Stopitch Cream 10 g Cream
PDF Leaflet Revision Date: 20 September 2022
Clinical Summary
Quick overview from the medicine insert
Indication
Topical treatment of corticosteroid responsive conditions.
Dosage (summary)
Apply sufficient quantity twice daily to affected area.
Pregnancy & Breastfeeding
Not recommended during pregnancy; safety in lactation not established.
Contraindications
- Hypersensitivity to active substance or excipients
- Rosacea
- Acne
- Peri-oral dermatitis
- Tuberculosis of the skin
- Varicose ulcers
- Skin infections (viral, fungal, bacterial)
Common side effects
- Adrenal gland suppression
- Withdrawal reactions (redness, burning, stinging, itch)
- Skin thinning and atrophic changes
Counselling Points
- Apply gently and thoroughly
- Avoid long-term continuous use
- Consult if condition recurs after treatment
Serious warnings
- Caution in facial dermatoses and near eyes
- Risk of rebound flares after discontinuation
- Long-term use may cause serious skin changes
Important Disclaimer
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic Indications
STOPITCH CREAM is indicated in the topical treatment of corticosteroid responsive
4.2 Posology and method of administration
A sufficient quantity of STOPITCH CREAM should be applied to completely cover the affected area. The cream should be massaged gently and thoroughly into the skin. The usual frequency of application is twice daily. For some patients, adequate maintenance therapy when indicated may be achieved with less frequent applications.
4.3 Contraindications
- Known hypersensitivity to the active substance or to any of the excipients listed under Section 6.1.
- Rosacea, acne, peri-oral dermatitis, tuberculosis of the skin and varicose ulcers.
- Skin lesions caused by infection with viruses (e.g. herpes simplex, vaccinia or varicella), fungi (e.g. candidiasis, tinea) or bacteria (e.g. impetigo).
4.4 Special warnings and precautions for use
- If a secondary microbial skin infection is present, suitable concomitant antimicrobial therapy should be instituted.
- STOPITCH CREAM should be used with particular caution in facial dermatoses, and only for short periods. A steroid rosacea-like facies may be produced.
- STOPITCH CREAM should be used with caution near the eyes.
- Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.
4.5 Interaction with other medicines and other forms of interaction
Interactions with other medicines: None known.
4.6 Fertility, pregnancy and lactation
Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore, STOPITCH CREAM should not be used during pregnancy. Safety in lactation has not been established. In the absence of sufficient data, the use during lactation is not recommended. No fertility data available.
4.7 Effects on ability to drive and use machines
The effects of STOPITCH CREAM on the ability to drive and use of machines is not established.
4.8 Undesirable effects
The undesirable effects listed are based on the MedDRA system organ classes (SOC) classification system. The frequency groupings listed conform to the following convention: Very common (u22651/10); common (u22651/100 to <1/10); uncommon (u22651/1 000 to <1/100); rare (u22651/10 000 to <1/1 000); very rare (<1/10 000) and unknown (cannot be estimated from the available data)
| System Organ Class | Frequency | Undesirable effect |
|---|---|---|
| Endocrine disorders | Unknown | Adrenal gland suppression (children u2013 severe: growth retarded and Cushingoid state) |
| Psychiatric disorders | Rare | Benign intracranial hypertension |
| Skin and subcutaneous tissue disorders | Unknown | Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules (see section 4.4) |
u2022 Long term continuous treatment with STOPITCH CREAM should be avoided as far as possible as this may cause atrophic changes in the skin leading to thinning, loss of elasticity, dilation of superficial blood vessels, telangiectasia and ecchymoses. The changes are particularly likely to occur on the face and when using sealed dressings.
u2022 Systemic absorption of the topically applied corticosteroid may occur, particularly under the following conditions:
- when large quantities are used or when application is made to wide areas of the body or to damaged skin;
- when the occlusive dressing technique is applied.
4.9 Overdose
In overdose, side effects can be precipitated and/or be of increased severity. Treatment is symptomatic and supportive.
