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LOSARTAN POTASSIUM LICONSA 50 MG FILM-COATED TABLETS

Active substance(s): LOSARTAN POTASSIUM / LOSARTAN POTASSIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Material Leaflet Drawing #: 231
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541164-01 LF LOSA ALM 25,50,100MG OLS SANDOZ UK

Date: 27.02.17

Laetus #: 20140
A

Version:

Folded:

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Pantones:

YES
NO

(*) Customer:

Signature:
Date:

Quality Assurance:
Signature:
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Drawed by:

black

Substitutes mat.#:

112

Losartan potassium

X

LICONSA
LEON FARMA

_ 1 mm
Dimensions: 140 x 540 +
Customer change:

Scale: 100%

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

533048

358

1 fold in horizontal to 140 x 270mm

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.

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”.

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

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 pressure lowering
effect of losartan.

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) in adults and in children and
adolescents 6 – 18 years of age.
• 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”).

2. What you need to know before
you take Losartan potassium
Do not take Losartan potassium
• if you are allergic to losartan or any of the
other ingredients of 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),
• 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

Children and adolescents
Losartan potassium has been studied in
children. For more information, talk to your
doctor.
Losartan is not recommended for use in
children suffering from kidney or liver
problems, as limited data are available in these
patient groups. Losartan is not recommended
for use in children under 6 years old, as it has
not been shown to work in this age group.

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
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this 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
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 and adolescent
Children below 6 years of age
Losartan is not recommended for use in
children under 6 years old, as it has not been
shown to work in this age group.

Material Leaflet Drawing #: 231
type:

Customer change:

Material #/
Product :

Folded:

Date: 27.02.17

A

Pantones:

YES
NO

(*) Customer:

Signature:
Date:

Quality Assurance:
Signature:
Date:

Drawed by:
Signature:
Date:

X

Internal change:

541164-01 LF LOSA ALM 25,50,100MG OLS SANDOZ UK

Laetus #: 20140
Version:

X

LICONSA
LEON FARMA

_ 1 mm
Dimensions: 140 x 540 +
Launch:

Scale: 100%

black

Substitutes mat.#:

112

533048

358

1 fold in horizontal to 140 x 270mm

Children aged 6-18 years old
The recommended starting dose in patients
who weight 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). The
doctor may increase the dose if blood pressure
is not controlled.
Other form(s) of this medicine may be more
suitable for children; ask your doctor or
pharmacist.
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.
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
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
once daily, according to your condition.
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.
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.
If you stop taking Losartan potassium
If you have any further questions on the use of
this medicine, 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, (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,
• debility,
• fatigue,
• too little sugar in the blood
(hypoglycaemia),
• too much potassium in the blood
(hyperkalaemia),
• reduced number of red blood cells
(anaemia),
• changes in kidney function including kidney
failure,
• increase in blood urea, serum creatinine and
serum potassium in patients with heart
failure
Uncommon (may affect up to 1 in 100 people):
• somnolence,
• headache,
• sleep disorders,
• feeling of increased heart rate (palpitations),
• severe chest pain (angina pectoris),
• shortness of breath (dyspnoea),
• abdominal pain,
• obstipation,
• diarrhoea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• rash,
• localised swelling (oedema).
• Cough.

Rare (may affect up to 1 in 1000 people):
• hypersensitivity,
• angioedema,
• 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.
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),
• 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 the the UK
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 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, 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
This leaflet was last revised in
December 2016

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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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