Curatoderm 4micrograms/g lotion

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 emulsion

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13050200; GTIN: 4042762048506

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CURATODERM® 4 MICROGRAMS/G LOTION
Tacalcitol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your
pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Curatoderm Lotion is and what it is used for
2. Before you use Curatoderm Lotion
3. How to use Curatoderm Lotion
4. Possible side effects
5. Storing your Curatoderm Lotion
6. Further information
1. WHAT CURATODERM LOTION IS AND WHAT IT IS USED FOR
Curatoderm Lotion contains tacalcitol which is a drug that belongs to
a group of medicines called
antipsoriatics and is a vitamin D derivative.
Curatoderm Lotion is used to treat a condition known as psoriasis
vulgaris especially on the scalp.
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 Lotion works by slowing down cell production
and bringing it back to
normal and helps to reduce inflammation.
2. BEFORE YOU USE CURATODERM LOTION
DO NOT USE CURATODERM LOTION
• if you are allergic (hypersensitive) to tacalcitol or any of the
other ingredients listed in sec-
tion 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 WITH CURATODERM LOTION
When applying Curatoderm Lotion to the face. Do not allow the lotion
to come in contact with the
eyes. If it do

Summary of Product characteristics

OBJECT 1
CURATODERM LOTION
Summary of Product Characteristics Updated 10-Jan-2018 | Almirall
Limited
1. Name of the medicinal product
Curatoderm 4 micrograms/ g Lotion
2. Qualitative and quantitative composition
Tacalcitol 4 micrograms/ g (as monohydrate)
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Cutaneous emulsion
A white, thin emulsion
4. Clinical particulars
4.1 Therapeutic indications
Psoriasis vulgaris, especially on the scalp
4.2 Posology and method of administration
_Adults and the Elderly_: Apply once daily to the affected areas,
preferably at bedtime. The amount applied
should not exceed 10 ml of lotion/day. When used together with
Curatoderm Ointment, the total dose of
tacalcitol should not exceed 280 μg/week (e.g. 30 ml of Curatoderm
Lotion plus 40 g of Curatoderm
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 with tacalcitol
ointment up to 18 months, and with tacalcitol lotion for up to 8
weeks.
Curatoderm Lotion can be used on all areas of the body (including
face, hairline, scalp, axilla and other
flexures_). _
_Children_: Not recommended. There is limited clinical experience with
tacalcitol in children.
4.3 Contraindications
Hypersensitivity to any of the constituents. Hypercalcaemia. 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 pustular or
erythrodermic exfoliative psoriasis as
the risk of hypercalcaemia may be enhanced.
When applying to the face avoid contact with t