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IRBESARTAN 300MG TABLETS

Active substance(s): IRBESARTAN

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Package leaflet: Information for the user
Irbesartan 75 mg tablets
Irbesartan 150 mg tablets
Irbesartan 300 mg tablets
Irbesartan
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
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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. 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, tell 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 Irbesartan tablets is and what
it is used for
2. What you need to know before you
take Irbesartan tablets
3. How to take Irbesartan tablets
4. Possible side effects
5. How to store Irbesartan tablets
6. Content of the pack and other
information
1. What Irbesartan tablets is and
what is used for
Irbesartan tablets 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. Irbesartan tablets prevents
the binding of angiotensin-II to these
receptors, causing the blood vessels
to relax and the blood pressure to
lower. Irbesartan tablets slows the
decrease of kidney function in
patients with high blood pressure and
type 2 diabetes.
Irbesartan tablets is used in the
treatment of high blood pressure
(hypertension essential) and for the
protection of the kidney in
hypertensive type 2 diabetic patients
with laboratory evidence of impaired
renal function.
2. What you need to know before
you take Irbesartan tablets
Do not take Irbesartan tablets
ƒ if
you
are
allergic
(hypersensitive) to irbesartan
or any other ingredients of
Irbesartan tablets
ƒ if you are more than 3
months pregnant. (It is also
better to avoid Irbesartan in
early pregnancy – see
pregnancy section).
ƒ if you have diabetes or
impaired kidney function
and you are treated with a
blood pressure lowering
medicine containing aliskiren.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Irbesartan tablets
ƒ if you suffer from excessive
vomiting or diarrhoea
ƒ if you suffer from kidney
problems
ƒ if you suffer from heart
problems
ƒ if you are to undergo any
surgery or receive anaesthetics,
you should also tell your
doctor about it
ƒ You must tell your doctor if
you think you are (or might
become) pregnant. Irbesartan
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).
ƒ 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 Irbesatan”.
Children and adolescents
This medicinal product should not be
used in children and adolescents

because the safety and efficacy have
not yet been fully established.
Other medicines and Irbesartan
tablets
Tell your doctor or pharmacist if you
are taking or have recently taken any
other medicines, including medicines
obtained without a prescription.
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 Irbesartan”
and “Warnings and precautions”).
Irbesartan tablets does not usually
interact with other medicines. Special
precautionary measures (e.g. blood
tests) may be appropriate if you take
potassium supplements, potassiumcontaining salt substitutes, potassiumsparing medicines (such as certain
diuretics) or lithium-containing medicines.
As with other blood pressure
lowering drugs, the effect of
irbesartan may be reduced when you
take non-steroidal anti-inflammatory
drugs.
Irbesartan tablets with food and
drink
Irbesartan tablets can be taken
before, during or after meals. The
tablets should be swallowed with a
drink of water.
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 Irbesartan
before you become pregnant or as
soon as you know you are pregnant
and will advise you to take another
medicine instead of Irbesartan.
Irbesartan 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 breastfeeding or about to start breastfeeding.
Irbesartan
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.
Irbesartan tablets is unlikely to affect
your ability to drive or use machines.
However, occasionally dizziness or
weariness
may
occur
during
treatment of high blood pressure. If
you experience these, you should
consult your doctor before attempting
such activities.
Irbesartan tablets contains lactose
Irbesartan tablets contains lactose
monohydrate
(see
"Further
information"). 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 Irbesartan tablets
Always take Irbesartan tablets
exactly as your doctor has told you.
You should check with your doctor
or pharmacist if you are not sure.
The usual dose is 150 mg once a day.
The dose may later be increased to
300 mg once daily depending on
blood pressure response. The
maximal blood pressure lowering
effect should be reached 4-6 weeks
after beginning treatment.

In patients with high blood pressure
and type 2 diabetes, 300 mg once
daily is the preferred maintenance
dose for the treatment of associated
kidney disease.
The doctor may advise a lower dose,
especially when starting treatment in
certain patients such as those on
haemodialysis, or those over the age
of 75 years.
Irbesartan tablets is for oral use and
is taken before, during or after meals.
The tablets should be swallowed with
a drink 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 Irbesartan
tablets until your doctor tells you
otherwise.
Irbesartan tablets should not be given
to children (under 18 years).
If you take more Irbesartan tablets
than you should
If you accidentally take too many
tablets, or a child swallows some,
contact your doctor immediately.
Too high a dose could cause
dizziness, fainting, rapid or pounding
heartbeat.
If you forget to take Irbesartan
tablets
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 dose.

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 Irbesartan tablets
Keep this medicine out of the sight
and reach of children.
Do not use Irbesartan tablets after the
expiry date which is stated on the
carton and on the blister after EXP.
The expiry date refers to the last day
of that month.
Store in the original package in order
to protect from light.
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 to protect
the environment.
6. Contents of the pack and other
information
What Irbesartan tablets contains

If you have any further questions on
the use of this medicine, ask your
doctor or pharmacist.

ƒ

4. Possible side effects

ƒ

Like all medicines, irbesartan can
cause side effects, although not
everybody gets them.
Some effects may be serious and may
require medical attention.
As with similar medicines, rare cases
of allergic skin reactions (rash,
urticaria), as well as localised
swelling of the face, lips and/or
tongue have been reported in patients
taking irbesartan. Uncommon cases
of jaundice (yellowing of the skin
and/or whites of the eyes) have also
been reported. If your get any of
these symptoms or get short of
breath, stop taking this medicine
and
contact
your
doctor
immediately.
Side effects reported in clinical
studies for patients treated with this
irbesartan were:
• Very common (may affect more
than 1 in 10 people): if you suffer
from high blood pressure and type
2 diabetes with kidney disease,
blood tests may show an
increased level of potassium.
• Common (may affect up to 1 in 10
people): dizziness, feeling sick/
vomiting, fatigue and blood tests
may show raised levels of an
enzyme that measure the muscle
and heart function (creatine kinase
enzyme). In patients with high
blood pressure and type 2 diabetes
with kidney disease, dizziness
when getting up from a lying or
sitting position, pain in joints or
muscles and decreased levels of a
protein in the red blood cells
(haemoglobin) were also reported.
• Uncommon (may affect up to 1 in
100 people): heart rate increased,
flushing, cough, diarrhoea, indigestion/
heartburn, sexual dysfunction (problems
with the sexual performance), chest
pain.
Some undesirable effects have been
reported
since
marketing
of
irbesartan. Undesirable effects where
the frequency is not known are:
feeling of spinning, headache, taste
disturbance, ringing in the ears,
muscle cramps, pain in joints and
muscles, abnormal liver function,
increased blood potassium levels,
impaired kidney function, and
inflammation of small blood vessels
mainly affecting the skin ( condition
known as leukocytoclastic vasculitis).
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.
Reporting of side effects
If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects not

The active substance is
irbesartan.
Each
tablet
contains 75/150/300 mg of
irbesartan.
The other ingredients are
cellulose
microcrystalline
(E460),
croscarmellose
sodium (E468), lactose
magnesium
monohydrate,
stearate
(E572),
silica
colloidal anhydrous (E551),
maize starch, povidone
K29/32
(E-1201)
and
hydrogenated castor oil.

What Irbesartan tablets looks like
and contents of the pack
Irbesartan 75 mg/ tablets are white,
cylindrical, biconvex tablets.
Irbesartan 150 mg/ tablets are white,
cylindrical, biconvex, scored on one
side tablets.
Irbesartan 300 mg/ tablets are white,
oblong, biconvex, scored on one side
tablets.
Irbesartan tablets are supplied in blisters
of pack sizes of 14, 28, 56 or 98.
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
This
medicinal
product
is
authorised in the Member States
under the following names:
United Kingdom
Irbesartan tablets
The Netherlands
Licolin 75 mg/150 mg/300 mg tablet
Austria
Licolin 75 mg/150 mg/300 mg tablette
Ireland
Licolin 75 mg/150 mg/300 mg
This leaflet was last revised
November 2015

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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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