Skip to Content

UK Edition. Click here for US version.

IRBESARTAN 150 MG FILM-COATED TABLETS

Active substance(s): IRBESARTAN

View full screen / Print PDF » Download PDF ⇩
Transcript
50 mm

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
What is in this leaflet:
1. What Irbesartan is and what it is used for
2. What do 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 further 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 DO 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 or pharmacist before taking
Irbesartan
• 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”.

140 mm

Same Size Artwork

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.
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.
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”).
If you take certain painkillers, called non-steroidal antiinflammatory drugs, the effect of irbesartan may be
reduced.

430 mm

Irbesartan 75mg film-coated tablets
Irbesartan 150mg film-coated tablets
Irbesartan 300mg film-coated tablets

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).

Irbesartan with food and drink
Irbesartan can be taken with or without food.
Pregnancy, breast-feeding and fertility
Pregnancy
You must tell your doctor if you think that 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 contains lactose monohydrate
If you have been told by your doctor that you have an
intolerance to some sugars (e.g. lactose monohydrate),
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.
The recommended dose is:
Patients with high blood pressure
The usual dose is 150mg once a day. The dose may
later be increased to 300mg once daily depending on
blood pressure response.

IXXXXXX

Package leaflet: Information for the user

50 mm

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.

Reporting of side effects
If you get any side effects, talk to your doctor, 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.

The maximal blood pressure lowering effect should be
reached 4-6 weeks after beginning treatment.
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 your medicine 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 your medicine
until your doctor tells you otherwise.
For 150mg and 300mg tablets, the score line is only to
facilitate breaking for ease of swallowing and not to
divide into equal doses.
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
product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Irbesartan 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.
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, 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.

5. HOW TO STORE IRBESARTAN
• Keep this medicine out of the sight and reach of children.
• Do not use Irbesartan 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 medicine 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
FURTHER INFORMATION
What Irbesartan contains
• Each tablet contains 75mg or 150mg or 300mg
irbesartan which is the active substance.
• The other ingredients are: lactose monohydrate,
microcrystalline cellulose, croscarmellose sodium,
poloxamer 188, pregelatinised maize starch and
magnesium stearate.
The tablet coating contains hydroxypropyl cellulose,
hypromellose, titanium dioxide and talc.
What Irbesartan looks like and contents of the pack
• 75mg: white to off-white, oblong, biconvex, filmcoated tablets, embossed with ‘BL’ on one side and
‘75’ on the other.
• 150mg: white to off-white, oblong, biconvex, filmcoated tablets embossed with ‘B’ and ‘L’ on either
side of the score line and ‘150’ on the other.
• 300mg: white to off-white, oblong, biconvex, filmcoated tablets embossed with ‘B’ and ‘L’ on either
side of the score line and ‘300’ on the other.
• Irbesartan is supplied in blister packs of 14, 28, 30,
56, 84, 90 or 98 film-coated tablets.Not all pack sizes
may be marketed.
Marketing Authorisation Holder and Manufacturer:
Bristol Laboratories Limited
Unit 3, Canalside, Northbridge Road, Berkhamsted,
Hertfordshire, HP4 1EG, United Kingdom
Telephone :0044(0)1442200922
Fax :
0044(0)1442873717
Email : info@bristol-labs.co.uk
Irbesartan 75mg film-coated tablets; PL 17907/0421
Irbesartan 150mg film-coated tablets; PL 17907/0422
Irbesartan 300mg film-coated tablets; PL 17907/0423
This leaflet was last revised in July 2016
To request the copy of this leaflet in Braille, large print or
audio format, please contact the licence holder at the
address (or telephone, fax, email) above.

• Not known (frequency cannot be estimated from
the available data):
vertigo, reduced number of platelets, headache, taste
disturbance, ringing in the ears, muscle cramps and
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).
V10 21-07-2016 D0

140 mm

Same Size Artwork

XXXXXX

• 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, jaundice
(yellowing of the skin and/or whites of the eyes).

430 mm

Patients with high blood pressure and type 2
diabetes with kidney disease
300mg once daily is the preferred maintenance dose for
the treatment of associated kidney disease.

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