FROVEX 2.5 mg film-coated tablets

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Frovatriptan succinate monohydrate

Saadav alates:

PCO Manufacturing Ltd.

ATC kood:

N02CC; N02CC07

INN (Rahvusvaheline Nimetus):

Frovatriptan succinate monohydrate

Annus:

2.5 milligram(s)

Ravimvorm:

Film-coated tablet

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

Selective serotonin (5HT1) agonists; frovatriptan

Volitamisolek:

Authorised

Loa andmise kuupäev:

2013-08-23

Infovoldik

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FROVEX
® 2.5 MG FILM-COATED TABLETS
frovatriptan
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 FROVEX is and what it is used for
2.
What you need to know before you take FROVEX
3.
How to take FROVEX
4.
Possible side effects
5.
How to store FROVEX
6.
Contents of the pack and other information
1.
WHAT FROVEX IS AND WHAT IT IS USED FOR
FROVEX 2.5 mg tablets contain frovatriptan, an anti-migraine treatment
belonging to the class of triptans (5-hydroxytryptamine (5HT
1
) selective
receptor agonists).
FROVEX 2.5 mg tablets is a medicine for the treatment of the headache
phase of a migraine attack with or without aura (a temporary strange
feeling before a migraine, which varies from person to person but can
affect, for example, vision, smell, hearing).
FROVEX 2.5 mg tablets should not be used to prevent a migraine
attack.
FROVEX is used to treat migraine attacks in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FROVEX
The diagnosis of migraine must have been clearly established by your
doctor.
DO NOT TAKE FROVEX

If you are allergic to frovatriptan or any of the other ingredients of
this medicine (listed in section 6.1)

if you have had a heart attack, or suffer or have suffered from
certain cardiovascular diseases such as angina pectoris
(characterised by crushing pain in the chest which can extend into
the left arm), or circulation disorders of the legs or arms
(especially
in the fingers and toes),

if you have h

Toote omadused

Health Products Regulatory Authority
31 January 2022
CRN00CR7J
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
FROVEX 2.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg of frovatriptan (as succinate
monohydrate).
Excipient(s) with known effects: lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Portugal _
Round, biconvex, white film-coated tablet, debossed with "m" on one
side and "2.5" on the other.
_Product imported from Italy_
Round, biconvex, white film-coated tablet, debossed with "m" on one
side and "2,5" on the other.
4 CLINICAL PARTICULARS
As per PA 0865/009/001
5 PHARMACOLOGICAL PROPERTIES
As per PA 0865/009/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Tablet core_
Lactose, anhydrous
Microcrystalline cellulose
Silica, colloidal anhydrous
Sodium starch glycollate (Type A)
Magnesium stearate
_ _
_Film Coat_
Opadry white:
Hypromellose (E 464)
Titanium dioxide (E 171)
Lactose, anhydrous
Macrogol 3000
Triacetin
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
31 January 2022
CRN00CR7J
Page 2 of 2
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30 °C.
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs with 6 tablets in a cardboard carton
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements. Any unused medicinal product or waste
material should be disposed of in accordance with local
requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/321/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: