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Daivobet ointment 15g.

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Daivobet ointment is used for topical treatment of plaque psoriasis (psoriasis vulgaris) in adults.

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

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WHAT A DAIVOBET IS AND WHAT IT IS USED

Diavobet ointment is used for topical treatment of plaque psoriasis (psoriasis vulgaris) in adults.

Psoriasis is caused by the over-reproduction of your skin cells. This results in redness, flaking and thickening of the skin.

Daivobet ointment contains calcipotriol and betamethasone. Calcipotriol 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 Diavobet

- 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 a specific type of psoriasis: these are erythrodermic, exfoliative and pustular psoriasis (ask your doctor)

Since Diavobet 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 fungus (eg foot fungus or pituitary)

- 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 redness of the face)

- 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 blood sugar / glucose levels can be influenced 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 bandages as this increases the absorption of the steroid

- Avoid use on large areas of damaged skin, mucous membranes or skin folds (loins, armpits, 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 Daivobet

Please 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 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 ointment contains butyl hydroxytoluene (E321)

Davobet ointment contains butylhydroxytoluene (E321). This can cause local skin reactions (eg contact dermatitis) or irritation of the eyes and mucous membranes.

3. HOW TO USE DAIVOBET

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

How to apply Daivobet: application to the skin.

Instructions for proper use

- Use only on psoriasis sites, not on psoriasis-free skin.

- Remove the cap and check that the tube is not opened before you first use the ointment.

- To pierce the foil, use the sharpened back of the cap.

- Squeeze ointment on clean soil.

- Gently rub in the skin to cover the area of ​​psoriasis affected until the skin has absorbed most of the ointment.

- Do not bandage, cover or bandage the tightly treated area of ​​the skin.

- Wash your hands well after using Davobet (unless you have used ointment to treat your hands). This will prevent accidental spread of the ointment to other parts of the body (especially the face, hair of the head, mouth and eyes).

- Do not worry if a little ointment accidentally falls on clean skin near the psoriasis area, wipe it off with greater spread.

- For maximum effect, it is recommended that you do not take a shower or wa

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 use more Daivobet than you should

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

Excessive use of Daivobet can lead to problems with blood calcium levels, which are usually normalized when treatment is stopped.

Your doctor may need a blood test to check that using too much ointment has not 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 Daivobet

Do not use a double dose to make up for a forgotten single dose.

If you stop using Daivobet

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 medicine, 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 for Daivobet have been reported:

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.

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

- pustular psoriasis (reddened area with yellowish purulent buds, usually on the hands or feet) may occur. If you notice this, stop using Daivobet and 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 (red area with yellowish purulent vesicles usually on the hands or feet). If you notice this, stop using Davobet 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 known to be 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 Dyvobet, tell your doctor immediately or go to the emergency room at your nearest hospital.

- Treatment with this ointment can lead to an increase in the level of calcium in the blood or urine (usually when an overdose of ointment is used). Signs of increased blood calcium are excessive urine output, constipation, muscle weakness, confusion and coma.

This can be serious and you should contact your doctor immediately. But when treatment is stopped, the levels return to normal.

Not so serious side effects

The following not-so-serious side effects have also been reported in Davobet

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

- Itching

- Peeling skin

Uncommon (may affect up to 1 in 100 people)

- Skin pain or irritation

- Skin inflammation rash (dermatitis)

- Redness of the skin due to enlargement of the small blood vessels (erythema) - Inflammation or swelling of the root of the hair (folliculitis)

- A change in skin color in the area where you used the ointment

- Rash

- A burning sensation on the skin

- Skin infection

- Thinning of the skin

- Appearance of red or purple discoloration on the skin (purpura or ecchymosis).

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

- Bacterial or fungal infection of the hair follicle (Furuncle)

- Allergic reactions

- Hypercalcemia

- Striae

- Sensitivity

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.

- Thinning of the skin

- Occurrence of superficial 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)

- Gold colored gel-filled bubbles (colloidal bubbles)

- Skin lightening (depigmentation)

- Inflammation or swelling of the hair root (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

- Feeling of burning and stinging

- Redness of the skin due to enlargement of the small blood vessels (erythema)

- Rash

- Skin inflammation rash (dermatitis)

- Exacerbation of psoriasis

HOW TO STORE DAIVOBET

- Keep out of the reach and sight of children.

- Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

- Do not store above 25 ° C.

- The tube should be discarded 1 year after first opening. Write the date of the first opening of the box of box provided for this purpose on the carton.

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 ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).

The other ingredients are:

liquid paraffin

a-tocopherol racemate

polyoxypropylene stearyl ether

white soft paraffin

butylhydroxytoluene (E321)

What Daivobet looks like and contents of the pack

Dayvobet ointment is an off-white to yellow colored ointment in aluminum / epoxyphenol tubes with a plastic screw cap.

Pack sizes: 15, 30, 60, 100 and 120 g.

Not all pack sizes may be marketed.

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