Consumer medicine information

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 TANILONE? 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 corticosteroid medicines applied to the skin 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 TANILONE? 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?

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 Section 6. Are there any side effects? in the full CMI.

1 Name of 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

4.9 Overdose

Excessive dosing may occur with prolonged or intensive topical use. See Section 4.8 Adverse Effects (Undesirable Effects) for further information.
Acute toxicity studies with methylprednisolone aceponate (namely oral ingestion, or single dermal application to a large area, under conditions favourable to absorption) do not indicate that any acute intoxication is expected.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Methylprednisolone aceponate did not elicit any genotoxic effects or chromosomal damage in in vitro and in vivo assays conducted in bacteria and mammalian cells.
Carcinogenicity. Animal studies to evaluate the carcinogenic potential of methylprednisolone aceponate have not been conducted. Other glucocorticoid drugs have been shown to cause hepatic tumours in rats and it must be assumed that methylprednisolone aceponate would have similar activity. However, in humans epidemiological surveys of many years of systemic glucocorticoid therapy have not revealed any evidence for a tumourigenic action of this substance class.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Methylprednisolone aceponate (MPA) is a white crystalline powder. It is soluble in methylene chloride, acetone and ethyl acetate and is sparingly soluble in hexane and ether.
The chemical name is 21-acetoxy-11β-hydroxy-6α-methyl-17-propionyloxy-1, 4- pregnadiene-3, 20- dione. The molecular formula is C₂₇H₃₆O₇. The molecular weight is 472.58.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMETACE.gif CAS number. 86401-95-8.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/TANILOST.gif