CURATODERM 4.17 mg/g Ointment

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Curatoderm
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
3. What is Curatoderm and what is it used for
4. Important information before using Curatoderm
   1. When not to use Curatoderm:
   2. Warnings and precautions
   3. Children
   4. Curatoderm and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Curatoderm contains the excipient white petrolatum - butylhydroxytoluene (E 321).
5. How to use Curatoderm
6. Possible side effects
   1. Reporting side effects
7. How to store Curatoderm
8. Contents of the pack and other information
   1. What Curatoderm contains
   2. What Curatoderm looks like and contents of the pack
   3. Marketing authorization holder and manufacturer

Package Leaflet: Information for the Patient

Curatoderm

Tacalcitolum monohydricum
4.17 µg/g, ointment

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Curatoderm and what is it 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 is Curatoderm and what is it used for

Curatoderm is an ointment. Curatoderm is indicated for the treatment of mild or moderate plaque psoriasis.
Tacalcitol, the active substance of Curatoderm, is a vitamin D3 analogue. It inhibits excessive growth of the epidermis, supports the normal process of keratinization, and modifies inflammatory processes.

2. Important information before using Curatoderm

When not to use Curatoderm:

Do not use the medicine on exudative lesions if there is significant occlusion associated with it.
Curatoderm should not be used in combination with medicines containing salicylic acid.

Warnings and precautions

Before starting treatment with Curatoderm, discuss it with your doctor or pharmacist.
Ultraviolet light, including sunlight, may cause the degradation of tacalcitol. When using tacalcitol in combination with ultraviolet radiation, UVA irradiation should be performed in the morning, and the application of the tacalcitol ointment in the evening, before bedtime.
If it is likely that the patient will be exposed to sunlight during treatment, the medicine should be applied in the evening, before bedtime.
In the case of concurrent treatment with calcium and/or vitamin D-containing medicines, periodic monitoring of calcium and protein levels in the urine is recommended. If elevated calcium levels in the blood are detected, treatment with Curatoderm should be discontinued immediately, and then the calcium and protein levels in the urine should be determined until these values normalize.
When applying the medicine to the face, be careful not to get the ointment into the eyes.
During treatment of the genital or anal area with Curatoderm, the excipient present in the composition of the medicine - liquid paraffin - may impair the quality of latex-containing products (e.g., condoms, diaphragms) and thus may reduce the safety of such products.

Children

The use of the medicine is not recommended in children under 12 years of age.

Curatoderm and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any medicines you plan to use.
Curatoderm should not be used in combination with medicines containing salicylic acid.
No interactions between tacalcitol and other medicines are known, and there are no reports of concomitant use with other anti-psoriatic medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Due to the lack of relevant data on the safety of using Curatoderm, it should not be used during pregnancy.
Breastfeeding
Due to the lack of relevant data on the safety of using Curatoderm, it should not be used during breastfeeding.

Driving and using machines

No data are available on the effects of the medicine on the ability to drive or use machines.

Curatoderm contains the excipient white petrolatum - butylhydroxytoluene (E 321).

Butylhydroxytoluene may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. How to use Curatoderm

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor.
If your doctor has not recommended otherwise:
Adults and children over 12 years of age:
Apply a small amount of ointment once a day 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 area.
In the case of treatment lasting up to 18 months, the amount of Curatoderm used is 2-3.5 g of ointment per day and should not exceed 10% of the total body surface area.
The duration of treatment depends on the severity of the lesions and is determined by the doctor.
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.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Curatoderm can cause side effects, although not everybody gets them.
The local effect of Curatoderm may, in individual cases, cause skin irritation, manifested by itching, burning, and redness.
Skin irritation and itching are usually mild and transient.
In rare cases, after using the medicine, contact dermatitis or exacerbation of psoriasis symptoms have been observed.
The following side effects have also been reported (frequency not known, cannot be estimated from the available data):

• Allergic reactions (including swelling, edema, and facial edema);
• Rash (erythematous, maculopapular, papular, vesicular);
• Elevated calcium levels in the blood (hypercalcemia). Some people using Curatoderm may experience other side effects.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: +48 22 49 21 301
fax: +48 22 49 21 309
e-mail: [email protected].
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Curatoderm

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

6. Contents of the pack and other information

What Curatoderm contains

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

What Curatoderm looks like and contents of the pack

Tube containing 20 g or 60 g of ointment.
Curatoderm is a semi-transparent, white ointment.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Almirall Hermal GmbH
Scholtzstrasse 3
D-21465 Reinbek
Germany
For more detailed information, please contact the representative of the marketing authorization holder:
Almirall Sp. z o.o.
ul. Pileckiego 63,
02-781 Warsaw
phone: 022 330 02 57
fax: 022 313 01 57
Date of the last revision of the leaflet: