Hyderm
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Hyderm, 1%, cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g cream contains 10 mg hydrocortisone
Excipients: Cetostearyl alcohol 30 mg
For a full list of excipients, see section 6.1.
PHARMACEUTICAL form
Cream
White cream
4. Clinical particulars
4.1 Therapeutic indications
Acute and chronic eczema of varying types. Anogenital pruritus.
4.2 Posology and method of administration
The cream should be thinly applied in the morning and evening. When the symptoms are under control the number of applications can usually be decreased and alternated with emollient therapy.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
4.4 Special warnings and precautions for use
Contact with the eyes should be avoided.
Hyderm cream should not be applied in open wounds.
As with all corticosteroids for external use, care should be taken when treating large body areas and during long-term treatment.
Hyderm contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
Children under 2 years should only be treated with Hyderm if prescribed by a doctor.
Treatment duration should not be more than 4-6 weeks, unless the patients are under regular supervision by physician.
In case of concomitant infection, an appropriate antifungal or antibacterial agent needs to be administered.
The risk for local adverse events is reduced if hydrocortisone is used without occlusion.
Topical corticosteroids are not suitable for treatment of perioral dermatitis, rosacea and acne vulgaris.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
Pregnancy
No known risks when used during pregnancy.
Lactation
Hydrocortisone is excreted in breast milk, but it is unlikely to affect a nursing child at therapeutic doses.
4.7 Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Side effects can be expected in approximately 1% of patients. Cases of sensitisation caused by hydrocortisone are rare, but have been reported.
|
Uncommon |
Skin and subcutaneous tissue disorders: Irritation, contact dermatitis |
Cases of allergic contact dermatitis (hydrocortisone) have been reported.
4.9 Overdose
Overdose is not expected, since the cream is intended for external use. If the cream has nevertheless accidentally been ingested, supporting measures should be taken as necessary.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: weak glucocorticoids
ATC code: D07AA02
Hyderm is a group I steroid with an anti-inflammatory and antipruritic effect. The cream is also suitable for treating weeping areas of skin.
5.2 Pharmacokinetic properties
Glucocorticoids have the ability to penetrate the stratum corneum of the epidermis and affect the deeper cell layers. Usually only a small proportion of the dose is absorbed, and it is thus not expected to affect the hormonal balance. Glucocorticoids may have a systemic effect in the event of increased absorption, e.g. when applied on large areas of inflamed skin, or on skin where the stratum corneum of the epidermis is damaged. Occlusive bandages increase absorption.
5.3 Preclinical safety data
There are no preclinical data considered relevant to the safety assessment, beyond that already taken into consideration in other parts of the SPC.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
White soft paraffin
Hydrogenated canolaoil
Isopropyl isostearate
Myristyl myristate
Glycerol monostearate
Cetostearyl alcohol
Macrogol stearate 100
Anhydrous citric acid
Sodium citrate
Butylene glycol
Purified water
6.2 Incompatibilities
Not relevant.
6.3 Shelf life
18 months
6.4 Special precautions for storage
Store below 25°C.
Nature and contents of container
30 g and 100 g plastic tubes with screw cap and snap-on cap respectively.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Any unused product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
ACO HUD NORDIC AB
Box 622
194 26 Upplands Väsby, Sweden
Tel: 08-622 36 50
Fax: 08-622 36 80
8. MARKETING AUTHORISATION NUMBER(S)
19817
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
2006-07-21/2011-07-21
10. DATE OF REVISION OF THE TEXT
2011-07-20