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IRBESARTAN ACCORD 300 MG FILM-COATED TABLETS

Active substance(s): IRBESARTAN

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Irbesartan

Market

UK

Language

English

Size

170 x 550 mm PIL

Min. Font Size

10

Version No.

5 (Page 1 of 2) (IB/04)

Date

08.03.13 (Irbesartan (ACC-UK)IB04-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Approved By
Quality Assurance

You may need to have blood checks if you
take:
Package leaflet: Information for the user

Irbesartan 75mg
Film-coated Tablets
Irbesartan 150mg
Film-coated Tablets
Irbesartan 300mg
Film-coated Tablets
irbesartan
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 further questions, please 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, call your doctor
or pharmacist. This includes any possible
side effects not listed in this leaflet.
What is in this leaflet:
1. What Irbesartan Tablets are and what they
are 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. Contents of the pack and other
information

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 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 adult patients
• 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. What you need to know before
you take Irbesartan Tablets
Do not take Irbesartan Tablets:
• If you are allergic to irbesartan or any of
the other ingredients of this medicine
(listed in section 6).
• If you are more than 3 months pregnant.(It
is also better to avoid Irbesartan Tablets in
early pregnancy)
Irbesartan Tablets should not be given to
children and adolescents under 18 years of
age.
Warnings and Precautions:
Talk to your doctor or pharmacist before
taking Irbesartan Tablets:
• 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 you
are ( or might become) pregnant.
Irbesartan Tablets 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).
Children
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:

• 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.
Irbesartan Tablets with food and drink
Irbesartan Tablets can be taken with or
without food. 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 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 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. Irbesartan
Tablets 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, talk to
your doctor before attempting to drive or use
machines.
Irbesartan Tablets contains lactose (as
lactose monohydrate)
Irbesartan Tablets contains lactose (as
lactose monohydrate). If you have been told
by your doctor that you have intolerance to
some sugars, contact your doctor before
taking this medicine. Patients with rare
hereditary problems of galactose
intolerance, the lapp lactase deficiency or
glucose-galactose malabsorption should not
take this medicinal product.

3. How to take Irbesartan
Tablets
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not
sure.
The recommended 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 effects 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. The tablets
should be swallowed with a sufficient
amount of fluid (e.g. one glass of water).
You can take Irbesartan Tablets with or
without food. 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.
Use in Children
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 take more Irbesartan Tablets than
you should
If you accidentally take too many tablets,
contact your doctor immediately.

Tell your doctor or pharmacist if you are
taking, or have recently taken any other
medicines, including medicines obtained
without a prescription.

The symptoms of overdose are hypotension
and tachycardia.

Irbesartan Tablets does not usually interact
with other medicines.

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 forget to take Irbesartan Tablets

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Irbesartan

Market

UK

Language

English

Size

170 x 550 mm PIL

Min. Font Size

10

Version No.

5 (Page 2 of 2) (IB/04)

Date

08.03.13 (Irbesartan (ACC-UK)IB04-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

If you stop taking Irbesartan Tablets
Do not discontinue the treatment without
consulting your doctor. It is important that
you take Irbesartan Tablets for as long as
your doctor prescribes it. This will keep your
blood pressure controlled and /or protect
your kidneys from worsening damage.
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. 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 this medicine and contact your
doctor immediately.
The frequency of the side effects listed
below is defined using the following
convention:
Very common: at least 1 in 10 patients or
more
Common: at least 1 in 100 and less than 1
in 10 patients
Uncommon: at least 1 in 1000 and less than
1 in 100 patients
Rare: at least 1 in 10,000 and less than 1 in
1000 patients
Very rare (less than 1 in 10,000 patients)
Not known (cannot be estimated from the
available data)
Side effects reported in clinical studies for
patients treated with Irbesartan Tablets
were:
Very common
 you suffer from high blood pressure and
type 2 diabetes with kidney disease, blood
test may show an increase in levels of
potassium.
Common
 Dizziness
 Feeling sick/vomiting and fatigue
 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 renal 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 undesirable effects have been
reported since marketing of Irbesartan
Tablets. 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
 Liver function abnormal
 Increased blood potassium levels
 Impaired renal function
 Inflammation of small blood vessels mainly
affecting the skin (a condition known as
leukocytoclastic vasculitis).
Uncommon cases of jaundice (yellowing of
the skinand/or whites of the eyes) have also
been reported.
If you get any side effects, talk to your
doctor or pharmacist. This includes any side
effects not listed in this leaflet.

5. How to store Irbesartan
Tablets
• Keep this medicine out of the sight and
reach of children.
• Do not use this medicine after 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.
• No special storage conditions
recommended.
• Do not remove the tablets from the blister
pack until you are ready to take the
medicine.
• 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 protect the environment.

Approved By
Quality Assurance

6. Contents of the pack and
other information
What Irbesartan Tablets contain:
The active substance is Irbesartan. Each
film–coated tablet of Irbesartan 75 mg, 150
mg, 300 mg contains 75 mg, 150 mg, 300
mg of Irbesartan.
The other ingredients in the tablet core are
Lactose monohydrate, Croscarmellose
Sodium (E468), Cellulose microcrystalline
(E460), Hypromellose E5 (E464), Silica,
colloidal anhydrous (E551), Magnesium
stearate (E572).
The other ingredients in the tablet coating
are hypromellose E5 (E464), macrogol 400,
lactose monohydrate and titanium dioxide
(E 171)
What Irbesartan 75,150, 300 mg Tablets
look like and the content of the packs:
Irbesartan 75 mg Tablets are White to off
white, oval, biconvex, film coated tablet
debossed ‘I 75’ on one side and plain on
other side.
Irbesartan 150 mg Tablets are White to off
white, oval, biconvex, film coated tablet
debossed ‘I 150’ on one side and plain on
other side.
Irbesartan 300 mg Tablets are White to off
white, oval, biconvex, film coated tablet
debossed ‘I 300’ on one side and plain on
other side.
Irbesartan, 75 mg, 150mg and 300 mg
Tablets are supplied in blister packs of 8,
14, 28, 56, 64 and 98 Tablets.
Not all pack sizes are marketed.
Marketing authorization holder
Accord Healthcare Limited.
Sage house, 319 Pinner road,
North Harrow, HA1 4HF United Kingdom
Manufacturer:
Accord Healthcare Limited.
Sage house, 319 Pinner road, North Harrow,
HA1 4HF
United Kingdom
Cemelog-BRS Ltd.
H-2040 Budaors, Vasut u.13
Hungary
The leaflet was last revised in 12/2012

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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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