Griseofulvin 500 mg film-coated tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Griseofulvin

Tilgjengelig fra:

Brown & Burk IR Limited

ATC-kode:

D01BA; D01BA01

INN (International Name):

Griseofulvin

Dosering :

500 milligram(s)

Legemiddelform:

Film-coated tablet

Terapeutisk område:

Antifungals for systemic use; griseofulvin

Autorisasjon status:

Marketed

Autorisasjon dato:

2011-03-25

Informasjon til brukeren

Griseofulvin 500 mg Tablets
YV: CTDv9
1.3.1 - 1
MODULE 1: ADMINISTRATIVE AND PRESCRIBING INFORMATION
MODULE 1.3 PRESCRIBING INFORMATION
MODULE 1.3.1 SMPC, LABELLING, LEAFLET
1.3.1.3 LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
Griseofulvin 500mg Film-coated Tablets
Griseofulvin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Griseofulvin is and what it is used for
2.
Before you take Griseofulvin
3.
How to take Griseofulvin
4.
Possible side effects
5.
How to store Griseofulvin
6.
Further information
Griseofulvin 500 mg Tablets
YV: CTDv9
1.3.1 - 2
1.
WHAT GRISEOFULVIN IS AND WHAT IT IS USED FOR
Griseofulvin
500mg
Tablets,
contain
an
anti-fungal
agent
called
Griseofulvin.
Griseofulvin kills the fungi that cause infections of the hair, skin,
scalp, groin (“jock
itch”), feet (“athlete’s foot”), and nails-ringworm. It does
this by being incorporated in
the skin, hair and nails, which takes the same time as they take to
grow. This is why
treatment lasts for a long time.
2.
BEFORE YOU TAKE GRISEOFULVIN
DO NOT TAKE GRISEOFULVIN
-
if you are allergic (hypersensitive) to griseofulvin or any of the
other ingredients of
the tablets-(see section 2)
-
if you suffer from a rare disease called porphyria
-
if you suffer from a rare painful skin and tissue disease called
Systemic Lupus
Erythematosus, or SLE
-
if you have severe liver disease
-
if you are pregnant, or you think you might be pregnant, or you are
planning to get
pregnant
-
if you are breastfeeding
If any of the above apply to you,
DO NOT
take the tablets and go back to your doctor.
TAKE SPECIAL CARE WITH GRI

Preparatomtale

Health Products Regulatory Authority
11 January 2021
CRN00C2LL
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Griseofulvin 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500mg griseofulvin
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet.
White to off white, round, biconvex film-coated tablet
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The treatment of fungal infections of the skin, scalp, hair, or nails
(Tinea barbae, Tinea capitis, Tinea corporis, Tinea cruris, Tinea
pedis, Tinea unguium) where topical therapy is considered
inappropriate, or the infection has proven refractory to topical
therapy.
Oral administration of griseofulvin for systemic therapy of fungal
infections enables newly formed keratin of the skin, hair, and
nails to resist fungal attack. As the new keratin extends, the old
infected keratin is shed.
Prior to therapy, the type of fungi responsible should be identified.
The use of griseofulvin is not justified in the treatment of
minor or trivial infections that will respond to topical therapy.
Before prescribing Griseofulvin Tablets, consideration should be given
to national and/or local guidance on the appropriate use
of antifungals.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_General:_
For oral administration.
Tablets should be swallowed whole with a glass of water. Griseofulvin
is recommended to be taken after a high fat meal, for
increased absorption and minimising GI distress, see section 5.2.
General measures in regard to hygiene should be observed to control
sources of infection or reinfection. Concomitant use of
appropriate topical agents is usually required, particularly in
treatment of tinea pedis. In some forms of tine pedis, yeasts and
bacteria may be involved as well as fungi. Griseofulvin will not
eradicate the bacterial or candidial infections.
_Adults_
The usual adult dose is 500 mg to 1000 mg daily. The dose should not
be less than 10 mg / Kg bodyw