Terbinafine 250mg tablets

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Terbinafine hydrochloride

Доступна з:

Dr Reddy's Laboratories (UK) Ltd

Код атс:

D01BA02

ІПН (Міжнародна Ім'я):

Terbinafine hydrochloride

Дозування:

250mg

Фармацевтична форма:

Oral tablet

Адміністрація маршрут:

Oral

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 05020500; GTIN: 05036072002944 05036072002937

інформаційний буклет

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 TERBINAFINE TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TERBINAFINE TABLETS
3.
HOW TO TAKE TERBINAFINE TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE TERBINAFINE TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT TERBINAFINE TABLETS ARE AND WHAT THEY ARE
USED FOR
Terbinafine is an antifungal medicine used to treat fungal skin and
nail infections.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TERBINAFINE TABLETS
DO NOT TAKE TERBINAFINE TABLETS
•
if you are
ALLERGIC
to terbinafine, or any of the other
ingredients of this medicine listed in section 6
•
if you have or have had any liver problems
•
if you are breast-feeding. WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Terbinafine
Tablets. If the answer to any of these questions is YES,
Terbinafine Tablets might not be the right medicine for you.
•
Are you
PREGNANT
or
TRYING
to
BECOME PREGNANT
?
•
Do you have any problems with your
KIDNEYS
or
LIVER
?
•
Do you have
PSORIASIS
?
•
Do you have
SYSTEMIC LUPUS
ERYTHEMATOSUS (SLE)
?
•
Do you have a
RASH
due to a high level of a specific type of
white blood cells?
CHILDREN AND ADOLESCENTS
Children should not normally be given Terbinafine Tablets. OTHER MEDICINES AND TERBINAFINE TABLETS
TELL YOUR DOCTOR
or pharmacist if you are taking, have recently
taken or might take any other medicines.
Some medicines can interfere with your treatment. Tell your
doctor if you are

Характеристики продукта

OBJECT 1
TERBINAFINE 250MG TABLETS
Summary of Product Characteristics Updated 06-Mar-2017 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Terbinafine 250mg Tablets
2. Qualitative and quantitative composition
Terbinafine Hydrochloride equivalent to 250mg Terbinafine per tablet
For the full list of excipients, see 6.1.
3. Pharmaceutical form
Tablet
Round white to off-white flat bevelled edge tablets with score line
and R250 on reverse
Diameter approx. 11 mm
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Terbinafine tablets are for the treatment of fungal infections of the
skin and nails caused by _Trichopyton _
(_T.rubrum, T.mentagrophytes, T.verrucosum, T.violaceum_),
_Microsporum canis and Epidermophyton _
_floccosum. _
1. Terbinafine 250 mg Tablets are indicated in the treatment of
ringworm (tinea corporis, tinea cruris and
tinea pedis) where oral therapy is considered appropriate due to the
site, severity or extent of the
infection.
2. Terbinafine 250 mg Tablets are indicated in the treatment of
onychomycosis
4.2 Posology and method of administration
Adults: 250mg once daily
The duration of treatment varies according to the indication and
severity
Skin Infections
Likely duration of treatment are as follows:
Tinea pedis (interdigital, plamtar/moccoasin type):
Tinea corporis:
2 to 6 weeks
4 weeks
Tinea cruris:
2 to 4 weeks
Onychomycosis
For most patients the duration of treatment is between 6 weeks and 3
months although treatment periods
of less than 3 months can be anticipated in younger patients or those
with fingernail infections or toenail
infections other than the big toe. 3 months is usually sufficient in
the treatment of toenail infections
although some patients may require 6 months treatment or longer. Poor
nail outgrowth during the first
weeks of treatment may indicate those patients where longer therapy is
required. The complete resolution
of signs and symptoms of infection