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IRBESARTAN 300MG FILM-COATED TABLETS

Active substance(s): IRBESARTAN

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Irbesartan 75mg film-coated Tablets
Irbesartan 150mg film-coated Tablets
Irbesartan 300mg film-coated Tablets
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.

• if you are going to have an operation (surgery) or be
given anaesthetics
• if you are taking aliskiren
You must tell your doctor if you think that 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).

What is in this leaflet:
1 W
 hat Irbesartan Tablets are and what
they are used for
2 What you need to know before you take
3 How to take
4 Possible side effects
5 How to store
6 Contents of the pack and other
information

Other medicines and Irbesartan tablets

1.

1 What Irbesartan Tablets are and what

they are used for

Irbesartan tablets belong 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 tablets are used in adult patients
• to treat high blood pressure (essential hypertension)
• t o protect the kidney in hypertensive type 2 diabetic
patients with laboratory evidence of impaired renal
function.

2 What you need to know before you take

Do not take Irbesartan tablets

• 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 tablets in early pregnancy –
see pregnancy section.)
• i f you have diabetes mellitus or impaired kidney
function and you are treated with aliskiren (another
medicine to treat high blood pressure).

Warnings and precautions

Talk to your doctor before taking Irbesartan tablets
• if you suffer from excessive vomiting or diarrhoea
• if you suffer from kidney problems
• if you suffer from heart problems
• if you receive Irbesartan tablets 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

continued top of next column

Children and adolescents

This medicinal product should not be used in children
and adolescents (under 18 years) because the safety
and efficacy have not yet been fully established.
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
take other precautions if you are taking aliskiren.

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.
Irbesartan tablets with food and drink
Irbesartan tablets can be taken with or without food.
The tablets should be swallowed with a drink of water.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be
pregnant or planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.

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 tablets 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 tablets are 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 tablets are
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 such activities.

continued over page

AAAG4883

colours/plates:

Irbesartan 75mg, 150mg & 300mg PIL - UK

1. Black

item no: AAAG4883

dimensions: 190 x 380

print proof no: 4

pharmacode:

origination date: 21.01.14

min pt size: 9pts

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 31.01.14

Technical Approval

revised by: S.Anson

date sent: 21.01.14

supplier: Actavis Bulgaria Dupnitsa

technically app. date: 22.01.14

Non Printing Colours
1.
2.
3.

3 How to take
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
The following strengths are available: 75mg, 150mg
and 300mg

Method of administration

Irbesartan tablets are for oral use and are taken with or
without food. The tablets should be swallowed with a
drink of water. You should try to take your daily dose at
about the same time each day. It is important that you
continue to take Irbesartan tablets until your doctor
tells you otherwise.

Patients with high blood pressure

The recommended dose is 150mg once a day. The
dose may later be increased to 300mg 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, 300mg 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 tablets 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 tablets than you
should

If you accidentally take too many tablets, contact your
doctor immediately. Symptoms of overdose can be
hypotension and tachycardia; bradycardia.

If you forget to take Irbesartan tablets

4
4

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.

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.
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 tablets 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.
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, 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 yellowing of the skin and/or whites of the eyes
(jaundice) have also been reported.

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 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
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 or tablet
container 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 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.

 ontents of the pack and other
6 C
information

What Irbesartan tablets contain

• The active substance is irbesartan. Each tablet
contains 75 mg, 150 mg or 300 mg of irbesartan.
• The other ingredients are: tablet core: croscarmellose
sodium (E468), microcrystalline cellulose (E460),
hypromellose (E464), mannitol (E421), magnesium
stearate (E572), silica, colloidal anhydrous (E551);
tablet coating: hydroxypropyl cellulose (E463),
hypromellose (E464), macrogol 6000, titanium
dioxide (E171).

What Irbesartan tablets looks like and
contents of the pack

The 75 mg tablets are white, elliptical, biconvex, filmcoated, marked ‘I’ on one side and ‘75’ on the other side.
The 150 mg tablets are white, elliptical, biconvex, filmcoated, marked ‘I’ on one side and ‘150’ on the other
side.
The 300 mg tablets are white, elliptical, biconvex, filmcoated, marked ‘I’ on one side and ‘300’ on the other
side.
Pack sizes:
Blisters: 10, 14, 28, 30, 56, 84, 90, 98, 100 tablets. Tablet
containers: 30, 60, 250 tablets. Not all pack sizes may
be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf Reykjavikurvegur 76-78, 220
Hafnarfjordur Iceland

Manufacturer

Actavis hf. Reykjavikurvegi 78, P.O.Box 420, IS-220
Hafnafjordur Iceland
Balkanpharma – Dupnitsa AD 3 Samokovsko Shosse
Str., Dupnitsa 2600, Bulgaria
This leaflet was last revised in February 2014.

continued top of next column

Actavis, Barnstaple, EX32 8NS, UK

AAAG4883

colours/plates:

Irbesartan 75mg, 150mg & 300mg PIL - UK

1. Black

item no: AAAG4883

dimensions: 190 x 380

print proof no: 4

pharmacode:

origination date: 21.01.14

min pt size: 9pts

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 31.01.14

Technical Approval

revised by: S.Anson

date sent: 21.01.14

supplier: Actavis Bulgaria Dupnitsa

technically app. date: 22.01.14

Non Printing Colours
1.
2.
3.

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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