Dovobet gel

Do not use Dovobet:

• if you are allergic (hypersensitive) to calcipotriol, betamethasone or any of the other ingredients of this medicine 
• if you have problems with calcium levels in your body 
• if you have certain types of psoriasis: these are erythrodermic, exfoliative and pustular.

As Dovobet contains a strong steroid, do NOT use it 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.

Instructions for proper use

• Use only on your psoriasis and do not use on skin which does not have psoriasis
• Shake the bottle before use and remove the cap
• Squeeze the gel onto a clean finger or directly onto the area affected by psoriasis
• Apply Dovobet to the affected area with your fingertips, and rub it in gently until the area affected by psoriasis is covered by a thin layer of gel
• Do not bandage, tightly cover or wrap the treated skin area
• Wash your hands well after using Dovobet. This will avoid accidentally spreading the gel to other parts of your body (especially the face, mouth and eyes)
• Do not worry if some gel 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 gel
• After applying the gel, avoid contact with textiles which are easily stained by grease (e.g. silk).

The active substances are:

Calcipotriol and betamethasone. One gram of gel contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).

The other ingredients are:

• paraffin, liquid
• polyoxypropylene stearyl ether
• castor oil, hydrogenated
• butylhydroxytoluene (E321)
• all-rac-α-tocopherol.

The following serious side effects have been
reported for Dovobet:
Uncommon (may affect up to 1 in 100 people):

• Worsening of your psoriasis. If your psoriasis gets worse, 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.

Common side effects (may affect up to 1 in 10
people):

• Itching.

Uncommon (may affect up to 1 in 100 people):

• Eye irritation
• Burning sensation of the skin
• Skin pain or irritation
• Inflammation or swelling of the hair root (folliculitis)
• Rash with inflammation of the skin (dermatitis)
• Redness of the skin due to widening of the small blood vessels (erythema)
• Acne (pimples)
• Dry skin
• Rash
• Pustular rash
• Infection of the skin.

Rare (may affect up to 1 in 1,000 people):

• Allergic reactions
• Stretch marks
• Skin exfoliation
• Rebound effect: A worsening of symptoms/psoriasis after ended treatment.