Dovobet 50 micrograms/0,5 mg Ointment

DOVOBET 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.

DOVOBET ointment contains calcipotriol and betamethasone. Calcipotriol helps to bring the rate of skin cell growth back to normal and betamethasone acts to reduce inflammation.

Do not use DOVOBET:

• If you are hypersensitive (allergic) to calcipotriol, betamethasone or any of the other ingredients in DOVOBET (listed in section 6)
• If you have problems with calcium levels in the body (ask your doctor)
• If you have certain types of psoriasis: these are erythrodermic, exfoliative and pustular (ask your doctor)
• If your kidneys or liver do not work properly
• If you are pregnant.

As DOVOBET 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)
• 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.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before and during use of DOVOBET 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.

Take special care with DOVOBET:

• Avoid use on more than 30 % of your body or using more than 15 grams per day
• Avoid using under 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 too much exposure to either natural or artificial light.

Children and adolescents

DOVOBET is not recommended for the use in children below the age of 18 years.

Other medicines and DOVOBET

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking this medicine. Do not use DOVOBET if you are pregnant. If your doctor has agreed that you can breastfeed, take care and do not apply DOVOBET to the breast area.

Do not share medicines prescribed for you with any other person. DOVOBET is for external use only. Always use DOVOBET exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Instruction for proper use:

• Use only on your psoriasis and do not use on skin which does not have 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 affected area of psoriasis until most of the ointment has disappeared into the skin
• Do not bandage, tightly cover or wrap the treated skin area
• Wash your hands well after using DOVOBET (unless you are using the ointment to treat your hands). This will avoid accidentally spreading the ointment to other parts of your body (especially the face, scalp, mouth and eyes)
• Do not worry if some ointment 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 DOVOBET ointment
• After applying the ointment, avoid contact with textiles which are easily stained by grease (e.g. silk).

Adults

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
• Your doctor may decide on repeated treatment
• Do not use more than 15 grams in one day.

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.

If you have the impression that the effect of DOVOBET is too strong or too weak, tell your doctor or pharmacist.

If you use more DOVOBET than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Contact your doctor if you have used more than 15 grams in one day. Excessive 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). Treatment is symptomatic (relating to symptoms) and supportive.

If you forget to use DOVOBET

Do not apply a double quantity to make up for forgotten individual applications.

If you stop using DOVOBET

The use of DOVOBET 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.

DOVOBET can have side effects. Not all side effects reported for DOVOBET are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using DOVOBET, please consult your healthcare provider for advice.

Serious side effects

Tell your doctor or 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 DOVOBET:

• Worsening of your psoriasis. If your psoriasis gets worse, tell your doctor as soon as possible.
• Pustular psoriasis may occur (a red area with yellowish pustules usually on the hands or feet). If you notice this, stop using 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. 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 DOVOBET 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 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 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

The following side effects may occur with the use of DOVOBET:

Frequent side effects:

• Itching
• Skin exfoliation
• Rash
• Burning sensation of the skin

Less frequent side effects:

• 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
• Infection of the skin
• Thinning of the skin
• Appearance of red or purple discolouration on the skin (purpura or ecchymosis)
• Bacterial or fungal infection of hair follicle (furuncle)
• Allergic reactions
• Hypokalaemic syndrome
• Hypercalcaemia
• Stretch marks
• Sensitivity of the skin to light resulting in a rash
• Acne (pimples)
• Excessive facial or chest hair growth in women (Hirsutism)
• Numbness in fingers
• High blood pressure
• Loss of proteins
• Gastric ulcer
• Dry skin
• Rebound effect: A worsening of symptoms/psoriasis after ended treatment

Frequency not known

(frequency cannot be estimated from the available data)

• 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 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).
• Swelling of the lower limbs (Oedema)

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 you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of DOVOBET. Additionally, suspected adverse reactions can be reported to the Holder of Certificate of Registration via [email protected].

Store all medicines out of reach of children. Store DOVOBET in the original container, in a cool place (at or below 25 ºC). Keep the container tightly closed. Do not use after the expiry date stated on the tube. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Shelf life after opening is 12 months.