50 micrograms / g + 0.5 mg / g gel 
calcipotriol and betamethasone

1. What Daivobet is and what it is used for

Daivobet is used for topical treatment of psoriasis of the scalp in adults and other skin areas for the treatment of mild to moderate psoriasis of the plaque type ( psoriasis Vulgaris) in adults. Psoriasis is caused by your skin cells regenerating far too quickly. This causes redness, flaking, and an increase in the thickness of the skin.

Daivobet contains calcipotriol and betamethasone. Calcipotriol helps to normalize the growth rate of skin cells and betamethasone relieves inflammation.

Calcipotriol and betamethasone contained in Daivobet may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist,t or another healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you use Daivobet

Do not use Daivobet

  • if you are allergic (hypersensitive) to calcipotriol, betamethasone, or any of the other ingredients of this medicine (listed in section 6).
  • if you have any disturbance in your body’s calcium metabolism (ask your doctor)
  • if you have certain types of psoriasis: These are erythrodermic, exfoliative, and pustular psoriasis (ask your doctor).

Because Daivobet contains a strong steroid, DO NOT use gel on your skin

  • skin infections caused by viruses (eg herpes or chickenpox)
  • skin infections caused by fungi (eg athlete’s foot or ringworm )
  • skin infections caused by bacteria
  • skin infections caused by parasites (eg scabies)
  • tuberculosis (TB)
  • perioral dermatitis (red rash around the mouth)
  • thin skin, vascular fragility, skin streaks
  • ichthyosis (dry, fish-skin-like skin)
  • acne (pimples)
  • rosacea (violent flushing or reddening of the face)
  • sore or damaged skin

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using/using Daivobet if

  • Using other medicines that contain corticosteroids you, because you can get side-effect s
  • you have been using this medicine for a long time and are planning to stop (because there is a risk that your psoriasis will get worse or “flare-up” if you suddenly stop using steroids )
  • you have diabetes mellitus (diabetes) as your blood sugar level may be affected by steroid- a
  • your skin becomes infected, as you may need to discontinue your treatment
  • you have a special type of psoriasis, so-called gutted psoriasis
  • you experience blurred vision or other visual disturbances.

Special care

  • Avoid using more than 30% of your body or using more than 15 grams per day
  • Avoid use under a bathing cap, bandage, or covering dressing, as it increases the uptake of steroid one
  • Avoid use on large areas of damaged skin, mucous membranes, or in skin folds (groin, armpits, under the breasts), as it increases the uptake of steroid a
  • Avoid use on the face or genitals, as these areas are very sensitive to steroids you
  • Avoid excessive sunbathing, excessive use of solarium or other forms of light therapy.

Children

Daivobet is not recommended for the treatment of children under 18 years of age.

Other medicines and Daivobet

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

If your doctor thinks you can breast-feed, be careful not to apply Daivobet to your breasts.

Driving and using machines

This medicine should not affect your ability to drive or use machines.

Daivobet contains butylhydroxytoluene (E321)

Daivobet contains butylhydroxytoluene (E 321) which may cause local skin reactions (eg contact dermatitis) or be irritating to eyes and mucous membranes.

3. How to use Daivobet

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

How to use Daivobet: For external use.

Instructions for use

  • Use only on areas affected by psoriasis and not on healthy skin
  • Shake the bottle before use and remove the cap
  • Squeeze the gel on a clean finger or directly on the area affected by psoriasis. Apply Daivobet to the psoriasis spots and massage gently with your fingertips until the area affected by psoriasis is covered with a thin layer of gel
  • Do not use bandages, opaque covers, or wraps on the treated skin area
  • Wash hands thoroughly after using Daivobet gel to avoid accidental contact with other parts of the body (especially face, mouth and eyes)
  • Do not worry if the gel accidentally comes in contact with healthy skin near the psoriasis spots, but wipe off the excess if it spreads too far
  • To achieve optimal effect, it is recommended not to shower or bathe immediately after applying Daivobet gel
  • Avoid contact of the gel after application with textiles that are easily stained by grease (eg silk).

If you have psoriasis of the scalp

  • Before applying Daivobet to the scalp, comb the hair through to remove loose scales. Tilt your head back to prevent the Daivobet from running down your face. It can make it easier to straighten your hair before using Daivobet. Apply Daivobet to the psoriasis spots and massage gently with your fingertips
  • It is not necessary to wash your hair before applying Daivobet
Instructions for application to the scalp

For best effect, hair should not be washed immediately after applying Daivobet. Leave the Daivobet on the scalp overnight or during the day. For hair washing after application, the following tips may be helpful.

Instructions for hair washing

If necessary, repeat steps 4 – 6 once or twice.

Treatment time

  • Use gel once a day, it can be most convenient in the evening
  • Recommended initial treatment time is 4 weeks for the scalp and 8 weeks for other areas
  • Your doctor may prescribe another treatment time
  • Your doctor may prescribe repeated treatment
  • Use a maximum of 15 grams per day.

If you are taking any other medicines containing calcipotriol, the total amount of medicines containing calcipotriol should not exceed 15 grams per day and the treated area should not exceed 30% of the total body surface area.

What can I expect when using Daivobet?

Most patients see a clear effect after 2 weeks of treatment, even if their psoriasis has not completely disappeared.

If you use more Daivobet then you should 

Contact your doctor if you have used more than 15 grams in one day.

Excessive use of Daivobet can cause problems with blood calcium levels, which usually return to normal when treatment is stopped.

Your doctor may need to take blood samples to rule out problems with high blood calcium levels caused by using too much gel.

Excessive, prolonged use can also cause the adrenal glands do not to function normally (the adrenal glands are close to the kidneys and produce hormones ).

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center immediately for risk assessment and advice.

If you forget to use Daivobet

Do not take a double dose to make up for a forgotten dose.

If you stop using Daivobet

Treatment with Daivobet should be stopped according to the doctor’s instructions. It may be necessary to gradually reduce the treatment, especially if you have been using the gel for a long time.

If you have any further questions on the use of this product, 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 are

Contact your doctor/nurse immediately or as soon as possible if any of the following occur. You may need to stop treatment.

The following serious adverse reactions have been reported with Daivobet

Uncommon (may affect up to 1 in 100 people)

  • Exacerbation of your psoriasis. If your psoriasis gets worse, contact your doctor as soon as possible.

Some serious side effects may occur with treatment with betamethasone (a strong steroid ), which is one of the ingredients in Daivobet. Tell your doctor as soon as possible if you get any serious side effects. These side effects are more common with long-term use, use in skin folds (eg groin, armpits, or under the breasts), when used under covering bandages or when used on large areas of the skin.

Such serious side effects can be:

  • Your adrenal glands may stop functioning normally. Symptoms are fatigue, depression, and anxiety
  • Cataract (symptoms are blurred or blurred vision, impaired night vision, and photosensitivity) or increased pressure inside the eye (symptoms are eye pain, red eyes, impaired or blurred vision)
  • Infection (because your immune system that fights infection can be inhibited or weakened)
  • Pustular psoriasis (red patches of skin with yellowish, full-blown blisters, usually on the hands or feet). If this happens, stop the treatment and contact your doctor as soon as possible
  • Effects on the metabolic control of diabetes mellitus (if you have diabetes you may experience fluctuations in your blood sugar).

Serious side effects can be caused by calcipotriol

  • Allergic reactions with deep swelling of the face or other parts of the body such as hands or feet. Swelling of the mouth or throat and difficulty breathing may occur. If you experience an allergic reaction, stop treatment and contact your doctor immediately or visit the emergency department at the nearest hospital
  • Treatment with this gel can cause elevated levels of calcium in the blood or urine (usually when too much gel has been used). Symptoms of high blood calcium levels include increased urinary excretion, constipation, muscle weakness, confusion, and coma. This can be serious and you should contact your doctor immediately. However, the values ​​are normalized when the treatment is stopped.

Minor side effects are

The following minor side effects have been reported with Daivobet

Common (may affect up to 1 in 10 people)

  • Itching

Uncommon (may affect up to 1 in 100 people)

  • Eye irritation
  • Hudsveda
  • Skin pain and skin irritation
  • Inflammation or swelling of the hair follicle ( folliculitis )
  • Rash with dermatitis ( dermatitis )
  • Skin redness due to dilation of peripheral blood vessels ( erythema )
  • Acne (pimples)
  • Dry skin
  • Rash
  • Rash with blisters
  • Skin infection

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

  • Allergic reaction
  • Stretch marks
  • Skin flaking
  • Rebound effect: Exacerbation of symptoms/psoriasis after stopping treatment

Has been reported (occurs in an unknown number of users)

  • White or gray hair may temporarily turn a yellowish color at the application site when treating the scalp
  • Tamsyn.

Less serious side effects when using betamethasone, especially for a long time can be any of the following. You should contact your doctor or nurse as soon as possible if you experience any of them

  • Skin thinning
  • Prominent vessels under the skin or streaks in the skin
  • Altered hair growth
  • Red rash around the mouth (perioral dermatitis )
  • Inflamed or swollen skin rash (allergic contact dermatitis )
  • Gold-colored jelly-filled bumps (colloidal milia)
  • Lighter skin color (loss of skin pigment)
  • Inflammation or swelling of the hair follicle ( folliculitis )

Other less serious side effects that can be caused by calcipotriol are

  • Dry skin
  • Sensitivity to light that can cause a rash
  • Eczema
  • Itching
  • Skin irritation
  • Burning and stinging sensation
  • Redness of the skin due to dilation of small blood vessels ( erythema )
  • Rash
  • Rash with dermatitis ( dermatitis )
  • Exacerbation of psoriasis

5. How to store Daivobet

  • 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 bottle after EXP. The expiration date is the last day of the specified month.
  • Store in a cold place. Store the bottle in the outer carton. Sensitive to light.
  • The bottle with any remaining gel should be discarded 6 months after the package has been broken.

The medicine 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.

6. Contents of the packaging and other information

Content declaration

The active substances are Calcipotriol and betamethasone.

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

Other ingredients are:

– Liquid paraffin

polypropylene stearyl ether

– hydrogenated castor oil

– butylhydroxytoluene (E 321)

– all- rac -α-tocopherol

What the medicine looks like and the contents of the pack

Daivobet is an almost clear, colorless to pale off-white gel in bottles of HD polyethylene with a spout of LD polyethylene and a screw cap made of HD polyethylene.

The bottles are packed in cartons.

Pack sizes: 15 g, 30 g, 60 g, 80 g, 2 × 60 g, 2×80 g, and 3×60 g.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Marketing Authorisation Holder:

LEO Pharma A / S

Industrial Park 55

DK-2750 Ballerup

Denmark

Manufacturer:

LEO Pharma A / S

Industrial Park 55

DK-2750 Ballerup

Denmark

LEO Laboratories Ltd. (LEO Pharma)

285 Cashel Road

Dublin 12

Ireland

For further information on this medicine, please contact the local representative of the Marketing Authorization Holder:

LEO Pharma AB

Box 404

201 24 Malmö

This medicinal product is authorized under the European Economic Area under the names:

Daivobet: Bulgaria, Denmark, Estonia, Finland, France, Iceland, Croatia, Latvia, Lithuania, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Czech Republic, Germany, Hungary, Austria

Dovobet: Belgium, Cyprus, Greece, Ireland, Italy, Luxembourg, Netherlands, UK

Information about this medicine is available on the Medical Products Agency’s website

Muhammad Nadeem

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