Eletriptan Upjohn 40 mg film-coated tablets

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

ELETRIPTAN HYDROBROMIDE

Disponible desde:

Viatris Hellas Ltd 253-255, Mesogion Avenue, 154 51 Neo Psychiko, Athens,, Greece

Código ATC:

N02CC06

Designación común internacional (DCI):

ELETRIPTAN HYDROBROMIDE 40 mg

formulario farmacéutico:

FILM-COATED TABLET

Composición:

ELETRIPTAN HYDROBROMIDE 40 mg

tipo de receta:

POM

Área terapéutica:

ANALGESICS

Estado de Autorización:

Authorised

Fecha de autorización:

2013-10-28

Información para el usuario

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ELETRIPTAN UPJOHN 20 AND 40MG 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 Upjohn is and what it is used for
2. What you need to know before you take Eletriptan Upjohn
3. How to take Eletriptan Upjohn
4. Possible side effects
5. How to store Eletriptan Upjohn
6. Contents of the pack and other information
1. WHAT ELETRIPTAN UPJOHN IS AND WHAT IT IS USED FOR
Eletriptan Upjohn contains the active substance eletriptan. Eletriptan
Upjohn 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 Upjohn 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 UPJOHN
DO NOT TAKE ELETRIPTAN UPJOHN:
•
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

Ficha técnica

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SUMMARY OF PRODUCT CHARACTERISTICS
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1. NAME OF THE MEDICINAL PRODUCT
Eletriptan Upjohn 20 mg film-coated tablets
Eletriptan Upjohn 40 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Eletriptan Upjohn 20 mg film-coated tablets
Each film-coated tablet contains 20 mg eletriptan (as hydrobromide).
Excipients with known effect:
Each film-coated tablet contains 23 mg lactose and 0.036 mg Sunset
yellow
Eletriptan Upjohn 40 mg film-coated tablets
Each film-coated tablet contains 40 mg eletriptan (as hydrobromide).
Excipients with known effect:
Each film-coated tablet contains 46 mg lactose and 0.072 mg Sunset
yellow
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet [tablet].
Eletriptan Upjohn 20 mg film-coated tablets
Round, convex, orange, of dimension 6.25 mm, debossed with ‘REP
20’ on one side and ‘Pfizer’ on
the other.
Eletriptan Upjohn 40 mg film-coated tablets
Round, convex, orange, of dimension 8 mm, debossed with ‘REP 40’
on one side and ‘Pfizer’ on
the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Eletriptan Upjohn is indicated in adults for acute treatment of the
headache phase of migraine
attacks, with or without aura.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Eletriptan Upjohn 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.
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Eletriptan Upjohn, if taken during the aura phase, has not been
demonstrated to prevent migraine
headache and therefore Eletriptan Upjohn should only be taken during
the headache phase of
migraine.
_ _
Eletriptan Upjohn 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 Upjohn has
been shown to be effective in
tre