoea,
glitazones and glucosidase inhibitors).
• nausea,
Like all medicines, this medicine can cause side effects, although not everybody • vomiting,
Adult patients with heart failure
gets them.
Treatment usually starts with 12.5 mg losartan (one tablet Losartan potassium
• hives (urticaria),
12.5 mg) once a day. Generally, the dose should be increased weekly step-by-step If you experience the following, stop taking losartan tablets and tell your doctor • itching (pruritus),
• rash,
(i.e., 12.5 mg daily during the first week, 25 mg daily during the second week,
immediately or go to the casualty department of your nearest hospital:
• localised swelling (oedema),
50 mg daily during the third week, 100 mg daily during the fourth week, 150 mg
A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat • cough.
daily during the fifth week) up to the maintenance dose as determined by your
that may cause difficulty in swallowing or breathing).
physician. A maximum dose of 150 mg losartan (for example, three tablets of
Rare (may affect up to 1 in 1,000 people):
Losartan potassium 50 mg or one tablet each of Losartan potassium 100 mg and This is a serious but rare side effect, which affects more than 1 out of 10,000
• hypersensitivity,
patients but fewer than 1 out of 1,000 patients. You may need urgent medical
Losartan potassium 50 mg) once daily may be used.
• angiooedema,
attention or hospitalisation.
• inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura),
In the treatment of heart failure, losartan is usually combined with a diuretic
• numbness or tingling sensation (paraesthesia),
The following side effects have been reported with losartan:
(medicine that increases the amount of water that you pass out through your
• fainting (syncope),
kidneys) and/or digitalis (medicine that helps to make the heart stronger and
Common (may affect up to 1 in 10 people):
• very rapid and irregular heartbeat (atrial fibrillation),
more efficient) and/or a beta-blocker.
• dizziness,
• brain attack (stroke),
• low blood pressure (especially after excessive loss of water from the body
Dosage in special patient groups
• inflammation of the liver (hepatitis),
within
blood
vessels
e.g.
in
patients
with
severe
heart
failure
or
under
The doctor may advise a lower dose, especially when starting treatment in
• elevated blood alanine aminotransferase (ALT) levels, usually resolved upon
treatment with high dose diuretics),
certain patients such as those treated with diuretics in high doses, in patients
discontinuation of treatment.
with liver impairment, or in patients over the age of 75 years. The use of losartan • dose-related orthostatic effects such as lowering of blood pressure appearing
Not
known (frequency cannot be estimated from the available data):
when
rising
from
a
lying
or
sitting
position
is not recommended in patients with severe hepatic impairment (see section
• reduced number of thrombocytes,
• debility,
“Do not take Losartan potassium”).
• migraine,
• fatigue,
Administration
• liver function abnormalities,
• too little sugar in the blood (hypoglycaemia),
The tablets should be swallowed with a glass of water. You should try to take
• muscle and joint pain,
• too much potassium in the blood (hyperkalaemia),
your daily dose at about the same time each day. It is important that you
• flu-like symptoms,
• changes in kidney function including kidney failure,
continue to take Losartan potassium until your doctor tells you otherwise.
• back pain and urinary tract infection,
• reduced number of red blood cells (anaemia),
• increased sensitivity to the sun (photosensitivity),
• increase in blood urea, serum creatinine and serum potassium in patients
If you take more Losartan potassium than you should
• unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis),
with heart failure.
If you accidently take too many tablets or a child swallows some, contact your
• impotence,
doctor immediately.
Symptoms of overdose are low blood pressure, increased heartbeat, possibly
decreased heartbeat.








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 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.
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 protect the environment.

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.
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 and 112 film-coated tablets,
Losartan potassium 25 mg: 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 and
112 film-coated tablets,
Losartan potassium 50 mg: 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 and
112 film-coated tablets,
Losartan potassium 100 mg: 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100
and 112 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., 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 02/2017.

P0497

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