Frovatriptan 2.5mg Film-coated Tablets

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Frovatriptan succinate monohydrate

Fáanlegur frá:

Chanelle Medical Unlimited Company

ATC númer:

N02CC; N02CC07

INN (Alþjóðlegt nafn):

Frovatriptan succinate monohydrate

Skammtar:

2.5 milligram(s)

Lyfjaform:

Film-coated tablet

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

Selective serotonin (5HT1) agonists; frovatriptan

Leyfisstaða:

Marketed

Leyfisdagur:

2013-07-19

Upplýsingar fylgiseðill

ID: PL169M –IE/H/0768/001/DC
VERSION: 07
EFFECTIVE DATE: 26/10/2022
Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
FROVATRIPTAN 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 Frovatriptan 2.5 mg film-coated tablets is and what it is used
for
2.
What you need to know before you take Frovatriptan 2.5 mg film-coated
tablets
3.
How to take Frovatriptan 2.5 mg film-coated tablets
4.
Possible side effects
5.
How to store Frovatriptan 2.5 mg film-coated tablets
6.
Contents of the pack and other information
1.
WHAT_ _FROVATRIPTAN 2.5 MG FILM-COATED TABLETS IS AND WHAT IT IS USED
FOR
Frovatriptan 2.5 mg film-coated tablets contain frovatriptan, an
anti-migraine treatment belonging
to the class of triptans (5-hydroxytryptamine (5HT1) selective
receptor agonists).
Frovatriptan 2.5 mg film-coated 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 attack, which
varies from person to person but can affect, for example, vision,
smell, hearing).
Frovatriptan 2.5 mg film-coated tablets should not be used to prevent
migraine attack.
Frovatriptan2.5 mg film-coated tablets is used to treat migraine
attacks in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FROVATRIPTAN 2.5 MG FILM-COATED
TABLETS
The diagnosis of migraine must have been clearly established by your
doctor.
DO NOT TAKE FROVATRIPTAN 2.5 MG FILM-COATED TABLETS:
•
if you are allergic _to_ frovat

Vara einkenni

Health Products Regulatory Authority
10 November 2022
CRN00D79W
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Frovatriptan 2.5mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg of frovatriptan (as
frovatriptan succinate monohydrate).
_Excipient(s) with known effect:_ Contains approximately 107 mg of
lactose per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Round white to off-white film-coated tablet, plain on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acute treatment of the headache phase of migraine attacks with or
without aura.
Frovatriptan 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 (18-65 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 Frovatriptan 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)
Health Products Regulatory Authority
10 November 2022
CRN00D79W
Page 2 of 9
Frovatriptan data in patients over 65 years remain limited. Therefore,
its use in this category of patients is not recommended.
Renal Impairment
No dosage adjustment is required in patients with renal impairment
(see section 5.2).