Pill Identifier App

LAMISIL CREAM

Active substance: TERBINAFINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000A

LAMISIL CREAM 30g
(terbinafine Hydrochloride)

This product is known by the above name but will be referred to as Lamisil Cream throughout this leaflet.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

1. What Lamisil Cream is and what it is used for
Lamisil Cream is used to treat patients with fungal and certain yeast infections of the skin. It attacks and kills
the fungus or yeast which is causing your infection.
2. Before you use Lamisil Cream
Do NOT use Lamisil Cream if you:
• are allergic (hypersensitive) to any of the ingredients in the product (see Section 6)
The cream is NOT recommended for use on children.

WARNING!

Take special care with Lamisil Cream
The cream is for external use only. Do not use on the face. Avoid contact with eyes. In case of accidental
contact with eyes, rinse thoroughly with running water.

Pregnancy and breast-feeding
Do not use the cream if you are pregnant or breastfeeding, unless advised to by your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
DATE:

Driving and using machines
Lamisil Cream is not expected to affect your ability to drive or operate machinery.
Important information about some of the ingredients of Lamisil Cream
• cetyl alcohol and stearyl alcohol: May cause local skin reactions (e.g. contact dermatitis).
For other ingredients see Section 6.

Apply the cream once or twice a day, for one to two weeks, but this will depend upon the type and area of
infection. Infections usually appear to improve within a few days of starting to use Lamisil Cream, but may
reappear if the cream is not applied regularly or is stopped too early.

UK PIL DATED JANUARY 2013
REPORTING OF SIDE EFFECTS

TVT CHECKED
6464/0398A

DATE OF PROOF:

Directions for use:
• Cleanse and dry the affected areas thoroughly and wash your hands. Treatment can be helped by
keeping the affected areas clean by regular washing and careful drying with your own clean towels
and clothes, and not rubbing or scratching the skin.
• Unscrew the cap then gently squeeze out a small amount of the cream onto your finger.
• Apply just enough cream to form a thin layer on the affected skin and surrounding areas.
• Rub in gently. When used between the toes, buttocks or on the groin, the treated area may be
covered with a light, fresh gauze strip, especially at night.
• Replace the cap on the tube and wash your hands.

11/03/14
CODE:

DT
ARTWORKER:

DATE:

05-0440

CUSTOMER: Waymade
PRODUCT: Lamisil cream 30g

PRE-PRESS NO.:

Q.A.
APPROVED:

3. How to use Lamisil Cream
Adults
Your doctor will decide the right amount of Lamisil Cream for you to use and will tell you for how long to use
your medication.

Even though you will not be using Lamisil Cream during the second week for Athlete’s foot, full skin healing
after the infection has cleared will continue for up to 4 weeks. If you have not noticed any signs of
improvement within 2 weeks of first starting treatment, please seek advice from your doctor or pharmacist.
Children
Use in Children is NOT recommended, since there are no data to support use in this population.
If you accidently swallow Lamisil Cream
Contact your doctor or nearest hospital emergency department if you, or someone else, has swallowed
some cream. Take any remaining medicine and this leaflet with you if possible. Symptoms of accidental
ingestion include headache, nausea (feeling sick), dizziness and stomach pain.
If you forget to use Lamisil Cream
If you miss an application, apply the cream as soon as possible then continue your treatment as before. If
you only remember at the time of your next application, just apply the cream and carry on as normal. It is
important to try to use the cream at the correct times as forgotten applications could risk the infection
returning.
If you stop using Lamisil Cream
Infections may come back if you do not use the cream regularly, or if you stop the treatment too early.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

Colour
Swatch

Black

WARNING!

CUSTOMER
APPROVED:

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
those obtained without a prescription.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

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 Lamisil Cream is and what it is used for
2. Before you use Lamisil Cream
3. How to use Lamisil Cream
4. Possible side effects
5. How to store Lamisil Cream
6. Further information.

PROOF HISTORY:
v.1 - waymade - 11/03/14

Leaflet Flat Size = 148 x 317

27mm

If any of these side effects get serious, or if you notice any side effect not listed in this leaflet, please
tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.



5. How to store Lamisil Cream
Do not use after the expiry date printed on the tube or carton label.
Lamisil cream 30g should be stored in a dry place below 25°C.
Keep out of the sight and reach of children.
Replace the cap on the tube after use.
If your doctor tells you to stop using the cream, please take it back to the pharmacist for safe
disposal. Only keep the cream if your doctor tells you to.
If the cream becomes discoloured or shows any other signs of deterioration, you should seek the
advice of your pharmacist before using it.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.

WARNING!








6. Further Information
Your medicine is called Lamisil cream 30g. It contains the active ingredient, terbinafine hydrochloride 1% in a
white cream base.

POM

PL No: 6464/0398

This product is manufactured by Novartis Pharma Produktions GmbH, Wehr, Germany and is procured from
within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

DATE:
11/03/14

UK PIL DATED JANUARY 2013
REPORTING OF SIDE EFFECTS

6464/0398A

TVT CHECKED

Lamisil® is a registered trademark of NOVARTIS AG

CODE:

DT
PRODUCT:

Lamisil cream 30g

ARTWORKER:

PRE-PRESS NO.:
Waymade
CUSTOMER:

DATE OF PROOF:

Q.A.
APPROVED:
05-0440

Leaflet revision and issue date (Ref.) 11.03.2014

Colour
Swatch

Black

WARNING!

Lamisil cream 30g is available as tubes of 30g.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Lamisil cream 30g also contains the following:
sodium hydroxide, benzyl alcohol, sorbitan monostearate, cetyl palmitate, cetyl alcohol, stearyl alcohol,
polysorbate 60, isopropyl myristate and demineralised water.

DATE:

CUSTOMER
APPROVED:

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Leaflet Flat Size = 148 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Common: (may affect up to 1 in 10 people): skin peeling, itching.
Uncommon: (may affect up to 1 in 100 people): skin lesions, scab, skin colour changes,
redness, burning, pain and irritation at the site of application. These common and uncommon side effects are
usually harmless and you can carry on using the cream.
Rare: (may affect up to 1 in 1000 people): eye irritation, dry skin, contact dermatitis, eczema,
worsening of symptoms.

PROOF HISTORY:
v.1 - waymade - 11/03/14

Notes:

27mm

4. Possible side effects
Like all medicines, Lamisil Cream can cause side effects, although not everybody gets them.
STOP using the cream and seek medical help immediately if you have any of the following very rare
allergic reactions:
• difficulty breathing or swallowing, swelling of the mouth, face, lips, tongue or throat (severe allergic
reaction).
• severe itching of the skin, with a red rash or raised lumps, hives or blisters.

Expand view ⇕

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.

Hide
(web1)