IRBESARTAN 150 MG TABLETS

Active substance: IRBESARTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

IRBESARTAN 75 mg TABLETS
IRBESARTAN 150 mg TABLETS
IRBESARTAN 300 mg 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 further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not pass it
on to others. It may harm them, even if their symptoms are
the same as yours.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What Irbesartan is and what it is used for.
2. Before you take Irbesartan.
3. How to take Irbesartan.
4. Possible side effects.
5. How to store Irbesartan.
6. 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. Angiotension-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
angiotension-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. BEFORE YOU TAKE IRBESARTAN
Do not take Irbesartan:
• if you are allergic (hypersensitive) to irbesartan or any of the
other ingredients of Irbesartan
• if you are more than 3 months pregnant. (It is also better to
avoid Irbesartan in early pregnancy - see 'Pregnancy' section).
Irbesartan should not be given to children and adolescents
(under 18 years).
Take special care with Irbesartan
Tell your doctor 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.
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).
Use in children
This medicinal product should not be used in children or
adolescents because the safety and efficacy have not yet been
fully established.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.

Irbesartan 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 non-steroidal
anti-inflammatory drugs, the effect of irbesartan may be
reduced.
Taking 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 months 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 the
treatment of high blood pressure. If you experience these,
talk to your doctor before attempting to drive or use
machines.
Important information about some of the ingredients of
Irbesartan
Irbesartan contains 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 Irbesartan exactly as your doctor has told you.
You should 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 (hypertension)
The usual dose is 150 mg Irbesartan once a day. The dose
may later be increased to 300 mg once daily depending on
your 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.

If you take more Irbesartan than you should
If you accidentally take too many tablets, contact your doctor
immediately.
Children should not take Irbesartan
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, 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.
The frequency of the side effects listed below is defined
using 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.
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
• 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) 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 the
frequency is not known are:
• feeling of spinning
• headache
• taste disturbance
• ringing in the ears (tinnitus)
• muscle cramps
• pain in joints and muscles
• abnormal liver function
• increased blood potassium levels
• impaired kidney function

• an 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.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
5. HOW TO STORE IRBESARTAN
Keep out of the reach and sight of children.
Do not use Irbesartan after the expiry date which is stated on
the carton after 'EXP'. The expiry date refers to the last day of
that month. The in-use shelf-life of the product when stored
in HDPE bottles is 90 days.
This medicinal product does not require any special storage
conditions.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Irbesartan contains
The active substance is: irbesartan. Each tablet contains 75 mg
150 mg, 300 mg of irbesartan. The other ingredients are
lactose monohydrate, povidone, microcrystalline cellulose,
croscarmellose sodium, magnesium stearate and silica,
colloidal anhydrous.
What Irbesartan looks like and contents of the pack
75 mg: Round, White to off-white, biconvex, bevelled edge
tablets 'M' on one side, 'IN1' on other side
150 mg: Round, White to off-white, biconvex, bevelled edge
tablets 'M' on one side, 'IN2' on other side.
300 mg: Oval, White to off white, biconvex, bevelled edge
tablets 'M' on one side, 'IN3' on other side.
Irbesartan is available in blister packs of 10, 14, 28, 30, 56, 57,
58, 60, 84, 90, 98 and 100, calendar packs of 14, 28, 56, 84
and 98 tablets and HDPE bottles with PP closures of 500 and
1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Jenson Pharmaceutical Services Limited, Carradine House,
237 Regents Park Road, London, N3 3LF, UK.
Manufacturers
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange
Road, Dublin 13, Ireland.
Mylan Hungary Kft., H-2900 Komarom, Mylan utca 1, Hungary.
Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.

This leaflet was last revised in: 07/2012

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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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