Skip to Content

UK Edition. Click here for US version.

IRBESARTAN BLUEFISH 150 MG FILM-COATED TABLETS

Active substance(s): IRBESARTAN

View full screen / Print PDF » Download PDF ⇩
Transcript
Bluefish Pharmaceuticals
Reason of change

Revised text received on 04.03.15

Irbesartan tablets

Product name
Strength

75/150/300 mg

Country

UK

Dimension
Component
Braille

Revision no.

Packs

Artwork code
NA

Manufacturer

M/IRB/UK/P01

Hetero - V

Black

150 x 300 mm
Leaflet

Artwork made to

100%
Blister Layout No.
NA

PDC

Reviewed
&
Approved by

Remarks Font size: Heading 13, 11 pts.
Rest all 7 pts.

RA

QA

Date: 04.03.2015
R1 - Initial mock-up artwork - 31.08.12

R2 - Comments from MHRA - 17.09.12

R3 - Revised text received on 19.01.2015 - 19.01.2015 R4 - Revised text received on 20.01.2015 - 20.01.15

150 mm

United Kingdom

PACKAGE LEAFLET: INFORMATION FOR THE USER
Irbesartan 75 mg film-coated tablets
Irbesartan 150 mg film-coated tablets
Irbesartan 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 or nurse.
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 or nurse. This includes any possible side
effects not listed in this leaflet. See section 4

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Irbesartan is and what it is used for
What you need to know before you take Irbesartan
How to take Irbesartan
Possible side effects
How to store Irbesartan
Contents of the pack and other information

1. WHAT IRBESARTAN IS AND WHAT IT IS USED
FOR

300 mm

01

Pantone Shades

NA

Revision
History

No. of colours

05

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
Irbesartan should not be given to children and adolescents
(under 18 years).
Warnings and precautions
Talk to your doctor or pharmacists 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 or 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 heading “Do not take Irbesartan”
and “Warning 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
anti-inflammatory drugs, the effect of irbesartan may be
reduced.
Irbesartan with food and drink and alcohol
Irbesartan can be taken with or without food.
Pregnancy, breast-feeding and fertility
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
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 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
Always take this medicine exactly as your doctor or
pharmacist 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.

150 mm



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.

Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special
storage conditions.

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.

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.

The maximal blood pressure lowering effect should be
reached 4-6 weeks after beginning treatment.

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.

If you take more Irbesartan than you should:
If you accidentally take too many tablets, contact your
doctor immediately.
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 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
product, 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.

300 mm

5. HOW TO STORE IRBESARTAN

As with similar medicines, rare cases of allergic skin
reactions (rash, urticaria), as well as localized 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: 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 undesirable effects have been reported since
marketing of irbesartan.Undesirable effects where
frequency is unknown 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 (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 or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of
this medicine.

6. CONTENTS OF
INFORMATION

THE

PACK

AND

OTHER

What Irbesartan contains




The active substance is Irbesartan. Each tablet of
Irbesartan 75 mg contains 75 mg of irbesartan. Each
tablet of Irbesartan 150 mg contains 150 mg of
irbesartan. Each tablet of Irbesartan 300 mg contains
300 mg of irbesartan.
The other ingredients are
Tablet core: cellulose microcrystalline, carmellose
calcium, povidone (Kollidon 30), silica colloidal
anhydrous, calcium stearate Tablet coating;
hypromellose (E464), titanium dioxide (E171), talc
(E553b).

What Irbesartan looks like and contents of the pack
Irbesartan 75 mg film-coated tablets are white to off
white, capsule shaped, biconvex, tablets debossed with
‘158’ on one side and ‘H’ on other side.
Irbesartan 150 mg film-coated tablets are white to off
white, capsule shaped, biconvex, tablets debossed with
‘159’ on one side and ‘H’ on other side.
Irbesartan 300 mg film-coated tablets are white to
off-white, capsule shaped, biconvex, tablets debossed
with ‘160’ on one side and ‘H’ on other side.
Irbesartan film-coated tablets are supplied in the
following pack sizes:
PVC/PVDC/Aluminium foil blisters in cartons of 10, 14,
28, 30, 56, 84, 90 or 98 film-coated tablets.
PVC/PE/PVDC/Aluminium foil blisters in cartons of 10,
14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Bluefish Pharmaceuticals AB
Torsgatan 11
111 23 Stockholm
Sweden
This medicinal product is authorised in the Member
States of the EEA under the following names:
Member state
Denmark
France

Proposed (invented) names
Irbesartan Bluefish
IRBESARTAN BLUEFISH
75 mg/150 mg/300 mg comprimé
pelliculé
Germany
Irbesartan Bluefish 75 mg/
150 mg/300 mg Filmtabletten
Hungary
Irbezartán Bluefish 150 mg/
300 mg filmtabletta
Netherlands
Irbesartan Bluefish 75 mg/
150 mg/300 mg filmomhulde
tabletten
Norway
Irbesartan Bluefish
Portugal (RMS) Irbesartan Bluefish
Spain
Irbesartan Bluefish 75 mg/
150 mg/300 mg comprimidos
recubiertos con película EFG
Sweden
Irbesartan Bluefish
United Kingdom Irbesartan Bluefish 75 mg/
150 mg/300 mg film-coated tablets
This leaflet was last revised in 22/12/2014.

Expand view ⇕

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.

Hide