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IRBESARTAN 75 MG TABLETS

Active substance(s): IRBESARTAN

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Package leaflet: Information for the patient

See also information under the heading “Do not take Irbesartan”.

Irbesartan 75 mg tablets
Irbesartan 150 mg tablets
Irbesartan 300 mg 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)

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 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 other information

1. What Irbesartan is and what it is used for
Irbesartan contains irbesartan, which 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 also
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 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 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 have had, or during treatment have, excessive vomiting
(being sick) or diarrhoea
• if you have been taking ‘water tablets’ or have been on a low
sodium diet
• if you suffer from kidney problems, including narrowing of
the kidney artery or have had a kidney transplant
• if you suffer from heart problems, including a narrowing
of the valves in the heart, an enlarged heart muscle or a
weakness of the heart muscle (heart failure)
• if you have a narrowing of the heart blood vessels, which
may cause chest pain e.g. angina
• 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 suffer from primary aldosteronism (a condition related
to high production of the hormone aldosterone, which causes
sodium retention and, in turn, an increase in blood pressure)
• if you are of Afro-Caribbean origin, as irbesartan may not be
as effective at lowering your blood pressure
• 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.

Description Irbesartan 300 mg,150 mg,75 mg 28
Component Type LeafletInsert
Affiliate Item Code 805536
Superceded Affiliate Item Code 684460
TrackWise PR No. 805536
MA No. PL 04569/ 1351,
1352, 1353

Packing Site/Printer N/A
Supplier Code 50060020

Pharma Code 4151
SAP No. N/A
Vendor Job No. 272705
Trackwise Proof No. 1
Glams Proof No. 1
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

During treatment
You should also tell your doctor:

• if you are going to have an operation (surgery) or be
given anaesthetics

Children and adolescent

This medicine 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 heading “Do not take Irbesartan” and
“Warnings and precautions”.

You may need to have blood checks if you take:

• p
 otassium supplements
• s alt substitutes containing potassium
• potassium-sparing medicines (water tablets) or medicines that
may increase the levels of potassium in the blood e.g. heparin
• medicines containing lithium (used to treat mental
health problems)
If you take certain painkillers, called non-steroidal antiinflammatory drugs, or “COX-2”inhibitors e.g. celecoxib or
acetylsalicyclic acid, the effect of irbesartan may be reduced.

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 breastfeeding. 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.
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 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.
• P
 atients with high blood pressure
The recommended dose is 150 mg once a day. The dose may
later be increased to 300 mg once daily depending on blood
pressure response.
• P
 atients 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 recommended maintenance dose for
the treatment of associated kidney disease.
50060020

Date: 25 JAN 2016
No. of colours
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1

Time: 12:35
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1/2

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v1/May 2015

The doctor may advise a lower dose, especially when starting
treatment if you are on haemodialysis or are aged 75 or older.
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. You may feel dizzy and/or feel your heart beating
faster or slower.

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.

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 internet at
www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store Irbesartan
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the carton, label or blister. The expiry date refers to the last day of
that month.
The in-use shelf-life of the product when stored in plastic bottles
is 90 days once opened.
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

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. If you notice any of the following side effects, stop
taking this medicine and contact your doctor or go to the
nearest hospital casualty department straight away:

Not known (frequency cannot be estimated from the
available data):

• I tchy red rash with swelling of the face, lips and/or tongue and
difficulty breathing.
• Yellowing of the skin and whites of the eyes, severe upper
stomach pain and feeling and being sick, which may be due to
liver problems.
• Rash with raised purple spots and flat red areas caused by
inflammation of small blood vessels (vasculitis).
• Passing water more often, in greater amounts which is pale in
colour, or straining or being unable to pass water or less often,
which may be darker in colour or may even be bloody. This
may be due to a problem with the kidneys.

Other possible side effects
Very common (may affect up to 1 in 10 people):

What Irbesartan contains

The active substance is irbesartan.
Each 75 mg tablet contains 75 mg of irbesartan.
Each 150 mg tablet contains 150 mg of irbesartan.
Each 300 mg tablet contains 300 mg of irbesartan.
The other ingredients are lactose monohydrate (see section
2 of this leaflet ‘Irbesartan contains lactose’), povidone,
microcrystalline cellulose, croscarmellose sodium, magnesium
stearate and silica and colloidal anhydrous.

What Irbesartan looks like and contents of the pack

75 mg tablets: Round, white to off-white tablets, with sides that
curve outwards, marked with “M” on one side, “IN1” on other side
150 mg tablets: Round, white to off-white tablets, with sides that
curve outwards, marked with “M” on one side, “IN2” on other side
300 mg tablets: Oval, white to off white tablets, with sides that
curve outwards, marked with “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 plastic bottles of 500 and 1000 tablets.
Not all pack sizes may be marketed.

• if you suffer from high blood pressure and type 2 diabetes
with kidney disease, blood tests may show an increased level
of potassium.

Marketing Authorisation Holder:

Common:

McDermott Laboratories Ltd. T/A Gerard Laboratories,
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland






dizziness
feeling sick/being sick (vomiting)
feeling tired (fatigue)
blood tests may show raised levels of an enzyme that
measures how the muscles and heart are working (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
* blood tests may show decreased levels of a protein in the
red blood cells (haemoglobin) were also reported.

Manufacturers:

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 01/2016.

Uncommon:








Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

y ou feel your heart beating faster (heart rate increased)
flushing
cough
diarrhoea
indigestion/heartburn
sexual dysfunction (problems with sexual performance)
chest pain

Not known (frequency cannot be estimated from the
available data):









f eeling of spinning
headache
taste disturbance
ringing in the ears
muscle cramps
pain in joints and muscles
blood tests may show that the liver is not working properly
blood tests may show increased blood potassium levels

50060020
805536

Description Irbesartan 300 mg,150 mg,75 mg 28
Component Type LeafletInsert
Affiliate Item Code 805536
Superceded Affiliate Item Code 684460
TrackWise PR No. 805536
MA No. PL 04569/ 1351,
1352, 1353

Packing Site/Printer N/A
Supplier Code 50060020

Pharma Code 4151
SAP No. N/A
Vendor Job No. 272705
Trackwise Proof No. 1
Glams Proof No. 1
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Date: 25 JAN 2016
No. of colours
Colours

1

Time: 12:35
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 200 X 360 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

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.

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