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IRBESARTAN NICHE 300MG FILM-COATED TABLETS

Active substance(s): IRBESARTAN

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Package leaflet: Information for the user

Irbesartan Niche 150 mg and 300 mg
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 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.

The name of your medicine is Irbesartan
Niche 150 mg or 300 mg Film-Coated Tablets.
It will be called Irbesartan Niche for ease
from here on.
What is in this leaflet:
1. What Irbesartan Niche is and what it is
used for
2. What you need to know before you take
Irbesartan Niche
3. How to take Irbesartan Niche
4. Possible side effects
5. How to store Irbesartan Niche
6. Contents of the pack and other
information

1. What Irbesartan Niche is and
what it is used for
Irbesartan Niche 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 Niche prevents the
binding of angiotensin-II to these receptors,
causing the blood vessels to relax and the
blood pressure to lower. Irbesartan Niche
slows the decrease of kidney function in
patients with high blood pressure and type 2
diabetes.
Irbesartan Niche 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 Niche
Do not take Irbesartan Niche:
■ 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 Niche
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
Irbesartan Niche should not be given to
children and adolescents (under 18 years).
Warnings and precautions
Talk to your doctor before taking
Irbesartan Niche 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 Niche 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:
q an ACE-inhibitor (for example enalapril,
lisinopril, ramipril), in particular if you
have diabetes-related kidney problems.
q 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 Niche”.
You must tell your doctor if you think you are
(or might become) pregnant. Irbesartan
Niche 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 Niche
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 Niche” and
“Warnings and precautions”).
Irbesartan Niche does 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 nonsteroidal anti-inflammatory drugs, the effect
of irbesartan may be reduced.
Irbesartan Niche with food and drink
Irbesartan Niche 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 Niche before you become
pregnant or as soon as you know you are
pregnant and will advise you to take another
medicine instead of Irbesartan Niche.
Irbesartan Niche 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
Niche 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 Niche 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.

3. How to take Irbesartan Niche
Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.
Irbesartan Niche is for oral use. Swallow the
tablets with a sufficient amount of fluid (e.g.
one glass of water). You can take Irbesartan
Niche 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 Niche until your doctor tells you
otherwise.
The recommended dose is:
■ 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 Niche should not be given to
children or adolescents under 18 years of
age. If a child swallows some tablets,
contact your doctor immediately.
If you take more Irbesartan Niche than
you should
If you accidentally take too many tablets,
contact your doctor immediately.
If you forget to take Irbesartan Niche
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.
Serious allergic reactions
As with similar medicines, rare cases of
allergic skin reactions (rash, urticaria (hives)),
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 Niche and contact
your doctor immediately.
Other side effects
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 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 measures the
muscle and heart function (creatine kinase
enzyme)
In patients with high blood pressure and
type 2 diabetes with kidney disease the
following side effects were also reported:
■ 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
■ diarrhoea
■ 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, reduced number of platelets,
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).
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.
Also you can help to make sure that
medicines remain as safe as possible by
reporting any unwanted side effects via the
internet at www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone 0808
100 3352 (available from 10 a.m. to 2 p.m.
Mondays to Fridays) or fill in a paper form
available from your local pharmacy.

5. How to store Irbesartan Niche
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 medicine 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 Niche film-coated
tablets contain:
■ The active substance is Irbesartan.
Irbesartan Niche film coated tablets
contain 150 milligrams (mg) or 300 mg of
Irbesartan.
■ The other core ingredients are mannitol
(E421), croscarmellose sodium, colloidal
anhydrous silica (E551), poloxamer 188,
magnesium stearate (E572) and for the
film-coating opadry white 03B28796
which contains hypromellose (E464),
titanium dioxide (E171) and macrogol.
What Irbesartan Niche film-coated
tablets look like and contents of the
pack:
■ The 150 mg tablets are white to off- white
coloured, oval shaped, biconvex, filmcoated tablets with “U” debossed on one
side and “I” debossed on the other side.
The tablet is approximately 4.8mm thick,
12.5mm long and 6.5mm wide.
■ The 300 mg tablets are white to off- white
coloured, oval shaped, biconvex, filmcoated tablets with “U” debossed on one
side and plain on the other side. The
tablet is approximately 5.6mm thick,
15.7mm long and 8.1mm wide.
The 150 mg and 300 mg tablets are supplied
in white opaque PVC/PVdC-Aluminium
blister packs of 10, 14, 28, 30, 56, 84, 90 or
98.
Not all pack sizes will be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation Holder is:
Niche Generics Limited,
1 The Cam Centre, Wilbury Way, Hitchin,
Hertfordshire, SG4 0TW, United Kingdom.
The Manufacturer is:
Niche Generics Limited,
Unit 5, 151 Baldoyle Industrial Estate,
Dublin 13, Ireland
This medicinal product is authorised in
the Member States of the EEA under
the following names:
United Kingdom and Ireland: Irbesartan
Niche
This leaflet was last revised in: 10/2017.

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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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