Active ingredient
- betamethasone dipropionate
- calcipotriol monohydrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 49452/0013.
Dalonev
PACKAGE LEAFLET: INFORMATION FOR THE USER
Dalonev 50 micrograms/g + 0.5 mg/g ointment
calcipotriol/betamethasone
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Dalonev is and what it is used for?
2. What you need to know before you use Dalonev
3. How to use Dalonev
4. Possible side effects
5. How to store Dalonev
6. Contents of the pack and other information
1. WHAT DALONEV IS AND WHAT IT IS USED FOR
Dalonev 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.
Dalonev ointment contains calcipotriol and betamethasone. Calcipotriol helps to bring the rate of skin cell growth back to normal and betamethasone acts to reduce inflammation.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DALONEV
Do not use Dalonev
As Dalonev contains a strong steroid do NOT use on skin affected by
Warnings and precautions
Talk to your doctor/<nurse>/pharmacist before using Dalonev if
Special precautions
Children and adolescents
Dalonev is not recommended for the use in children and adolescents below the age of 18 years.
Pregnancy and breast-feeding
Do not use Dalonev 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 Dalonev 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.
Dalonev contains butylhydroxytoluene (E321)
Butylhydroxytoluene (E321) may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
3. HOW TO USE DALONEV
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 Dalonev: Cutaneous use.
Instruction for proper use
Duration of treatment
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 Dalonev?
Most patients see obvious results after 2 weeks, even if the psoriasis is not yet cleared at that point.
If you have used more Dalonev than you should
Contact your doctor if you have used more than 15 grams in one day. Excessive use of Dalonev 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 Dalonev
Do not take a double dose to make up for forgotten individual doses.
If you stop using Dalonev
The use of Dalonev 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 Dalonev:
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Some serious side effects are known to be caused by betamethasone (a strong steroid), one of the ingredients in Dalonev. 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:
Serious side effects known to be caused by calcipotriol
Less serious side effects
The following less serious side effects have been reported for Dalonev.
Common side effects (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
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.
Less serious side effects known to be caused by calcipotriol include the following
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. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE DALONEV
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.
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Dalonev 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 Dalonev looks like and contents of the pack
Dalonev 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
Manufacturer
This medicine is authorised in the Member States of the EEA under the following names:
Austria: Calcipotriol/Betamethason Dermapharm 50 Mikrogramm/g + 0,5 mg/g Salbe
Germany: Calcipotriol comp. acis 50 Mikrogramm/g + 0,5 mg/g Salbe
United Kingdom: Dalonev 50 micrograms/g + 0.5 mg/g ointment
This leaflet was last revised in February 2020.
AT/H/0828/001/DC
Rathbone Square, Tanfield Road, Croydon, CR0 1BT, UK
+44 (0)203 870 7504
+44 (0)203 870 7504
+44 (0)203 870 7504
+44 (0)203 870 7504