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EPROSARTAN 400MG FILM-COATED TABLETS

Active substance(s): EPROSARTAN MESILATE / EPROSARTAN MESYLATE

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Version:TEVA
4 UK Ref: February 2015

Version:

EPROSARTAN
300 mg, 400 mg AND 600 mg
FILM-COATED TABLETS

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
PACKAGE LEAFLET:
pregnancy section
INFORMATION FOR THE USER
• you are taking any of the following
Read all of this leaflet carefully before
medicines used to treat high blood
you start taking this medicine because
pressure:
it contains important information for
• an ACE-inhibitor (for example
you.
enalapril, lisinopril, ramipril), in
• Keep this leaflet. You may need to
particular if you have
read it again.
diabetes-related kidney problems
• If you have any further questions,
• aliskiren.
ask your doctor or pharmacist.
Your doctor may check your kidney
• This medicine has been prescribed
function, blood pressure, and the
for you only. Do not pass it on to
amount of electrolytes (e.g. potassium)
others. It may harm them, even if
in your blood at regular intervals. See
their signs of illness are the same as also information under the heading
yours.
‘Do not take Eprosartan’.
• If you get any side effects, talk to
If any of the above apply to you (or you
your doctor or pharmacist. This
are not sure), talk to your doctor or
includes any possible side effects not
pharmacist before taking Eprosartan.
listed in this leaflet. See section 4.
Children and adolescents
WHAT IS IN THIS LEAFLET:
Children and adolescents under 18
1. What Eprosartan is and what it is
years should not take eprosartan.
used for
Other medicines and Eprosartan
2. What you need to know before you
Tell your doctor or pharmacist if you
take Eprosartan
are taking, have recently taken or
3. How to take Eprosartan
might take any other medicines. This
4. Possible side effects
includes medicines obtained without a
5. How to store Eprosartan
prescription, including herbal
6. Contents of the pack and other
medicines. This is because Eprosartan
information
can affect the way some other medicines
work. Also some other medicines can
1 WHAT EPROSARTAN IS AND affect the way Eprosartan works.
WHAT IT IS USED FOR
Eprosartan contains the active
substance eprosartan.

In particular, tell your doctor or
pharmacist if you are taking the
following:
• lithium – for mood problems. Your
doctor must monitor the lithium level
in your blood because Eprosartan
may increase the level
• medicines for pain and inflammation
such as ibuprofen, diclofenac,
celecoxib, etoricoxib or lumiracoxib
(non-steroidal anti-inflammatory
medicines).

Eprosartan belongs to a group of
medicines called ‘angiotensin II
receptor antagonists’. It blocks the
action of a substance in your body
called ‘angiotensin II’. This substance
causes your blood vessels to narrow.
This makes it more difficult for the
blood to flow through the vessels and
so your blood pressure increases. By
blocking this substance, the vessels
The following medicines may increase
relax and your blood pressure decreases.
the effect of Eprosartan:
Eprosartan is used to treat high blood • medicines that lower your blood
pressure (hypertension).
pressure.

2

WHAT YOU NEED TO KNOW
BEFORE YOU TAKE
EPROSARTAN

Do not take Eprosartan:
• if you are allergic to eprosartan or
any of the other ingredients of this
medicine (listed in Section 6)
• if you have severe liver disease
• if you have severe problems with the
blood flow in your kidneys or serious
restriction to blood flow in a single
functioning kidney
• if you are more than 3 months
pregnant (it is also better to avoid
eprosartan 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.

The following medicines may decrease
the effect of Eprosartan:
• indometacin – for pain, stiffness,
swelling and lowering a high
temperature.
If any of the above applies to you (or
you are not sure), talk to your doctor or
pharmacist before taking Eprosartan.

If you are taking any of the following
medicines your doctor may carry out
blood tests:
• medicines containing potassium or
potassium-sparing medicines
• medicines that increase potassium
levels such as ‘heparin’ and ‘ACE
inhibitors’.
Talk to your doctor or pharmacist
before taking Eprosartan. Depending
on the outcome of your blood tests,
your doctor may decide to change your
treatment with these medicines or
Do not take eprosartan if any of the
above apply to you. If you are not sure, Eprosartan.
talk to your doctor or pharmacist
Your doctor may need to change your
before taking eprosartan.
dose and/or take other precautions:
Warnings and precautions
Talk to your doctor or pharmacist
before taking Eprosartan.
Check with your doctor or pharmacist
before taking this medicine if:
• you have any other liver problems
• you have any other kidney problems.
Your doctor will check how well your
kidneys are working before you start
your treatment and at intervals
during your treatment. Your doctor
will also check the potassium,
‘creatinine’ and ‘uric acid’ levels in
your blood
• you have a heart problem such as
coronary heart disease, heart failure,
a narrowing of your blood vessels or
heart valves, or a problem with your
heart muscle
• you produce too much of a hormone
called ‘aldosterone’
• you are on a low-salt diet, taking
‘water tablets’ or are being sick or
have diarrhoea. This is because they
may cause your blood volume or the
sodium level in your blood to
decrease. These should be corrected
before starting treatment with
Eprosartan
• you know you have raised potassium
levels in your blood
• you think you are (or might become)
pregnant. Eprosartan is not
recommended in early pregnancy

• if you are taking an ACE-inhibitor or
aliskiren (see also information under
the headings ‘Do not take Eprosartan’
and ‘Warnings and precautions’).
Eprosartan with food and drink
• you can take the tablets with or
without food
• speak to your doctor before taking
Eprosartan if you are on a low-salt
diet. Not having enough salt may
cause your blood volume or the
sodium level in your blood to get
lower.
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 Eprosartan before you
become pregnant or as soon as you
know you are pregnant and will
advise you to take another medicine
instead of Eprosartan
• Eprosartan is not recommended in
early pregnancy, and must not be
taken when more than 3 months
pregnant. 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

4

T

• Eprosartan is not recommended for
mothers who are breast-feeding.
Your doctor may choose another
treatment for you if you wish to
breast-feed, especially if your baby is
newborn, or was born prematurely.
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor or pharmacist for advice before
taking this medicine.






back or joint pain
urinary tract infection
rash, itching and hives
feeling sick, being sick, diarrhoea,
stomach pain, indigestion
• feeling weak (asthenia)
• stuffy nose (rhinitis), sore or hoarse
throat, breathlessness, cough, chest
infection
• general pain.
Uncommon: may affect up to 1 in 100
people
• low blood pressure. You may feel
light-headed or dizzy
• too high potassium levels in the
blood
• swelling under the skin
• allergic reaction.

Driving and using machines
Eprosartan is unlikely to affect your
ability to drive or use tools and
machines. However, you may feel
sleepy or dizzy while taking
Eprosartan. If this happens, do not
drive or use any tools or machines and
Rare: may affect up to 1 in 1000 people
talk to your doctor.
• anaemia
Eprosartan contains lactose (a type of
• increased urea levels in the blood.
sugar)
Not known: frequency cannot be
If you have been told by your doctor
estimated from the available data
that you cannot tolerate or digest
• loss of muscle tone and strength
some sugars, talk to your doctor
• dizziness on standing up
before taking this medicine.
• swelling of the face
3 HOW TO TAKE EPROSARTAN • kidney problems, including kidney
failure.
Always take this medicine exactly as
Reporting of side effects
your doctor or pharmacist has told
If you get any side effects, talk to your
you. Check with your doctor or
doctor or pharmacist. This includes any
pharmacist if you are not sure.
possible side effects not listed in this
Adults
leaflet. You can also report side effects
The recommended dose is 600 mg
directly via the Yellow Card Scheme at:
eprosartan once daily.
www.mhra.gov.uk/yellowcard
Use in children and adolescents
Eprosartan should not be given to
children and adolescents aged under
18 years.

By reporting side effects you can help
provide more information on the
safety of this medicine.

Taking this medicine
• take this medicine by mouth
• swallow the tablet whole with plenty
of fluid, such as a glass of water
• do not crush or chew the tablets
• take the tablets in the morning at
around the same time each day.

Keep this medicine out of the sight
and reach of children.

If you take more Eprosartan than you
should
If you take more Eprosartan than you
should or someone accidently takes
some, talk to a doctor or go to a
hospital straight away. Take the
medicine pack with you. The following
effects can happen:
• feeling light-headed and dizzy due to
a fall in your blood pressure
(hypotension)
• feeling sick (nausea)
• feeling sleepy.
If you forget to take Eprosartan
• if you forget a dose, take it as soon
as you remember it
• if you forget to take a dose and it is
nearly time for your next dose, skip
the missed dose. Do not take a
double dose to make up for a
forgotten dose.
If you stop taking Eprosartan
Do not stop taking Eprosartan without
talking to your doctor first.
If you have any further questions on
the use of this medicine, ask your
doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can
cause side effects, although not
everybody gets them. The following
side effects may happen with this
medicine:

5

HOW TO STORE
EPROSARTAN

Do not use this medicine after the
expiry date which is stated on the
carton and blister foil after ‘EXP’. The
expiry date refers to the last day of that
month.
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

What Eprosartan contains
The active substance is eprosartan (as
mesilate). Each tablet contains either
300 mg, 400 mg or 600 mg of
eprosartan.
The other ingredients are:
Tablet core: lactose monohydrate,
microcrystalline cellulose,
pregelatinised maize starch, silica
colloidal anhydrous, povidone,
polysorbate 80, crospovidone,
magnesium stearate.
Film-coating: hypromellose,
hydroxypropylcellulose (E463),
titanium dioxide (E171), macrogol 400.
The film-coating for the 400 mg tablets
also contains yellow and red iron
oxides (E172).

What Eprosartan looks like and
contents of the pack
The 300 mg tablets are white, ovaloid
Allergic reactions (may affect up to 1 in shaped, biconvex film-coated tablets.
The 400 mg tablets are
100 people)
peach-coloured, oval shaped, biconvex
If you have an allergic reaction, stop
taking and see a doctor straight away. film-coated tablets. The 600 mg tablets
are white, capsule shaped, biconvex
The signs may include:
• skin reactions such as a rash or hives film-coated tablets.
with swelling (urticaria)
Eprosartan tablets are available in
• swelling of the lips, face, throat or
aluminium blister packs containing 4, 7,
tongue
14, 28, 50, 56, 98 and 280 film-coated
• shortness of breath
tablets.
• swelling of your face, swelling of
Not all pack sizes may be marketed.
skin and mucous membrane
(angiodema).
Marketing Authorisation Holder:
Other possible side effects of
Eprosartan include:

TEVA UK Limited, Eastbourne,
BN22 9AG, UK

Very common: may affect more than 1
in 10 people
• headache.

Manufacturer:
Niche Generics Limited, Unit 5, 151
Baldoyle Industrial Estate, Dublin 13

Common: may affect up to 1 in 10
people
• viral infection
• raised fat (triglyceride) levels in the
blood
• feeling dizzy, feeling unusually tired
• feeling depressed
• chest pain, palpitations (missed heart
beats)

This leaflet was last revised in 01/2015.
PL 00289/1905
PL 00289/1906
PL 00289/1907

20095-A

140 x 460
254827.01-GB

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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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