FROVEX 2.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FROVATRIPTAN

Available from:

LTT Pharma Limited

ATC code:

N02CC; N02CC07

INN (International Name):

FROVATRIPTAN

Dosage:

2.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Administration route:

Oral use

Units in package:

Blister packs with 6 tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

Almac Pharma Services Limited, Berlin-Chemie AG, A.Menarini Manufacturing Logistics and Services S.r.l, Laboratories Menarini

Therapeutic group:

Selective 5-HT1 receptor agonists

Therapeutic area:

Selective serotonin (5HT1) agonists; frovatriptan

Therapeutic indications:

Acute treatment of the headache phase of migraine attacks with or without aura

Authorization status:

Authorised

Authorization date:

2015-04-17

Patient Information leaflet

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:
What Frovex is and what it is used for
What you need to know before you take Frovex
How to take Frovex
Possible side effects
How to store Frovex
Contents of the pack and other information
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 (5HT1)
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.
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 attack (TIA),
*
if you have severely or moderately high blood pressure

Summary of Product characteristics

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(s): lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
_Product imported from Greece_
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_
Anhydrous lactose,
Microcrystalline cellulose
Magnesium stearate
Sodium starch glycollate_ (_Type A)
Silica, colloidal anhydrous
_Tablet Coat_
Opadry white:
Titanium dioxide (E 171)
Anhydrous lactose,
Hypromellose (E 464)
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.
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
PVC/PE/ACLAR/Aluminium blister