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LOSARTAN POTASSIUM LICONSA 50 MG FILM-COATED TABLETS

Active substance(s): LOSARTAN POTASSIUM

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Do not take Losartan potassium
• if you are allergic to losartan or any of the
other ingredients f this medicine (listed in
section 6),
• 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 and
breast-feeding”),
• if you have diabetes or impaired kidney
function and you are treated with a blood
pressure lowering medicine containing
aliskiren.
Warning and precautions
Talk to your doctor or pharmacist before
taking Losartan potassium.
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).
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),

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 X” and “Warnings and precautions”).
Losartan potassium with food and drink
Losartan potassium may be taken with or
without food.
Pregnancy and breast-feeding
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
Losartan potassium contains lactose
monohydrate. If you have been told by your
doctor that you have an intolerance to some
sugars, contact your doctor before taking this
medicine.
3. HOW TO TAKE LOSARTAN POTASSIUM
Always take this medicine exactly as your
doctor has told you. Check with your doctor 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.
Adult patients with High Blood Pressure
Treatment usually starts with 50 mg losartan
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 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 or adolescent (6 to 18 years old)
The recommended dose in patients who
weigh between 20 kg and 50 kg is 25 mg
administered once a day. The doctor may
increase the dose if blood pressure is not
controlled.

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
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
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
fewer than 1 out of 1,000 patients. You may
need urgent medical attention or
hospitalisation.
The following side effects have been reported
with Losartan potassium :
Common (may affect up to 1 in 10 people):
• dizziness,
• low blood pressure,
• debility,
• fatigue,
• too less sugar in the blood
(hypoglycaemia),
• too much potassium in the blood
(hyperkalaemia),
• reduced number of red blood cells
(anaemia),
• changes in kidney function (may be
reversible upon discontinuation of
treatment) including kidney failure,
• increase in blood urea, serum creatinine
and serum potassium in patients with heart
failure,
• vertigo.
Uncommon (may affect up to 1 in 100 people):
• 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,
• constipation,
• diarrhoea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• rash,
• localised swelling (oedema),
• Cough,
• oedema (swelling).

Side effects in children are similar to those
seen in adults.
Reporting of suspected adverse reactions
If you get any side effects, talk to your doctor,
pharmacist or nurse. 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 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 carton after EXP. The
expiry date refers to the last day of that
month.
No special storage conditions are required. Do
not open the blister pack until you are ready
to take the medicine.
Do not throw away medicines via wastewater.
Ask your pharmacist how to throw away
medicines you no longer use. These measures
will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Losartan potassium contains
The active substance is losartan potassium.
Each Losartan potassium 25 mg tablet
contains 25 mg of losartan potassium.
Each Losartan potassium 50 mg tablet
contains 50 mg of losartan potassium.
Each Losartan potassium 100 mg tablet
contains 100 mg of losartan potassium.
The other ingredients are:
- Tablet core: lactose monohydrate,
pregelatinised maize starch,
microcrystalline cellulose and magnesium
stearate.
- Tablet coating: hyprolose, hypromellose
and titanium dioxide.
What Losartan potassium looks like and
contents of the pack
Losartan potassium is supplied as round
white unscored film-coated tablets
containing 25 mg of losartan potassium.
Losartan potassium is supplied as round
white unscored film-coated tablets
containing 50 mg of losartan potassium.
Losartan potassium is supplied as round
white unscored film-coated tablets
containing 100 mg of losartan potassium.
Losartan potassium is supplied in the
following pack sizes:
Losartan potassium 25 mg - PVC/PE/PVDC
blister packages with aluminium foil lidding
in packs of 7, 10, 14, 15, 21, 28, 25, 50, 56, 90,
98, 100, 210 or 280 tablets
Losartan potassium 50 mg - PVC/PE/PVDC
blister packages with aluminium foil lidding
in packs of 7, 10, 14, 15, 21, 28, 30, 50, 56, 90,
98, 100, 210 or 280 tablets.
Losartan potassium 100 mg - PVC/PE/PVDC
blister packages with aluminium foil lidding
in packs of 7, 10, 14, 15, 21, 28, 30, 50, 56, 90,
98, 100, 210 or 280 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Laboratorios LICONSA S.A.
Gran Via Carlos 98,
7th Floor 08028, Barcelona
SPAIN
Manufacturer:
Laboratorios LICONSA, S.A.
Avda. Miralcampo, Nº 7,
Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara),
SPAIN
Distributor:
Creo Pharma Ltd
Felsted Business Centre, Felsted,
Essex CM6 3LY, UK.
This leaflet was last revised in
November 2014

CRE-LOS-PIL-145_01
24/03/2015

Myriad Pro 10/11 pt

2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE LOSARTAN POTASSIUM

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.

This medicine does not allow to take the
12.5 mg dose. In those cases in which losartan
12.5 mg is prescribed your doctor will have to
choose another product.

Typefaces

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
potassium has been shown to decrease the
risk of stroke (“LIFE indication”).

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 once daily, according to your
condition.

Pantone
Black

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.

Other medicines and Losartan potassium
Tell your doctor or pharmacist if you are
taking, have recently taken or might take 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, baclofene, 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,
triamteren, 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.

Patients with Heart Failure
Treatment usually starts with 12.5 mg losartan
once a day.

Not known (frequency cannot be estimated
from the available data):
• reduced number of thrombocytes,
• migraine,
• liver function abnormalities,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to the sun
(photosensitivity),
• unexplained muscle pain with dark
(tea-coloured)urine (rhabdomyolisis),
• impotence,
• 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).

Important
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David Heaton is unable to do this and cannot
accept liability for any errors.
Colours may not reproduce accurately on this
proof. You should refer to Pantone Reference
Guides for accurate colour match.

1. WHAT LOSARTAN POTASSIUM IS AND
WHAT IT IS USED FOR

Children and adolescents
Losartan potassium has been studied in
children. For more information, talk to your
doctor.

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).

No. of Draft Date
Reason for Draft
_01
24/03/2015 New file
_02
29/05/2015 Text revision

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

• if you are taking any of the following
medicines used to treat high blood
pressure:
− an ACE-inhibitor (for example enalapril,
lisinopril, ramipril), in particular if you
have diabetes-related kidney problems.
− 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 take Losartan potassium”.

24/03/2015
Creo Pharma
UK
CRE-LOS-PIL-145

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 gets, talk to
your doctor or pharmacist. This includes
any possible side effects not listed in this
leaflet. See section 4.

Adult patients with high blood pressure and
type 2 diabetes
Treatment usually starts with 50 mg losartan
once a day. The dose may later be increased
to 100 mg losartan once daily depending on
your blood pressure response.

Date
Client
Country
Job No.

Losartan potassium

Rare (may affect up to 1 in 1000 people):
• inflammation of blood vessels (vasculitis
including Henoch-Schonlein purpura),
• numbness or tingling sensation
(paraesthesia),
• fainting (syncope),
• very rapid and irregular heartbeat (artrial
fibrillation) brain attack (stroke),
• inflammation of the liver (hepatitis),
• elevated blood alanine aminotransferase
(ALT) levels, usually resolved upon
discontinuation of treatment.

Losartan potassium
25 mg / 50 mg / 100 mg
140 x 540 mm
n/a
1

Losartan potassium 25 mg / 50 mg / 100 mg
Film-coated Tablets

The recommended dose in patients who
weigh above 50 kg is 50 mg administered
once a day. The doctor may increase the dose
if blood pressure is not controlled.

Product Title
Strength
PIL Format
Initial Code
No of Colours

PACKAGE LEAFLET: INFORMATION FOR THE USER

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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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