Q: Who should NOT take Tacalcitol?

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypercalcaemia and any disorder associated with altered calcium metabolism. Guttate or pustular psoriasis (psoriasis punctata and psoriasis pustulosa). Severe hepatic, renal or cardiac disease, owing to the increased risk of developing hypercalcaemia or experiencing serious clinical sequelae from it. Products containing more than 500 IU of vitamin D must not be used during treatment with Curatoderm.

Q: Can Tacalcitol be used during pregnancy?

Pregnancy There is no experience of the use of Curatoderm in pregnancy. Animal studies have shown no embryotoxic effects in rats or rabbits (see section 5.3). The potential risk to humans is unknown. Curatoderm should therefore not be used during pregnancy. Breast-feeding Tacalcitol and its principal metabolite are excreted in the milk of lactating rats. It is not known whether tacalcitol is excreted in human breast milk. Treatment with Curatoderm is therefore not indicated during breast-feeding

Q: What precautions should be taken with Tacalcitol?

Patients should be advised, when applying the product to the face, to avoid contact with healthy skin and with the eyes. Owing to the lack of clinical experience, use in children under 12 years of age is not recommended. The product should not be applied to more than 15–20% of body surface area, depending on the duration of treatment (see section 4.2). Monitoring of calcium levels is advised in patients receiving concomitant calcium or vitamin D and in those with impaired renal function. Butylat

Q: What ATC class does Tacalcitol belong to?

Tacalcitol: ATC D05AX04. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Question 1

What is Tacalcitol used for?

Accepted Answer

Topical treatment of psoriasis vulgaris, particularly mild to moderate forms in adults.

Question 2

How does Tacalcitol work?

Accepted Answer

Pharmacotherapeutic group: antipsoriatics, tacalcitol
ATC code: D05AX04
The active substance of Curatoderm, tacalcitol, is an analogue of vitamin D3.

Question 3

What is the active ingredient in Tacalcitol?

Accepted Answer

Tacalcitolum (Tacalcitolum monohydricum)

Question 4

What pharmaceutical form is Tacalcitol available in?

Accepted Answer

Tacalcitol: Maść 4,17 mg/g (na skórę)

Question 5

Is Tacalcitol OTC or prescription only?

Accepted Answer

Tacalcitol requires a doctor's prescription.

Question 6

What are the side effects of Tacalcitol?

Accepted Answer

The frequency of adverse reactions is defined as follows: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).
Immune system disorders
Not known: hypersensitivity reactions (including swelling, oedema and facial oedema).
Metabolism and nutrition disorders
Not known: hypercalcaemia.
Skin and subcutaneous tissue disorders
Rare: skin irritation (e.g. burning, erythe

Question 7

Who should NOT take Tacalcitol?

Accepted Answer

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Hypercalcaemia and any disorder associated with altered calcium metabolism.
Guttate or pustular psoriasis (psoriasis punctata and psoriasis pustulosa).
Severe hepatic, renal or cardiac disease, owing to the increased risk of developing hypercalcaemia or experiencing serious clinical sequelae from it.
Products containing more than 500 IU of vitamin D must not be used during treatment with Curatoderm.

Question 8

Can Tacalcitol be used during pregnancy?

Accepted Answer

Pregnancy
There is no experience of the use of Curatoderm in pregnancy.
Animal studies have shown no embryotoxic effects in rats or rabbits (see section 5.3). The potential risk to humans is unknown. Curatoderm should therefore not be used during pregnancy.
Breast-feeding
Tacalcitol and its principal metabolite are excreted in the milk of lactating rats.
It is not known whether tacalcitol is excreted in human breast milk. Treatment with Curatoderm is therefore not indicated during breast-feeding

Question 9

What precautions should be taken with Tacalcitol?

Accepted Answer

Patients should be advised, when applying the product to the face, to avoid contact with healthy skin and with the eyes.
Owing to the lack of clinical experience, use in children under 12 years of age is not recommended.
The product should not be applied to more than 15–20% of body surface area, depending on the duration of treatment (see section 4.2).
Monitoring of calcium levels is advised in patients receiving concomitant calcium or vitamin D and in those with impaired renal function.
Butylat

Question 10

Who manufactures Tacalcitol?

Accepted Answer

Almirall Hermal GmbH (Niemcy)

Question 11

What ATC class does Tacalcitol belong to?

Accepted Answer

Tacalcitol: ATC D05AX04. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Tacalcitol

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