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EPROSARTAN MYLAN 600 MG FILM-COATED TABLETS

Active substance(s): EPROSARTAN MESYLATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

EPROSARTAN 300 mg
FILM-COATED TABLETS
EPROSARTAN 400 mg
FILM-COATED TABLETS
EPROSARTAN 600 mg
FILM-COATED TABLETS
(eprosartan)

Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may need to read it
again
• If you have further questions, ask your doctor
or pharmacist
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Eprosartan is and what it is used for
2. Before you take Eprosartan
3. How to take Eprosartan
4. Possible side effects
5. How to store Eprosartan
6. Further information.
1. WHAT EPROSARTAN IS AND WHAT IT IS
USED FOR
Eprosartan belongs to a family of medicines
known as angiotensin II antagonists.
Angiotensin II is produced in your body and
causes blood vessels to become narrower.
This makes the blood flow through the vessels
more difficult and the blood pressure increases.
Eprosartan blocks this action so that the blood
vessels relax and the blood pressure is lowered.
Eprosartan is used to treat high blood pressure
(hypertension).
2. BEFORE YOU TAKE EPROSARTAN
Do not take Eprosartan if:
• 
you are allergic (hypersensitive) to eprosartan
or any of the other ingredients in Eprosartan
tablets
• 
you are more than 3 months pregnant. (It
is also better to avoid Eprosartan in early
pregnancy – see pregnancy section.)
• 
you have severe liver problems
• 
you have damaged blood flow to the kidneys
or serious constrictions in a single functioning
kidney
• 
you have diabetes or impaired kidney
function and you are treated with a blood
pressure lowering medicine containing
aliskiren.
Do not take eprosartan if any of the above
apply to you. If you are not sure, talk to
your doctor or pharmacist before taking
eprosartan.
Warnings and precautions
Take special care with Eprosartan:
Talk to your doctor or pharmacist before taking
Eprosartan:
• 
if you think that you are (or might become)
pregnant. Eprosartan 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)
• 
if you are dehydrated, have low salt levels
because you are on a low salt diet or are
taking water tablets or you have diarrhoea
or vomiting. These conditions should be
corrected before you start taking Eprosartan.
• 
if you know you have raised potassium levels
in your blood
• 
if you suffer from heart disease eg. heart valve
disease, or an enlarged heart
• 
if you have severe kidney problems, have had
a kidney transplant or need dialysis
• 
if you have narrowing or a blockage of the
blood vessels leading to your kidneys or if you
only have one kidney
• 
if you have liver problems
• 
if you have a condition affecting your adrenal
gland (hyperaldosteronism)
• 
if you are black, taking Eprosartan may be less
effective in lowering the 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

Description Eprosartan 400/600/300mg All
Component Type Leaflet
Affiliate Item Code 655991
Superceded Affiliate Item Code 464656
TrackWise PR No. 655991
MA No.

04569/1227,
1228 & 1229

Packing Site/Printer N/A
Supplier Code 50059771

Pharma Code 3999
SAP No. N/A
Vendor Job No. 256521
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

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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"
Other medicines and Eprosartan
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines obtained
without a prescription, or the following:
• 
other blood pressure lowering medicine
• 
potassium supplements, potassium-sparing
agents or potassium-containing salt
substitutes
• 
a diuretic ('water tablet') and calcium channel
blockers eg. sustained – release nifedipine
• 
heparin, used to treat blood clots
• 
supplements or salt substitutes containing
potassium
• 
lithium, used to treat certain mental disorders
• 
medicines for pain and inflammation such as
ibuprofen, diclofenac, celecoxib, etoricoxib or
lumiracoxib (Non-steriodal anti-inflammatory
medicines)
• 
aspirin (more than 3 g per day) used for pain,
fever and to prevent blood clotting
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 headings
"Do not take Eprosartan" and "Warnings and
precautions").
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
using Eprosartan.
Taking Eprosartan with food and drink
This medicine can be taken with or without
food.
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, 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. Eprosartan is not
recommended for mothers who are breastfeeding, 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.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
There is no information available to suggest
Eprosartan affects your ability to drive or use
machines. However, Eprosartan may cause side
effects in some patients such as feeling tired or
dizziness. Do not drive or operate machines if
your ability to drive or use machines is affected.
Important information about some of the
ingredients of Eprosartan
This medicine contains lactose monohydrate.
If you have been told by your doctor that you
have an intolerance to some sugars, such as
lactose, contact your doctor before taking this
medicine.
3. HOW TO TAKE EPROSARTAN
Always take Eprosartan exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
Swallow the tablets whole with water once
a day, with or without food. Try to take your
tablets at the same time each day.
Adults
The usual starting dose is 600 mg of Eprosartan
once a day.
Eprosartan may be used alone or along with
other medicine eg. a diuretic, to help lower your
blood pressure.
Children
Children and adolescents under 18 years should
not take Eprosartan.

655991

Date: 16 Jun 2015
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Patients with liver or kidney problems Do not take Eprosartan if you have severe liver
problems (see section 2, ‘Do not take
Eprosartan if:’). If you have kidney problems,
your doctor may give you a lower dose.
If you take more Eprosartan than you should:
Contact your doctor or nearest hospital
emergency department immediately.
Remember to take the container and any
remaining tablets with you. Symptoms of
overdose include low blood pressure resulting
in dizziness especially when getting up from a
sitting or lying position.
If you forget to take a dose of Eprosartan:
Take the next dose as soon as you remember
unless it is almost time for your next dose.
Do not take two doses within 12 hours of each
other or take a double dose to make up for
a forgotten dose. If you miss several doses,
contact your doctor.
If you suddenly stop taking Eprosartan:
Your blood pressure may increase. Speak to your
doctor first before stopping this medicine.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Eprosartan can cause side
effects, although not everybody gets them.
If any of the following happen, stop taking
Eprosartan and tell your doctor immediately
or go to your nearest hospital emergency
department you may need urgent medical
treatment:
• 
itchy swollen skin, skin rash
• 
feeling short of breath or wheezy
• 
swelling of the face, lips, tongue and/or
throat.
These may be signs of a severe allergic reaction
which could be life threatening.
A list of possible side effects and their
frequency that were reported in clinical
studies is given below:
Very common side effects (affects more than 1
user in 10)
• 
headache
Common side effects (affects 1 to 10 users in
100)
• 
viral infection
• 
raised fat (triglyceride) levels in the blood
• 
dizziness, feeling unusually tired
• 
feeling depressed
• 
chest pain, palpitations (missed heart beats)
• 
a runny nose, sore or hoarse throat,
breathlessness, cough, chest infection
• 
back or joint pain
• 
urinary tract infection
• 
feeling or being sick, diarrhoea, stomach pain,
indigestion
• 
feeling weak
• 
general pain
• 
rash, itching and hives
Uncommon side effects (affects 1 to 10 users
in 1,000)
• 
too much potassium levels in the blood
• 
swelling under the skin
• 
low blood pressure
• 
allergic reaction
Rare side effects (affects 1 to 10 users in
10,000)
• 
anaemia
• 
increase in urea levels in the blood
Not known side effects (frequency cannot be
estimated from the available data):
• 
loss of muscle tone and strength
• 
dizziness on standing up
• 
swelling of the face

The following additional side effects were
reported by the market:
Changes in kidney function, including renal
failure, in patients at risk.
If any of the side effects gets serious, or if you
notice any side effects not mentioned in the
leaflet, please tell your pharmacist or doctor.
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
Keep out of the reach and sight of children.
Do not take Eprosartan after the expiry date
stated on the carton, blister or bottle after 'EXP'.
The expiry date refers to the last day of that
month.
There are no special storage requirements for
this medicine.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Eprosartan film-coated tablets contain
The active substance is eprosartan (as the
mesylate).
Each tablet contains either 300 mg, 400 mg or
600 mg of eprosartan.
The other ingredients are:
Tablet core - lactose monohydrate,
pregelatinized maize starch, microcrystalline
cellulose, colloidal anhydrous silica, magnesium
stearate, polysorbate 80, povidone K-12,
crospovidone Type B.
Film- coating – hydroxypropyl cellulose (E462),
hypromellose 6 cP, titanium dioxide (E171),
macrogol 400. The film-coating for the 400 mg
tablets also contains yellow and red iron oxides
(E172).
Printing ink – shellac, black iron oxide (E172),
ammonium hydroxide 28 %, propylene glycol
What Eprosartan looks like and contents of the
pack
The 300 mg tablets are off-white oval tablets
marked 'M EN1' on one side. The 400 mg tablets
are pink, capsule-shaped tablets marked 'M EN2'
on one side. The 600 mg tablets are off-white
capsule-shaped tablets marked 'M EN3' on one
side.
Eprosartan Tablets are available in HDPE
bottles containing 500 film-coated tablets
and aluminium blister packs containing 14,
28, 30, 56, 98, 100 and 168 film-coated tablets.
Calendar pack sizes of 14, 28, 56, 98 and 168
film-coated tablets
Not all pack sizes and presentation may be
marketed
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft., H-2900, Komárom,
Mylan útca.1, Hungary

This leaflet was last revised in 06/2015

Description Eprosartan 400/600/300mg All
Component Type Leaflet
Affiliate Item Code 655991
Superceded Affiliate Item Code 464656
TrackWise PR No. 655991
MA No.

04569/1227,
1228 & 1229

Packing Site/Printer N/A
Supplier Code 50059771

Pharma Code 3999
SAP No. N/A
Vendor Job No. 256521
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Sign-offs

Date: 16 Jun 2015
No. of colours
Colours

1

655991
50059771

Time: 16:29
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro

Body Text Size 10pt

Dimensions 170 x 480mm

Min Text Size used 10pt

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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