Curatoderm

Package leaflet: Information for the user

Curatoderm
Tacalcitol monohydrate
4.17 µg/g, ointment
Please read all of this leaflet carefully before using the medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Curatoderm is and what it is used for

Curatoderm is an ointment. Curatoderm is indicated for use in mild or moderate plaque psoriasis.
Tacalcitol – the active substance in Curatoderm – is a vitamin D3 analogue. It inhibits excessive epidermal proliferation, promotes normal keratinization, and modifies inflammatory processes.

2. Important information before using Curatoderm

When not to use Curatoderm:

• if the patient is allergic to tacalcitol or any of the other ingredients of this medicine (listed in section 6);
• if the patient has pustular or eruptive psoriasis;
• if the patient has disorders associated with disturbances in calcium metabolism;
• if the patient has severe liver, kidney, or heart disease.

Do not use Curatoderm on oozing erythematous lesions if occlusion is clearly present.
Curatoderm must not be used concomitantly with medicines containing salicylic acid.
Warnings and precautions
Before starting treatment with Curatoderm, consult your doctor or pharmacist.
Ultraviolet light, including sunlight, may cause degradation of tacalcitol. When tacalcitol is used in combination with ultraviolet radiation, UVA irradiation should be performed in the morning hours, while the tacalcitol ointment should be applied in the evening, before bedtime.
If there is a likelihood that the patient will be exposed to sunlight during treatment, the medicine should be applied in the evening, before bedtime.
When treating simultaneously with medicines containing calcium and/or vitamin D, periodic monitoring of calcium and protein levels in urine is recommended. If elevated calcium levels in blood are detected, treatment with Curatoderm must be discontinued immediately, followed by monitoring of calcium and protein levels in urine until these values return to normal.
When applying the medicine to the face, care should be taken to avoid contact with the eyes.
When treating the genital or anal area with Curatoderm, the excipient present in the medicine—liquid paraffin—may impair the quality of latex-containing products (e.g. condoms, vaginal diaphragms) and thus may reduce the safety of such products.
Children
Use of Curatoderm is not recommended in children under 12 years of age.
Curatoderm and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Curatoderm must not be used concomitantly with medicines containing salicylic acid.
Currently, no interactions of tacalcitol with other medicines are known, and there are no reports on concomitant use with other antipsoriatic agents.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Due to lack of adequate safety data, Curatoderm should not be used during pregnancy.
Breastfeeding
Due to lack of adequate safety data, Curatoderm should not be used during breastfeeding.
Driving and operating machinery
There are no data on adverse effects of the medicine affecting the ability to drive, operate machinery, or psycho-motor performance.
Curatoderm contains in its excipient – white soft paraffin – butylhydroxytoluene (E 321).
Butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Curatoderm

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor.
If the physician has not advised otherwise:
Adults and children over 12 years of age:
Apply a small amount of the ointment once daily to the affected skin area.
During treatment lasting up to 8 weeks, the amount of Curatoderm used should not exceed
10 g per day, and the treated area should not exceed 15% of the total body surface.
For treatment lasting up to a maximum of 18 months, the amount of Curatoderm used should be
2–3.5 g of ointment per day and should not exceed 10% of the total body surface.
The duration of treatment depends on the severity of the condition and is determined by the physician.
It is recommended to apply the ointment in the evening, before bedtime.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
In case of any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Curatoderm may cause adverse reactions, although not everyone experiences them.
Local action of Curatoderm may in individual cases cause skin irritation, manifesting as itching, burning, and redness.
Skin irritation and itching are generally mild and transient in nature.
In rare cases, contact dermatitis or worsening of psoriasis symptoms has been observed after application of the medicine.
The following adverse reactions have also been reported (frequency unknown, cannot be estimated based on available data):

• Hypersensitivity reactions (including swelling, edema, and facial edema);
• Skin rashes (erythematous, macular, papular, vesicular);
• Elevated blood calcium levels (hypercalcemia).

Other adverse reactions may occur in some individuals during treatment with Curatoderm.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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, e-mail: [email protected].

Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to gather additional information on the safety of the medicine.

5. How to store Curatoderm

Keep this medicine out of sight and reach of children. There are no special
instructions regarding storage temperature. Store the tube in its original
packaging.
Shelf life after first opening the tube: 6 months.
Do not use this medicine after the expiry date stated on the tube seal and carton
after: Expiry date. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect
the environment.

6. Contents of the pack and other information

What Curatoderm contains

• The active substance is tacalcitol monohydrate. One gram of the medicinal product contains 4.17 µg of tacalcitol monohydrate.
• The other ingredients (excipients) are: diisopropyl adipate, liquid paraffin, white soft paraffin (containing butylhydroxytoluene E 321).

What Curatoderm looks like and contents of the pack
The tube contains 20 g or 60 g of ointment.
Curatoderm is a semi-transparent, white ointment.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Almirall Hermal GmbH
Scholtzstrasse 3
D-21465 Reinbek
Germany
For further information, please contact the representative of the Marketing Authorisation Holder:
Almirall Sp. z o.o.
ul. Pileckiego 63,
02-781 Warsaw
tel.: 022 330 02 57
fax: 022 313 01 57