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EPROSARTAN NICHE 400 MG FILM-COATED TABLETS

Active substance(s): EPROSARTAN MESILATE

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Package Leaflet: Information for the User

Eprosartan Niche 300 mg, 400 mg and 600 mg
Film-Coated Tablets
Eprosartan
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 Eprosartan Niche is and what it is
used for
2. What you need to know before you
take Eprosartan Niche
3. How to take Eprosartan Niche
4. Possible side effects
5. How to store Eprosartan Niche
6. Contents of the pack and other
information

an ACE-inhibitor (for example enalapril,
lisinopril, ramipril), in particular if you
have diabetes-related kidney problems.
q aliskiren
Your doctor may check your kidney function,
blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood
at regular intervals. See also information
under the heading “Do not take Eprosartan
Niche”.
If any of the above apply to you (or you are not
1. What Eprosartan Niche is
sure), talk to your doctor or pharmacist before
and what it is used for
taking Eprosartan Niche.
Eprosartan Niche contains the active substance Children and adolescents
eprosartan.
Children and adolescents under 18 years
Eprosartan belongs to a group of medicines
should not take eprosartan.
called ‘angiotensin II receptor antagonists’. It
Other medicines and Eprosartan Niche
blocks the action of a substance in your body
Tell your doctor or pharmacist if you are taking,
called ‘angiotensin II’. This substance causes
have recently taken or might take any other
your blood vessels to narrow. This makes it
more difficult for the blood to flow through the medicines. This includes medicines obtained
without a prescription, including herbal
vessels and so your blood pressure increases.
medicines. This is because Eprosartan Niche
By blocking this substance, the vessels relax
can affect the way some other medicines work.
and your blood pressure decreases.
Also some other medicines can affect the way
Eprosartan is used to treat high blood pressure Eprosartan Niche works.
(hypertension).
In particular, tell your doctor or
pharmacist if you are taking the following:
2. What you need to know
before you take Eprosartan ■ lithium – for mood problems. Your doctor
must monitor the lithium level in your blood
Niche
because Eprosartan may increase the level.
Do not take Eprosartan Niche:
■ Medicines for pain and inflammation such as
■ if you are allergic to eprosartan or any of
ibuprofen, diclofenac, celecoxib, etoricoxib
the other ingredients of this medicine
or lumiracoxib (non-steroidal anti(listed in Section 6)
inflammatory medicines).
■ if you have severe liver disease
The following medicines may increase the
■ if you have severe problems with the blood
effect of Eprosartan Niche:
flow in your kidneys or serious restriction to ■ medicines that lower your blood pressure.
blood flow in a single functioning kidney
The following medicines may decrease the
■ if you are more than 3 months pregnant (it is effect of Eprosartan Niche:
also better to avoid eprosartan in early
■ indometacin – for pain, stiffness, swelling
pregnancy – see pregnancy section)
and lowering a high temperature.
■ if you have diabetes or impaired kidney
If any of the above applies to you (or you are
function and you are treated with a blood
not sure), talk to your doctor or pharmacist
pressure lowering medicine containing
before taking Eprosartan Niche.
aliskiren.
If you are taking any of the following
Do not take eprosartan if any of the above
medicines your doctor may carry out
apply to you. If you are not sure, talk to your
doctor or pharmacist before taking eprosartan. blood tests:
■ medicines containing potassium or
Warnings and precautions
potassium-sparing medicines
Talk to your doctor or pharmacist before taking ■
medicines
that increase potassium levels
Eprosartan Niche.
such as ‘heparin’ and ‘ACE inhibitors’.
Check with your doctor or pharmacist before
Talk to your doctor or pharmacist before taking
taking this medicine if:
Eprosartan Niche. Depending on the outcome
■ you have any other liver problems
of your blood tests, your doctor may decide to
■ you have any other kidney problems. Your
change your treatment with these medicines or
doctor will check how well your kidneys are Eprosartan Niche.
working before you start your treatment
Your doctor may need to change your
and at intervals during your treatment. Your dose and/or take other precautions:
doctor will also check the potassium,
■ if you are taking an ACE-inhibitor or aliskiren
‘creatinine’ and ‘uric acid’ levels in your
(see also information under the headings
blood
“Do not take Eprosartan Niche” and
■ you have a heart problem such as coronary
“Warnings and precautions”).
heart disease, heart failure, a narrowing of
Eprosartan Niche with food and drink
your blood vessels or heart valves, or a
■ You can take the tablets with or without food.
problem with your heart muscle
■ Speak to your doctor before taking
■ you produce too much of a hormone called
Eprosartan Niche if you are on a low-salt
‘aldosterone’
diet. Not having enough salt may cause
■ you are on a low-salt diet, taking ‘water
your blood volume or the sodium level in
tablets’ or are being sick or have diarrhoea.
your blood to get lower.
This is because they may cause your blood
volume or the sodium level in your blood to Pregnancy and breast-feeding
decrease.These should be corrected before Pregnancy
starting treatment with Eprosartan Niche
■ You must tell your doctor if you think you are
■ you know you have raised potassium levels
(or might become) pregnant. Your doctor
will normally advise you to stop taking
in your blood
Eprosartan Niche before you become
■ you think you are (or might become)
pregnant or as soon as you know you are
pregnant. Eprosartan Niche is not
pregnant and will advise you to take another
recommended in early pregnancy and must
medicine instead of Eprosartan Niche.
not be taken if you are more than 3 months
■ Eprosartan Niche is not recommended in
pregnant, as it may cause serious harm to
early pregnancy, and must not be taken
your baby if used at that stage – see
when more than 3 months pregnant. It may
pregnancy section.
cause serious harm to your baby if used
■ you are taking any of the following
after the third month of pregnancy.
medicines used to treat high blood pressure:
q

Breast-feeding
■ Tell your doctor if you are breast-feeding or
about to start breast-feeding.
■ Eprosartan Niche 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.
Driving and using machines
Eprosartan Niche is unlikely to affect your
ability to drive or use tools and machines.
However, you may feel sleepy or dizzy while
taking Eprosartan Niche. If this happens, do not
drive or use any tools or machines and talk to
your doctor.
Eprosartan Niche contains lactose (a type
of sugar)
If you have been told by your doctor that you
cannot tolerate or digest some sugars, talk to
your doctor before taking this medicine.

3. How to take Eprosartan
Niche
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
Adults
The recommended dose is 600 mg eprosartan
once daily.
Use in children and adolescents
Eprosartan Niche should not be given to
children and adolescents aged under 18 years.
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
If you take more Eprosartan Niche than
you should
If you take more Eprosartan Niche 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 Niche
■ 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 Niche
Do not stop taking Eprosartan Niche without
talking to your doctor first.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

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 lightheaded or dizzy.
■ too high potassium levels in the blood
■ swelling under the skin
■ allergic reaction
Rare: may affect up to 1 in 1000 people
■ anaemia
■ increased urea levels in the blood
Not known: frequency cannot be estimated
from the available data
■ loss of muscle tone and strength
■ dizziness on standing up
■ swelling of the face
■ kidney problems, including kidney failure
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 Yellow Card
Scheme 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 Eprosartan
Niche
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 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 Niche 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 Niche looks like and
contents of the pack
The 300 mg tablets are white, ovaloid shaped,
biconvex film-coated tablets. The 400 mg
tablets are peach-coloured, oval shaped,
4. Possible side effects
biconvex film-coated tablets. The 600 mg
Like all medicines, this medicine can cause side tablets are white, capsule shaped, biconvex
effects, although not everybody gets them. The film-coated tablets.
following side effects may happen with this
Eprosartan Niche tablets are available in
medicine:
aluminium blister packs containing 4, 7, 14, 28,
Allergic reactions (may affect up to 1 in 100
50, 56, 98 and 280 film-coated tablets.
people)
Not all pack sizes may be marketed.
If you have an allergic reaction, stop taking and
Marketing Authorisation Holder and
see a doctor straight away. The signs may
Manufacturer
include:
Marketing Authorisation Holder:
■ skin reactions such as a rash or hives with
Niche Generics Ltd, 1 The Cam Centre, Wilbury
swelling (urticaria)
Way, Hitchin, Hertfordshire, SG4 0TW, United
■ swelling of the lips, face, throat or tongue
Kingdom
■ shortness of breath
Manufacturer:
■ swelling of your face, swelling of skin and
Niche Generics Limited, Unit 5, 151 Baldoyle
mucous membrane (angiodema)
Industrial Estate, Dublin 13, Ireland.
Other possible side effects of Eprosartan
This medicinal product is authorised in the
Niche include:
Member States of the EEA under the
Very common: may affect more than 1 in 10
following names:
people
Ireland and UK: Eprosartan Niche 300 mg, 400
■ headache
mg and 600 mg film-coated tablets
Common: may affect up to 1 in 10 people
Germany: Eprosartan Unichem 600 mg
■ viral infection
filmtabletten
■ raised fat (triglyceride) levels in the blood
The Netherlands: Eprosartan Unichem 400 mg
■ feeling dizzy, feeling unusually tired
and 600 mg filmomhulde tabletten
■ feeling depressed
This leaflet was last revised in
■ chest pain, palpitations (missed heart beats) 01/2015
■ back or joint pain
■ urinary tract infection
■ rash, itching and hives

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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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