Imigran Ftab 100 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sumatriptan

Available from:

Lexon Pharmaceuticals (Ireland) Limited

ATC code:

N02CC; N02CC01

INN (International Name):

Sumatriptan

Dosage:

100 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Selective serotonin (5HT1) agonists; sumatriptan

Authorization date:

2020-08-28

Patient Information leaflet

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 Imigran is and what it is used for What you need to know before you take Imigran Ftab film-coated
tablets How to take Imigran Ftab film-coated tablets Possible side effects How to store Imigran Ftab film-coated tablets Contents of the pack and other information
WHAT IMIGRAN IS AND WHAT IT IS USED FOR
EACH IMIGRAN FTAB FILM-COATED TABLET CONTAINS A SINGLE DOSE of
sumatriptan, which belongs to a group of medicines called triptans
_(also _
_known as 5-HT_
_1_
_ receptor agonists)._
IMIGRAN FTAB FILM-COATED TABLETS ARE USED TO TREAT MIGRAINE HEADACHES
WITH OR WITHOUT WARNING SIGNS (AURA) AND TO TREAT MIGRAINE HEADACHES
ASSOCIATED WITH MENSTRUATION.
Migraine symptoms may be caused by the temporary widening of blood
vessels in the head. Imigran Ftab film-coated tablets are believed to
reduce
the widening of these blood vessels. This in turn helps to take away
the
headache and relieve other symptoms of a migraine attack, such as
feeling
or being sick (nausea or vomiting) and sensitivity to light and sound.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IMIGRAN FTAB FILM-COATED TABLETS
DO NOT TAKE IMIGRAN FTAB FILM-COATED TABLETS:
*
IF YOU ARE ALLERGIC to sumatriptan, or any of the other ingredients
(listed in Section 6).
*
IF YOU HAVE A HEART PROBLEM such as narrowing of the arteries_
(Ischaemic _
_ heart disease)_ or chest pains_ (angina)_, or have already had a
heart attack.
*
IF YOU HAVE CIRCULATION PROBLEMS IN YOUR LEGS that cause cramp-like
pains when you walk

Summary of Product characteristics

Health Products Regulatory Authority
16 March 2022
CRN00CV8V
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imigran Ftab 100 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets containing 100 mg of sumatriptan base as the succinate salt.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Italy._
White film-coated, triangular shaped, biconvex tablet debossed "GS
YE7" on one face and "100" on the other.
4 CLINICAL PARTICULARS
As per PA1077/008/007.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Anhydrous dibasic calcium phosphate
Cellulose microcrystalline
Sodium bicarbonate
Croscarmellose sodium
Magnesium stearate
Hypromellose
Titanium oxide (E171)
Glycerol triacetate
6.2 INCOMPATIBILITIES
Not applicable.
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 30ºC.
6.5 NATURE AND CONTENTS OF CONTAINER
Foil blister packs, contained in a cardboard carton.
Pack sizes 6 tablets.
Health Products Regulatory Authority
16 March 2022
CRN00CV8V
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon Pharmaceuticals (Ireland) Limited
Block 3
Harcourt Centre
Harcourt Road
Dublin 2
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23176/032/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 28
th
August 2020
10 DATE OF REVISION OF THE TEXT
October 2021