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IRBESARTAN 150MG FILM-COATED TABLET

Active substance(s): IRBESARTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Irbesartan 150 mg film-coated tablets
Irbesartan

Read all of this leaflet carefully
before you start taking this medicine.
! 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
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.

Irbesartan Tablets do not usually
interact with other medicines.
You may need to have blood checks if
you take:
! potassium supplements
! salt substitutes containing potassium
! potassium-sparing medicines (such
as certain diuretics)
! medicines containing lithium
If you take certain painkillers, called
non-steroidal anti-inflammatory drugs,
the effect of irbesartan may be reduced.
Taking Irbesartan Tablets with food
and drink
Irbesartan Tablets can be taken with or
without food.

In this leaflet:
1. What Irbesartan Tablets are and
what they are used for
2. Before you take Irbesartan Tablets
3. How to take Irbesartan Tablets
4. Possible side effects
5. How to store Irbesartan Tablets
6. Further information

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 Tablets before you
become pregnant or as soon as you
know you are pregnant and will advise
you to take another medicine instead of
Irbesartan Tablets. Irbesartan Tablets
are 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.

1. WHAT IRBESARTAN TABLETS
ARE AND WHAT THEY ARE USED
FOR
Irbesartan Tablets belong 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 prevent 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 are used
! to treat high blood pressure
(essential hypertension)
! to protect the kidney in patients with
high blood pressure, type 2 diabetes
and laboratory evidence of impaired
kidney function.
2. B E F O R E Y O U T A K E
IRBESARTAN TABLETS
Do not take Irbesartan Tablets
! if you are allergic (hypersensitive) to
irbesartan or any other ingredients of
Irbesartan Tablets
! if you are more than 3 months
pregnant. (It is also better to avoid
Irbesartan Tablets in early pregnancy
see pregnancy section.)
Irbesartan Tablets should not be given
to children and adolescents (under 18
years).
Take special care with Irbesartan
Tablets
Tell your doctor if any of the following
apply to you:
! if you get excessive vomiting or
diarrhoea
! if you suffer from kidney problems
! if you suffer from heart problems
! if you receive Irbesartan Tablets for
diabetic kidney disease. In this
case your doctor may perform
regular blood tests, especially for
measuring blood potassium levels in
case of poor kidney function
! if you are going to have an
operation (surgery) or be given
anaesthetics
You must tell your doctor if you think that
you are (or might become) pregnant.
I r b e s a r t a n Ta b l e t s a r e n o t
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).
Using 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.

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Breastfeeding
Tell your doctor if you are breast-feeding
or about to start breast-feeding.
I r b e s a r t a n Ta b l e t s a r e n o t
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.
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Driving and using machines
No studies on the effects on the ability to
drive and use machines have been
performed. Irbesartan Tablets are
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, talk to your
doctor before attempting to drive or use
machines.
Important information about some of
the ingredients of Irbesartan Tablets
Irbesartan Tablets contain lactose. If
you have been told by your doctor that
you have an intolerance to some sugars
(e.g. lactose), 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.
Other strengths are available.
Method of administration
Irbesartan Tablets is for oral use.
Swallow the tablets with a sufficient
amount of fluid (e.g. one glass of water).
You can take Irbesartan Tablets with or
without food. 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.
Patients with high blood pressure
The usual dose is 150 mg once a day.
The dose may later be increased to 300
mg (two tablets a day) once daily
depending on blood pressure response.
Patients with high blood pressure and
type 2 diabetes with kidney disease
In patients with high blood pressure and
type 2 diabetes, 300 mg (two tablets a
day) 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.
The maximal blood pressure lowering
effect should be reached 4-6 weeks
after beginning treatment.
If you take more Irbesartan Tablets
than you should
If you accidentally take too many
tablets, contact your doctor
immediately.
Children should not take Irbesartan
Tablets
Irbesartan Tablets should not be given
to children under 18 years of age. If a
child swallows some tablets, contact
your doctor immediately.
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.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Irbesartan Tablets
can cause side effects, although not
everybody gets them. Some of these
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. If you get any
of these symptoms or get short of
breath, stop taking Irbesartan Tablets
and contact your doctor immediately.
The frequency of the side effects listed
below is defined using the following
convention:
Very common:
Common:
Uncommon:
Rare:
Very rare:
Not known:

affects more than 1
user in 10
affects 1 to 10 users in
100
affects 1 to 10 users in
1,000
affects 1 to 10 users in
10,000
affects less than 1 user
in 10,000
Frequency cannot be
estimated from the
available data

Side effects reported in clinical studies
for patients treated with Irbesartan
Tablets were:

! Very common: if you suffer from high
blood pressure and type 2 diabetes
with kidney disease, blood tests may
show an increased level of
potassium.

! Common: dizziness, feeling
sick/vomiting, fatigue and blood tests
may show raised levels of an enzyme
that measures 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, low blood
pressure 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: heart rate increased,
flushing, cough, diarrhoea,
indigestion/heartburn, sexual
dysfunction (problems with sexual
performance), chest pain.

Some side effects have been reported
since marketing of irbesartan but the
frequency for them to occur is not
known. These side effects are:
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 (a 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.
5. HOW TO STORE IRBESARTAN
TABLETS
Keep out of the reach and sight 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.
This medicinal product does not require
any special storage conditions.
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 Irbesartan Tablets contains
The active substance is irbesartan.
Each tablet contains 150 mg irbesartan.
The other ingredients are lactose
monohydrate, microcrystalline
cellulose, croscarmellose sodium,
hypromellose, colloidal anhydrous
silica, magnesium stearate, titanium
dioxide (E171) and macrogol 3350.
What Irbesartan Tablets looks like
and contents of the pack
Irbesartan Tablets 150 mg film-coated
tablets are white, oblong, convex and
scored on one side.
The score line is only to facilitate
breaking for ease of swallowing and not
to divide into equal doses.
Irbesartan Tablets 150 mg film-coated
tablets are supplied in blister packs of
14, 28, 30, 56 and 90 film-coated
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
Leicester, LE3 0PA,
United Kingdom
Manufacturer
We s t P h a r m a
Produções de
Especialidades Farmacêuticas, S.A.
Rua João de Deus, n.º 11, Venda Nova,
2700-486 Amadora, Portugal
Atlantic Pharma
Produções
Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2;
Abrunheira, 2710-089 Sintra, Portugal
This leaflet was last approved in
04/2011

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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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