Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Betamethasone dipropionate, Calcipotriol monohydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
FOR Dovobet ointment is used on the skin to treat plaque psoriasis (psoriasis vulgaris) in adults. Psoriasis is caused by your skin cells being produced too quickly. This causes redness, scaling and thickness of your skin. Dovobet ointment contains calcipotriol and betamethasone. Calcipotriol helps to bring the rate of skin cell growth back to normal and betamethasone acts to reduce inflammation. Corticosteroid creams, ointments and other topical preparations come in four different potencies or strengths. These are known as mild, moderately potent, potent or very potent. Healthcare professionals will usually refer to topical corticosteroid potency rather than strength. A potent or strong corticosteroid has a much stronger effect than a mild corticosteroid when using the same amount. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. Betamethasone is classed as a strong corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition.
E DOVOBET® Do not use Dovobet • • •
If you are allergic (hypersensitive) to calcipotriol, betamethasone or any of the other ingredients of this medicine (listed in section 6) If you have problems with calcium levels in the body (ask your doctor) If you have certain types of psoriasis: these are erythrodermic, exfoliative and pustular (ask your doctor).
As Dovobet contains a strong steroid do NOT use on skin affected by
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skin infections caused by viruses (e.g. cold sores or chicken pox) skin infections caused by a fungus (e.g. athlete's foot or ringworm) skin infections caused by bacteria skin infections caused by parasites (e.g. scabies) tuberculosis (TB) perioral dermatitis (red rash around the mouth) thin skin, easily damaged veins, stretch marks ichthyosis (dry skin with fish-like scales) acne (pimples) rosacea (severe flushing or redness of the skin on the face) ulcers or broken skin.
Warnings and precautions Talk to your doctor/nurse/pharmacist before and during use of Dovobet if • • • • • •
you are using other medicines that contain corticosteroids, as you may get side effects you have used this medicine for a long time and plan to stop (as there is a risk your psoriasis will get worse or 'flare up' when steroids are stopped suddenly) you have diabetes mellitus (diabetes), as your blood sugar/glucose level may be affected by the steroid your skin becomes infected, as you may need to stop your treatment you have a certain type of psoriasis called guttate psoriasis you experience blurred vision or other visual disturbances.
Special precautions
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Driving and using machines This medicine should not have any effect on your ability to drive or use machines. Dovobet ointment contains Butylhydroxytoluene (E321) Dovobet ointment contains butylhydroxytoluene (E321). This may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
DOVOBET® Always use Dovobet exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. How to put on Dovobet: Cutaneous use. Instruction for proper use
What should I expect when I use Dovobet? Most patients see obvious results after 2 weeks, even if the psoriasis is not yet cleared at that point.
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If you use more Dovobet than you should Contact your doctor if you have used more than 15 grams in one day. Excessive use of Dovobet may cause a problem with calcium in your blood, which usually normalises when discontinuing treatment. Your doctor may need to carry out blood tests to check that using too much ointment has not caused a problem with calcium in your blood. Excessive prolonged use can also cause your adrenal glands to stop working properly (these are found near the kidneys and produce hormones). If you forget to use Dovobet Do not take a double dose to make up for a forgotten dose. If you stop using Dovobet The use of Dovobet should be stopped as indicated by your doctor. It may be necessary for you to stop this medicine gradually, especially if you have used it for a long time. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects Tell your doctor/nurse immediately or as soon as possible if any of the following happens. You may have to stop your treatment. The following serious side effects have been reported for Dovobet: Uncommon (may affect up to 1 in 100 people)
• •
Your adrenal glands may stop working properly. Signs are tiredness, depression and anxiety. Cataracts (signs are cloudy and foggy vision, difficulty seeing at night and sensitivity to light) or an increase in pressure inside the eye (signs are eye pain, red eye, decreased or cloudy vision) Infections (because your immune system which fights infections may be suppressed or weakened) Pustular psoriasis (a red area with yellowish pustules usually on the hands or feet). If you notice this, stop using Dovobet and tell your doctor as soon as possible.
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Impact on the metabolic control of diabetes mellitus (if you have diabetes you may experience fluctuations in the blood glucose levels).
Serious side effects known to be caused by calcipotriol
Bacterial or fungal infection of hair follicle (furuncle) Allergic reactions Hypercalcaemia Stretch marks Sensitivity of the skin to light resulting in a rash Acne (pimples) Dry skin Rebound effect: A worsening of symptoms/psoriasis after ended treatment.
Frequency not known (frequency cannot be estimated from the available data)
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Thinning of the skin Appearance of surface blood vessels or stretch marks Changes in hair growth Red rash around the mouth (perioral dermatitis) Skin rash with inflammation or swelling (allergic contact dermatitis) Golden coloured gel-filled bumps (colloid milia) Lightening of skin colour (depigmentation) Inflammation or swelling of the hair root (folliculitis).
Less serious side effects known to be caused by calcipotriol include the following
not listed in this leaflet. You can also report side effects directly 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. By reporting side effects you can help provide more information on the safety of this medicine.
DOVOBET® • • • •
Keep this medicine out of the sight and reach of children Do not use this medicine after the expiry date, which is stated on the label after EXP. The expiry date refers to the last day of that month Do not store the product above 25°C The tube should be discarded 1 year after first opening. Write the date you first opened the tube in the space provided on the carton.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Dovobet contains The active substances are: Calcipotriol and betamethasone. One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of
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betamethasone (as dipropionate). The other ingredients are:
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butylhydroxytoluene (E321).
What Dovobet looks like and contents of the pack Dovobet ointment is an off-white to yellow coloured ointment filled in aluminium/epoxyphenol tubes with polyethylene screw cap. Pack sizes: 15, 30, 60, 100 and 120 g. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation holder is: LEO Pharma A/S Industriparken 55, DK-2750 Ballerup, Denmark The manufacturer is: LEO Laboratories Ltd. Cashel Road, Dublin 12, Ireland.
This leaflet was last revised in July 2024.
For information in large print, Braille or audio/CD, telephone +44 (0)1844 347333 Detailed information on this medicine is available on the website of the Medicines and Healthcare Products Regulatory Agency, www.mhra.gov.uk
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Dovobet 50 micrograms/g + 0.5 mg/g ointment comes as ointment containing 50mcg / 0.5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Dovobet 50 micrograms/g + 0.5 mg/g ointment is betamethasone dipropionate, calcipotriol monohydrate.
This leaflet reproduces the patient information leaflet approved for Dovobet 50 micrograms/g + 0.5 mg/g ointment, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy in adults.
Posology
Dovobet ointment should be applied to the affected area once daily.
The recommended treatment period is 4 weeks. There is experience with repeated courses of Dovobet up to 52 weeks. If it is necessary to continue or restart treatment after 4 weeks, treatment should be continued after medical review and under regular medical supervision.
When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g. The body surface area treated with calcipotriol containing medicinal products should not exceed 30 % (see section 4.4).
Special populations
Renal and hepatic impairment
The safety and efficacy of Dovobet ointment in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.
Paediatric population
The safety and efficacy of Dovobet ointment in children below 18 years have not been established. Currently available data in children aged 12 to 17 years are described in section 4.8 and 5.1 but no recommendation on a posology can be made.
Method of administration
Dovobet ointment should be applied to the affected area. In order to achieve optimal effect, it is not recommended to take a shower or bath immediately after application of Dovobet ointment.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Dovobet is contraindicated in erythrodermic, exfoliative and pustular psoriasis.
Due to the content of calcipotriol Dovobet is contra-indicated in patients with known disorders of calcium metabolism (see section 4.4).
Due to the content of corticosteroid Dovobet is contraindicated in the following conditions: Viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wounds (see section 4.4).
Effects on endocrine system
Dovobet ointment contains a potent group III steroid and concurrent treatment with other steroids must be avoided. Adverse reactions found in connection with systemic corticosteroid treatment, such as adrenocortical suppression or impact on the metabolic control of diabetes mellitus may occur also during topical corticosteroid treatment due to systemic absorption.
Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids. Application on large areas of damaged skin or on mucous membranes or in skin folds should be avoided since it increases the systemic absorption of corticosteroids (see section 4.8).
In a study in patients with both extensive scalp and extensive body psoriasis using a combination of high doses of Dovobet gel (scalp application) and high doses of Dovobet ointment (body application), 5 of 32 patients showed a borderline decrease in cortisol response to adrenocorticotropic hormone (ACTH) challenge after 4 weeks of treatment (see section 5.1).
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 a 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.
Effects on calcium metabolism
Due to the content of calcipotriol, hypercalcaemia may occur if the maximum daily dose (15 g) is exceeded. Serum calcium is normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the recommendations relevant to calcipotriol are followed. Treatment of more than 30 % of the body surface should be avoided (see section 4.2).
Local adverse reactions
Dovobet contains a potent group III-steroid and concurrent treatment with other steroids on the same treatment area must be avoided. Skin of the face and genitals are very sensitive to corticosteroids. The medicinal product should not be used in these areas. The patient must be instructed in correct use of the medicinal product to avoid application and accidental transfer to the face, mouth and eyes. Hands must be washed after each application to avoid accidental transfer to these areas.
Concomitant skin infections
When lesions become secondarily infected, they should be treated with antimicrobiological therapy. However, if infection worsens, treatment with corticosteroids should be stopped (see section 4.3).
Discontinuation of treatment
When treating psoriasis with topical corticosteroids there may be a risk of generalised pustular psoriasis or of rebound effects when discontinuing treatment. Medical supervision should therefore continue in the post-treatment period.
Long-term use
With long-term use there is an increased risk of local and systemic corticosteroid adverse reactions. The treatment should be discontinued in case of adverse reactions related to long-term use of corticosteroid (see section 4.8).
Unevaluated use
There is no experience with the use of Dovobet in guttate psoriasis.
Concurrent treatment and UV exposure
There is limited experience for the use of this medicinal product on the scalp. Dovobet ointment for body psoriasis lesions has been used in combination with Dovobet gel for scalp psoriasis lesions, but there is limited experience of combination of Dovobet with other topical anti-psoriatic products at the same treatment area, other anti-psoriatic medicinal products administered systemically or with phototherapy.
During Dovobet treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. Topical calcipotriol should be used with UVR only if the physician and patient consider that the potential benefits outweigh the potential risks (see section 5.3).
Adverse reactions to excipients
Dovobet ointment contains butylhydroxytoluene (E321) as an excipient which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
The label will state strong steroid.
No interaction studies have been performed with Dovobet.
Pregnancy
There are no adequate data from the use of Dovobet in pregnant women. Studies in animals with glucocorticoids have shown reproductive toxicity (see section 5.3), but a number of epidemiological studies (less than 300 pregnancy outcomes) have not revealed congenital anomalies among infants born to women treated with corticosteroids during pregnancy. The potential risk for humans is uncertain. Therefore, during pregnancy, Dovobet should only be used when the potential benefit justifies the potential risk.
Breast-feeding
Betamethasone passes into breast milk but risk of an adverse effect on the infant seems unlikely with therapeutic doses. There are no data on the excretion of calcipotriol in breast milk. Caution should be exercised when prescribing Dovobet ointment to women who breast-feed. The patient should be instructed not to use Dovobet on the breast when breast-feeding.
Fertility
Studies in rats with oral doses of calcipotriol or betamethasone dipropionate demonstrated no impairment of male and female fertility (see section 5.3).
Dovobet has no or negligible influence on the ability to drive and use machines.
The estimation of the frequency of adverse reactions is based on a pooled analysis of data from clinical studies including post-authorisation safety studies and spontaneous reporting.
The most frequently reported adverse reactions during treatment are various skin reactions, like pruritus and skin exfoliation.
Pustular psoriasis and hypercalcaemia have been reported.
Adverse reactions are listed by MedDRA SOC and the individual adverse reactions are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
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)
Not known (cannot be estimated from the available data)
Infections and infestations
Uncommon ≥1/1,000 to <1/100
Skin infection*
Folliculitis
Rare ≥1/10,000 to <1/1,000
Furuncle
Immune system disorders
Rare ≥1/10,000 to <1/1,000
Hypersensitivity
Metabolism and nutrition disorders
Rare ≥1/10,000 and to <1/1,000
Hypercalcaemia
Eye disorders
Not known
Vision, blurred****
Skin and subcutaneous tissue disorders
Common ≥1/100 to < 1/10
Skin exfoliation
Pruritus
Uncommon ≥1/1,000 to <1/100
Skin atrophy
Exacerbation of psoriasis
Dermatitis
Erythema
Rash**
Purpura or ecchymosis
Skin burning sensation
Skin irritation
Rare ≥1/10,000 to <1/1,000
Pustular psoriasis
Skin striae
Photosensitivity reaction
Acne
Dry skin
General disorders and administration site conditions
Uncommon ≥1/1,000 to <1/100
Application site pigmentation changes
Application site pain***
Rare ≥1/10,000 to <1/1,000
Rebound effect
*Skin infections including bacterial, fungal and viral skin infections have been reported.
**Various types of rash reactions such as exfoliative rash, rash papular and rash pustular have been reported.
***Application site burning is included in application site pain.
****See section 4.4.
Paediatric population:
In an uncontrolled open study, 33 adolescents aged 12-17 years with psoriasis vulgaris were treated with Dovobet ointment for 4 weeks to a maximum of 56 g per week. No new adverse events were observed and no concerns regarding systemic corticosteroid effect were identified. The size of this study does however not allow firm conclusions regarding the safety profile of Dovobet ointment in children and adolescents.
The following adverse reactions are considered to be related to the pharmacological classes of calcipotriol and betamethasone, respectively:
Calcipotriol
Adverse reactions include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, eczema, psoriasis aggravated, photosensitivity and hypersensitivity reactions including very rare cases of angioedema and facial oedema.
Systemic effects after topical use may appear very rarely causing hypercalcaemia or hypercalciuria (see section 4.4).
Betamethasone (as dipropionate)
Local reactions can occur after topical use, especially during prolonged application, including skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and colloid milia.
When treating psoriasis with topical corticosteroids there may be a risk of generalised pustular psoriasis.
Systemic reactions due to topical use of corticosteroids are rare in adults, however they can be severe. Adrenocortical suppression, cataract, infections, impact on the metabolic control of diabetes mellitus and increase of intra-ocular pressure can occur, especially after long term treatment. Systemic reactions occur more frequently when applied under occlusion (plastic, skin folds), when applied on large areas and during long term treatment (see 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: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Use above the recommended dose may cause elevated serum calcium which subsides when treatment is discontinued. The symptoms of hypercalcaemia include polyuria, constipation, muscle weakness, confusion and coma.
Excessive prolonged use of topical corticosteroids may suppress the pituitary-adrenal functions resulting in secondary adrenal insufficiency which is usually reversible. In such cases symptomatic treatment is indicated.
In case of chronic toxicity the corticosteroid treatment must be discontinued gradually.
It has been reported that due to misuse one patient with extensive erythrodermic psoriasis treated with 240 g of Dovobet ointment weekly (corresponding to a daily dose of approximately 34 g) for 5 months (maximum recommended dose 15 g daily) developed Cushing's syndrome during treatment and then pustular psoriasis after abruptly stopping treatment.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Dovobet 50 micrograms/g + 0.5 mg/g ointment. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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