- Approval Id
- 535c270b148d051a
- Drug Approval Emc Name
- Hc45 Hydrocortisone Cream
- Drug Name
- Hc45 Hydrocortisone Cream
- Company Name
- Karo Pharma AB
- Company Address
- Klara Norra Kyrkogata 33, Stockholm, Sweden
- Company Website
- https://www.karopharma.com/
- Company Telephone
- +44 (0) 8000461977
- Company Medical Info Direct Line
- +44 (0) 8000461977
- Company Medical Info Email
- MedinfoUK@karopharma.com
- Company Customer Care Direct Line
- +44 (0) 8000461977
- Atc Code
- D07AA02
- Legal Category
- Pharmacy
- Authorisation Holder
- Karo Pharma AB
Box 16184
103 24 Stockholm
Sweden
- Authorisation Number
- PL 50567/0012
- Authorisation Date
- 07/11/1986 / 12/11/1998
- Instruction Authorisation Holder
- Karo Pharma AB
Box 16184
103 24 Stockholm
Sweden
- Instruction Authorisation Number
- PL 50567/0012
- Instruction Authorisation Date
- 07/11/1986 / 12/11/1998
- Instruction Composition
- Active ingredients:
Hydrocortisone Acetate BP 1.0% w/w
Excipients:
Also contains Cetomacrogol emulsifying wax (with Cetostearyl Alcohol)
For full list of excipients, see section 6.1
- Instruction Dosage Form
- A smooth, white cream
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Irritant contact dermatitis, allergic contact dermatitis, insect bite reactions, mild to moderate eczema.4.2 Posology and method of administration
\*\*Posology\*\*
Once or twice a day, for a maximum of 7 days. If the condition is not improved, consult your doctor.
\*\*Elderly population\*\*
Dosage adjustments are not considered necessary in the elderly.
\*\*Paediatric population\*\*
Dosage recommendations as above for children over 10 years of age. The product should not be used in children under 10 years of age without medical advice.
\*\*Method of administration\*\*
For topical administration.
Apply accurately and sparingly to a small area. Massage gently into the skin.4.3 Contraindications
Hypersensitivity to hydrocortisone acetate or to any other excipients listed in section 6.1
The product should not be used on the eyes or face (for example, in rosacea or perioral dermatoses), the ano-genital area or on broken or infected skin including impetigo, cold sores, acne athlete's foot, or infected bites and stings.
In the presence of untreated infections of bacterial, viral, tuberculous or fungal origin.
Not for use with an occlusive dressing or on large areas of the body.4.4 Special warnings and precautions for use
The product should not be used during pregnancy or breast-feeding unless recommended by a health care professional (see section 4.6).
If the condition does not improve consult your doctor. Prolonged use of the product is not recommended (see section 4.2) as continuous uninterrupted application may cause local atrophy of the skin, striae and superficial vascular dilatation.
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.
Contains: Cetomacrogol emulsifying wax with Cetostearyl Alcohol, which may cause local skin reactions (e.g. contact dermatitis).
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.4.5 Interaction with other medicinal products and other forms of interaction
None known4.6 Fertility, pregnancy and lactation
\*\*Pregnancy\*\*
This product should not be used in pregnancy without medical advice. There are no or limited amount of data from the use of topical corticosteroids in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).
\*\*Breast-feeding\*\*
This product should not be used whilst breast-feeding unless recommended by a health care professional. Corticosteroids are excreted in human milk. There is no information about effects on lactation. A risk to new-borns/infants cannot be excluded.
\*\*Fertility\*\*
No known effects.4.7 Effects on ability to drive and use machines
None known4.8 Undesirable effects
If any signs of hypersensitivity, including allergic contact dermatitis or worsening of the original condition appear, treatment should be immediately discontinued.
Adverse events which have been associated with topical corticosteroids are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
| | | |
| --- | --- | --- |
| \*\*System Organ Class\*\* | \*\*Frequency\*\* | \*\*Adverse Events\*\* |
| Skin and Subcutaneous Tissue Disorders | Not known | Skin atrophy, telangiectasia, skin striae, acne, rosacea, pigmentation disorder, hypertrichosis 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) |
| Musculoskeletal and Connective Tissue Disorders | Not known | Collagen disorder |
| Eye Disorders | Uncommon | Vision, blurred (see also section 4.4) |
\*\*Reporting of Suspected Adverse Reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google or Apple App Store.4.9 Overdose
Acute overdose is highly unlikely. No special precautions or antidotes are likely to be needed. Chronic overdose or misuse may increase the risk of topical or systemic steroid-related adverse effects, including hypothalamic pituitary adrenal (HPA) axis suppression and Cushing's syndrome.
Management of overdose with topical corticosteroids includes gradual discontinuation under medical supervision.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
\*\*Pharmacotherapeutic Group:\*\* Corticosteroids, dermatological preparations; corticosteroids, weak (group I); \*\*ATC Code:\*\* D07AA02
Hydrocortisone acetate is a well characterised corticosteroid which has anti-inflammatory activity resulting, at least in part, from binding with a steroid receptor. Hydrocortisone acetate reduces inflammation by stabilising cell membranes, preventing the release of destructive enzymes, antagonising histamine and the release of kinins, inhibiting accumulation of macrophages and reducing capillary wall permeability and oedema formation.5.2 Pharmacokinetic properties
Not applicable5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Whilst there is inadequate evidence on safety in human pregnancy, animal studies have demonstrated a possible association between topical corticosteroids and foetal abnormalities, including cleft palate and intra-uterine growth retardation.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
White soft paraffin
Liquid paraffin
Phenoxyethanol
Purified water
Cetomacrogol emulsifying wax (includes cetostearyl alcohol)6.2 Incompatibilities
None known6.3 Shelf life
3 years6.4 Special precautions for storage
Store below 25°C6.5 Nature and contents of container
Internally lacquered collapsible aluminium membrane-sealed tube with a polypropylene cap. Pack size is 15g.6.6 Special precautions for disposal and other handling
None
- Instruction Content
- ## Composition
Active ingredients:
Hydrocortisone Acetate BP 1.0% w/w
Excipients:
Also contains Cetomacrogol emulsifying wax (with Cetostearyl Alcohol)
For full list of excipients, see section 6.1
## Pharmaceutical Form
A smooth, white cream
## Clinical Particulars
4.1 Therapeutic indications
Irritant contact dermatitis, allergic contact dermatitis, insect bite reactions, mild to moderate eczema.4.2 Posology and method of administration
\*\*Posology\*\*
Once or twice a day, for a maximum of 7 days. If the condition is not improved, consult your doctor.
\*\*Elderly population\*\*
Dosage adjustments are not considered necessary in the elderly.
\*\*Paediatric population\*\*
Dosage recommendations as above for children over 10 years of age. The product should not be used in children under 10 years of age without medical advice.
\*\*Method of administration\*\*
For topical administration.
Apply accurately and sparingly to a small area. Massage gently into the skin.4.3 Contraindications
Hypersensitivity to hydrocortisone acetate or to any other excipients listed in section 6.1
The product should not be used on the eyes or face (for example, in rosacea or perioral dermatoses), the ano-genital area or on broken or infected skin including impetigo, cold sores, acne athlete's foot, or infected bites and stings.
In the presence of untreated infections of bacterial, viral, tuberculous or fungal origin.
Not for use with an occlusive dressing or on large areas of the body.4.4 Special warnings and precautions for use
The product should not be used during pregnancy or breast-feeding unless recommended by a health care professional (see section 4.6).
If the condition does not improve consult your doctor. Prolonged use of the product is not recommended (see section 4.2) as continuous uninterrupted application may cause local atrophy of the skin, striae and superficial vascular dilatation.
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.
Contains: Cetomacrogol emulsifying wax with Cetostearyl Alcohol, which may cause local skin reactions (e.g. contact dermatitis).
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.4.5 Interaction with other medicinal products and other forms of interaction
None known4.6 Fertility, pregnancy and lactation
\*\*Pregnancy\*\*
This product should not be used in pregnancy without medical advice. There are no or limited amount of data from the use of topical corticosteroids in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).
\*\*Breast-feeding\*\*
This product should not be used whilst breast-feeding unless recommended by a health care professional. Corticosteroids are excreted in human milk. There is no information about effects on lactation. A risk to new-borns/infants cannot be excluded.
\*\*Fertility\*\*
No known effects.4.7 Effects on ability to drive and use machines
None known4.8 Undesirable effects
If any signs of hypersensitivity, including allergic contact dermatitis or worsening of the original condition appear, treatment should be immediately discontinued.
Adverse events which have been associated with topical corticosteroids are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
| | | |
| --- | --- | --- |
| \*\*System Organ Class\*\* | \*\*Frequency\*\* | \*\*Adverse Events\*\* |
| Skin and Subcutaneous Tissue Disorders | Not known | Skin atrophy, telangiectasia, skin striae, acne, rosacea, pigmentation disorder, hypertrichosis 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) |
| Musculoskeletal and Connective Tissue Disorders | Not known | Collagen disorder |
| Eye Disorders | Uncommon | Vision, blurred (see also section 4.4) |
\*\*Reporting of Suspected Adverse Reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google or Apple App Store.4.9 Overdose
Acute overdose is highly unlikely. No special precautions or antidotes are likely to be needed. Chronic overdose or misuse may increase the risk of topical or systemic steroid-related adverse effects, including hypothalamic pituitary adrenal (HPA) axis suppression and Cushing's syndrome.
Management of overdose with topical corticosteroids includes gradual discontinuation under medical supervision.
## Pharmacological Properties
5.1 Pharmacodynamic properties
\*\*Pharmacotherapeutic Group:\*\* Corticosteroids, dermatological preparations; corticosteroids, weak (group I); \*\*ATC Code:\*\* D07AA02
Hydrocortisone acetate is a well characterised corticosteroid which has anti-inflammatory activity resulting, at least in part, from binding with a steroid receptor. Hydrocortisone acetate reduces inflammation by stabilising cell membranes, preventing the release of destructive enzymes, antagonising histamine and the release of kinins, inhibiting accumulation of macrophages and reducing capillary wall permeability and oedema formation.5.2 Pharmacokinetic properties
Not applicable5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Whilst there is inadequate evidence on safety in human pregnancy, animal studies have demonstrated a possible association between topical corticosteroids and foetal abnormalities, including cleft palate and intra-uterine growth retardation.
## Pharmaceutical Particulars
6.1 List of excipients
White soft paraffin
Liquid paraffin
Phenoxyethanol
Purified water
Cetomacrogol emulsifying wax (includes cetostearyl alcohol)6.2 Incompatibilities
None known6.3 Shelf life
3 years6.4 Special precautions for storage
Store below 25°C6.5 Nature and contents of container
Internally lacquered collapsible aluminium membrane-sealed tube with a polypropylene cap. Pack size is 15g.6.6 Special precautions for disposal and other handling
None
