- Approval Id
- 597743083b001e17
- Drug Approval Emc Name
- Bettamousse 1mg/g (0.1%) cutaneous foam
- Drug Name
- Bettamousse 1mg/g (0.1%) cutaneous foam
- Company Name
- RPH Pharmaceuticals AB
- Company Address
- Box 603, 101 32 Stockholm, Sweden
- Company Website
- //www.recipharm.com
- Company Telephone
- +44 (0)845 023 0467
- Company Medical Info Direct Line
- +44 207 862 1716
- Company Medical Info Email
- safety@elc-group.com
- Company Customer Care Direct Line
- +44(0)845 023 0467
- Company Stock Availability
- +44(0)845 023 0467
- Atc Code
- D07AC
- Legal Category
- Prescription only medicine
- Authorisation Holder
- RPH Pharmaceuticals AB
Box 603
101 32 Stockholm
Sweden
- Authorisation Number
- PL 36301/0036
- Authorisation Date
- 19 April 1996/19 April 2001
- Instruction Authorisation Holder
- RPH Pharmaceuticals AB
Box 603
101 32 Stockholm
Sweden
- Instruction Authorisation Number
- PL 36301/0036
- Instruction Authorisation Date
- 19 April 1996/19 April 2001
- Instruction Composition
- 1 g of foam contains 1 mg betamethasone (0.1 %) as valerate
\*\*Excipients with known effect\*\*:
Cetyl Alcohol 1.10 % w/w
Stearyl alcohol 0.50 % w/w
Propylene glycol (E1520) 2.00 % w/w
Ethanol anhydrous 57.79% w/w
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Cutaneous foam.
White, foam mousse.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Bettamousse is indicated for steroid responsive dermatoses of the scalp, such as psoriasis.4.2 Posology and method of administration
\*\*Posology\*\*
Adults, the elderly and children (over the age of six years): No more than a “golf-ball” sized amount of mousse (containing approximately 3.5mg betamethasone), or proportionately less for children twice daily (in the morning and evening) until the condition improves. If there is no improvement after 7 days, treatment should be discontinued. Once the condition has improved, application is reduced to once a day and after daily treatment it may be possible to maintain improvement by applying even less frequently.
\*Paediatric population\*
In children over the age of 6 years, this product should not, in general, be used for longer than 5 to 7 days.
\*\*Method of administration\*\*
For topical use.
Note: for proper dispensing of foam, the container should be held upside down and the actuator depressed.
The patient or carer should shake the can well before use, remove the cap, invert the can and dispense required amount of mousse onto a clean saucer or something similar. Dispensing directly onto hands should be avoided as the mousse will begin to melt when it touches skin. The product is to be massaged sparingly into the affected areas of the scalp. It is recommended to wash hands immediately after use. Hair should not be washed immediately after use, allowing the mousse to work overnight or through the day.4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Bacterial, fungal, parasitic or viral infections of the scalp unless simultaneous treatment is initiated.
Dermatoses in children under six years of age.4.4 Special warnings and precautions for use
Avoid contact with the eyes, open wounds and mucosae. Do not use near a naked flame.
The least amount of mousse required to control the disease should be used for the shortest possible time. This should minimise the potential for long term side effects. This is particularly the case in children, as adrenal suppression can occur even without its use with an occlusive dressing.
As with other topical corticosteroids, at least monthly clinical review is recommended if treatment is prolonged, and it may be advisable to monitor for signs of systemic activity.
The use of topical corticosteroids in psoriasis requires careful supervision. Glucocorticoids can mask, activate and worsen a skin infection. Development of secondary infection requires appropriate antimicrobial therapy and may necessitate withdrawal of topical corticosteroid therapy. Occlusive treatment should be avoided when there are signs of secondary infection. There is a risk of the development of generalised pustular psoriasis or local or systemic toxicity due to impaired barrier function of the skin.
\*\*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.
Tolerance may develop and rebound relapse may occur on withdrawal of treatment. 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. 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 advice is recommended in these cases or other treatment options should be considered.
\*\*Excipients\*\*
This medicine contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
This medicine contains 2022 mg alcohol (ethanol) in each “golf-ball” sized amount of mousse (approx. 3.5g), which is equivalent to 57.79% w/w. It may cause burning sensation on damaged skin. Do not use near an open flame, lit cigarette or some devices (e.g. hairdryers).
This medicine contains 70 mg of propylene glycol in each “golf-ball” sized amount of mousse (approx. 3.5g) which is equivalent to 2% w/w.4.5 Interaction with other medicinal products and other forms of interaction
Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir and itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor.4.6 Fertility, pregnancy and lactation
\*\*Pregnancy\*\*
There is no or limited data from the use of betamethasone valerate in pregnant women. Bettamousse should only be used in pregnancy if the potential benefit outweighs the risk.
Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development such as cleft palate, but the relevance of this in man is unknown. Reduced placental and birth weight have been recorded in animals and man after long-term treatment.
\*\*Breastfeeding\*\*
Bettamousse should only be used in lactation if the potential benefit outweighs the risk.
Betamethasone valerate is excreted in maternal milk, a risk of therapeutic doses having an effect on new borns/infants cannot be excluded.
\*\*Fertility\*\*
None4.7 Effects on ability to drive and use machines
Bettamousse has no known influence on the ability to drive and use machines.4.8 Undesirable effects
The following side effects can occur with topical use of steroids:
They are ranked under headings of frequency using the following convention:
Very Common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very Rare (<1/10,000)]; Frequency not known (cannot be estimated from the available data)
| | | |
| --- | --- | --- |
| \*\*System Organ Class\*\* | \*\*Frequency\*\* | \*\*Adverse Events\*\* |
| Infections and infestations | Very rare | Opportunistic infection |
| Immune system disorders | Very rare | Local hypersensitivity |
| Endocrine disorders | Very rare | Hypothalamic-pituitary adrenal (HPA) axis suppression Cushingoid features (e.g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract, hypertension, increased weight/obesity, decreased endogenous cortisol levels, alopecia, trichorrhexis |
| Eye disorders | Not known | Vision, blurred (see also Section 4.4) |
| Skin and subcutaneous disorders | Common | Pruritus, local skin burning/skin pain |
| Very rare | Allergic contact dermatitis /dermatitis, erythema, rash, urticaria, pustular psoriasis, skin thinning\\* / skin atrophy\\*, skin wrinkling\\*, skin dryness\\*, striae\\*, telangiectasias\\*, pigmentation changes\\*, hypertrichosis, exacerbation of underlying symptoms \\*Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression. |
| Not known | 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) |
| General disorders and administration site conditions | Very rare | Application site irritation/pain |
If signs of hypersensitivity appear, application should be stopped immediately.
\*\*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 www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Acute overdosage is very unlikely to occur. However, in the case of chronic overdosage or misuse, the features of hypercorticism may appear. In this situation topical steroids should be discontinued under careful clinical supervision, with supportive therapy if appropriate.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic (ATC) code: DO7AC: Corticosteroids, dermatological preparations, potent (group III).
Betamethasone valerate is a glucocorticosteroid which has topical anti-inflammatory activity.5.2 Pharmacokinetic properties
Under conditions of normal use, topical administration of betamethasone Valerate is not associated with clinically significant systemic absorption.5.3 Preclinical safety data
Topical administration of corticosteroids to pregnant animals has been associated with abnormalities of foetal development and growth retardation, although the relevance of this in humans is unknown.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Cetyl alcohol
Stearyl alcohol
Polysorbate 60
Ethanol anhydrous
Purified Water
Propylene glycol (E1520)
Citric acid anhydrous
Potassium Citrate
Butane/Propane6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.6.3 Shelf life
2 years6.4 Special precautions for storage
Do not store above 25°C. Do not refrigerate. Store upright.6.5 Nature and contents of container
Pressurised container.
Aluminium EP-lined can with Precision valve and clear cover cap, with a net weight of 50 or 100g.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
- Instruction Content
- ## Composition
1 g of foam contains 1 mg betamethasone (0.1 %) as valerate
\*\*Excipients with known effect\*\*:
Cetyl Alcohol 1.10 % w/w
Stearyl alcohol 0.50 % w/w
Propylene glycol (E1520) 2.00 % w/w
Ethanol anhydrous 57.79% w/w
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Cutaneous foam.
White, foam mousse.
## Clinical Particulars
4.1 Therapeutic indications
Bettamousse is indicated for steroid responsive dermatoses of the scalp, such as psoriasis.4.2 Posology and method of administration
\*\*Posology\*\*
Adults, the elderly and children (over the age of six years): No more than a “golf-ball” sized amount of mousse (containing approximately 3.5mg betamethasone), or proportionately less for children twice daily (in the morning and evening) until the condition improves. If there is no improvement after 7 days, treatment should be discontinued. Once the condition has improved, application is reduced to once a day and after daily treatment it may be possible to maintain improvement by applying even less frequently.
\*Paediatric population\*
In children over the age of 6 years, this product should not, in general, be used for longer than 5 to 7 days.
\*\*Method of administration\*\*
For topical use.
Note: for proper dispensing of foam, the container should be held upside down and the actuator depressed.
The patient or carer should shake the can well before use, remove the cap, invert the can and dispense required amount of mousse onto a clean saucer or something similar. Dispensing directly onto hands should be avoided as the mousse will begin to melt when it touches skin. The product is to be massaged sparingly into the affected areas of the scalp. It is recommended to wash hands immediately after use. Hair should not be washed immediately after use, allowing the mousse to work overnight or through the day.4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Bacterial, fungal, parasitic or viral infections of the scalp unless simultaneous treatment is initiated.
Dermatoses in children under six years of age.4.4 Special warnings and precautions for use
Avoid contact with the eyes, open wounds and mucosae. Do not use near a naked flame.
The least amount of mousse required to control the disease should be used for the shortest possible time. This should minimise the potential for long term side effects. This is particularly the case in children, as adrenal suppression can occur even without its use with an occlusive dressing.
As with other topical corticosteroids, at least monthly clinical review is recommended if treatment is prolonged, and it may be advisable to monitor for signs of systemic activity.
The use of topical corticosteroids in psoriasis requires careful supervision. Glucocorticoids can mask, activate and worsen a skin infection. Development of secondary infection requires appropriate antimicrobial therapy and may necessitate withdrawal of topical corticosteroid therapy. Occlusive treatment should be avoided when there are signs of secondary infection. There is a risk of the development of generalised pustular psoriasis or local or systemic toxicity due to impaired barrier function of the skin.
\*\*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.
Tolerance may develop and rebound relapse may occur on withdrawal of treatment. 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. 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 advice is recommended in these cases or other treatment options should be considered.
\*\*Excipients\*\*
This medicine contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
This medicine contains 2022 mg alcohol (ethanol) in each “golf-ball” sized amount of mousse (approx. 3.5g), which is equivalent to 57.79% w/w. It may cause burning sensation on damaged skin. Do not use near an open flame, lit cigarette or some devices (e.g. hairdryers).
This medicine contains 70 mg of propylene glycol in each “golf-ball” sized amount of mousse (approx. 3.5g) which is equivalent to 2% w/w.4.5 Interaction with other medicinal products and other forms of interaction
Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir and itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor.4.6 Fertility, pregnancy and lactation
\*\*Pregnancy\*\*
There is no or limited data from the use of betamethasone valerate in pregnant women. Bettamousse should only be used in pregnancy if the potential benefit outweighs the risk.
Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development such as cleft palate, but the relevance of this in man is unknown. Reduced placental and birth weight have been recorded in animals and man after long-term treatment.
\*\*Breastfeeding\*\*
Bettamousse should only be used in lactation if the potential benefit outweighs the risk.
Betamethasone valerate is excreted in maternal milk, a risk of therapeutic doses having an effect on new borns/infants cannot be excluded.
\*\*Fertility\*\*
None4.7 Effects on ability to drive and use machines
Bettamousse has no known influence on the ability to drive and use machines.4.8 Undesirable effects
The following side effects can occur with topical use of steroids:
They are ranked under headings of frequency using the following convention:
Very Common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very Rare (<1/10,000)]; Frequency not known (cannot be estimated from the available data)
| | | |
| --- | --- | --- |
| \*\*System Organ Class\*\* | \*\*Frequency\*\* | \*\*Adverse Events\*\* |
| Infections and infestations | Very rare | Opportunistic infection |
| Immune system disorders | Very rare | Local hypersensitivity |
| Endocrine disorders | Very rare | Hypothalamic-pituitary adrenal (HPA) axis suppression Cushingoid features (e.g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract, hypertension, increased weight/obesity, decreased endogenous cortisol levels, alopecia, trichorrhexis |
| Eye disorders | Not known | Vision, blurred (see also Section 4.4) |
| Skin and subcutaneous disorders | Common | Pruritus, local skin burning/skin pain |
| Very rare | Allergic contact dermatitis /dermatitis, erythema, rash, urticaria, pustular psoriasis, skin thinning\\* / skin atrophy\\*, skin wrinkling\\*, skin dryness\\*, striae\\*, telangiectasias\\*, pigmentation changes\\*, hypertrichosis, exacerbation of underlying symptoms \\*Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression. |
| Not known | 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) |
| General disorders and administration site conditions | Very rare | Application site irritation/pain |
If signs of hypersensitivity appear, application should be stopped immediately.
\*\*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 www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Acute overdosage is very unlikely to occur. However, in the case of chronic overdosage or misuse, the features of hypercorticism may appear. In this situation topical steroids should be discontinued under careful clinical supervision, with supportive therapy if appropriate.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic (ATC) code: DO7AC: Corticosteroids, dermatological preparations, potent (group III).
Betamethasone valerate is a glucocorticosteroid which has topical anti-inflammatory activity.5.2 Pharmacokinetic properties
Under conditions of normal use, topical administration of betamethasone Valerate is not associated with clinically significant systemic absorption.5.3 Preclinical safety data
Topical administration of corticosteroids to pregnant animals has been associated with abnormalities of foetal development and growth retardation, although the relevance of this in humans is unknown.
## Pharmaceutical Particulars
6.1 List of excipients
Cetyl alcohol
Stearyl alcohol
Polysorbate 60
Ethanol anhydrous
Purified Water
Propylene glycol (E1520)
Citric acid anhydrous
Potassium Citrate
Butane/Propane6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.6.3 Shelf life
2 years6.4 Special precautions for storage
Do not store above 25°C. Do not refrigerate. Store upright.6.5 Nature and contents of container
Pressurised container.
Aluminium EP-lined can with Precision valve and clear cover cap, with a net weight of 50 or 100g.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
