FUCIDIN 20 mg /G Cream

Зміст інструкції

1. Fucidin 20 mg/g cream, 20 mg/g ointment
   1. What is Fucidin and what is it used for
   2. What you need to know before using Fucidin
   3. How to use Fucidin
   4. Possible side effects
   5. How to store Fucidin
   6. Contents of the pack and other information

Fucidin 20 mg/g cream, 20 mg/g ointment

Fusidic acid / Sodium fusidate

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Fucidin and what is it used for

Fucidin contains the active ingredient fusidic acid, an antibiotic that stops the growth of bacteria.
Fucidin is indicated in adults and childrenfor skin infections caused by bacteria sensitive to fusidic acid.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Fucidin

Do not use Fucidin if you/the child

• is allergic to fusidic acid or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Fucidin.
Take particular care when applying this medicine to the face.

Avoidcontact with the eyesas eye disorders may occur (see section 4
“Possible side effects”).

Occlusive dressing
Do not use an occlusive dressing (such as bandages or transparent film) during treatment with Fucidin unless indicated and in any case apply less frequent applications.

In case of prolonged treatment
In case of prolonged treatment, allergic reactions may occur (see section 4 “Possible
side effects”).

Resistant germs (germs against which fusidic acid is not effective)
Bacterial resistance (ability to survive) has been found for a type of bacterium (Staphylococcus aureus)
with the topical use of fusidic acid. As with all antibiotics, prolonged or recurrent use of Fucidin may
increase the risk of developing antibiotic resistance.

Other medicines and Fucidin
Tell your doctor or pharmacist if you/the child is taking, has recently taken or might
take any other medicines.
The possibility of interactions with systemically administered medicines (i.e. those that
reach the site of action through the bloodstream) is minimal as the absorption of Fucidin into the bloodstream is negligible.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.

• Pregnancy:you can use Fucidin if you are pregnant.
• Breastfeeding:you can use Fucidin if you are breastfeeding, but avoid applying it to the breast.
• Fertility:you can use Fucidin if you are a woman of childbearing age.

Driving and using machines
Fucidin does not or negligibly alters the ability to drive vehicles or use machines.

Fucidin cream contains butylhydroxyanisole, cetyl alcohol and potassium sorbate
These excipients may cause local skin reactions (e.g. contact dermatitis).
Butylhydroxyanisole may also cause irritation to the eyes and mucous membranes.

Fucidin ointment contains cetyl alcohol, lanolin and butylhydroxytoluene
These excipients may cause localized skin reactions (e.g. contact dermatitis).
Butylhydroxytoluene may also cause irritation to the eyes and mucous membranes.

3. How to use Fucidin

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults and children
The recommended dose is one application 2 or 3 times a day.
In case of occlusive dressing, less frequent applications are recommended.

If you use more Fucidin than you should
In case of ingestion/accidental intake of an excessive dose of Fucidin, immediately notify your doctor or go to the nearest hospital.

If you forget to use Fucidin
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you/the child experience the following side effects during treatment with Fucidin STOP
treatment and contact your doctor who will establish the appropriate therapy:

• allergic reactions

Further side effects that may occur during the use of Fucidin are listed below:

Uncommon(may affect up to 1 in 100 people)

• skin inflammation (dermatitis, including contact dermatitis and eczema),
• skin rash that may manifest with redness (erythema), pustules, blisters, spots and dots, or widespread rash),
• itching,
• swelling (edema),
• pain at the application site (including a burning sensation on the skin),
• irritation at the application site.

Rare(may affect up to 1 in 1000 people)

• urticaria (hives),
• swelling of the skin and underlying tissues (angioedema),
• blisters,
• allergic reactions,
• eye inflammations (conjunctivitis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can also report side effects directly through the national reporting
system
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Fucidin

Fucidin 20 mg/g cream: store at a temperature below 25°C.
Fucidin 20 mg/g ointment: this medicine does not require any special storage conditions.
Shelf life after first opening: 90 days.
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 package after Exp. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fucidin 20 mg/g cream contains
1 g of cream contains:

• The active ingredient is fusidic acid 20 mg;
• The other components are: butylhydroxyanisole, cetyl alcohol, potassium sorbate(see paragraph “Fucidin contains butylhydroxyanisole, cetyl alcohol and potassium sorbate”), glycerol, liquid paraffin, polysorbate 60, white soft paraffin, all-rac-α-tocopherol, hydrochloric acid, purified water.

What Fucidin 20 mg/g ointment contains
1 g of ointment contains:

• The active ingredient is sodium fusidate 20 mg (equivalent to 19.18 mg of fusidic acid);
• The other components are: lanolin, cetyl alcohol, butylhydroxytoluene(see paragraph “Fucidin contains lanolin, cetyl alcohol and butylhydroxytoluene”), liquid paraffin, white soft paraffin, all-rac-α-tocopherol.

Description of the appearance of Fucidin and contents of the pack
Fucidin cream is presented as a cream in tubes of 15 g and 30 g.
Fucidin ointment is presented as an ointment in tubes of 15 g and 30 g.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
LEO Pharma A/S, Industriparken 55- 2750 Ballerup (DK)
Marketing Authorisation Holder in Italy: LEO Pharma S.p.A. Via Amsterdam 125- 00144 Roma

Manufacturer
LEO Laboratories Limited, 285 Cashel Road, Dublin 12, Ireland