Consumer Information for: FUCIDIN H
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
FUCIDIN® H Cream is used to treat atopic dermatitis (eczema), a condition where the skin is red, swollen, itchy and infected by germs (bacteria).
Antibacterial drugs like FUCIDIN® H Cream treat only bacterial infections. They do not treat viral
infections. Although you may feel better early in your treatment, FUCIDIN®H Cream should be
used exactly as directed. Misuse or overuse of FUCIDIN® H Cream could lead to the growth of
bacteria that will not be killed by FUCIDIN®H Cream (resistance). This means that FUCIDIN® H
Cream may not work for you in the future. Do not share your medicine.
What it does
FUCIDIN® H Cream contains 2 medicines that work together in different ways:
- fusidic acid: an antibiotic that kills bacteria.
- hydrocortisone acetate: a corticosteroid that reduces swelling, redness, pain and itchiness in the skin.
When it should not be used
- you are allergic to any of the ingredients in FUCIDIN H or the container (aluminium).
- you have skin infections caused by a fungus, such as athlete’s foot, ringworm.
- you have skin conditions caused by virus such as cold sores or chicken pox.
- you have skin conditions caused by tuberculosis.
- you have skin rashes following vaccinations.
- you have skin condition called perioral dermatitis.
- you have a skin condition called rosacea.
What the medicinal ingredient is
2% fusidic acid (hemihydrate) and 1% hydrocortisone acetate.
What the non-medicinal ingredients are
butylated hydroxyanisol, cetyl alcohol, glycerol (85%), liquid paraffin, potassium sorbate, polysorbate 60, white soft paraffin and purified water.
What dosage form it comes in
FUCIDIN® H is a white cream.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take FUCIDIN® H Cream. Talk about any health conditions or problems you may have, including if you:
- are pregnant or if you become pregnant during treatment with FUCIDIN® H Cream.
- are breastfeeding or intend to breastfeed.
Other warnings you should know about:
- Do not use Fucidin® H Cream over a long time (more than 14 days).
- Use Fucidin® H Cream exactly as directed. Do not apply more or less of it or apply it more often than prescribed by your doctor. If you misuse or overuse FUCIDIN® H Cream your infection may not be completely cured and the bacteria may become resistant to antibiotics.
- Do not apply it on broken or damaged skin or sensitive skin areas such as lips or genital area, except on the advice of a doctor.
- Do not wrap or bandage the treated area, except on the advice of a doctor.
- If you use Fucidin® H Cream in large amounts, it may make the chance of getting any side effects higher. Also, your skin may get more sensitive to this medicine.
- Do not let FUCIDIN® H get into your eyes. If the cream gets into the eye, this may lead to glaucoma or other eyes conditions.
- Fucidin® H Cream contains butyl hydroxyanisole, cetyl alcohol and potassium sorbate as non-medicinal ingredients. These ingredients may cause a red, itchy rash (Contact dermatitis) on your skin where Fucidin® H Cream is applied. Butyl hydroxyl-anisole may also cause irritation to the eyes and mucous membranes (such as lips or genital area).
Interactions with this medication
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with FUCIDIN® H Cream:
The use of FUCIDIN® H Cream with other medicines has not been studied. However, since medicines can interact with each other, tell your healthcare professional if you are using other medicines to treat your atopic dermatitis. In particular, tell them if you are using medicines that contain corticosteroids.
Proper use of this medication
Adults and children 3 years of age and older:
Apply the cream to the affected areas 3 times per day for a maximum of 2 weeks.
Overdose
Missed Dose
If you forget to use FUCIDIN® H Cream, use it as soon as you remember. Next time, follow your regular application routine.
Side effects and what to do about them
These are not all the possible side affects you may feel when taking FUCIDIN® H Cream. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.
Side effects from using FUCIDIN® H Cream may include:
- itching, burning or irritation in the area where the medication is used
- various types of skin rashes (dermatitis) in the area where the medication is used
- thinning skin, stretch marks or surface veins
- skin redness
- lightening of your skin colour
- changes in the growth of your body hair
- excessive sweating
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Uncommon | |||
| Allergic reactions: dizziness, itching, severe rash, swelling (mouth, throat, lips, hands), trouble breathing. | ✔ | ||
| Worsening of eczema: increased itching, redness and swelling. | ✔ | ||
| Rare | |||
| Adrenal effects: fatigue, increased urination/thirst, problems controlling blood sugar levels, weakness, weight loss, delayed weight gain and slow growth in children. | ✔ | ||
| Glaucoma: hazy or blurred vision, severe eye and head pain, nausea or vomiting (accompanying severe eye pain), sudden sight loss. | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Store below 30°C. Use within 3 months of first opening the tube.
Keep out of reach and sight of children and pets.
Reporting side effects
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about FUCIDIN® H Cream:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.leo-pharma.ca, or by calling 1-800-668-7234.
This leaflet was prepared by LEO Pharma Inc.
™LEO Pharma A/S used under license by LEO Pharma Inc., Thornhill, L3T 7W8
Last Revised JUNE-30-2017
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