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.

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Dovonex 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 Calcipotriol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Calcipotriol
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for

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.

Page 1 of 7

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).

What you need to know before you take it

e Dovonex® Do not use Dovonex

  • If you are allergic (hypersensitive) to calcipotriol or any of the other ingredients of this medicine (listed in section 6) •

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

  • If you are already having ultraviolet (UV) light treatment
  • If you have guttate, erythrodermic, exfoliative or pustular psoriasis. Ask your doctor if you are unsure. Excess calcium in the blood (hypercalcaemia) This medicine can cause an increase in calcium levels in the body so it is important that you do not exceed the recommended dose (See section 4). Raised calcium levels can produce
  • Increased amounts of urine (passing water more frequently or in greater quantities than usual) and/or increased thirst
  • Dry or metallic taste in the mouth
  • Stomach upsets (including pain, nausea, vomiting and constipation)
  • Weak muscles and/or pain in the bones
  • Tiredness, fatigue and confusion If you get any of these tell your doctor straight away. You may get too much calcium in your blood when you use this medicine. Please read section 4 of this leaflet so that you can spot any signs this may be happening to you. Your doctor may need to change your dose. You are not likely to get too much calcium in your blood if you use the dose prescribed for you. You can find the dose that you should use in section 3 of this leaflet. You are more likely to get too much calcium in your blood if you use more than the recommended dose each week. Do not use Dovonex on your face as it may irritate the skin on your face or accidentally get in your eyes. Page 2 of 7

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.

Page 3 of 7

How to take it

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.

Possible side effects

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:

  • You have difficulty breathing
  • Your face including around your eyes swell
  • Your skin develops a severe rash, particularly if the skin is blistering or bleeding. You should tell your doctor straight away if you spot any of the following signs which may be due to too much calcium in your blood or urine:
  • You need to pass water (urine) more often
  • You feel thirsty or have lost your appetite
  • You have a dry mouth or a metallic taste in your mouth
  • You feel weak or have pain in your muscles or bones
  • You have a headache or pain in your stomach
  • You feel sick or have constipation. Other possible side effects: The possible side effects in the following section of this leaflet are usually mild. Common side effects (may affect up to 1 in 10 people)
  • Skin irritation
  • Worsening of your psoriasis
  • Dermatitis
  • Redness
  • Flaking skin
  • Burning or stinging feeling
  • Itchy rash and skin inflammation in the area where the medicine is used Page 5 of 7

• •

Itching skin Pain in the area where the medicine is used.

Uncommon side effects (may affect up to 1 in 100 people)

  • Folliculitis (infection in the hair follicle)
  • Rash
  • Red, itchy, scaly rash. Blisters may form. These may weep or become crusty (eczema)
  • Dry skin
  • Changes in skin colour where the medicine is used. Rare side effects (may affect up to 1 in 1000 people)
  • Hypersensitivity (allergic reaction)
  • Hypercalcaemia (too much calcium in the blood)
  • Temporary increased sensitivity to sunlight
  • Skin swelling or puffiness (oedema)
  • Itchy raised rash (hives)
  • Seborrhoeic dermatitis (such as dandruff or cradle cap)
  • Hypercalciuria (too much calcium in the urine). Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects 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.

How to store it

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.

Contents of the pack and other information

What Dovonex contains

  • The active substance is calcipotriol. Dovonex ointment contains 50 micrograms of calcipotriol in each gram of ointment.
  • The other ingredients are disodium edetate, disodium phosphate dihydrate, all-rac-α tocopherol, liquid paraffin, macrogol (2) stearyl ether, propylene glycol, purified water and white soft paraffin. You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet. What Dovonex looks like and contents of the pack Dovonex is an off-white to yellowish white translucent ointment. Dovonex comes in aluminium tubes of 5 grams, 15 grams, 30 grams, 60 grams, 100 grams, 120 grams and 240 grams. Page 6 of 7

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

®

Page 7 of 7

Frequently asked questions about Dovonex Ointment

How do I take Dovonex Ointment?

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.

What is the active substance in Dovonex Ointment?

The active substance in Dovonex Ointment is calcipotriol.

Where does this information come from?

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.

Can I get Dovonex 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.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Calcipotriol (3 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Dovonex®* Ointment is indicated for the topical treatment of plaque psoriasis (psoriasis vulgaris) amenable to topical therapy.

4.2. Posology and method of administration

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.

4.3. Contraindications

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).

4.4. Special warnings and precautions for use

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.

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed with Dovonex®*.

4.6. Fertility, pregnancy and lactation

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.

4.7. Effects on ability to drive and use machines

Calcipotriol has no or negligible influence on the ability to drive and to 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 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.

4.9. Overdose

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.

🇷🇴 Known in Romania as

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.

  • DAIVOBET 50 micrograme/0,5 mg/g prescription partial — not the same combinationCOMBINATII (CALCIPOTRIOLUM+BETAMETHASONUM) · skin / topical
  • DAIVOBET 50 micrograme/0,5mg/g prescription partial — not the same combinationCOMBINATII (CALCIPOTRIOLUM+BETAMETHASONUM) · skin / topical
  • ENSTILUM 50 micrograme/0,5 mg/g prescription partial — not the same combinationCOMBINATII (CALCIPOTRIOLUM+BETAMETHASONUM) · skin / topical

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 →

🇵🇱 Known in Poland as

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.

  • Daivobet partial — not the same combinationCalcipotriolum + Betamethasonum · skin / topical
  • Psotriol partial — not the same combinationCalcipotriolum + Betamethasonum · skin / topical

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 about this leaflet

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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