Dovobet ointment
calcipotriol/betamethasone
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.- If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.- If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
There is information on the following
- 1. What is Dovobet and what is it used for?
- 2. Before you use Dovobet
- 3. How to use Dovobet
- 4. Possible side effects
- 5. How to store Dovobet
- 6. Further information
What Is Dovobet And What Is It Used For?
Dovobet ointment contains calcipotriol (a substance like Vitamin D) and betamethasone (a steroid). Calcipotriol helps to bring the rate of skin cell growth back to normal. Betamethasone is a corticosteroid, which acts to reduce inflammation (and should not be confused with anabolic steroids, which are mis-used by some body-builders and athletes).
Dovobet ointment is used on the skin to treat a certain type of psoriasis called plaque psoriasis (psoriasis vulgaris). Psoriasis is caused by your skin cells being produced too quickly. This causes redness, scaling and thickness of your skin.
Dovobet treats the symptoms of your psoriasis and helps bring the rate at which your skin cells are produced back to normal.
Before You Use Dovobet
Do not use Dovobet if you:
- are allergic or hypersensitive to calcipotriol, betamethasone or any of the other ingredients in the ointment
- have known disorders of calcium levels in the body (ask your doctor)
- have other types of psoriasis: these are guttate, erythrodermic, exfoliative and pustular (ask your doctor)
- have serious liver or kidney disease
As Dovobet contains a strong steroid do NOT use on skin affected by:
- infections caused by viruses (e.g. cold sores or chicken pox)
- infections caused by bacteria
- infections caused by parasites (e.g. scabies)
tuberculosis (TB) or syphilis- infections caused by a fungus (e.g. athlete’s foot or ringworm)
acne
rosacea (severe flushing or redness of the skin on the face)
perioral dermatitis (red rash around the mouth)
thin skin, easily damaged veins, stretch marks
ichthyosis (dry skin with fish-like scales)
ulcers or broken skin- itching of the anus (back passage) or genitals (sex organs)
Take special care with Dovobet:
- and avoid concurrent treatment with other medicines that contain corticosteroids, as you may get side-effects
- if you have diabetes mellitus (sugar-diabetes), as your blood sugar/glucose level may be affected by the steroid
- if your skin becomes infected, as you may need to stop your treatment
If any of the above applies to you, tell your doctor/nurse/pharmacist before you use this product.
Before you use Dovobet there are things to be aware of:
- wash hands after use to prevent contact with face, mouth, eyes and scalp
- do not treat more than 30% of your body or use more than 100 grams per week
- do not use under bandages or dressings as it increases the absorption of the steroid
- do not use on large areas of damaged skin or skin folds (groin, armpits, under breasts) as it increases the absorption of the steroid
- do not use on the face or genitals (sex organs) as they are very sensitive to steroids
- do not sunbathe too much, or use a solarium and other forms of light treatment too much.
- as there is a risk your psoriasis will get worse or ‘flare up’ when steroids are stopped suddenly, please contact your doctor if you have used this medicine for a long time and plan to stop.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Do not use Dovobet
if you are pregnant (or might be pregnant) or 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 Dovobet to the breast area.
Children and adolescents
Dovobet is not recommended for use in children and adolescents below the age of 18 years.
Driving and using machines
This medicine should not have any effect on your ability to drive or use machinery.
How To Use Dovobet
Always use Dovobet exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Instruction for usage
- Dovobet is only available on prescription from your doctor.
- Use only on your psoriasis and do not use on skin which is not affected by 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 area affected by psoriasis until most of the ointment has disappeared into the skin.
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.
Do not use
more than 15 grams in one day or
100 grams in one week or
on more than 30% of your body
- Do not worry if some ointment accidentally gets on normal skin near your psoriasis, but wipe it off if it spreads too far.
- Wash your hands immediately after use (unless you are using the ointment to treat your hands). This will avoid accidentally spreading ointment to other parts of your body (especially the face, scalp, mouth and eyes).
- After applying the ointment do not wear clothes which are easily stained by grease (e.g. silk)
If you have used too much Dovobet
Contact your doctor if you have used more than 15 g in one day or 100 g in one week or if you have used the ointment on more than 30% of your body surface.
Excessive prolonged use of Dovobet 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 Dovobet
Do not worry. Use it as soon as you remember then go on as before.
If you stop using Dovobet
Follow your doctor’s instructions on how to stop using Dovobet.
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 about the use of this product, ask your doctor or pharmacist.
Dovobet Ointment Side Effects
Like all medicines, Dovobet can cause side effects, but not everybody gets them.
Approximately 1 in 10 people may experience side effects but most of these are reactions at the site where the ointment has been applied and are usually mild and temporary.
Serious side effects:
Uncommon (affects less than 1 in 100 people)
- Worsening of your psoriasis. If your psoriasis gets worse, tell your doctor as soon as possible.
Rare (affects less than 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 taking Dovobet 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 Dovobet. You should tell your doctor as soon as possible if any of the serious side effects occur: - 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)
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 bandages or dressings or use on large areas of skin.
Very rare (affects less than 1 in 10,000 people)
- 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 taking Dovobet, 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 bone pain, constipation, poor appetite, nausea and vomiting. This can be serious and you should contact your doctor as soon as possible. However, when the treatment is stopped, the levels return to normal.
Less serious side effects caused by using betamethasone, include the following. You should tell your doctor as soon as possible if you notice 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)
- Shiny brown gel-filled bumps (colloid milia)
- Lightening of skin colour (depigmentation)
The following less serious side effects have also been reported for Dovobet.
If any of them last a long time or cause you problems, you should tell your doctor or nurse.
Common side effects (affects less than 1 in 10 people)
- Itching
- Rash
- Burning sensation
Uncommon (affects less than 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
Other reactions, which have been reported, include
- Dry skin
- Sensitivity of the skin to light resulting in a rash has also been reported
- Eczema
Do not stop Dovobet unless your doctor tells you to, as it may be necessary for you to stop this medicine gradually.
If you notice the above or any other changes in your health while taking this medicine, tell your doctor.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Dovobet
Keep out of the reach and sight of children.
- Do not store the product above 25°C.
- Do not use after the expiry date stated on the label (EXP). This expiry date refers to the last day of that month.
- The tube should be discarded 12 months after first opening. Write the date you first opened the tube in the space provided on the carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What is in Dovobet ointment?
The active substances are:
- calcipotriol 50 microgram/g (as hydrate) and
- betamethasone 0.5 mg/g (as dipropionate).
The other ingredients are:
- liquid paraffin
- α-tocopherol
- polyoxypropylene-15-stearyl ether
- white soft paraffin
What Dovobet looks like and contents of the pack
The ointment comes in tubes of 15 grams, 30 grams, 60 grams, 100 grams and 120 grams.
Not all pack sizes may be marketed.
Dovobet ointment is an off-white to yellow coloured ointment.
The Marketing Authorisation holder is:
The manufacturer is:
This medicinal product is authorised in the member states of the EEA under the following names:
Daivobet: Denmark, France, Germany, Iceland, Norway, Portugal, Sweden, Finland, Switzerland, Lithuania, Estonia, Latvia, Slovenia, Malta, Poland, Czech Republic, Hungary
Daivobet Pomada: Spain
Dovobet: Ireland, Luxembourg, Greece, Netherlands, Belgium, Italy, Cyprus, United Kingdom
Psorcutan Beta: Austria, Italy and Germany
Token: Italy
Delcibet: Denmark
For further information about this product, contact the local representative of the Marketing Authorisation Holder:
Date leaflet last approved: June 2007.
More about psoriasis
Psoriasis is when your skin cells multiply too quickly. This causes the raised red patches and scaling you are familiar with. You can get psoriasis anywhere on your body; stress can make your psoriasis worse. Psoriasis is not infectious so you do not need to worry about other people catching it from you. The cause of psoriasis is not known, but you are more likely to have psoriaisis if there is a family history of this condition.
For further information about your psoriasis, you can contact:
Registered charity number: 257414.
Registered Trade Mark
LEO
019353-08
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