FROVEX 2.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FROVATRIPTAN

Available from:

Menarini International Operations Luxembourg S.A.

ATC code:

N02CC; N02CC07

INN (International Name):

FROVATRIPTAN

Dosage:

2.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Selective serotonin (5HT1) agonists; frovatriptan

Authorization status:

Marketed

Authorization date:

2002-05-17

Patient Information leaflet

1
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 ischaem

Summary of Product characteristics

Health Products Regulatory Authority
30 September 2021
CRN00CD61
Page 1 of 9
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: approximately 100 mg of lactose per
tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round biconvex white film-coated tablet, debossed with "m" on one side
and "2.5" on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acute treatment of the headache phase of migraine attacks with or
without aura.
FROVEX is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Frovatriptan should be taken as early as possible after the onset of a
migraine attack but it is also effective when taken at a
later stage. Frovatriptan should not be used prophylactically.
If a patient does not respond to the first dose of frovatriptan, a
second dose should not be taken for the same attack, since no
benefit has been shown.
Frovatriptan may be used for subsequent migraine attacks.
ADULTS (18 TO 65 YEARS OF AGE)
The recommended dose of frovatriptan is 2.5 mg.
If the migraine recurs after initial relief, a second dose may be
taken, providing there is an interval of at least 2 hours between
the two doses.
The total daily dose should not exceed 5 mg per day.
PAEDIATRIC POPULATION (UNDER 18 YEARS)
The safety and efficacy of FROVEX in children and adolescents aged
below the age of 18 years have not been established.
Therefore, its use in this age group is not recommended. No data are
available.
_Elderly (over 65 years)_
Frovatriptan data in patients over 65 years remain limited. Therefore,
its use in this category of patients is not recommended.
RENAL IMPAIRMENT
Health Products Regulatory Authority
30 September 2021
CRN00CD61
Page 2 of 9
No dosage adjustment is required in patients with renal impairment
(see section 5.2).
HEPATIC IMPA