Terbinafine 250mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Terbinafine hydrochloride

可用日期:

Teva UK Ltd

ATC代码:

D01BA02

INN（国际名称）:

Terbinafine hydrochloride

剂量:

250mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 05020500; GTIN: 5017007021155

资料单张

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BBBA5650
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 belongs to a group of medicines called
antifungal drugs. Terbinafine tablets are used for the
treatment of fungal infections of:
•
The groin area.
•
The skin (ring worm).
•
Toe and finger nails (yellow, opaque and thickened
nails).
•
The feet (athlete’s foot).
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).
•
have or have had any LIVER problems.
•
are BREAST-FEEDING.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST before taking
Terbinafine tablets if you:
•
are PREGNANT or trying to become pregnant.
•
have any problems with your KIDNEYS or LIVER.
•
have PSORIASIS (scaling skin disease)
•
have SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) (auto-
immune disorder, affecting the skin, joints, kidneys
& brain), as it may worsen whilst you are taking
Terbinafine tablets.
•
have a RASH due to a high level of a specific type
of white blood cells.
CHILDREN AND ADOLESCENTS
Use in children is not reco

产品特点

OBJECT 1
TERBINAFINE 250MG TABLETS
Summary of Product Characteristics Updated 14-Oct-2019 | Accord-UK Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Terbinafine 250mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 250 mg terbinafine, as terbinafine hydrochloride.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
White, round, flat, 11 mm tablets, scored on both sides with side
scores, marked “T” above and “1” below
the score on one side.
4. Clinical particulars
4.1 Therapeutic indications
1. Treatment of Terbinafine tablets sensitive fungal infections such
as Tinea corporis, Tinea cruris and Tinea
pedis (caused by Dematophytes see Section 5.1) is considered
appropriate due to the site, severity or extent
of the infection.
2. The treatment of onychomycosis (Terbinafine tablets-sensitive
fungal infection of the nails) caused by
dermatophytes.
N.B. Orally administered Terbinafine tablets are not effective against
Pit