Duosone

Package leaflet: Information for the user

Duosone, (50 micrograms + 0.5 mg)/g, gel
Calcipotriol + Betamethasone
Please read all of this leaflet carefully before 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 further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Duosone is and what it is used for
2. What you need to know 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 Duosone is and what it is used for

Duosone contains the active substances: calcipotriol and betamethasone. Calcipotriol helps restore
normal skin cell growth rate, and betamethasone has an anti-inflammatory effect.
Duosone is used in the topical treatment of scalp psoriasis in adults and mild to moderate plaque-type
psoriasis (psoriasis vulgaris) in adults, affecting body skin other than the scalp.
Psoriasis is caused by excessive skin cell growth. This leads to redness, scaling and thickening of the skin.

2. Important information before using Duosone

When not to use Duosone:

• if the patient is allergic to calcipotriol, betamethasone, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has disorders of calcium levels in the blood (consult a doctor);
• if the patient has been diagnosed with other types of psoriasis, such as erythrodermic psoriasis, pustular psoriasis, or exanthematic psoriasis (consult a doctor).

Duosone contains a potent corticosteroid medicine (betamethasone), therefore it should NOT be used in skin conditions such as:

• viral skin infections (e.g. herpes simplex or chickenpox)
• fungal skin infections (e.g. athlete’s foot or 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, skin striae (stretch marks)
• ichthyosis (dry, scaly skin resembling fish scales)
• acne (pimples)
• rosacea (intense redness or flushing of the facial skin)
• skin ulcers or damaged skin

Warnings and precautions
Before starting and during treatment with Duosone, consult your doctor or pharmacist if:

• the patient is using other medicines containing corticosteroids, as adverse effects may occur;
• the patient has used this medicine for a long time and plans to stop treatment (because there is a risk that psoriasis may worsen or flare up due to sudden discontinuation of steroid-containing medicine);
• the patient has diabetes, as steroid-containing medicines may affect blood sugar/glucose levels;
• a skin infection has occurred, as treatment may need to be discontinued;
• the patient has a specific type of psoriasis called guttate psoriasis;
• the patient experiences blurred vision or other visual disturbances.

Precautions:

• avoid applying the medicine to more than 30% of the body surface and using more than 15 g per day;
• avoid using the medicine under occlusive swim caps, bandages, or dressings, as this increases steroid absorption;
• avoid applying the medicine to large areas of damaged skin, mucous membranes, or skin folds (groin, armpits, under the breasts), as this increases steroid absorption;
• avoid application to the face and genital organs (genitalia), as these areas are particularly sensitive to steroids;
• avoid excessive sun exposure, use of 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
Inform your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, plans to become pregnant, or is breastfeeding, she should consult a doctor before using this medicine.
If the doctor approves breastfeeding, caution should be exercised and Duosone should not be applied to the breast area.

Driving and operating machinery
This medicine is unlikely to have any effect on the ability to drive or operate machinery.

Duosone contains butylated hydroxytoluene (E321)
Duosone contains butylated hydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

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 in doubt, consult your
doctor or pharmacist.
How to use Duosone:
Topical application.
Instructions for correct use

• Apply Duosone only 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 gel to the psoriatic lesions using the fingertips, gently rubbing it in until the affected skin is covered with a thin layer of gel.
• Do not cover treated areas with bandages, occlusive dressings, or wraps.
• After applying Duosone, wash your hands thoroughly. This helps prevent accidental transfer of the gel to other parts of the body (especially face, mouth, and eyes).
• Do not be concerned if a small amount of gel accidentally spreads to healthy skin near the psoriatic lesion, but 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 are easily stained by oily substances (e.g. silk).

When using Duosone for psoriasis of the scalp:
Before applying Duosone to the hairy scalp, comb the hair to remove any loose, flaking skin.
Tilt the head to prevent Duosone from running onto the face. It may be helpful to part the hair before
application. Apply Duosone to the affected areas with the fingertips and gently massage in.
It is not necessary to wash the hair before applying Duosone.

For optimal effectiveness, washing hair is not recommended immediately after application of
Duosone medication. Duosone should be left on the hairy scalp overnight or throughout the day.
When washing the hair after application, the following instructions may be helpful:

If necessary, steps 4–6 may be repeated once or twice.
Duration of treatment

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

When using other medicines containing calcipotriol, the total amount of medicines containing calcipotriol must not exceed 15 grams per day, and the treated skin area should not exceed 30% of the total body surface area.
What results to expect when using Duosone
Most patients observe clear treatment results after 2 weeks, even if psoriasis symptoms have not yet completely resolved at the treated site.
Using more than the recommended dose of Duosone
If more than 15 g per day is used, contact your doctor.
Excessive use of Duosone at too high a dose may also cause disturbances in blood calcium levels, which usually resolve after stopping treatment.
Your doctor may order blood tests to check whether using a higher-than-recommended dose of the gel has caused disturbances in blood calcium levels.
Prolonged use of Duosone at a high dose may also cause adrenal gland dysfunction (adrenal glands are glands located next to the kidneys that produce hormones).
Missing a dose of Duosone
Do not apply a double dose to make up for a missed dose.
Stopping Duosone treatment
Duosone treatment should be discontinued according to your doctor's instructions. Gradual discontinuation may be necessary, especially if the medicine has been used for a prolonged period.
If you have any further questions about the use of this medicine, consult 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
If any of the following symptoms occur, inform your doctor or nurse immediately or as quickly as possible.
Discontinuation of treatment may be necessary.
There have been reports of the following serious adverse effects with Duosone:

• Exacerbation of psoriasis. If psoriasis worsens, 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 Duosone. Inform your doctor as soon as possible if any serious adverse effects occur. These are likely to occur after prolonged use, use in skin folds (groin, underarms, under breasts), use under occlusive dressings, or application over large areas of skin.
Adverse effects include:

• Adrenal gland problems (symptoms include fatigue, depression, and anxiety).
• Cataract (cloudy vision, difficulty seeing at night, and light sensitivity) or increased intraocular pressure (eye pain, redness of the eye, blurred or reduced vision).
• Infections (because the immune system fighting infections may be suppressed or weakened).
• Pustular psoriasis (a red area with yellowish pustules, usually on the hands or feet). If such symptoms are observed, discontinue use of Duosone and inform your doctor immediately.
• Effects on diabetes control (in patients with diabetes, fluctuations in blood glucose levels may occur).

Serious adverse 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 lips or throat and difficulty breathing may occur. If an allergic reaction occurs, discontinue use of Duosone immediately and inform your doctor or go to the nearest hospital emergency department without delay.
• Treatment with this gel may lead to increased calcium levels in the blood or urine (usually due to excessive use of the gel). Signs of elevated calcium levels include excessive urination, constipation, muscle weakness, confusion, and drowsiness. This condition may be serious and you should contact your doctor immediately. However, calcium levels usually return to normal after stopping treatment.

Less serious adverse effects
There have been reports of the following less serious adverse effects with Duosone.

Frequent (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
• Skin pain or irritation
• Inflammation or swelling at the hair root (folliculitis)
• Skin rash with inflammation (dermatitis)
• Skin redness due to dilation of small blood vessels (erythema)
• Acne (pimples)
• Dry skin
• Rash
• Pustular psoriasis
• Skin infections

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

• Allergic reactions
• Stretch marks
• Skin peeling
• Rebound effect: worsening of psoriasis symptoms after stopping treatment

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

• White or grey hairs may temporarily turn yellowish at the site of application when the medicine is applied to hairy scalp.
• Blurred vision

Less serious adverse effects that should be reported to your doctor or nurse as soon as they are noticed, 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)
• Golden, gel-filled nodules (colloid milia)
• Lightening of skin color (depigmentation)
• Inflammation or swelling of hair follicles (folliculitis)

Other less serious adverse effects associated with calcipotriol that have been reported include:

• Dry skin
• Skin sensitivity to light causing rash
• Rash
• Itching
• Skin irritation
• Burning or stinging sensation
• Skin redness due to dilation of small blood vessels (erythema)
• Rash
• Skin rash with inflammation (dermatitis)
• Worsening of psoriasis

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Duosone

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the tube and carton: Expiry date (EXP). The expiry date refers to the last day of the stated month.
• Do not store in the refrigerator.
• Discard the tube containing any remaining gel 6 months after first opening.

Medicines must 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 in this medicine 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:

• Liquid paraffin
• Polyoxypropylene stearyl ether
• Hydrogenated castor oil
• Butylhydroxytoluene (E321)

What Duosone looks like and contents of the pack
Duosone is a nearly transparent gel, colourless to slightly whitish, packed in a white cylindrical tube made of HDPE with a white PP cap.
The tube is placed in a cardboard box.
Pack sizes:
1 tube containing 30 g
1 tube containing 60 g

Marketing Authorisation 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 authorised for sale in the European Economic Area countries under the following names:
Poland: Duosone