Daivobet gel 15g.

WHAT A DAIVOBET IS AND WHAT IT IS USED

Daivobet is used for topical treatment of scalp psoriasis in adults and for the treatment of mild to moderate plaque psoriasis (psoriasis vulgaris) on the skin of other parts of the body in adults. Psoriasis is caused by the over-reproduction of your skin cells. This results in redness, flaking and thickening of the skin.

Daivobet contains calcipotriol and betamethasone. Capcipotriol helps to normalize the growth rate of skin cells, and betamethasone acts to reduce inflammation.

2. WHAT YOU SHOULD KNOW BEFORE USING YOUR 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 problems with calcium levels in the body (ask your doctor)
- if you have certain types of psoriasis: these are erythrodermic, exfoliative and pustular psoriasis (ask your doctor)

Since Daivobet contains a strong steroid, DO NOT apply it on skin affected by:
- skin infections caused by viruses (eg herpes or chicken pox)
- skin infections caused by fungi (eg fungus on the feet or trichophytia) - skin infections caused by bacteria
- skin infections caused by parasites (eg scabies)
- Tuberculosis (TB)
- perioral dermatitis (red rash around the mouth)
- thinning of the skin, easily injured veins, stretch marks
- ichthyosis (dry skin with fish-like flakes)
- Acne (youth pimples)
- rosacea (severe redness or red skin)
- ulcers or damaged skin

Warnings and precautions
Talk to your doctor / nurse / pharmacist before and while using Dyvobet if:
- use other medicines that contain corticosteroids as you may get side effects
- you have been using this medicine for a long time and plan to stop it (as there is a risk that your psoriasis will worsen or "flare" again by suddenly stopping the steroids)
- have diabetes mellitus (diabetes) as your blood sugar / glucose level may be affected by the steroid
- Your skin begins to become infected as you may need to stop your treatment
- you have a certain type of psoriasis called guttate (drip).
- You have blurred vision or other visual disturbances

Special precautions
- Avoid use on more than 30% of your body or use more than 15 grams a day
- Avoid using under the bathing cap and under bandages as this increases the absorption of the steroid
- Avoid use on large areas of damaged skin, mucous membranes or skin folds (loins, armpits, skin under the breast) as the absorption of the steroid increases
- Avoid use on the face or genitals (genitals) as they are very sensitive to steroids
- Avoid overexposure to the sun, overuse of solarium and other forms of phototherapy.

Children
Davobet is not recommended for use in children below 18 years of age.

Other medicines and Divobet
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. If your doctor agrees that you may be breast-feeding, be careful not to administer Davobet in the areas around and across the breast.

Driving and using machines
This medicine has no effect on your ability to drive or use machines.

Davobet contains butyl hydroxytoluene (E321)
Davobet contains butyl hydroxytoluene (E321), which can lead to local skin reactions (eg contact dermatitis) or irritation to the eyes and mucous membranes.

3. HOW TO USE DAIVOBET

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

How to apply Daivobet: Apply to the skin.

Instructions for proper use
- Use only on psoriasis sites, not on psoriasis-free skin.
- Shake the bottle before use and remove the cap.
- Squeeze the gel on clean soil or directly on the area affected by psoriasis.
- Apply the Davobet on the affected area with the tip of your fingers and rub it gently until the area affected by psoriasis is covered with a thin layer of gel.
- Do not bandage, cover or bandage the tightly treated area of ​​the skin.
- Wash your hands after you have used Davobet. This will prevent the accidental spread of the gel over other parts of the body (especially the face, mouth and eyes).
- Do not worry if a little gel accidentally falls on clear skin near the psoriasis area, wipe it off with greater spread.
- For maximum effect, it is recommended that you do not take a shower
Shake the bottle before use.
Drop a drop of Daivobet on the tip of your finger.
Apply directly to sections of the scalp with thick plaques and rub the Daivobet gel into the skin.
Depending on the affected areas, an amount of 1-4 g (up to 1 teaspoon) is usually sufficient.

For optimum effect, it is recommended that you do not wash your hair immediately after applying Dyvobet. Let Davobet stay on the scalp overnight or all day long. When washing your hair after application, the following instructions can be used:
Apply a soft shampoo on dry hair, mainly on the areas where the gel has been applied.
Leave the shampoo on your head for a few minutes before washing.
Wash your hair as usual.
If necessary, repeat steps 4-6 once or twice.

Duration of treatment
- Use the gel once a day. It may be more convenient to use the gel in the evening.
- The recommended treatment period is 4 weeks for the scalp and 8 weeks for other parts.
- Your doctor will decide whether to set a different treatment period.
- Your doctor may prescribe re-treatment.
- Do not use more than 15 grams in one day.

If you are using other medicines with calcipotriol, the total dose of calcipotriol should not exceed 15 grams per day and the area treated should not exceed 30% of the total body surface area.

What should I expect when using Daivobet?
Most patients see clear results after 2 weeks, even if psoriasis has not cleared by this time.

If you used more Dovobet than you should
Contact your doctor if you have used more than 15 grams in one day.
Excessive use of Dyvobet can lead to a problem with blood calcium levels, which are usually normalized when treatment is stopped.
Your doctor should do a blood test to see if using too much gel has caused a problem with your blood calcium levels.
Excessive use can also cause the adrenal glands to stop functioning properly (they are located close to the kidneys and produce hormones).

If you forget to use Dyvobet
Do not use a double dose to make up for forgotten single doses.

If you stop using Dyvobet
The use of Daivobet should be stopped at the recommendation of your doctor. You may need 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 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:
Tell your doctor / nurse immediately or as soon as possible if any of the following occurs. You may need to stop treatment.

The following serious side effects have been reported for Dyvobet
Uncommon (may affect up to 1 in 100 people)
- Exacerbation of your psoriasis. If your psoriasis gets worse, tell your doctor as soon as possible.

Some of the serious side effects are known to be caused by betamethasone (a strong steroid), one of the ingredients of Dayvobet. You should tell your doctor as soon as possible if any of these serious side effects occur. These side effects are more likely to occur after prolonged use, when used in skin folds (eg groin, armpits or under the chest), use under tight dressing or use on a large skin area.

These side effects include the following:
- Adrenal glands may stop working properly. The signs are fatigue, depression and anxiety.
- Cataracts (signs are blurred vision, difficulty seeing at night and sensitive to light) or increased intraocular pressure (signs are eye pain, red eyes, decreased vision or blurred vision).
- Infections (because the immune system that fights infections may be suppressed or weakened)
- pustular psoriasis (reddened area with yellowish purulent vesicles usually on the hands or feet). If you notice this, stop using Daivobet and tell your doctor as soon as possible.
- Effect on the metabolic control of diabetes (if you have diabetes, you may have fluctuations in blood sugar levels)

Serious side effects caused by calcipotriol
- Allergic reactions with swelling of the face or other parts of the body such as hands (wrist down) or legs (ankle down). Mouth / throat swelling and breathing problems may occur. If you have an allergic reaction, stop using Daivobet, tell your doctor immediately or go to the emergency room at your nearest hospital.
- Treatment with this gel can lead to an increase in the level of calcium in the blood or urine (usually when too much gel is used). Signs of increased calcium in the blood are excessive urine output
The less serious side effects caused by the use of betamethasone, especially with prolonged use, include the following. Tell your doctor or nurse as soon as possible if you notice any of them:
- Thinning of the skin
- Appearance of superficial veins or stretch marks
- Changes in hair growth
- Red rash around the mouth (perioral dermatitis)
- skin rash with inflammation or swelling (allergic contact dermatitis)
- Gold colored gel bubbles (colloidal bubbles)
- Skin lightening (depigmentation)
- Hair root inflammation or edema (folliculitis)

The less severe side effects reported to be caused by calcipotriol are:
- Dry skin
- Skin sensitivity to light leading to rash
- Eczema
- Itching
- Skin irritation
- Burning and stinging sensation
- Redness of the skin due to enlargement of the small blood vessels (erythema)
- Rash

HOW TO STORE DAIVOBET

- Keep this medicine out of the reach and sight of children.
- Do not use this medicine after the expiry date which is stated on the label after 'Todo until:'. The expiry date refers to the last day of that month.
- Do not refrigerate. Keep the bottle in the outer carton in order to protect it from light.
- Discard the bottle with the remaining gel 3 months after first opening.

Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACKAGING AND ADDITIONAL INFORMATION

What Daivobet contains
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:
- Liquid paraffin
- Polyoxypropylene stearyl ether
- Hydrogenated castor oil
- Butyl hydroxytoluene (E321)
- And - tocopherol racemate

What Daivobet looks like and contents of the pack
The Daivobet is an almost transparent, colorless to almost white gel filled in high density polyethylene bottles with a low density polyethylene nozzle and a high density polyethylene cap.

The bottles are placed in a carton.

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

He all types of packaging can be marketed.

 

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