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Active substance(s): IRBESARTAN

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Package leaflet: Information for the user

Irbesartan 300 mg film-coated tablets

Method of administration
Irbesartan Tablets are for oral use. Swallow the
tablets with a sufficient amount of fluid (e.g. one
glass of water). You can take Irbesartan Tablets
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 Tablets
until your doctor tells you otherwise.

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.

Read all of this leaflet carefully before you
See also information under the heading “Do not
start taking this medicine because it
take Irbesartan Tablets”
Uncommon (may affect up to 1 in 100
contains important information for you.
people): heart rate increased, flushing,
Keep this leaflet. You may need to read it
You must tell your doctor if you think you are (or
cough, diarrhoea, indigestion/heartburn,
might become) pregnant. Irbesartan Tablets are
Patients with high blood pressure
sexual dysfunction (problems with sexual
If you have any further questions, ask your
not recommended in early pregnancy, and must
The usual dose is 150 mg once a day (two
performance), chest pain.
doctor, pharmacist or nurse.
not be taken if you are more than 3 months
tablets a day). The dose may later be increased
This medicine has been prescribed for you
pregnant, as it may cause serious harm to your
to 300 mg (four tablets a day) once daily
Some undesirable effects have been reported
only. Do not pass it on to others. It may
baby if used at that stage (see pregnancy
depending on blood pressure response.
since marketing of irbesartan. Undesirable
harm them, even if their signs of illness are
effects where the frequency is not known are:
the same as yours.
Patients with high blood pressure and
feeling of spinning, headache, taste
If you get any side effects, talk to your
Children and adolescents
type 2 diabetes with kidney disease
disturbance, ringing in the ears, muscle
doctor, pharmacist or nurse. This includes
This medicinal product should not be used in
In patients with high blood pressure and type 2
cramps, pain in joints and muscles, reduced
any possible side effects not listed in this
children and adolescents because the safety
diabetes, 300 mg (four tablets a day) once daily
number of platelets, abnormal liver function,
leaflet. See section 4.
and efficacy have not yet been fully
is the preferred maintenance dose for the
increased blood potassium levels, impaired
treatment of associated kidney disease.
kidney function, and inflammation of small
What is in this leaflet:
blood vessels mainly affecting the skin (a
1. What Irbesartan Tablets are and what they
Other medicines and Irbesartan Tablets
The doctor may advise a lower dose, especially
condition known as leukocytoclastic vasculitis).
are used for
Tell your doctor or pharmacist if you are taking,
when starting treatment in certain patients such
Uncommon cases of jaundice (yellowing of the
2. What you need to know before you take
have recently taken or might take any other
as those on haemodialysis, or those over the
skin and/or whites of the eyes) have also been
Irbesartan Tablets
age of 75 years.
3. How to take Irbesartan Tablets
4. Possible side effects
Your doctor may need to change your dose
The maximal blood pressure lowering effect
Reporting of side effects
5. How to store Irbesartan Tablets
and/or to take other precautions:
should be reached 4-6 weeks after beginning
If you get any side effects, talk to your doctor,
6. Contents of the pack and other information
If you are taking an ACE-inhibitor or aliskiren
pharmacist or nurse. This includes any possible
(see also information under the headings “Do
side effects not listed in this leaflet. You can
1. What Irbesartan Tablets are and what
not take Irbesartan Tablets” and “Warnings
Use in children and adolescents
also report side effects directly via the Yellow
they are used for
and precautions”).
Irbesartan Tablets should not be given to
Card Scheme at:
children and under 18 years of age. If a child
By reporting side effects you can help provide
Irbesartan Tablets belong to a group of
You may need to have blood checks if you
swallows some tablets, contact your doctor
more information on the safety of this medicine.
medicines known as angiotensin-II receptor
antagonists. Angiotensin-II is a substance
potassium supplements
5. How to store Irbesartan Tablets
produced in the body which binds to receptors
salt substitutes containing potassium
If you take more Irbesartan Tablets than you
in blood vessels causing them to tighten. This
potassium-sparing medicines (such as
Keep this medicine out of the sight and reach of
results in an increase in blood pressure.
certain diuretics)
If you accidentally take too many tablets,
Irbesartan Tablets prevent the binding of
medicines containing lithium
contact your doctor immediately.
angiotensin-II to these receptors, causing the
Do not use this medicine after the expiry date
blood vessels to relax and the blood pressure
If you take certain painkillers, called nonIf you forget to take Irbesartan Tablets
which is stated on the carton and on the blister
to lower. Irbesartan Tablets slow the decrease
steroidal anti-inflammatory drugs, the effect of
If you accidentally miss a daily dose, just take
after EXP. The expiry date refers to the last day
of kidney function in patients with high blood
irbesartan may be reduced.
the next dose as normal. Do not take a double
of that month.
pressure and type 2 diabetes.
dose to make up for a forgotten dose.
Irbesartan Tablets with food and drink
This medicinal product does not require any
Irbesartan Tablets are used
Irbesartan Tablets can be taken with or without
If you have any further questions on the use of
special storage conditions.
to treat high blood pressure (essential
this medicine, ask your doctor, pharmacist or
Do not throw away any medicines via
to protect the kidney in patients with high
Pregnancy and breast-feeding
wastewater or household waste. Ask your
blood pressure, type 2 diabetes and
If you are pregnant or breast-feeding, think you
4. Possible side effects
pharmacist how to throw away medicines you
laboratory evidence of impaired kidney
may be pregnant or are planning to have a
no longer use. These measures will help
baby, ask your doctor or pharmacist for advice
Like all medicines, this medicine can cause
protect the environment.
before taking this medicine.
side effects, although not everybody gets them.
2. What you need to know before you take
Some of these effects may be serious and may
6. Contents of the pack and other
Irbesartan Tablets
require medical attention.
You must tell your doctor if you think you are (or
Do not take Irbesartan Tablets
might become) pregnant. Your doctor will
As with similar medicines, rare cases of allergic
What Irbesartan Tablets contains
if you are allergic to irbesartan or any of the
normally advise you to stop taking Irbesartan
skin reactions (rash, urticaria), as well as
The active substance is irbesartan. Each tablet
other ingredients of this medicine (listed in
Tablets before you become pregnant or as
localised swelling of the face, lips and/or
contains 300 mg irbesartan.
section 6)
soon as you know you are pregnant and will
tongue have been reported in patients taking
if you are more than 3 months pregnant.
advise you to take another medicine instead of
irbesartan. If you get any of these symptoms or
The other ingredients are lactose monohydrate,
(It is also better to avoid Irbesartan Tablets
Irbesartan Tablets. Irbesartan Tablets are not
get short of breath, stop taking Irbesartan
microcrystalline cellulose, croscarmellose
in early pregnancy - see pregnancy
recommended in early pregnancy, and must not
Tablets and contact your doctor
sodium, hypromellose, colloidal anhydrous
be taken when more than 3 months pregnant,
silica, magnesium stearate, titanium dioxide
if you have diabetes or impaired kidney
as it may cause serious harm to your baby if
(E171) and macrogol 3350.
function and you are treated with a blood
used after the third month of pregnancy.
The frequency of the side effects listed below is
pressure lowering medicine containing
defined using the following convention:
What Irbesartan Tablets look like and
contents of the pack
Tell your doctor if you are breast-feeding or
Very common:
may affect more than 1 in 10
Irbesartan 300 mg film-coated tablets are white,
Warnings and precautions
about to start breast-feeding. Irbesartan Tablets
oblong and convex.
Talk to your doctor, pharmacist or nurse before
are not recommended for mothers who are
may affect up to 1 in 10
taking Irbesartan Tablets and if any of the
breast-feeding, and your doctor may choose
Irbesartan 300 mg film-coated tablets are
following apply to you:
another treatment for you if you wish to breastUncommon:
may affect up to 1 in 100
supplied in blister packs of 14, 28, 30, 56 and
if you get excessive vomiting or
feed, especially if your baby is newborn, or was
90 film-coated tablets.
born prematurely.
Not known:
frequency cannot be
if you suffer from kidney problems
estimated from the available
Not all pack sizes may be marketed.
if you suffer from heart problems
Driving and using machines
if you receive Irbesartan Tablets for
No studies on the effects on the ability to drive
Marketing Authorisation Holder
diabetic kidney disease. In this case your
and use machines have been performed.
Side effects reported in clinical studies for
Morningside Healthcare Ltd
doctor may perform regular blood tests,
Irbesartan Tablets are unlikely to affect your
patients treated with irbesartan were:
115 Narborough Road, Leicester, LE3 0PA
especially for measuring blood potassium
ability to drive or use machines. However,
Very common (may affect more than 1 in 10
levels in case of poor kidney function
occasionally dizziness or weariness may occur
people): if you suffer from high blood
if you are going to have an operation
during treatment of high blood pressure. If you
pressure and type 2 diabetes with kidney
(surgery) or be given anaesthetics
experience these, talk to your doctor before
disease, blood tests may show an
West Pharma Produções de Especialidades
if you are taking any of the following
attempting to drive or use machines.
increased level of potassium.
Farmacêuticas, S.A.
medicines used to treat high blood
Rua João de Deus, n.º 11, Venda Nova, 2700pressure:
Irbesartan Tablets contain lactose. If you
Common (may affect up to 1 in 10 people):
486 Amadora, Portugal
 an ACE-inhibitor (for example enalapril,
have been told by your doctor that you have an
dizziness, feeling sick/vomiting, fatigue and
lisinopril, ramipril) in particular if you
intolerance to some sugars (e.g. lactose),
blood tests may show raised levels of an
Atlantic Pharma Produções Farmacêuticas,
have diabetes-related kidney problems.
contact your doctor before taking this medicine.
enzyme that measures the muscle and
 aliskiren
heart function (creatine kinase enzyme). In
Rua da Tapada Grande, n.º 2; Abrunheira,
Your doctor may check your kidney function,
3. How to take Irbesartan Tablets
patients with high blood pressure and type 2
2710-089 Sintra, Portugal
blood pressure, and the amount of electrolytes
diabetes with kidney disease, dizziness
(e.g. potassium) in your blood at regular
Always take this medicine exactly as your
when getting up from a lying or sitting
This leaflet was last revised in March 2017
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.

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