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LOSARTAN POTASSIUM LICONSA 25 MG FILM-COATED TABLETS

Active substance: LOSARTAN POTASSIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

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

Read all of this leaflet carefully before taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your 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 notice 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
potassium 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, think you may be or are planning to
become pregnant (see also “Pregnancy and
breast-feeding”),
• 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
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 angioedema
(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).
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, 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 heparine),
• 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 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
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 potassium 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 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.
Important information about some of the
ingredients of Losartan potassium
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 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.
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 and 50kg is 25 mg administered
once a day. The doctor may increase the dose if
blood pressure is not controlled
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
Adults 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).

Continued on the next page >>

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.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Losartan potassium 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 side effects of medicines are classified as
follows:
very common: happening in more than 1 in 10
patients
common: happening in 1 in 100 to 1 in 10
patients
uncommon: happening in 1 in 1,000 to 1 in 100
patients
rare: happening in 1 in 10,000 to 1 in 1,000
patients
very rare: happening in less than 1 in 10,000
patients
not known: (cannot be estimated from the
available data)
The following side effects have been reported
with Losartan potassium:
Common:
• 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:
• 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).

Not known:
• reduced number of thrombocytes,
• migraine,
• liver function abnormalities,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary track 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)
Side effects in children are similar to those seen
in adults.
If any of the side effects get serious, or if you
notice any side effects 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.
No special storage conditions are required. Do
not open the blister pack until you are ready to
take the medicine.
Medicines should not be disposed of via
wastewater 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 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 Vía Carlos III, 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
Sandoz Limited
Frimley Business Park
Frimley, Camberley
Surrey
GU16 7SR
This leaflet was last revised in 09/2014

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.
SZ00000LT000

Artwork Proof Box
Ref: N001 - Register Sandoz as OLS
Proof no.
001.0

Date prepared:
11/09/2014

Colours:
Black
Dimensions: 140 x 594 mm

Font size:
8pt
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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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