Skip to Content

EPROSARTAN 600 MG FILM-COATED TABLETS

Active substance(s): EPROSARTAN MESILATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user

Eprosartan 300mg, 400mg and 600mg film-coated tablets

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 any 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 signs of illness 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. See section 4.
and you also have a kidney problem. Your doctor might
sometimes check your blood to make sure that
Eprosartan is not affecting the amount of potassium in
your blood

In this leaflet:
1. What Eprosartan is and what it is used for
2. What you need to know before you take Eprosartan


You suffer from lactose intolerance (see section
'Eprosartan contains lactose')



You think 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, breast-feeding and
fertility” section)

Eprosartan 300mg, 400mg and 600mg film-coated tablets
contains a medicine called eprosartan mesilate. This
belongs to a group of medicines called 'angiotensin II
receptor antagonists'.



You have been told you have Conn's syndrome (primary
hyperaldosteronism) i.e. your body is making too much
of the hormone aldosterone. Eprosartan may not work,
so check with your doctor.

This medicine is used to treat high blood pressure, also
called hypertension.



You are taking medicines to treat high blood preassure
such as aliskiren or an ACE-inhibitor (for example
enalapril, lisinopril, ramipril), particularly if you have
diabetes-realated kidney problems.

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

The main cause of high blood pressure is narrowing of the
blood vessels. This increases the amount of work your heart
must do to pump blood around your body. You may not feel
unwell, but if high blood pressure is not treated, it can lead
to heart disease and stroke.
How Eprosartan works:


Angiotensin II is a chemical found in the body which
makes your blood vessels contract. This makes it more
difficult for blood to pass through them



This causes your blood pressure to rise



Eprosartan works by preventing the chemical,
angiotensin II, from causing your blood vessels to
contract. This has the effect of lowering your blood
pressure.

You may be given Eprosartan on its own or with another
medicine used to treat high blood pressure. Using both
medicines together will lower your blood pressure more
than one on its own.
The active ingredient in this medicine is eprosartan
mesilate. This is the new name for eprosartan mesylate.
The active ingredient itself has not changed.
2. What you need to know before you take Eprosartan
Do not take Eprosartan:


if you are allergic (hypersensitive) to eprosartan or any
of the other ingredients of this medicine (listed in
section 6 below);



if you have severe liver problems;



if you are more than 3 months pregnant (it is also better
to avoid Eprosartan in early pregnancy – see “
Pregnancy, breast-feeding and fertility” section)



if you have damaged blood flow to the kidneys or
serious constrictions in a single functioning kidney



if 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 this medicine.

Your doctor may check your kidney function, blood
pressure, and the amount of electrolytes (e.g. potassium) in
your blood at regular intervals.
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Eprosartan. See
also Section 2 of this leaflet under the heading “Do not take
Eprosartan”.
Other medicines and Eprosartan
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes
medicines obtained without a prescription, including herbal
medicines. Your doctor may need to change your dose
and/or to take other precautions.
In particular, tell your doctor or pharmacist if you are taking
any of the following medicines:
• Medicines for pain and inflammation such as ibuprofen,
diclofenac, celecoxib, etoricoxib or lumiracoxib (Nonsteroidal anti-inflammatory medicines)


Potassium supplements, potassium-sparing agents or
potassium-containing salt substitutes



Medicines that increase potassium levels such as
heparin



Water tablets (Diuretics) such as hydrochlorothiazide
and calcium channell blocker such as nifedipine which
may be used to help lower your blood pressure



Aspirin (more than 3 g per day) used for pain, fever and
to prevent blood clotting



Lithium used for mental problemsACE inhibitors or
aliskiren (See also Section 2 of this leaflet under the
headings “Do not take Eprosartan” and “Take special
care with Eprosartan”)

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 any of the above apply to you (or you are not sure), talk to
your doctor or pharmacist before taking Eprosartan.

Warnings and precautions

Pregnancy, breast-feeding and fertility

Talk to your doctor or pharmacist before taking Eprosartan
if:

Pregnancy



You have heart, kidney or liver problems, especially
severe heart failure, narrowing of the heart valves,
thickening of heart muscle (hypertrophic
cardiomyopathy)

If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor for
advice before taking this medicine.



You have narrowing or a blockage of the blood vessels
leading to your kidneys or if you only have one kidney



You have recently been sick or had diarrhoea



You are taking water tablets (diuretics) and they make
you feel dizzy when you stand up

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.



You are taking water tablets or potassium supplements

Breast-feeding

Size: 180 x 360 mm

PHARMA CODE

PHARMA CODE

eprosartan mesilate

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.



Feeling or being sick (nausea or vomiting)



Diarrhoea



Runny nose

Uncommon (at least 1 in 1000 and less than 1 in 100
patients):

Driving and using machines



Low blood pressure (hypotension)

You may feel tired or dizzy when you start taking
Eprosartan. If this happens, do not drive or use any tools or
machines until these effects wear off.



Sudden swelling of your face, lips or tongue and
breathing problems. These may be signs of a severe
allergic reactions and may be life threatening.

Eprosartan contains lactose:

Not known

Eprosartan contains lactose (a type of sugar). If you have
been told by your doctor that you cannot tolerate or digest
some sugars (have an intolerance to some sugars), talk to
your doctor before taking this medicine.



3. How to take Eprosartan
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
Taking this medicine


Your doctor will tell you how many tablets to take and
for how long. It is important that you keep taking the
tablets for as long as your doctor tells you.

Only remove a tablet from the blister strip when it is time to
take your medicine.
Take your tablet with or without food
Take your tablets at about the same time each day.
The recommended dose is:
Adults aged under 75 years
The usual starting dose is 600 mg once a day
Your doctor may increase your daily dose to 800 mg
(two 400 mg tablets).
Elderly people (aged 75 or over) and people with kidney
or liver problems

Changes in kidney function including kidney failure in
patients with existing kidney problems.

Blood tests
If you need a blood sample taking for testing, you should
remind your doctor that you are taking Eprosartan, as it may
affect the result.
Reporting of side effects
If you get any side effects, talk to your doctoror pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via 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 this medicine out of the sight and reach of children.
Do not use Eprosartan after the expiry date which is stated
on the label and carton after EXP. The expiry date refers to
the last day of that month.
Do not use Eprosartan if you notice any visible signs of
deterioration.
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.

No dose adjustment is required in elderly people.
If you have liver or kidney problems, consult your doctor.
Your doctor will decide your daily dosage.
Use in children and adolescents:
Eprosartan should not be used in children and adolescents
under 18 years of age.
If you take more Eprosartan than you should
If you take more Eprosartan than you should, talk to a
doctor or go to a hospital straight away. Take the medicine
pack with you. Symptoms of overdose include headache,
dizziness or allergic reactions (rhinitis- hay fever).
If you forget to take Eprosartan


If you forget to take a dose, take it as soon as you
remember



Take your next dose at the normal time



Do not take two doses within 12 hours of each other.

If you have any further questions on the use of this product,
ask your doctor or pharmacist.
If you stop taking Eprosartan
Keep taking this medicine until your doctor tells you to
stop. Do not stop taking Eprosartan just because you feel
better.

6. Contents of the pack and other information
What Eprosartan contains:
The active substance is eprosartan (as mesilate). Each
tablet contains 300mg, 400mg or 600mg of eprosartan.
The other ingredients are: lactose, microcrystalline cellulose
(E460), magnesium stearate (E572), croscarmellose sodium,
hydroxypropylcelluse, hypromellose, titanium dioxide
(E171), polysorbate 80 (E433) and macrogol 400


The 300 mg and 600 mg tablets also contain opadry
white



The 400 mg tablets also contain iron oxides (E172) and
opadry pink

What Eprosartan looks like and contents of the pack
300 mg: White to off white, oval shaped, biconvex filmcoated tablets debossed with 'I' on one side and '120' on
other side.
400 mg: Pink, oval shaped, biconvex film-coated tablets
debossed with 'I' on one side and '121' on other side.
600 mg: White to off-white, modified capsule shaped,
biconvex film-coated tablets debossed with 'H' on one side
and '188' on other side.
Eprosartan is available in blister packs containing 28 or 56
tablets.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.



Sudden swelling of your face, lips or tongue and
breathing problems. These may be signs of a severe
allergic reaction and may be life threatening. This side
effect is uncommon (at least 1 in 1000 and less than 1 in
100 patients)

A list of possible side effects reported in clinical studies
with eprosartan is given below:
Very common (at least 1 in 10 patients or more):


Headache

Common (at least 1 in 100 and less than 1 in 10 patients):


Skin rashes or itching



Weakness or lack of strength



Feeling dizzy

Marketing Authorisation Holder
Hetero Europe S.L.
Viladecans Business Park, Catalunya 83-85 – Edificio
Brasil, 08840
Viladecans –Barcelona, Spain
Manufacturer
Pharmadox Healthcare, Ltd.
KW20A Kordin Industrial Park, Paola, PLA 3000
Malta
This leaflet was last revised in December 2015

PHARMA CODE

PHARMA CODE

Stop taking Eprosartan and see a doctor straight away if
you develop any of the following symptoms - you may
need urgent medical treatment:

Marketing Authorisation Holder and Manufacturer

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.

Hide