Trosyl 283mg/ml nail solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tioconazole

Available from:

Pfizer Ltd

ATC code:

D01AC07

INN (International Name):

Tioconazole

Dosage:

283mg/1ml

Pharmaceutical form:

Medicated nail lacquer

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13100200; GTIN: 5013457017601

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TROSYL® 283 MG/ML NAIL SOLUTION
TIOCONAZOLE 283 MG/ML
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Trosyl is and what it is used for
2.
What you need to know before you use Trosyl
3.
How to use Trosyl
4.
Possible side effects
5.
How to store Trosyl
6.
Contents of the pack and other information
1.
WHAT TROSYL IS AND WHAT IT IS USED FOR
This medicine contains tioconazole, which is one of a group of
medicines called antifungals.
Trosyl is used in adults and children to treat nail infections caused
by certain fungi.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TROSYL
DO NOT USE TROSYL:
•
If you have ever had an allergic reaction to tioconazole or any of the
other ingredients of this
medicine (listed in section 6).
•
If you have ever had an allergic reaction to any other medicines you
have taken or used to treat fungal
infection.
•
If you are pregnant.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Trosyl:
•
If you are breast-feeding as you may be told to stop during your
treatment.
Make sure you do not put this medicine in your eyes.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your
doctor or pharmacist for advice before using this medicine.
2
3.
HOW TO USE TROSYL
Always use this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or
pharmacist if you are not sure.
•
Apply the nail solution thinly t

Summary of Product characteristics

OBJECT 1
TROSYL NAIL SOLUTION
Summary of Product Characteristics Updated 25-Jul-2013 | Pfizer
Limited
1. Name of the medicinal product
Trosyl 283 mg/ml Nail Solution
2. Qualitative and quantitative composition
Tioconazole 283 mg/ml.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Cutaneous solution. A clear pale yellow solution for topical
application.
4. Clinical particulars
4.1 Therapeutic indications
Tioconazole is a broad spectrum imidazole antifungal agent. Trosyl
Nail Solution is indicated for the
topical treatment of nail infections due to susceptible fungi
(dermatophytes and yeasts) and bacteria.
4.2 Posology and method of administration
_Route of administration: _Topical.
_ADULTS_ The solution should be applied to the affected nails and
immediately surrounding skin every
twelve hours using the applicator brush supplied.
The duration of treatment is up to six months but may be extended to
twelve months.
_USE IN THE ELDERLY_ No special precautions are required. Use the
adult dose.
_USE IN CHILDREN_ No special precautions are required. Use the adult
dose.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Trosyl Nail Solution is contraindicated in individuals who have been
shown to be hypersensitive to
imidazole antifungal agents.
Use is contraindicated during pregnancy (see section 4.6).
4.4 Special warnings and precautions for use
Trosyl Nail Solution is not for ophthalmic use.
4.5 Interaction with other medicinal products and other forms of
interaction
None known.
4.6 Fertility, pregnancy and lactation
Pregnancy
In animal studies tioconazole was not teratogenic. At high doses it
increased the incidence of renal
abnormalities in rat embryos, but this effect was minor and transient
and was not evident in weaned
animals.
There is insufficient evidence as to the drug's safety in human
pregnancy although absorption after topical
administration is negligible. Because of the extensive duration of
treatment required for nail