FROVEX 2.5 mg film-coated tablets

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

FROVATRIPTAN

Saadav alates:

IMED Healthcare Ltd.

ATC kood:

N02CC; N02CC07

INN (Rahvusvaheline Nimetus):

FROVATRIPTAN

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:

2018-05-04

Infovoldik

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 had a stroke or a transient ischaemic att

Toote omadused

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 effect
Lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (Tablet)
_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 PA0865/009/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0865/009/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Tablet core_
Lactose, anhydrous
Microcrystalline cellulose
Silica, colloidal anhydrous
Sodium starch glycolate (Type A)
Magnesium stearate
_Tablet Coat_
Opadry white:
Hypromellose (E 464)
Titanium dioxide (E 171)
Lactose, anhydrous
Macrogol 3000
Triacetin
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister 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.
Blister: store in the original package in order to protect from
moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
PVC/PE/ACLAR/Aluminium blister packs wi