Vazkepa

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Icosapent ethyl

Available from:

Amarin Pharmaceuticals Ireland Limited

ATC code:

C10AX

INN (International Name):

icosapent ethyl

Therapeutic group:

Lipid modifying agents

Therapeutic area:

Dyslipidemias

Therapeutic indications:

Indicated to reduce cardiovascular risk as an adjunct to statin therapy.

Product summary:

Revision: 5

Authorization status:

Authorised

Authorization date:

2021-03-26

Patient Information leaflet

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VAZKEPA 998 MG S
OFT CAPSULES
icosapent ethyl
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vazkepa is and what it is used for
2.
What you need to know before you take Vazkepa
3.
How to take Vazkepa
4.
Possible side effects
5.
How to store Vazkepa
6.
Contents of the pack and other information
1.
WHAT VAZKEPA IS AND WHAT IT IS USED FOR
Vazkepa contains the active substance icosapent ethyl, a highly
purified omega-3 fatty acid from fish
oil.
Vazkepa lowers levels of triglycerides (types of fat) in the blood and
it is used with a statin medicine
(that lowers blood cholesterol) to prevent cardiovascular events, such
as:
-
heart attack
-
stroke
-
death from heart or vascular disease
Vazkepa is used in adults with high blood triglycerides who already
have heart disease or have
diabetes and other conditions that put them at a higher risk of
cardiovascular events.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VAZKEPA
_ _
DO NOT TAKE VAZKEPA
-
If you are
ALLERGIC TO ICOSAPENT ETHYL
, soya or any of the other ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Vazkepa:
-
If you are
ALLERGIC TO FISH OR TO SHELLFISH
.
-
If you have
PROBLEM

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Vazkepa 998 mg soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 998 mg of icosapent ethyl.
Excipients with known effect
Each capsule contains 30 mg maltitol (E965 ii), 83 mg sorbitol (E420
ii) and soya lecithin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soft capsule (capsule)
Oblong soft capsule, 25 x 10 mm, printed with “IPE” in white ink,
with a light yellow to amber shell
containing a colourless to pale yellow liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vazkepa is indicated to reduce the risk of cardiovascular events in
adult statin-treated patients at high
cardiovascular risk with elevated triglycerides (≥ 150 mg/dL [≥
1.7 mmol/L]) and
•
established cardiovascular disease, or
•
diabetes, and at least one other cardiovascular risk factor.
For study details including cardiovascular risk factors and results
with respect to effects on
cardiovascular events see section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended daily oral dose is 4 capsules taken as two 998 mg
capsules twice daily.
If a dose is missed, patients should take it as soon as they remember.
However, if one daily dose is
missed, the next dose should not be doubled.
_Elderly (≥ 65 years) _
No dose adjustment is necessary based on age (see section 5.2).
_Renal impairment _
No dose reduction is recommended (see also section 5.2).
_ _
_Hepatic impairment _
3
No dose reduction is recommended (see also sections 4.4 and 5.2).
_Paediatric population _
There is no relevant use of icosapent ethyl in children aged <18 years
of age in reducing the risk of
cardiovascular events in statin-treated patients at high
cardiov