TANILONE methylprednisolone aceponate 1 mg/g fatty ointment tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

methylprednisolone aceponate, Quantity: 1 mg/g

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Ointment

Composition:

Excipient Ingredients: white soft paraffin; microcrystalline wax; liquid paraffin; hydrogenated castor oil

Administration route:

Topical

Units in package:

50 g, 15 g, 20 g

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

TANILONE fatty ointment is indicated for the topical treatment of eczema and psoriasis in adults and children.

Product summary:

Visual Identification: White to yellowish, translucent ointment.; Container Type: Tube; Container Material: Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-11-29

Patient Information leaflet

TANILONE fatty ointment
1
TANILONE
FATTY OINTMENT
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING TANILONE?
TANILONE fatty ointment contains the active ingredient
methylprednisolone aceponate. It is used to relieve the redness,
swelling, itching and irritation of the skin in eczema and psoriasis
patients.
For more information, see Section 1. Why am I using [medicine name]?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TANILONE?
Do not use if you have ever had an allergic reaction to
methylprednisolone aceponate, other topical corticosteroid medicines
or any of the ingredients listed at the end of the CMI.
Do not use on open wounds or other treated skin areas.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
[medicine name]? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TANILONE and affect how it works.
For more information, see Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE THIS MEDICINE?
Apply thinly to the affected area of skin.
More instructions can be found in Section 4. How do I use TANILONE? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TANILONE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
TANILONE.
•
Stop using this medicine if you develop a skin allergy.
•
Tell your doctor if you become pregnant.
LOOKING AFTER
YOUR MEDICINE
•
Keep TANILONE fatty ointment in a cool dry place, stored below 30°C.
For more information, see Section 5. What should I know while using
TANILONE? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
Common side effects include itching, burning and redness.
For more information, including what to do if you have any side
effects, see

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
TANILONE (METHYLPREDNISOLONE ACEPONATE)
FATTY OINTMENT
1
NAME OF THE MEDICINE
Methylprednisolone aceponate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TANILONE fatty ointment contains methylprednisolone aceponate 1 mg/g
(0.1 % w/w).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
White to yellowish translucent ointment; free from lumps and gritty
particles; free of visible contamination.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TANILONE fatty ointment is indicated for the topical treatment of
eczema and psoriasis in adults and
children.
4.2
DOSE AND METHOD OF ADMINISTRATION
FOR EXTERNAL TOPICAL USE ONLY. KEEP AWAY FROM EYES.
The duration of use should be less than 12 weeks in adults and less
than 4 weeks in children.
TANILONE fatty ointment should usually be applied as a thin coating
once per day to the affected
areas. In the treatment of psoriasis, twice daily application may be
required.
TANILONE fatty ointment is suitable for very dry skin and chronic
stage of skin conditions which
require an anhydrous base. The base has an occlusive effect. It is
suitable for treatment of areas
where the stratum corneum is particularly thick, such as the pressure
areas of elbows, knees, palms
and soles.
4.3
CONTRAINDICATIONS
TANILONE is contraindicated in viral diseases (e.g. vaccinia,
varicella/herpes zoster) and when
tuberculous or syphilitic processes and post-vaccination skin
reactions are present in the area to be
treated. If rosacea, ulcera, atrophic skin diseases, acne vulgaris or
perioral dermatitis are present,
TANILONE must not be applied to the face.
Hypersensitivity to methylprednisolone aceponate or any component of
the formulation.
Children under four months due to lack of experience.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
FOR EXTERNAL TOPICAL USE ONLY. KEEP AWAY FROM EYES.
2
TANILONE should not be allowed to come into contact with deep open
wounds, muscosae or the
eyes when being applied to the face.
Additional specific