Eletriptan 20mg Film-coated tablet

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

ELETRIPTAN

Fáanlegur frá:

Chanelle Medical Unlimited Company

ATC númer:

N02CC; N02CC06

INN (Alþjóðlegt nafn):

ELETRIPTAN

Skammtar:

20 milligram(s)

Lyfjaform:

Film-coated tablet

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

Selective serotonin (5HT1) agonists; eletriptan

Leyfisstaða:

Not marketed

Leyfisdagur:

2017-07-28

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
ELETRIPTAN 20 MG FILM-COATED TABLETS
ELETRIPTAN 40 MG FILM-COATED TABLETS
Eletriptan
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 Eletriptan is and what it is used for
2.
What you need to know before you take Eletriptan
3.
How to take Eletriptan
4.
Possible side effects
5.
How to store Eletriptan
6.
Contents of the pack and other information
1.
WHAT ELETRIPTAN IS AND WHAT IT IS USED FOR
This medicine contains the active substance eletriptan. Eletriptan is
one of a group of
medicines called serotonin receptor agonists. Serotonin is a natural
substance found in the
brain that helps to narrow the blood vessels.
Eletriptan can be used to treat migraine headache with or without aura
in adults. Before the
start of a migraine headache, you may experience a phase called an
aura, which can involve
vision disorders, numbness and speech disorders
.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ELETRIPTAN
DO NOT TAKE ELETRIPTAN:
•
If you are allergic (hypersensitive)
to eletriptan, or any of the other ingredients of this
medicine (listed in section 6).
•
If you have severe liver or kidney disease.
•
If you have moderate to severe high blood pressure or untreated mild
high blood pressure.
•
If you have ever had heart problems, [e.g. heart attack, angina, heart
failure or significant
abnormal heart rhythm (arrhythmia), temporary, sudden narrowing of one
of the coronary
arteries].
•
If you have poor circulation (peripheral vascular disease).
•
If you

Vara einkenni

Health Products Regulatory Authority
11 January 2024
CRN00CYSY
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eletriptan 20mg Film-coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg eletriptan (as hydrobromide).
Excipients with known effect:
Each film-coated tablet contains 23 mg lactose and 0.0602 mg Sunset
yellow FCF aluminium lake (E110)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Orange, round, convex shaped film-coated tabletsplain on one side and
embossed with “20” on the other side, approximately 6
mm in diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Eletriptan is indicated in adults for the acute treatment of the
headache phase of migraine attacks, with or without aura.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Eletriptan tablets should be taken as early as possible after the
onset of migraine headache but they are also effective if taken
at a later stage during a migraine attack.
Eletriptan, if taken during the aura phase, has not been demonstrated
to prevent migraine headache and therefore Eletriptan
should only be taken during the headache phase of migraine.
Eletriptan tablets should not be used prophylactically.
_Adults (18-65 years of age):_
The recommended initial dose is 40 mg.
_If headache returns within 24 hours:_ If the migraine headache recurs
within 24 hours of an initial response, a second dose of the
same strength of Eletriptan has been shown to be effective in treating
the recurrence. If a second dose is required, it should not
be taken within 2 hours of the initial dose.
_If no response is obtained:_If a patient does not achieve a headache
response to the first dose of Eletriptan within 2 hours, a
second dose should not be taken for the same attack as clinical trials
have not adequately established efficacy with the second
dose. Clinical trials show that patients who do not respond to the
treatment of an attack are still likely to respond