Curatoderm 4micrograms/g ointment

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tacalcitol monohydrate

Available from:

Almirall Ltd

ATC code:

D05AX04

INN (International Name):

Tacalcitol monohydrate

Dosage:

4microgram/1gram

Pharmaceutical form:

Cutaneous ointment

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13050200; GTIN: 5000167019148 5000167019155 5000167030037

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CURATODERM® 4 MICROGRAMS/G OINTMENT
Tacalcitol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

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 signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Curatoderm Ointment is and what it is used for
2. What you need to know before you use Curatoderm Ointment
3. How to use Curatoderm Ointment
4. Possible side effects
5. How to store Curatoderm Ointment
6. Contents of the pack and other information
1. WHAT CURATODERM OINTMENT IS AND WHAT IT IS USED FOR
Curatoderm Ointment contains tacalcitol which is a drug that belongs
to a group of medicines called
antipsoriatics and is a vitamin D derivative.
Curatoderm Ointment is used to treat a condition known as psoriasis
vulgaris. Psoriasis is a skin disorder
in which itchy, red, flaky patches appear on the skin or scalp. Within
affected areas of skin, new cells are
being produced faster than normal, but old dead cells are only being
shed at the normal rate. As live skin
cells accumulate, the skin becomes thickened and inflamed.
Curatoderm Ointment works by slowing down cell production and bringing
it back to normal and helps
reduce inflammation.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CURATODERM OINTMENT
DO NOT USE CURATODERM OINTMENT

if you are allergic to tacalcitol or any of the other ingredients of
this medicine (listed in section 6).

if you have ever had problems with too much calcium in your blood
(hypercalcaemia or other
disorders of calcium metabolism).
If this applies to you do not use this medicine and speak to your
doctor.
TAKE SPECIAL CARE W

Summary of Product characteristics

OBJECT 1
CURATODERM OINTMENT
Summary of Product Characteristics Updated 27-Feb-2018 | Almirall
Limited
1. Name of the medicinal product
Curatoderm 4μg/g Ointment
2. Qualitative and quantitative composition
One gram of ointment contains 4μg/g of tacalcitol (4.17μg/g of
tacalcitol monohydrate).
Excipients with known effect
Butylhydroxytoluene (E 321) contained in the excipient Paraffin, white
soft
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Ointment
4. Clinical particulars
4.1 Therapeutic indications
Curatoderm ointment is indicated for the treatment of psoriasis
vulgaris in adults.
4.2 Posology and method of administration
Posology
_Adults and the Elderly: _
Apply sparingly, once daily to the affected areas, preferably at
bedtime. The amount applied should not
exceed l0g of ointment/day. Ointment). Normally duration of treatment
depends on the severity of the
lesions and should be decided by the physician. There is clinical
trial experience with continuous and
intermittent treatment in adults up to twelve months.
Curatoderm Ointment can be used on all areas of the body (including
face, hairline, scalp, axilla and other
flexures).
When used on the scalp the ointment can be shampooed out the next
morning.
_Paediatric population:_
The safety and efficacy of Curatoderm Ointment in children and
adolescents under 18 years have not
been established.
4.3 Contraindications
• Hypersensitivity to the active substance or to any of the
excipients listed in section 6.1.
• Patients with hypercalcaemia or other known disorders of calcium
metabolism.
4.4 Special warnings and precautions for use
At the doctor's discretion, in patients at risk of hypercalcaemia, or
patients taking high Vitamin D
preparations (in excess of 500 IU vitamin D) albumin corrected serum
calcium levels should be closely
monitored. Treatment should be stopped if hypercalcaemia occurs.
Serum calcium levels should also be monitored in patients with renal
impairment. Care should be
exercised in patients with generalised pustu