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EPROSARTAN MYLAN 400 MG FILM-COATED TABLETS

Active substance(s): EPROSARTAN MESYLATE / EPROSARTAN MESILATE / EPROSARTAN MESILATE

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Package leaflet: Information for the patient

Eprosartan 300 mg
Film-coated Tablets
Eprosartan 400 mg
Film-coated Tablets
Eprosartan 600 mg
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.

What is in this leaflet

1. What Eprosartan is and what it is used for
2. What you need to know before you take
Eprosartan
3. How to take Eprosartan
4. Possible side effects
5. How to store Eprosartan
6. Contents of the pack and other
information

1. What Eprosartan is and what it
is used for
Eprosartan belongs to a family of medicines
known as angiotensin II receptor blockers.
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. What you need to know before
you take Eprosartan
Do not take Eprosartan if:

•• y ou are allergic to eprosartan or any of
the other ingredients of this medicine
(listed in section 6)
•• 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.

Warnings and precautions

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 or have low salt
levels (because you are on a low salt diet,
are taking water tablets or you have, or
have had, 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 e.g.
heart valve disease, an enlarged heart
or weakness of the heart muscle (heart
failure)
•• 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
kidney(s)
•• if you have any other liver problems
•• if you have a condition affecting your
adrenal gland (hyperaldosteronism)

•• if you are of Afro-Caribbean origin,
as eprosartan may be less effective in
lowering 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
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 if”.

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 medicines
•• potassium supplements, potassiumsparing agents or potassium-containing
salt substitutes
•• a diuretic (‘water tablet’)
•• medicines that can increase blood
potassium levels, such as heparin, used to
treat blood clots
•• lithium, used to treat certain mental
disorders
•• medicines for pain and inflammation
such as aspirin (more than 3 g per
day), ibuprofen, diclofenac, celecoxib,
etoricoxib or lumiracoxib (non-steroidal
anti-inflammatory medicines) used for
pain, fever
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 if” 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.

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 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.
Ask your doctor or pharmacist for advice
before taking this 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.

Eprosartan tablet 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 this medicine exactly as your
doctor or pharmacist has told you. 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 recommended dose is 600 mg of
eprosartan once a day.
Eprosartan may be used alone or along
with other medicine e.g. a diuretic, to help
lower your blood pressure.
50060113

Description Eprosartan 400/600/300mg All
Component Type Leaflet
Affiliate Item Code 673638
Superceded Affiliate Item Code 655991
TrackWise PR No. 673638
MA No. 04569/1227,

1228 & 1229

Packing Site/Printer N/A
Supplier Code 50060113

Pharma Code 4216
SAP No. N/A
Vendor Job No. 259516
Trackwise Proof No. 7
Glams Proof No. 1
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Date: 18 May 2017
No. of colours
Colours

1

Time: 14:45
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro

Body Text Size 11 pt

Dimensions 170 x 480mm

Min Text Size used 10 pt

Sign-offs

v1/May 2015

Use in children and adolescents

Children and adolescents under 18 years
should not take eprosartan.

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 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 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, this medicine 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
as 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.

•• C
 hanges in kidney function, including
kidney failure (you may have lower back
pain, produce little or no urine, or urine
that is passed may be cloudy or have
blood in it). This is more likely to occur in
certain patients at risk.
A list of possible side effects and their
frequency that were reported in clinical
studies is given below:
Very common side effects (may affect
more than 1 in 10 people)
•• headache
Common side effects (may affect up to 1 in
10 people)
•• dizziness
•• a runny nose
•• feeling or being sick, diarrhoea
•• feeling weak
•• rash, itching

5. How to store Eprosartan
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, blister
or bottle 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 tablet contains

The active substance is eprosartan (as
mesilate). Each tablet contains either
300 mg, 400 mg or 600 mg of eprosartan.
he other ingredients are:

The other ingredients are:
Tablet core: lactose monohydrate,
pregelatinised 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 tablet looks like and
contents of the pack

The 300 mg tablets are white to off-white
oval tablets marked ‘M EN1’ on one side.
The 400 mg tablets are pink, capsuleshaped tablets marked ‘M EN2’ on one side.
The 600 mg tablets are off-white capsuleshaped tablets marked ‘M EN3’ on one side.
Eprosartan tablets are available in plastic
bottles containing 500 film-coated tablets
and blister packs containing 14, 28, 30, 56,
98, 100 and 168 film-coated tablets and
calendar pack sizes of 14, 28, 56, 98 and
168 film-coated tablets.
Not all pack sizes and presentations may
be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom

Manufacturers

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 May 2017.

Uncommon side effects (may affect up to
1 in 100 people)
•• low blood pressure

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.

673638
50060113

Description Eprosartan 400/600/300mg All
Component Type Leaflet
Affiliate Item Code 673638
Superceded Affiliate Item Code 655991
TrackWise PR No. 673638
MA No. 04569/1227,

1228 & 1229

Packing Site/Printer N/A
Supplier Code 50060113

Pharma Code 4216
SAP No. N/A
Vendor Job No. 259516
Trackwise Proof No. 7
Glams Proof No. 1
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Date: 18 May 2017
No. of colours
Colours

1

Time: 14:45
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro

Body Text Size 11 pt

Dimensions 170 x 480mm

Min Text Size used 10 pt

Sign-offs

v1/May 2015

Expand Transcript

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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