PACKAGE LEAFLET: INFORMATION FOR THE USER

Dovobet® Ointment

(calcipotriol/ betamethasone dipropionate)

The name of your medicine is Dovobet Ointment but will be referred to as Dovobet throughout this leaflet.

What is in this leaflet

1.    What Dovobet is and what it is used for?

2.    What you need to know before you use Dovobet

3.    How to use Dovobet

4.    Possible side effects

5.    How to store Dovobet

6.    Contents of the pack and other information

1.    WHAT DOVOBET IS AND WHAT IT IS USED FOR?

Dovobet ointment is used on the skin to treat plaque psoriasis (psoriasis vulgaris) in adults. Psoriasis is caused by your skin cells being produced too quickly. This causes redness, scaling and thickness of your skin.

Dovobet ointment contains calcipotriol and betamethasone.

Calcipotriol helps to bring the rate of skin cell growth back to normal and betamethasone acts to reduce inflammation.

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE DOVOBET Do not use Dovobet:

•    If you are allergic (hypersensitive) to calcipotriol, betamethasone or any of the other ingredients of Dovobet (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 (ask your doctor).

As Dovobet contains a strong steroid do NOT use on skin affected by

•    infections caused by viruses (e.g. cold sores or chicken pox)

•    infections caused by a fungus (e.g. athlete’s foot or ringworm)

•    infections caused by bacteria

•    infections caused by parasites (e.g. scabies)

•    tuberculosis (TB) or syphilis

•    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

•    itching of the anus (back passage) or genitals (sex organs). Warning and Precaution

Talk to your doctor/nurse/pharmacist before using Dovobet if

•    you are using other medicines that contain corticosteroids, as you may get side effects

•    you have used this medicine for a long time and plan to stop (as there is a risk your psoriasis will get worse or ‘flare up' when steroids are stopped suddenly)

•    you have diabetes mellitus (diabetes), as your blood sugar/glucose level may be affected by the steroid

•    your skin becomes infected, as you may need to stop your treatment

•    you have a certain type of psoriasis called guttate psoriasis

•    you have serious liver or kidney disease.

Special precautions

•    Avoid use on more than 30 % of your body or using more than 15 grams per day

•    Avoid using under bandages or dressings as it increases the absorption of the steroid

•    Avoid use on large areas of damaged skin or skin folds (groin, armpits, under breasts) as it increases the absorption of the steroid

•    Avoid use on the face or genitals (sex organs) as they are very sensitive to steroids

•    Avoid excessive sunbathing, excessive use of solarium and other forms of light treatment.

Children

Dovobet is not recommended for the use in children below the age of 18 years.

Other medicines and Dovobet

Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Do not use Dovobet if you are pregnant (or might be pregnant) or if you are breast-feeding, unless you have agreed it with your doctor first. If your doctor has agreed that you can breast-feed, take care and do not apply Dovobet to the breast area.

Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines

This medicine should not have any effect on your ability to drive or use machines.

Important information about some of the ingredients of Dovobet ointment

Dovobet ointment contains butylhydroxytoluene (E321). This may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

3. HOW TO USE DOVOBET

Always use Dovobet exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How to put on Dovobet: Cutaneous use.

Instruction for proper use

•    Use only on your psoriasis and do not use on skin which does not have psoriasis

•    Remove the cap and check that the seal in the tube is not broken before you first use the ointment

•    To break the seal, use the point in the back of the cap

•    Squeeze the ointment onto a clean finger

•    Rub gently into your skin to cover the affected area of psoriasis until most of the ointment has disappeared into the skin

•    Do not bandage, tightly cover or wrap the treated skin area

•    Wash your hands well after using Dovobet (unless you are using the ointment to treat your hands). This will avoid accidentally spreading the ointment to other parts of your body (especially the face, scalp, mouth and eyes)

•    Do not worry if some ointment 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 ointment

•    After applying the ointment avoid contact with textiles which are easily stained by grease (e.g. silk).

Duration of treatment

•    Use the ointment once a day. It may be more convenient to use the ointment in the evening

•    The normal initial treatment period is 4 weeks but your doctor may decide on a different treatment period

•    Your doctor may decide on repeated treatment

•    Do not use more than 15 grams in one day.

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

What should I expect when I use Dovobet?

Most patients see obvious results after 2 weeks, even if the psoriasis is not yet cleared at that point.

If you have used more Dovobet than you should

Contact your doctor if you have used more than 15 grams in one day. Excessive prolonged use of Dovobet may cause a problem with calcium in your blood, which usually normalises when discontinuing treatment.

Your doctor may need to carry out blood tests to check that using too much ointment has not caused a problem with calcium in your blood. Excessive prolonged use can also cause your adrenal glands to stop working properly (these are found near the kidneys and produce hormones).

If you forget to use Dovobet

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

If you stop using Dovobet

The use of Dovobet should be stopped as indicated by your doctor.

It may be necessary for you to stop this medicine gradually, especially if you have used it for a long time.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Dovobet can cause side effects, although not everybody gets them.

Approximately 1 in 10 people may experience side effects but most of these are reactions at the site where the ointment has been applied and are usually mild and temporary.

Serious side effects

The following serious effects have been reported for Dovobet: Uncommon (affects less than 1 in 100 people)

•    Worsening of your psoriasis. If your psoriasis gets worse, tell your doctor as soon as possible.

Rare (affects less than 1 in 1,000 people)

•    Pustular psoriasis may occur (a red area with yellowish pustules usually on the hands or feet). If you notice this, stop using Dovobet and 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:

•    Your adrenal glands may stop working properly. Signs are tiredness, depression and anxiety

•    Cataracts (signs are cloudy and foggy vision, difficulty seeing at night and sensitivity to light) or an increase in pressure inside the eye (signs are eye pain, red eye, decreased or cloudy vision)

•    Infections (because your immune system which fights infections may be suppressed or weakened)

•    Impact on the metabolic control of diabetes mellitus (if you have diabetes you may experience fluctuations in the blood glucose levels).

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 bandages or dressings or use on large areas of skin.

Serious side effects known to be caused by calcipotriol

•    Allergic reactions with deep swelling of the face or other parts of the body such as the hands or feet. Swelling of the mouth/throat and trouble breathing may occur. If you have an allergic reaction, stop using Dovobet, tell your doctor immediately or go to the casualty department at your nearest hospital

•    Treatment with this ointment may cause the level of calcium in your blood or urine to increase (usually when too much ointment has been used). Signs of increased calcium in blood is bone pain, constipation, poor appetite, nausea and vomiting. This can be serious and you should contact your doctor as soon as possible. However, when the treatment is stopped, the levels return to normal.

Less serious side effects

The following less serious side effects have been reported for Dovobet. If any of them last a long time or cause you problems, you should tell your doctor or nurse.

Common side effects (affect less than 1 in 10 people)

•    Itching

•    Rash

•    Burning sensation.

Uncommon (affect less than 1 in 100 people)

•    Skin pain or irritation

•    Rash with inflammation of the skin (dermatitis)

•    Redness of the skin due to widening of the small blood vessels (erythema)

•    Inflammation or swelling of the hair root (folliculitis)

•    Changes in skin colour in the area you have used the ointment.

Not known frequency

•    Rebound effect: A worsening of symptoms/psoriasis after ended treatment.

Less serious side effects caused by using betamethasone, include the following. You should tell your doctor as soon as possible if you notice them.

•    Thinning of the skin

•    Appearance of surface 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)

•    Shiny brown gel-filled bumps (colloid milia)

•    Lightening of skin colour (depigmentation).

Less serious side effects known to be caused by calcipotriol include the following

•    Dry skin

•    Sensitivity of the skin to light resulting in a rash has also been reported

•    Eczema.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.

This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE DOVOBET

•    Keep out of the sight and reach of children.

•    Do not store the product above 25°C.

•    Do not use after the expiry date stated on the label (EXP). This expiry date refers to the last day of that month.

•    The tube should be discarded 12 months after first opening.

Write the date you first opened the tube in the space provided on the carton.

Medicines 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.

If your ointment become discoloured or show any signs of deterioration, you should seek the advice of your pharmacist.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What is in Dovobet® ointment?

One gram of ointment contains 50micrograms of calcipotrol (as monohydrate) and 0.5mg of betamethasone (as dipropionate) as an active substance.

The other ingredients are:

•    liquid paraffin    • polyoxypropylene-15-stearyl ether

•    a-tocopherol    • white soft paraffin

•    butylated hydroxytoluene (E321)

What Dovobet® looks like and contents of the pack

The ointment is off-white to yellow.

The ointment is available in tubes of 30 grams.

Manufactured by: LEO Laboratories Ltd. Cashel Road, Dublin 12, Ireland.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK

DOVOBET® 50microgram/g + 0.5mg/g ointment PL: 18799/2006    [POM]

For further information about this product, contact the local representative of the Marketing Authorisation Holder:

LEO Laboratories Limited, Princes Risborough, Bucks HP27 9RR, UK.

Tel: (01844) 347333

e-mail: medical-info.uk@leo-pharma.com

For further information about your psoriasis, you can contact:

The Psoriasis Association mail@psoriasis.demon.co.uk

Leaflet date: 01.04.2014

Dovobet is a registered Trade Mark of Leo.