Daivobet 50 micrograms/0.5 mg/g ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Daivobet 50 micrograms/0.5 mg/g ointment

calcipotriol/betamethasone

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Daivobet is and what it is used for
2. What you need to know before using Daivobet
3. How to use Daivobet
4. Possible side effects
5. How to store Daivobet
6. Contents of the pack and other information

1. What Daivobet is and what it is used for

Daivobet ointment is used on the skin to treat plaque psoriasis (psoriasis vulgaris) in adults. Psoriasis is caused by an excessively rapid production of skin cells. This leads to redness, scaling, and thickening of the skin.

Daivobet ointment contains calcipotriol and betamethasone. Calcipotriol helps normalize the rate of skin cell growth, and betamethasone reduces inflammation.

2. What you need to know before using Daivobet

Do not use Daivobet

• If you are allergic (hypersensitive) to calcipotriol, betamethasone, or to any of the other ingredients of this medicine (listed in section 6)
• If you have problems with calcium levels in your body (consult your doctor)
• If you have certain types of psoriasis, such as erythrodermic, exfoliative, or pustular psoriasis (consult your doctor).

Since Daivobet contains a potent corticosteroid, do NOT use it on skin affected by:

• Skin infections caused by viruses (e.g., herpes or chickenpox)
• Skin infections caused by fungi (e.g., athlete’s foot or ringworm)
• Skin infections caused by bacteria
• Skin infections caused by parasites (e.g., scabies)
• Tuberculosis
• Perioral dermatitis (red rash around the mouth)
• Thin skin, fragile blood vessels, or stretch marks
• Ichthyosis (dry, scaly skin)
• Acne (spots)
• Rosacea (redness or flushing of the facial skin)
• Ulcers or damaged skin.

Warnings and precautions

Consult your doctor/nurse/pharmacist before and during treatment with Daivobet if:

• You are using other medicines containing corticosteroids, as you may experience adverse effects
• You have used this medicine for a long time and plan to stop (since there is a risk that your psoriasis may worsen or 'rebound' when steroids are suddenly discontinued)
• You have diabetes mellitus (diabetes), as your blood sugar/glucose levels may be affected by the steroid
• A skin infection develops, as treatment may need to be interrupted
• You have a type of psoriasis called guttate psoriasis
• You experience blurred vision or other visual disturbances.

Special precautions

• Avoid use on more than 30% of your body surface or more than 15 grams per day
• Avoid using dressings or bandages, as they increase steroid absorption
• Avoid use over large areas of damaged skin, mucous membranes, or skin folds (groin, armpits, under the breasts), as this increases steroid absorption
• Avoid use on the face or genitals (sex organs), as these areas are highly sensitive to steroids
• Avoid excessive sun exposure, excessive use of artificial tanning, and other light therapies.

Children

The use of this medicine is not recommended in children under 18 years of age.

Using Daivobet with other medicines

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. If your doctor agrees that you may breastfeed, take care not to apply Daivobet to the breast area.

Driving and using machines

This medicine does not affect your ability to drive or operate machinery.

Daivobet ointment contains butylhydroxytoluene (E321)

Daivobet ointment may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxytoluene (E321).

3. How to use Daivobet

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

How to use Daivobet: Cutaneous use.

Instructions for proper use

• Use it only on areas affected by psoriasis and do not apply it to unaffected skin
• Before first use of the ointment, remove the cap and check that the seal on the tube is intact
• To break the seal, use the protrusion located on the back of the cap
• Apply the ointment onto a clean finger
• Gently rub it into the skin to cover the affected psoriatic area until most of the ointment has disappeared from the skin
• Do not apply a dressing, or cover or wrap the treated skin area
• Wash your hands thoroughly after using Daivobet (unless you are treating your hands). This will help prevent accidental contact of the ointment with other parts of your body (especially the face, scalp, mouth, and eyes)
• Do not worry if a small amount of ointment is accidentally applied to healthy skin near your psoriasis, but clean it off if it spreads excessively
• To achieve optimal effect, it is recommended not to shower or bathe immediately after applying Daivobet ointment
• After applying the ointment, avoid contact with fabrics that may be easily stained by grease (e.g., silk).

Duration of treatment

• Use the ointment once daily. It may be more convenient to apply the ointment at night
• The usual initial treatment period is 4 weeks, but your doctor may decide on a different duration
• Your doctor may decide that you should repeat the treatment
• Do not use more than 15 grams in one day.

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

What should I expect when using Daivobet?

Most patients notice obvious results within 2 weeks, even though the psoriasis may not have completely cleared by then.

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 may cause a problem with calcium levels in your blood, which usually returns to normal once treatment is stopped.

Your doctor may need to perform blood tests to ensure that overuse of the ointment has not caused a problem with your blood calcium levels.

Prolonged and excessive use may also cause your adrenal glands to stop functioning properly (these are located near the kidneys and produce hormones).

Contact the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and amount used.

If you forget to use Daivobet

Do not apply a double dose to make up for missed doses.

If you stop treatment with Daivobet

Treatment with Daivobet should be discontinued as directed by your doctor. You may need to stop using this medicine gradually, especially if you have been using it for a long time.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Inform your doctor/nurse immediately or as soon as possible if you experience any of the following adverse effects. You may need to stop your treatment.

The following serious adverse effects have been reported for Daivobet:

Uncommon (may affect up to 1 in 100 people)

• Worsening of your psoriasis. If your psoriasis worsens, inform your doctor as soon as possible.

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

• Pustular psoriasis (a red area with yellowish pustules, usually on the hands or feet) may occur. If this happens to you, stop using Daivobet and inform your doctor as soon as possible.

It is known that some serious adverse effects are caused by betamethasone (a potent steroid), one of the components of Daivobet. If you experience any of these serious adverse effects, inform your doctor as soon as possible. These adverse effects are more likely to occur with long-term use, when applied to skin folds (e.g., groin, armpits, or under the breasts), when the treated area is covered, or when used over large skin areas.

The adverse effects include the following:

• Your adrenal glands may stop functioning properly. Symptoms include fatigue, depression, and anxiety.
• Cataracts (symptoms include blurred or hazy vision, reduced night vision, and light sensitivity) or increased pressure inside the eye (symptoms include eye pain, red eye, blurred vision, or reduced 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 this happens to you, stop using Daivobet and inform your doctor as soon as possible.
• Effect on metabolic control of diabetes mellitus (if you have diabetes, you may experience changes in blood glucose levels).

Serious adverse effects caused by calcipotriol

• Allergic reactions with severe swelling of the face or other body parts such as the hands or feet. Swelling of the mouth/throat and breathing difficulties may occur. If you experience an allergic reaction, stop using Daivobet, inform your doctor immediately, or go to the nearest hospital emergency department.
• Treatment with this ointment may cause an increase in calcium levels in your blood or urine (usually when too much ointment is used). Symptoms of elevated blood calcium include excessive urination, constipation, muscle weakness, confusion, and coma. This can be serious and you should contact your doctor immediately. However, calcium levels return to normal once treatment is stopped.

Less serious adverse effects

The following less serious adverse effects have been reported for Daivobet.

Frequent adverse effects (may affect up to 1 in 10 people)

• Itching
• Skin peeling

Uncommon (may affect up to 1 in 100 people)

• Skin pain or irritation
• Skin rash with skin inflammation (dermatitis)
• Redness of the skin due to dilation of small blood vessels (erythema)
• Inflammation or swelling of the hair root (folliculitis)
• Changes in skin color at the site where the ointment was applied
• Skin rash (rash)
• Burning sensation
• Skin infection
• Thinning of the skin
• Appearance of purple or red discoloration of the skin (purpura or bruising)

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

• Infection of the hair follicle caused by bacteria or fungi (boil)
• Allergic reactions
• Hypercalcemia
• Stretch marks
• Skin sensitivity to light leading to a skin rash
• Acne (spots)
• Dry skin
• Rebound effect: Worsening of symptoms/psoriasis after stopping treatment.

Frequency not known (cannot be estimated from available data):

• Blurred vision

Less serious adverse effects caused by the use of betamethasone, especially with prolonged use, include the following. If you notice any of these, inform your doctor or nurse as soon as possible.

• 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)
• Golden-yellow papules (colloidal miliaria)
• Skin discoloration (depigmentation)
• Inflammation or swelling of the hair root (folliculitis)

Less serious adverse effects caused by calcipotriol include:

• Dry skin
• Skin sensitivity to light leading to a skin rash
• Eczema
• Itching
• Skin irritation
• Burning and itching sensation
• Redness of the skin due to dilation of small blood vessels (erythema)
• Skin rash (rash)
• Skin rash (rash) with skin inflammation (dermatitis)
• Worsening of psoriasis

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Daivobet

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label after EXP. The expiry date is the last day of the month indicated.
• Do not store this medicine above 25 °C.
• The tube should be discarded one year after first opening. Write the date you first opened the tube in the space provided for this purpose on the carton.

Medicines should not be disposed of via wastewater or household waste. Instead, return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Daivobet

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 components are:

• liquid paraffin
• all-rac-α-tocopherol
• polyoxyl stearate ether
• white soft paraffin
• butylhydroxytoluene (E321).

Appearance of Daivobet and contents of the pack

Daivobet ointment is a white to yellowish ointment supplied in aluminium/epoxyphenolic tubes with a polyethylene screw cap.

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is:

LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark

The manufacturer is:

LEO Laboratories Ltd.
Cashel Road, Dublin 12, Ireland.

This medicinal product is authorised in the European Economic Area member states under the following names:

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

Dovobet: Belgium, Cyprus, Greece, Ireland, Italy, Luxembourg, Netherlands, United Kingdom

Date of the most recent revision of this leaflet: August 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.