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TIOCONAZOLE 283 MG/ML MEDICATED NAIL LACQUER

Active substance(s): TIOCONAZOLE

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Tioconazole 283 mg/ml Medicated
Nail Lacquer

Pharmacode IIIXIXI

Tioconazole
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 Tioconazole is and what it is used for
2. What you need to know before you use
Tioconazole
3. How to use Tioconazole
4. Possible side effects
5. How to store Tioconazole
6. Contents of the pack and other information

1. What Tioconazole is and what it is
used for
Tioconazole is one of a group of medicines called
antifungals. The active ingredient is tioconazole.
Tioconazole is used in adults and children to treat
nail infections caused by certain fungi.

2. What you need to know before you
use Tioconazole
Do not use Tioconazole:
• If you are allergic to:
º Tioconazole or any of the other
ingredients of this medicine (listed in
section 6)
º Other imidazole antifungal medicines
you have taken to treat a fungal infection.
The symptoms may include itching, reddening of
the skin or difficulty in breathing.
• If you are pregnant

Warnings and precautions:
Talk to your doctor or pharmacist before using
Tioconazole:
• 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.
Tioconazole is not for ophthalmic use.
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.

3. How to use Tioconazole
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
• Apply the medicated nail lacquer thinly to
cover the whole of the affected nail(s) and
surrounding skin using the brush provided.
Apply the lacquer every 12 hours.
• Leave the lacquer to dry for 10-15 minutes
after application.
• The lacquer does not dry hard. A transparent,
slightly greasy film is left on the nail. This film
contains the antifungal agent and it slowly
passes through the nail to reach the site of
infection.
• The film should be left intact as long as
possible. This allows the antifungal agent to
have maximum effect.
• Try to avoid putting your hands (or feet if your
toenails are affected) in soapy water
immediately after applying the solution. Soap
or detergent removes the film. Water alone
does not remove the film.
• If you need to wash anything by hand, it is best
to wear rubber gloves.
• It is usual for treatment to last for up to six
months, and in some cases 12 months.
The dosage and duration of treatment are the
same for children and adults.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
If anyone accidentally swallows this medicine:
If you accidentally take this medicine by your

Pharmacode IIIXIXI

Package leaflet: Information for the user

mouth, contact your doctor or accident and
emergency department straight away.

By reporting side effects you can help provide
more information on the safety of this medicine.

4. Possible side effects

5. How to store Tioconazole

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Tioconazole is generally well tolerated. You may
experience mild and transient local irritation
symptoms (including local allergic reactions)
during initial treatment. If you experience an
allergic reaction, stop the treatment and consult
your doctor.
Anaphylactoid reactions have been reported in
patients treated with other formulations than the
dermatological preparation.
Common side effects (may affect up to 1 in 10
people).
Swelling of hand and feet.
Uncommon side effects (may affect up to 1 in
100 people).
Rash and dermatitis.
Not known (frequency can not be estimated
from the available data)
- Allergic reaction
- Paresthesia (tingling sensations in the hands or
feet)
- Blistering of the skin, contact dermatitis, dry
skin, swelling around the eyes, nail disorder
(including discolouration, inflammation or
pain), itch, skin irritation, peeling of the skin,
hives and pain.
If you get these symptoms, stop using
Tioconazole and tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly:
In the UK via the UK Yellow Card Scheme, Website:
www.mhra.gov.uk/yellowcard
In Ireland to:
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie

Inflammable. Avoid flame and heat. Do not
refrigerate. Keep the bottle tightly closed
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date,
which is stated on the carton and the bottle label
after EXP. The expiry date refers to the last day of
that month. The medicated nail lacquer should be
used within 6 months after the first opening.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help you protect the environment.

6. Contents of the pack and other
information
What Tioconazole contains
The active substance is tioconazole. One ml of
product contains 283 mg of tioconazole.
The other ingredients are ethyl acetate and
undecylenic acid.
What Tioconazole looks like and contents of
the pack
Tioconazole is a clear solution for cutaneous use.
Tioconazole is contained in an amber type III
soda-lime silica glass bottle with a HDPE/LDPE
screw cap fitted with a nylon brush applicator
containing 12 ml.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Creo Pharma Limited, Felsted Business Centre,
Felsted, Essex CM6 3LY, UK
Manufacturer:
Doppel Farmaceutici S.r.L.,
Via Martiri delle Foibe, 1,
29016 Cortemaggiore (PC), Italy
This leaflet was revised in August 2015

30103374.001

CRE-TIO-PIL-132_04
20/08/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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