Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Calcipotriol/Betamethasone 50 micrograms/g + 0.5 mg/g ointment
⚠ This medicine appears to have been discontinued
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, Calcipotriol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
FOR Calcipotriol/Betamethasone 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. Calcipotriol/Betamethasone ointment contains calcipotriol and betamethasone. Calcipotriol helps to bring the rate of skin cell growth back to normal and the corticosteroid 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.
What you need to know before you take it
E CALCIPOTRIOL/BETAMETHASONE OINTMENT Do not use Calcipotriol/Betamethasone ointment
- if you are allergic to calcipotriol, betamethasone or any of the other ingredients of this medicine (listed in section 6)
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- 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 Calcipotriol/Betamethasone ointment contains a strong steroid do NOT use on skin affected by
- 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, pharmacist or nurse before using Calcipotriol/Betamethasone ointment 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. Special precautions
- Avoid use on more than 30 % of your body or using more than 15 grams per day
- Avoid using under bandages or dressings as it increases the absorption of the steroid
- Avoid use on large areas of damaged skin, on mucous membranes or in skin folds (groin, armpits, under breasts) as it increases the absorption of the steroid
- Avoid use on the face or genitals (sex organs) as they are very sensitive to steroids
- Avoid excessive sunbathing, excessive use of solarium and other forms of light treatment
- Contact your doctor if you experience blurred vision or other visual disturbances. Children and adolescents Calcipotriol/Betamethasone ointment is not recommended for the use in children and adolescents below the age of 18 years. Other medicines and Calcipotriol/Betamethasone ointment Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding
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Do not use Calcipotriol/Betamethasone ointment if you are pregnant (or might be pregnant) or if you are breast-feeding, unless you have agreed it with your doctor first. If your doctor has agreed that you can breast-feed, take care and do not apply Calcipotriol/Betamethasone ointment to the breast area. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines This medicine should not have any effect on your ability to drive or use machines. Calcipotriol/Betamethasone ointment contains butylhydroxytoluene (E321) Butylhydroxytoluene (E321) may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
How to take it
CALCIPOTRIOL/BETAMETHASONE OINTMENT Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. How to put on Calcipotriol/Betamethasone ointment: Cutaneous use. Instruction for proper use
- Use only on your psoriasis and do not use on skin which does not have psoriasis
- Remove the cap and check that the seal in the tube is not broken before you first use the ointment
- To break the seal, use the point in the back of the cap
- Squeeze the ointment onto a clean finger
- Rub gently into your skin to cover the affected area of psoriasis until most of the ointment has disappeared into the skin
- Do not bandage, tightly cover or wrap the treated skin area
- Wash your hands well after using Calcipotriol/Betamethasone ointment (unless you are using the ointment to treat your hands). This will avoid accidentally spreading the ointment to other parts of your body (especially the face, scalp, mouth and eyes)
- Do not worry if some ointment accidentally gets on normal skin near your psoriasis, but wipe it off if it spreads too far
- In order to achieve optimal effect, it is recommended not to take a shower or bath immediately after application of Calcipotriol/Betamethasone ointment
- After applying the ointment avoid contact with textiles which are easily stained by grease (e.g. silk). Duration of treatment
- Use the ointment once a day. It may be more convenient to use the ointment in the evening.
- The normal initial treatment period is 4 weeks but your doctor may decide on a different treatment period
- Your doctor may decide on repeated treatment
- Do not use more than 15 grams in one day. If you use other calcipotriol containing medicines, the total amount of calcipotriol medicines must not exceed 15 grams per day and the area treated should not exceed 30 % of the total body surface. What should I expect when I use Calcipotriol/Betamethasone ointment?
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Most patients see obvious results after 2 weeks, even if the psoriasis is not yet cleared at that point. If you have used more Calcipotriol/Betamethasone ointment than you should Contact your doctor if you have used more than 15 grams in one day. Excessive use of Calcipotriol/Betamethasone ointment 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 Calcipotriol/Betamethasone ointment Do not take a double dose to make up for forgotten individual doses. If you stop using Calcipotriol/Betamethasone ointment The use of Calcipotriol/Betamethasone ointment 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 Calcipotriol/Betamethasone ointment: Uncommon (may affect up to 1 in 100 people)
- Worsening of your psoriasis. If your psoriasis gets worse, tell your doctor as soon as possible. Rare (may affect up to 1 in 1,000 people)
- Pustular psoriasis may occur (a red area with yellowish pustules usually on the hands or feet). If you notice this, stop using Calcipotriol/Betamethasone ointment and tell your doctor as soon as possible. Some serious side effects are known to be caused by betamethasone (a strong steroid), one of the ingredients in Calcipotriol/Betamethasone ointment. You should tell your doctor as soon as possible if any of the serious side effects occur. These side effects are more likely to happen after long-term use, use in skin folds (e.g. groin, armpits or under breasts), use under occlusion or use on large areas of skin. The side effects include the following:
- Your adrenal glands may stop working properly. Signs are tiredness, depression and anxiety.
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- 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 Calcipotriol/Betamethasone ointment and tell your doctor as soon as possible.
- 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
- Allergic reactions with deep swelling of the face or other parts of the body such as the hands or feet. Swelling of the mouth/throat and trouble breathing may occur. If you have an allergic reaction, stop using Calcipotriol/Betamethasone ointment, tell your doctor immediately or go to the casualty department at your nearest hospital.
- Treatment with this ointment may cause the level of calcium in your blood or urine to increase (usually when too much ointment has been used). Signs of increased calcium in blood are excessive secretion of urine, constipation, muscle weakness, confusion and coma. This can be serious and you should contact your doctor immediately. However, when the treatment is stopped, the levels return to normal. Less serious side effects The following less serious side effects have been reported for Calcipotriol/Betamethasone ointment. Common side effects (may affect up to 1 in 10 people)
- Itching
- Skin exfoliation. Uncommon (may affect up to 1 in 100 people)
- Skin pain or irritation
- Rash with inflammation of the skin (dermatitis)
- Redness of the skin due to widening of the small blood vessels (erythema)
- Inflammation or swelling of the hair root (folliculitis)
- Changes in skin colour in the area you have used the ointment
- Rash
- Burning sensation
- Infection of the skin
- Thinning of the skin
- Appearance of red or purple discolouration on the skin (purpura or ecchymosis). Rare (may affect up to 1 in 1,000 people)
- 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.
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Less serious side effects caused by using betamethasone, especially for a long time, include the following. You should tell your doctor or nurse as soon as possible if you notice any of them.
- 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)
- Blurred vision. Less serious side effects known to be caused by calcipotriol include the following
- Dry skin
- Sensitivity of the skin to light resulting in a rash
- Eczema
- Itching
- Skin irritation
- Burning and stinging sensation
- Redness of the skin due to widening of the small blood vessels (erythema)
- Rash
- Rash with inflammation of the skin (dermatitis)
- Worsening of psoriasis. Steroid withdrawal reaction: If used over prolonged periods a withdrawal reaction, which might appear to be different from the previous condition, may occur in some patients during treatment or within days to weeks after stopping treatment, with some or all of the following features: redness of the skin which can extend beyond the initial area treated, a burning or stinging sensation, intense itching, peeling of the skin, oozing open sores. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: 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.
How to store it
CALCIPOTRIOL/BETAMETHASONE OINTMENT 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 medicine above 25 °C. Do not refrigerate. 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.
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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.
Contents of the pack and other information
What Calcipotriol/Betamethasone ointment contains The active substances are: Calcipotriol and betamethasone. One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate). The other ingredients are: Liquid paraffin, polyoxypropylene stearyl ether (contains butylhydroxytoluene (E321)), white soft paraffin (contains all-rac-α-Tocopherol). What Calcipotriol/Betamethasone ointment looks like and contents of the pack Calcipotriol/Betamethasone ointment is an off-white to yellow coloured ointment filled in aluminium/epoxy-phenol tubes with polyethylene screw cap. Pack sizes: 15 g, 30 g, 35 g, 50 g, 60 g, 100 g, 100 g (as bundle pack 2 x 50 g), 120 g and 120 g (as bundle pack 2 x 60 g). Not all pack sizes may be marketed. Marketing Authorisation Holder Neon Healthcare Limited 8 The Chase, John Tate Road Hertford SG13 7NN United Kingdom Manufacturer mibe GmbH Arzneimittel Münchener Straße 15 06796 Brehna Germany
This leaflet was last revised in June 2025.
Frequently asked questions about Calcipotriol/Betamethasone 50 micrograms/g + 0.5 mg/g ointment
How do I take Calcipotriol/Betamethasone 50 micrograms/g + 0.5 mg/g ointment?
Calcipotriol/Betamethasone 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.
What is the active substance in Calcipotriol/Betamethasone 50 micrograms/g + 0.5 mg/g ointment?
The active substance in Calcipotriol/Betamethasone 50 micrograms/g + 0.5 mg/g ointment is betamethasone, calcipotriol.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Calcipotriol/Betamethasone 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.
Can I get Calcipotriol/Betamethasone 50 micrograms/g + 0.5 mg/g ointment without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: betamethasone, calcipotriol
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy in adults.
4.2. Posology and method of administration
Posology
Calcipotriol/Betamethasone ointment should be applied to the affected area once daily.
The recommended treatment period is 4 weeks. There is experience with repeated courses of Calcipotriol/Betamethasone ointment 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 Calcipotriol/Betamethasone ointment in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.
Paediatric population
The safety and efficacy of Calcipotriol/Betamethasone 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
Calcipotriol/Betamethasone 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 Calcipotriol/Betamethasone ointment.
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Calcipotriol/Betamethasone ointment is contraindicated in erythrodermic, exfoliative and pustular psoriasis.
Due to the content of calcipotriol Calcipotriol/Betamethasone ointment is contraindicated in patients with known disorders of calcium metabolism (see section 4.4).
Due to the content of corticosteroid Calcipotriol/Betamethasone ointment 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).
4.4. Special warnings and precautions for use
Effects on endocrine system
Calcipotriol/Betamethasone 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 calcipotriol+betamethasone dipropionate gel (scalp application) and high doses of calcipotriol+betamethasone dipropionate 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).
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
Calcipotriol/Betamethasone ointment 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 Calcipotriol/Betamethasone ointment in guttate psoriasis.
Concurrent treatment and UV exposure
There is limited experience for the use of this medicinal product on the scalp. Calcipotriol+betamethasone dipropionate ointment for body psoriasis lesions has been used in combination with calcipotriol+betamethasone dipropionate gel for scalp psoriasis lesions, but there is limited experience of combination of calcipotriol+betamethasone dipropionate ointment with other topical anti-psoriatic products at the same treatment area, other anti-psoriatic medicinal products administered systemically or with phototherapy.
During Calcipotriol/Betamethasone ointment 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).
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.
Adverse reactions to excipients
Calcipotriol/Betamethasone 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.
Topical steroid withdrawal syndrome
Long term 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.
The label will state strong steroid.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with Calcipotriol/Betamethasone ointment.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of Calcipotriol/Betamethasone ointment 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, Calcipotriol/Betamethasone ointment 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 Calcipotriol/Betamethasone ointment to women who breast-feed. The patient should be instructed not to use Calcipotriol/Betamethasone ointment 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).
4.7. Effects on ability to drive and use machines
Calcipotriol/Betamethasone ointment has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
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.
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 to <1/1,000)
Hypercalcaemia
Eye disorders
Not known (cannot be estimated from the available data)
Vision, blurred (see also section 4.4)
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
Paediatric population:
In an uncontrolled open study, 33 adolescents aged 12-17 years with psoriasis vulgaris were treated with calcipotriol+betamethasone dipropionate 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 Calcipotriol/Betamethasone 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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
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 calcipotriol+betamethasone dipropionate 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.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- DAIVOBET 50 micrograme/0,5 mg/g prescriptionCOMBINATII (CALCIPOTRIOLUM+BETAMETHASONUM) · skin / topical
- DAIVOBET 50 micrograme/0,5mg/g prescriptionCOMBINATII (CALCIPOTRIOLUM+BETAMETHASONUM) · skin / topical
- ENSTILUM 50 micrograme/0,5 mg/g prescriptionCOMBINATII (CALCIPOTRIOLUM+BETAMETHASONUM) · skin / topical
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 →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- DaivobetCalcipotriolum + Betamethasonum · skin / topical
- PsotriolCalcipotriolum + Betamethasonum · skin / topical
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 about this leaflet
Ask anything about Calcipotriol/Betamethasone 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.