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 Calcipotriol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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Dovonex contains the active substance calcipotriol. Dovonex belongs to a group of medicines called anti-psoriatics. It is a type of vitamin D. Vitamin D controls how the cells in your skin grow. If the cells in your skin grow too much you may get psoriasis. Psoriasis is a condition where your skin develops raised red patches and silver coloured scaly patches. The scaly patches are dead cells that would normally fall off your skin without you noticing. Dovonex works by reducing the amount of cells your skin makes. This means your skin symptoms will reduce too. These diagrams explain how your skin may improve when you use this medicine. Your skin before treatment.
After about two weeks you may see a change in your skin. The scaly or flaky patches usually clear up first. They will feel smoother.
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The redness of the skin will start to clear up next. It may clear up in the centre first.
Dovonex is used to treat: •
Plaque psoriasis (psoriasis vulgaris).
e Dovonex® Do not use Dovonex
If you have been told by a doctor that you have high or low levels of a substance called calcium in your body (calcium metabolism disorders)
•
If you have severe kidney problems
•
If you have severe liver problems
•
Do not use on your face
•
Do not use on children under 6 years old.
Warnings and precautions: Talk to your doctor, pharmacist or nurse before using Dovonex
Be careful when using Dovonex in skin folds such as armpits or under the breasts. You may be more likely to get skin side effects in these areas. Your doctor may tell you to limit your exposure to natural or artificial sunlight, e.g. sunbathing and sun beds, while you are using this medicine. 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 Do not use this medicine on children under 6 years old. Other medicines and Dovonex Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes any medicines which you have bought without a prescription or herbal medicines. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. If your doctor has agreed that you can breast-feed, do not apply Dovonex to the breast area. Driving and using machines This medicine should not have any effect on your ability to drive or use machines. Check with your doctor if you develop any effects that may interfere with your ability to drive, operate machinery or take part in any other activity where they may put you or others at risk. Important information about some of the ingredients of Dovonex Dovonex contains propylene glycol. Propylene glycol may cause skin irritation. Do not use this medicine in babies less than 4 weeks old with open wounds or large areas of broken or damaged skin (such as burns) without talking to your doctor or pharmacist. Please ask your doctor if you are worried about any of the ingredients in this medicine.
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Dovonex®
Always use Dovonex exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How to put on Dovonex
This medicine is only for using on your skin or the skin of a child. Do not swallow it. Do not put it inside your body. Never put this medicine on your face or the face of your child as it may cause irritation. Do not mix Dovonex with any other medicines. Remove the cap. Check the seal is not broken before you first use the ointment. If you have a 240 gram tube, remove the foil seal on the tube.* If you have a 15 gram, 30 gram, 60 gram, 100 gram or 120 gram tube, you will need to break the seal by using the point in the back of the cap.* Always wash your hands before using Dovonex. Put your medicine on the skin which has the psoriasis. You can squeeze your medicine on to your skin directly. You can squeeze it on to your finger first if you wish. Put your medicine on thickly. Then rub it in gently to cover the psoriasis. Always wash your hands after using Dovonex. This will stop any medicine accidentally spreading to other parts of your body. Do not worry if you accidentally get any ointment on your normal skin, but wash it off if it spreads too far. Unless you are using the ointment to treat your hands, always wash your hands after using Dovonex. You should try to keep your skin well moisturised particularly after a bath or shower. If you use a moisturiser wait for it to soak in before you use your medicine. How much Dovonex to use Your doctor will tell you how much Dovonex to use, or give to your child. For the best results you should use Dovonex twice each day. If you are an adult, your doctor may suggest you use the medicine once a day. If you use it twice a day, use it in the morning and in the evening. To remind you to use your medicine it may help to use it when you do another regular action, such as brushing your teeth. Adults: Your dose will depend on how bad your psoriasis is. Your doctor will prescribe the dose that is right for you. Use the medicine once or twice each day. Follow the advice of your doctor. Do not use more than 100 grams each week. Children and adolescents: The dose will depend on how bad the psoriasis is. Your doctor will prescribe the dose that is right for your child. •
Children over 12 years old: Use the medicine twice each day. Page 4 of 7
Do not use more than 75 grams each week. •
Children between 6 and 12 years old: Use the medicine twice each day. Do not use more than 50 grams each week.
•
Children under 6 years old: Do not use on children under 6 years of age.
If you use more Dovonex than you should Tell your doctor straight away. You may get too much calcium in your blood. Please read sections 2 and 4 of this leaflet so you can spot any signs that this may be happening to you. Your doctor may tell you to stop using your medicine until the amount of calcium in your blood goes back to normal. If you forget to use Dovonex If you forget to use your medicine, use it as soon as you remember. Then next use your medicine at the usual time. If you have any further questions about using this medicine, please ask your doctor or pharmacist.
Like all medicines, Dovonex can cause side effects, although not everybody gets them. Important side effects to look out for: You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction:
• •
Itching skin Pain in the area where the medicine is used.
Uncommon side effects (may affect up to 1 in 100 people)
Dovonex® • • • •
Keep this medicine out of the sight and reach of children. Do not use Dovonex ointment after the expiry date which is stated on the tube and carton (EXP). The expiry date refers to the last day of that month. The tube should be discarded 6 months after first opening. Write the date you first opened the tube in the space provided on the carton. Do not store above 25oC.
Do not throw away any medicines via waste water or in household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Dovonex contains
Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: LEO Laboratories Limited, Maidenhead, Berkshire SL6 3UD, UK Manufacturer: LEO Laboratories Limited, Dublin 12, Ireland. This leaflet was last revised in April 2023.
For information in large print, Braille or audio/CD, telephone +44 (0)1844 347333 Registered Trade Mark
®
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Dovonex Ointment comes as ointment. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Dovonex Ointment is calcipotriol.
This leaflet reproduces the patient information leaflet approved for Dovonex 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.
Dovonex®* Ointment is indicated for the topical treatment of plaque psoriasis (psoriasis vulgaris) amenable to topical therapy.
Adults:
Dovonex®* Ointment should be applied to the affected area once or twice daily. For maximum benefit use the ointment twice daily. Maximum weekly dose should not exceed 100 g.
Children over 12 years:
Dovonex®* Ointment should be applied to the affected area twice daily. Maximum weekly dose should not exceed 75 g.
Children aged 6 to 12 years:
Dovonex®* Ointment should be applied to the affected area twice daily. Maximum weekly dose should not exceed 50 g.
Children under 6 years:
There is limited experience of the use of Dovonex®* Ointment in this age group. A maximum safe dose has not been established.
These dose recommendations are based on extensive experience in adults. In respect of children, clinical experience in children has shown Dovonex®* to be safe and effective over eight weeks at a mean dose of 15 g per week but with wide variability in dose among patients. Individual dose requirement depends on the extent of psoriasis but should not exceed the above recommendations. There is no experience of use of Dovonex®* in combination with other therapies in children.
Hypersensitivity to the active substance or any of the excipients listed in section 6.1
Due to the content of calcipotriol, Dovonex® is contraindicated in patients with known disorders of calcium metabolism (see section 4.4).
Effects on calcium metabolism
Due to the content of calcipotriol, hypercalcaemia may occur if the maximum weekly dose is exceeded. Care should be exercised in patients with other types of psoriasis, since hypercalcaemia has been reported in patients with generalised pustular or erythrodermic exfoliative psoriasis. Serum calcium is normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the dosage recommendations are followed. The maximum weekly dose in adults is 100 g of cream or ointment (equivalent to 5 mg of calcipotriol) or 60 ml of scalp solution (equivalent to 3 mg of calcipotriol). When cream, ointment or cutaneous solution are applied together, the total dose of calcipotriol should not exceed 5 mg per week.
Local adverse reactions
Dovonex® should not be applied to the face, as it may cause skin irritation
The patient must be instructed in correct use of the product to avoid accidental transfer to the face and eyes. Hands must be washed after each application to avoid accidental transfer to these areas.
UV exposure
During Dovonex®* Ointment treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. Dovonex®* should be used with UV radiation only if the physician and patient consider that the potential benefits outweigh the potential risks (see section 5.3).
Unevaluated use
Due to lack of data, Dovonex®* should be avoided in guttate, erythrodermic, exfoliative and pustular psoriasis.
Due to lack of data, Dovonex®* should be avoided in patients with severe liver and kidney disease.
Adverse reactions to excipients
Dovonex®* ointment contains propylene glycol as an excipient which may cause skin irritation.
Fire hazard
Instruct patients not to 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.
No interaction studies have been performed with Dovonex®*.
Pregnancy
The safety of the use of topical calcipotriol during human pregnancy has not been established, however studies in animals have shown reproductive toxicity when calcipotriol was administered orally. Calcipotriol should not be used during pregnancy unless clearly necessary.
Breast-feeding
It is unknown whether calcipotriol is excreted in breast milk. Caution should be exercised when prescribing Dovonex®* to women who breast-feed. The patient should be instructed not to use Dovonex®* on the breast when breast-feeding.
Fertility
Studies in rats with oral doses of calcipotriol demonstrated no impairment of male and female fertility.
Calcipotriol has no or negligible influence on the ability to drive and to use machines.
The estimation of the frequency of adverse reactions is based on a pooled analysis of data from clinical studies and spontaneous reporting.
The most frequently reported adverse reactions during treatment are pruritus, skin irritation and erythema.
Systemic reactions (hypercalcaemia and hypercalciuria) have been reported. The risk of developing such reactions increases if the recommended total dose is exceeded (see section 4.4).
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
Approximately 25% of the patients treated with Dovonex®* Ointment could experience an adverse reaction. These reactions are usually mild.
Infections and infestations
Uncommon (≥1/1,000 to <1/100)
Folliculitis
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
Skin and subcutaneous tissue disorders
Common (≥1/100 to < 1/10)
Psoriasis aggravated
Dermatitis
Erythema
Skin exfoliation
Skin burning sensation
Skin irritation
Pruritus
Uncommon (≥1/1,000 to <1/100)
Rash*
Dry skin
Rare (≥1/10,000 to <1/1,000)
Photosensitivity reaction
Skin oedema
Urticaria
Seborrhoeic dermatitis
Renal and urinary disorders
Rare (≥1/10,000 to <1/1,000)
Hypercalciuria
General disorders and administration site conditions
Common (≥1/100 to <1/10)
Application site pain
Uncommon (≥1/1,000 to <1/100)
Application site pigmentation changes
* Various types of rash reactions such as rash erythematous, rash maculo-papular, rash morbilliform, rash papular and rash pustular have been reported.
Reporting of suspected adverse reactionsReporting 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 hypercalcemia include polyuria, constipation, muscle weakness, confusion and coma.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Calcipotriol. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
Some of these do not contain exactly the same active substances — check each one. 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
⚠ Not the same combination. This medicine contains Calcipotriol. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
Some of these do not contain exactly the same active substances — check each one. 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 Dovonex 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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