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 Gel
⚠ 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 dipropionate, Calcipotriol monohydrate 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 gel is used as topical treatment of scalp psoriasis in adults and on the skin of other body areas to treat mild to moderate 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 gel 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 GEL Do not use Calcipotriol/Betamethasone gel
- If you are allergic (hypersensitive) to calcipotriol, betamethasone or any of the other ingredients of Calcipotriol/Betamethasone gel (listed in section 6)
- If you have problems with calcium levels in your body (ask your doctor)
- If you have certain types of psoriasis: these are erythrodermic, exfoliative and pustular (ask your doctor). As Calcipotriol/Betamethasone gel 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)
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- 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 Warning and precautions Talk to your doctor/nurse/pharmacist before using Calcipotriol/Betamethasone gel 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
- Avoid use on more than 30 % of your body or using more than 15 grams per day
- Avoid using under a bathing cap, 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. If there is a worsening of your condition during use consult your prescriber – you may be experiencing an allergic reaction, have an infection or your condition requires a different treatment. If you experience a recurrence of your condition shortly after stopping treatment, within 2 weeks, do not restart using Calcipotriol/Betamethasone gel without consulting your prescriber unless your prescriber has previously advised you to do so. If your condition has resolved and on recurrence the redness extends beyond the initiation treatment area and you experience a burning sensation, please seek medical advice before restarting treatment. Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. Children Calcipotriol/Betamethasone gel is not recommended for the use in children below the age of 18 years. Other medicines and Calcipotriol/Betamethasone gel Please tell your doctor, pharmacist or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding If you are pregnant or breast-feeding or are planning to have a baby, ask your doctor for advice before using this medicine. If your doctor has agreed that you can breast-feed, take care and do not apply Calcipotriol/Betamethasone gel to the breast area. Ask your doctor or pharmacist for advice before taking this medicine.
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Driving and using machines This medicine should not have any effect on your ability to drive or use machines. Calcipotriol/Betamethasone gel 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 GEL Always use Calcipotriol/Betamethasone gel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. How to put on Calcipotriol/Betamethasone gel: Cutaneous use. Instruction for proper use
- Use only on your psoriasis and do not use on skin which does not have psoriasis
- Shake the bottle before use and remove the cap
- Squeeze the gel onto a clean finger or directly onto the area affected by psoriasis
- Apply Calcipotriol/Betamethasone gel to the affected area with your fingertips, and rub it in gently until the area affected by psoriasis is covered by a thin layer of gel
- Do not bandage, tightly cover or wrap the treated skin area
- Wash your hands well after using Calcipotriol/Betamethasone gel. This will avoid accidentally spreading the gel to other parts of your body (especially the face, mouth and eyes)
- Do not worry if some gel 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 gel
- After applying the gel avoid contact with textiles which are easily stained by grease (e.g. silk). If you have scalp psoriasis:
- Before applying Calcipotriol/Betamethasone gel to the scalp, comb the hair to remove any loose scales. It may help to part your hair. Tilt your head to make sure Calcipotriol/Betamethasone gel does not run onto your face. Washing your hair before application of Calcipotriol/Betamethasone gel is not necessary. 1. Shake bottle before use. 2. Apply a drop of Calcipotriol/Betamethasone gel to fingertip. 3. Apply directly to scalp areas where you can feel the raised plaque and rub Calcipotriol/Betamethasone gel on to the skin. Depending on the affected area 1-4 g (up to 1 teaspoon) is normally enough. In order to achieve optimal effect, it is recommended that the hair is not washed immediately after application of Calcipotriol/Betamethasone gel. Let Calcipotriol/Betamethasone gel remain on the scalp during the night or during the day. When washing hair after application the following instructions might be useful: 4. Apply a mild shampoo to the dry hair, especially to those areas where the gel was applied. 5. Leave the shampoo on the scalp for a couple of minutes before washing. 6. Wash your hair as usual. If necessary, repeat steps 4-6 once or twice. Duration of treatment
- Use the gel once a day. It may be more convenient to use the gel in the evening.
- The normal initial treatment period is 4 weeks for scalp areas and 8 weeks for nonscalp areas.
- 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.
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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 gel? 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 gel than you should Contact your doctor if you have used more than 15 grams in one day. Excessive use of Calcipotriol/Betamethasone gel 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 gel has not caused a problem with calcium in your blood. Excessive prolonged use can also cause your adrenal glands to stop working properly (the adrenal glands are found near the kidneys and produce hormones). If you forget to use Calcipotriol/Betamethasone gel Do not take a double dose to make up for a forgotten dose. If you stop using Calcipotriol/Betamethasone gel The use of Calcipotriol/Betamethasone gel 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.
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. 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. Some serious side effects are known to be caused by betamethasone (a strong steroid), one of the ingredients in Calcipotriol/Betamethasone gel. 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.
- 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 gel 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 gel, tell your doctor immediately or go to the casualty department at your nearest hospital.
- Treatment with this gel may cause the level of calcium in your blood or urine to
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increase (usually when too much gel 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 Common side effects (may affect up to 1 in 10 people)
- Itching Uncommon (may affect up to 1 in 100 people)
- Eye irritation
- Burning sensation of the skin
- Skin pain or irritation
- Inflammation or swelling of the hair root (folliculitis)
- Rash with inflammation of the skin (dermatitis)
- Redness of the skin due to widening of the small blood vessels (erythema)
- Acne (pimples)
- Dry skin
- Rash
- Pustular rash
- Infection of the skin Rare (may affect up to 1 in 1,000 people)
- Allergic reactions
- Stretch marks
- Skin exfoliation
- Rebound effect: A worsening of symptoms/psoriasis after ended treatment. Frequency unknown (frequency cannot be estimated from the available data):
- White or grey hair can transiently change to a yellowish colour at the application site when used on the scalp
- Blurred vision. 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 of the skin 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:
- 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 If used continuously for prolonged periods a withdrawal reaction may occur on 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
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skin, oozing open sores. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any 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 GEL Keep out of the reach and sight of children. Do not use Calcipotriol/Betamethasone gel 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 30 °C. Keep the bottle in the outer carton in order to protect from light. Discard the bottle with any remaining gel 6 months after first opening. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
Contents of the pack and other information
What Calcipotriol/Betamethasone gel contains The active substances are: Calcipotriol and betamethasone. One gram of gel contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate). The other ingredients are: Liquid paraffin, polyoxypropylene stearyl ether, hydrogenated castor oil, butylhydroxytoluene (E321) What Calcipotriol/Betamethasone gel looks like and contents of the pack Calcipotriol/Betamethasone gel is an almost clear, colourless to slightly off-white gel filled in bottles with polyethylene screw cap. Pack sizes: 30 g, 60 g Not all pack sizes may be marketed. Marketing Authorisation Holder Stirling Anglian Pharmaceuticals Limited Hillington Park Innovation Centre 1 Ainslie Road Hillington Park Glasgow G52 4RU United Kingdom Manufacturer mibe GmbH Arzneimittel Münchener Straße 15 06796 Brehna Germany This leaflet was last revised in July 2024.
Frequently asked questions about Calcipotriol/Betamethasone 50 micrograms/g + 0.5 mg/g Gel
How do I take Calcipotriol/Betamethasone 50 micrograms/g + 0.5 mg/g Gel?
Calcipotriol/Betamethasone 50 micrograms/g + 0.5 mg/g Gel comes as gel 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 Gel?
The active substance in Calcipotriol/Betamethasone 50 micrograms/g + 0.5 mg/g Gel is betamethasone dipropionate, calcipotriol monohydrate.
Are there equivalent medicines to Calcipotriol/Betamethasone 50 micrograms/g + 0.5 mg/g Gel?
Medicines with the same active substance, strength and form include: Calcipotriol/Betamethasone 50 micrograms/g + 0.5 mg/g gel, Dovobet 50 microgram/g + 0.5 mg/g gel. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Calcipotriol/Betamethasone 50 micrograms/g + 0.5 mg/g Gel, 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 Gel 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 dipropionate, calcipotriol monohydrate
- 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 scalp psoriasis in adults. Topical treatment of mild to moderate “non-scalp” plaque psoriasis vulgaris in adults.
4.2. Posology and method of administration
Posology
Calcipotriol/Betamethasone gel should be applied to affected areas once daily. The recommended treatment period is 4 weeks for scalp areas and 8 weeks for “non-scalp” areas. If it is necessary to continue or restart treatment after this period, 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).
If used on the scalp
All the affected scalp areas may be treated with Calcipotriol/Betamethasone gel. Usually an amount between 1 g and 4 g per day is sufficient for treatment of the scalp (4 g corresponds to one teaspoon).
Special populations
Renal and hepatic impairment
The safety and efficacy of Calcipotriol/Betamethasone gel in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.
Paediatric population
The safety and efficacy of Calcipotriol/Betamethasone gel 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 gel should not be applied directly to the face or eyes. In order to achieve optimal effect, it is not recommended to take a shower or bath, or to wash the hair in case of scalp application, immediately after application of Calcipotriol/Betamethasone gel. Calcipotriol/Betamethasone gel should remain on the skin during the night or during the day.
The bottle should be shaken before use and Calcipotriol/Betamethasone gel applied to the affected area. The hands should be washed after use.
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Calcipotriol/Betamethasone gel is contraindicated in erythrodermic, exfoliative and pustular psoriasis.
Due to the content of calcipotriol Calcipotriol/Betamethasone gel is contraindicated in patients with known disorders of calcium metabolism (see section 4.4).
Due to the content of corticosteroid Calcipotriol/Betamethasone gel 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 gel 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).
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
Calcipotriol/Betamethasone gel 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 gel in guttate psoriasis.
Concurrent treatment and UV exposure
Calcipotriol+betamethasone dipropionate ointment for body psoriasis lesions has been used in combination with calcipotriol+betamethasone dipropionate gel for scalp psoriasis lesions. There is limited experience of combination of calcipotriol+betamethasone dipropionate gel with other topical anti-psoriatic products at the same treatment area, other anti-psoriatic medicinal products administered systemically or with phototherapy.
During Calcipotriol/Betamethasone gel 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
Calcipotriol/Betamethasone gel 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 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.
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 gel.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of Calcipotriol/Betamethasone gel 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 gel 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 gel to women who breast-feed. The patient should be instructed not to use Calcipotriol/Betamethasone gel 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 gel 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 reaction during treatment is pruritus.
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 available data)
Infections and infestations
Uncommon ≥1/1,000 to <1/100
Skin infection*
Folliculitis
Immune system disorders
Rare ≥1/10,000 to <1/1,000
Hypersensitivity
Eye disorders
Uncommon ≥1/1,000 to <1/100
Eye irritation
Not known
Vision, blurred*****
Skin and subcutaneous tissue disorders
Common ≥1/100 to < 1/10
Pruritus
Uncommon ≥1/1,000 to <1/100
Exacerbation of psoriasis
Dermatitis
Erythema
Rash**
Acne
Skin burning sensation
Skin irritation
Dry skin
Rare ≥1/10,000 to <1/1,000
Skin striae
Skin exfoliation
Not known (cannot be estimated from available data)
Hair colour changes***
Withdrawal reactions†
General disorders and administration site conditions
Uncommon ≥1/1,000 to <1/100
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.
*** Transient discolouration of the hair at scalp application site, to a yellowish colour in white or grey hair, has been reported.
**** Application site burning is included in application site pain
***** See section 4.4.
† 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).
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).
Paediatric population:
No clinically relevant differences between the safety profiles in adult and adolescent populations have been observed. A total of 216 adolescent subjects were treated in three open label clinical trials. See section 5.1 for further details regarding the trials.
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.
💬 Ask about this leaflet
Ask anything about Calcipotriol/Betamethasone 50 micrograms/g + 0.5 mg/g Gel. 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.