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IRBESARTAN DR. REDDYS 150 MG FILM-COATED TABLETS

Active substance(s): IRBESARTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Irbesartan 75 mg, 150 mg, 300 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 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.
What is in this leaflet:
1 What Irbesartan is and what it is used for
2 What you need to know before you take Irbesartan
3 How to take Irbesartan
4 Possible side effects
5 How to store Irbesartan
6 Contents of the pack and information

1.What Irbesartan is and what it is used for
Irbesartan 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
prevents the binding of angiotensin-II to these receptors,
causing the blood vessels to relax and the blood
pressure to lower. Irbesartan slows the decrease of
kidney function in patients with high blood pressure and
type 2 diabetes.
Irbesartan 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
Do not take Irbesartan
• if you are allergic to irbesartan or any other
ingredients of this medicine (listed in section 6)
• if you are more than 3 months pregnant. (It is
also better to avoid Irbesartan in early pregnancy –
see pregnancy section)
• 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 before taking Irbesartan and 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 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
• 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
Irbesartan”.

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).
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
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
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”).
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 antiinflammatory drugs, the effect of irbesartan may be
reduced.
Irbesartan with food and drink
Irbesartan can 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 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 breast-feeding or about to
start breast-feeding. Irbesartan is not recommended for
mothers who are breast-feeding, and your doctor may
choose another treatment for you if you wish to breastfeed, 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 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 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
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you are
not sure.
Method of administration
Irbesartan is for oral use. Swallow the tablets with a
sufficient amount of fluid (e.g. one glass of water). You
can take Irbesartan 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 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 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 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.
Use in children and adolescents
Irbesartan 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 than you should
If you accidentally take too many tablets, contact your
doctor immediately.
If you forget to take Irbesartan
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
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
Irbesartan and contact your doctor immediately.
The frequency of the side effects listed below is defined
using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Side effects reported in clinical studies for patients
treated with 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 potassium.
Common (may affect up to 1 in 10 people):
• dizziness
• feeling sick/vomiting
• 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 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
• decreased levels of a protein in the red blood cells
(haemoglobin)
Uncommon (may affect up to 1 in 100 people:
• heart rate increased
• flushing
• cough
• diarrhea
• indigestion/heartburn
• sexual dysfunction (problems with 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

inflammation of small blood vessels mainly
affecting the skin (a condition known as
leukocytoclastic vasculitis)
Uncommon cases of jaundice (yellowing of the skin
and/or whites of the eyes) have also been reported.
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 Yellow Card Scheme at:
http://yellowcard.mhra.gov.uk/. By reporting side effects
you can help provide more information on the safety of
this medicine.

5. How to store Irbesartan
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 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.
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.

6. Contents of the pack and other
information
What Irbesartan contains
• The active substance is irbesartan. Each filmcoated tablet contains 75 mg, 150 mg, or 300 mg
irbesartan.
• The other ingredients are: Tablet core; lactose
monohydrate, povidone, crospovidone,
microcrystalline cellulose, colloidal anhydrous
silica, magnesium stearate Tablet coating; lactose
monohydrate, hypromellose, titanium dioxide and
macrogol 4000

What Irbesartan looks like and contents of the pack
The tablets are white to off-white, oval shaped, film
coated tablets with ‘IRB’ debossed on one side and
‘75’, ‘150’ or ‘300’ on other side.
Tablets are blister-packed in cartons of 28, 30, 50, 56,
60, 98 or 100 film-coated tablets. Not all pack sizes
may be marketed.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road,
Beverley, HU17 0LD, United Kingdom
This medicinal product is authorised in the Member
States of the EEA under the following names:
Italy: Irbesartan ESSETI 75 mg, 150 mg, 300 mg
compresse rivestite con film
United Kingdom: Irbesartan 75 mg, 150 mg, 300 mg
film-coated tablets
This leaflet was last revised in 11/2014

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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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