Duosone

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Duosone, (50 micrograms + 0.5 mg)/g, gel

Calcipotriol + Betamethasone

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, you should ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Duosone and what is it used for

Duosone contains the active substances calcipotriol and betamethasone. Calcipotriol helps to
restore the normal rate of skin cell growth, and betamethasone has an anti-inflammatory
effect. Duosone is used for the local treatment of scalp psoriasis in adults and mild to moderate
plaque psoriasis (psoriasis vulgaris) in adults, on non-scalp skin. Psoriasis is caused by the skin
cells growing too quickly. This leads to redness, scaling, and thickening of the skin.

2. Important information before using Duosone

When not to use Duosone:

• if you are allergic to calcipotriol, betamethasone, or any of the other ingredients of this medicine (listed in section 6);
• if you have disorders of calcium metabolism in the blood (you should consult your doctor);
• if you have other types of psoriasis, such as erythrodermic psoriasis, pustular psoriasis, or guttate psoriasis (you should consult your doctor).

Duosone contains a strong steroid (betamethasone), so you must not use this medicine in the
treatment of certain skin conditions, such as:

• skin infections caused by viruses (e.g., herpes or chickenpox)
• skin infections caused by fungi (e.g., athlete's foot or fungal infections caused by dermatophytes)
• bacterial skin infections
• parasitic skin infections (e.g., scabies)
• tuberculosis
• perioral dermatitis (red rash around the mouth)
• thin skin, fragile blood vessels, stretch marks
• ichthyosis (dry skin with scales similar to fish scales)
• acne (pimples)
• rosacea (severe flushing or redness of the skin on the face)
• ulcers or damaged skin

Warnings and precautions

Before starting and during treatment with Duosone, you should discuss with your doctor or
pharmacist if:

• you are using other medicines that contain corticosteroids, as side effects may occur;
• you have used this medicine for a long time and plan to stop using it, (as there is a risk that psoriasis may worsen or flare up when treatment with a steroid medicine is stopped suddenly);
• you have diabetes, as steroid medicines may affect blood sugar levels;
• you have a skin infection, as treatment may need to be stopped;
• you have a certain type of psoriasis called guttate psoriasis;
• you have blurred vision or other vision problems.

Precautions

• avoid using the medicine on more than 30% of the body surface and using more than 15 g per day;
• avoid using the medicine under a bathing cap, bandages, or dressings, as this increases the absorption of the steroid;
• avoid using the medicine on large areas of damaged skin, on mucous membranes, or in skin folds (groin, armpits, under the breasts), as this increases the absorption of the steroid;
• avoid using the medicine on the face and genital areas, as they are particularly sensitive to steroids;
• avoid excessive sunbathing, using sunbeds, or other forms of phototherapy.

Children and adolescents

Duosone is not recommended for use in children and adolescents under 18 years of age.

Duosone and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently
taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby,
you should ask your doctor for advice before using this medicine. If your doctor agrees that you
can breastfeed, you should be careful not to apply Duosone to the breast area.

Driving and using machines

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

Duosone contains butylhydroxytoluene (E321)

Duosone contains butylhydroxytoluene (E321), which may cause local skin reactions (e.g.,
contact dermatitis) or eye and mucous membrane irritation.

Duosone contains hydrogenated castor oil

Duosone contains hydrogenated castor oil, which may cause skin reactions.

3. How to use Duosone

This medicine should always be used exactly as your doctor has told you. If you are not sure,
ask your doctor or pharmacist. How to use Duosone: Apply to the skin. Instructions for proper
use

• The medicine should only be applied to areas affected by psoriasis, not to unaffected skin.
• Shake the tube before use and remove the cap.
• Squeeze the gel onto a clean finger or directly onto the affected areas.
• Apply the medicine to the affected areas using your fingertips and gently rub it in until the
  affected skin is covered with a thinlayer of gel.
• Do not cover the treated areas with bandages, tight dressings, or band-aids.
• After using Duosone, wash your hands thoroughly. This will help prevent accidental transfer
  of the gel to other parts of the body (especially the face, mouth, and eyes).
• You should not worry if a small amount of gel accidentally gets on healthy skin near the
  psoriasis area, but you should wipe it off if it spreads too far.
• To achieve optimal effect, it is not recommended to take a shower or bath immediately
  after applying Duosone gel.
• After applying the gel, avoid contact with fabrics that may stain easily due to the fat
  content (e.g., silk).

In case of use on the scalp:
Before applying Duosone to the scalp, you should comb your hair to remove any
scaling. You should tilt your head to prevent Duosone from running onto your face.
Before applying Duosone, it may be helpful to part your hair. You should apply Duosone to
the affected areas using your fingertips, then gently massage it in.

It is not necessary to wash your hair before applying Duosone.

To achieve optimal effect, it is not recommended to wash your hair immediately after applying Duosone. You should leave Duosone on the scalp for the whole night or day. When washing your hair after application, the following instructions may be helpful:

If necessary, steps 4-6 can be repeated once or twice.

Duration of treatment

• The gel should be applied once a day. It may be more convenient to use the gel in the evening.
• Usually, the initial treatment period is 4 weeks on the scalp and 8 weeks on other areas of the skin.
• Your doctor may decide on a different treatment period.
• Your doctor may decide to repeat the treatment.
• You should not use more than 15 grams of the medicine per day.

In case of using other medicines containing calcipotriol, the total amount of calcipotriol-
containing medicines should not exceed 15 grams per day, and the treated skin area should
not exceed 30% of the total body surface.
What results to expect when using Duosone
Most patients observe noticeable treatment results after 2 weeks, even if the symptoms of
psoriasis have not yet disappeared in the treated area.

Using more Duosone than recommended

If you use more than 15 g per day, you should contact your doctor. Excessive use of Duosone
may also cause disturbances in calcium levels in the blood, which usually disappear after
treatment is stopped. Your doctor may order blood tests to check if the use of more than the
recommended amount of gel has caused disturbances in calcium levels in the blood.
Long-term use of Duosone in large amounts may also cause disturbances in adrenal function
(the adrenal glands are located near the kidneys and produce hormones).

Missing a dose of Duosone

You should not use a double dose to make up for a missed dose.

Stopping treatment with Duosone

Treatment with Duosone should be stopped as directed by your doctor. It may be necessary to
gradually stop treatment, especially if it has been used for a long time.
If you have any further questions about the use of this medicine, you should ask your doctor or
pharmacist.

4. Possible side effects

Like all medicines, Duosone can cause side effects, although not everybody gets them.
Severe side effects
If you get any of the following symptoms, you should tell your doctor or nurse immediately
or as soon as possible. Treatment may need to be stopped.
There have been reports of the following severe side effects with Duosone:
Uncommon (may affect up to 1 in 100 people)

• Worsening of psoriasis. If your psoriasis worsens, you should tell your doctor as soon as possible.

It is known that some severe side effects are caused by betamethasone (a strong steroid), which
is one of the ingredients of Duosone. You should tell your doctor as soon as possible if you get
any of the severe side effects. They are likely to occur after long-term use, use in skin folds
(in the groin, under the arms, under the breasts), use under occlusive dressings, or use on large
areas of skin. The side effects include:

• Adrenal gland problems. Symptoms include tiredness, depression, and anxiety.
• Cataracts (cloudy vision, difficulty seeing at night, and sensitivity to light) or increased pressure in the eye (eye pain, redness of the eye, decreased or blurred vision).
• Infections (as the immune system that fights infection may be weakened or suppressed).
• Pustular psoriasis (red area with yellowish pustules usually on the hands or feet). If you notice
  such symptoms, you should stop using Duosone and tell your doctor as soon as possible.
• Affecting the control of diabetes (in case of diabetes, fluctuations in blood sugar levels may
  occur).

Severe side effects 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 have an
  allergic reaction, you should stop using Duosone and immediately tell your doctor or go to the emergency room of the nearest hospital.
• As a result of treatment with this gel, an increase in calcium levels in the blood or urine may
  occur (usually in case of excessive use of the gel). Signs of elevated calcium levels in the blood
  include excessive urination, constipation, muscle weakness, confusion, and coma. This condition can be severe and you should contact your doctor immediately.However, after stopping treatment, calcium levels return to normal.

Mild side effects
There have been reports of the following mild side effects with Duosone.
Common (may affect up to 1 in 10 people)

• Itching

Uncommon (may affect up to 1 in 100 people)

• Eye irritation
• Burning sensation of the skin
• Pain or irritation of the skin
• Inflammation or swelling of the hair follicle (folliculitis)
• Rash with skin inflammation (dermatitis)
• Redness of the skin due to the dilation of small blood vessels (erythema)
• Acne (pimples)
• Dryness of the skin
• Rash
• Pustular psoriasis
• Skin infections.

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

• Allergic reactions
• Stretch marks
• Peeling of the skin
• Rebound effect: worsening of psoriasis symptoms after treatment is stopped.

Frequency not known (frequency cannot be estimated from the available data)

• White or gray hair may temporarily turn yellow at the application site in case of use on the
  scalp.
• Blurred vision

Mild side effects that you should tell your doctor or nurse about as soon as possible, especially
those caused by long-term use of betamethasone, include:

• Thinning of the skin
• Appearance of superficial veins or stretch marks
• Change in hair growth rate
• Red rash around the mouth (perioral dermatitis)
• Skin rash with accompanying inflammation or swelling (allergic contact dermatitis)
• Yellowish fluid-filled bumps (colloid milia)
• Lightening of skin color (depigmentation)
• Inflammation or swelling of the hair follicle (folliculitis)

Other mild side effects caused by calcipotriol that have been reported include:

• Dryness of the skin
• Sensitivity of the skin to light, manifested as a rash
• Pruritus
• Irritation of the skin
• Burning or stinging sensation
• Redness of the skin due to the dilation of small blood vessels (erythema)
• Rash
• Rash with skin inflammation (dermatitis)
• Worsening of psoriasis

Reporting 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 to the Department
of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices,
and Biocidal Products

• Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl You can also report side effects to the marketing authorization holder.

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

5. How to store Duosone

• The medicine should be stored out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the tube and on the carton
  after EXP. The expiry date refers to the last day of that month.
• Do not store in the refrigerator.
• Discard the tube containing any remaining gel after 6 months of first opening.

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 protect the environment.

6. Contents of the pack and other information

What Duosone contains

The active substances of Duosone are calcipotriol and betamethasone. One gram of gel contains
50 micrograms of calcipotriol (as calcipotriol monohydrate) and 0.5 mg of betamethasone (as
betamethasone dipropionate). The other ingredients are:

• Light liquid paraffin
• Stearyl polyoxypropylene ether
• Hydrogenated castor oil
• Butylhydroxytoluene (E321)

What Duosone looks like and contents of the pack

Duosone is a nearly transparent, colorless to slightly white gel packaged in a white cylindrical
tube with a white polypropylene cap. The tube is placed in a cardboard box.
Pack sizes:
1 tube of 30 g
1 tube of 60 g

Marketing authorization holder and manufacturer

Marketing authorization holder

Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, D24PPT3, Dublin
24, Ireland

Manufacturer

C.P.M. ContractPharma GmbH, Fruehlingsstrasse 7, 83620 Feldkirchen-Westerham, Germany

This medicine is authorized in the Member States of the European Economic Area under the
following names:

Germany
Calcipotriol/Betamethason Bausch Health
Poland
Duosone

Date of last revision of the leaflet: