Psoriderm Scalp Lotion Shampoo

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Coal tar

Available from:

Dermal Laboratories Ltd

ATC code:

D05AA

INN (International Name):

Coal tar

Dosage:

2.5 percent weight/volume

Pharmaceutical form:

Shampoo

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Tars

Authorization status:

Marketed

Authorization date:

1980-12-01

Patient Information leaflet

PACKAGE LEAFLET Information for the user
Psoriderm Scalp Lotion Shampoo
distilled coal tar 2.5% w/v
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or
nurse has told you.
Keep this leaflet. You may need to read it again. Ask your doctor,
pharmacist or nurse if you
need more information or advice. If you get any side effects , talk to
your doctor, pharmacist
or nurse. This includes any possible side effects not listed in this
leaflet. See section 4. You
must talk to a doctor if your skin condition is not improving or if it
feels worse after 4 weeks.
What is in this leaflet:
1.
What Psoriderm Scalp Lotion Shampoo is and what it is used for
2.
What you need to know before you use Psoriderm Scalp Lotion Shampoo
3.
How to use Psoriderm Scalp Lotion Shampoo
4.
Possible side effects
5.
How to store Psoriderm Scalp Lotion Shampoo
6.
Contents of the pack and other information
1. WHAT PSORIDERM SCALP LOTION SHAMPOO IS AND WHAT IT IS USED
FOR

Psoriderm Scalp Lotion Shampoo is a shampoo treatment for scalp
psoriasis (areas of
raised, red, sometimes itchy, patches of skin, covered with silvery
scales
WITHOUT
any
blistering or tenderness).

The shampoo is for use by
ADULTS, THE ELDERLY AND CHILDREN.

This product contains the active ingredient
DISTILLED COAL TAR
, which stops itching and
restores normal skin development.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PSORIDERM SCALP
LOTION SHAMPOO
DO NOT USE PSORIDERM SCALP LOTION SHAMPOO:

if you are
ALLERGIC (HYPERSENSITIVE)
to distilled coal tar, or any of the other ingredients
of this medicine listed in Section 6;

on psoriasis that feels and looks sore and angry, or on pustular
psoriasis (which is
very tender, inflamed, and involves small blisters filled with pus);

on infected skin.
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE
when using this product: Keep the undiluted shampoo, and the lather,
aw

Summary of Product characteristics

Health Products Regulatory Authority
06 January 2020
CRN00927L
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Psoriderm Scalp Lotion Shampoo
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Distilled Coal Tar2.5% w/v
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Shampoo
Golden-brown coloured foaming therapeutic shampoo.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the topical treatment of psoriasis of the scalp.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Use as a shampoo, daily if necessary, reducing the frequency of use to
once or twice a week as the condition improves.
Thereafter, occasional use may be necessary.
_For adults, children and the elderly_: wet the hair thoroughly. Apply
a small amount of the shampoo to the scalp (approximately
a quantity the size of a two Euro piece for short hair, adjusting up
depending on length/thickness of hair) and massage gently
until a rich lather has been generated. Retain on the scalp for a few
minutes. Remove excess lather with the hands before
rinsing with warm water. If necessary, repeat the above procedure.
4.3 CONTRAINDICATIONS
Not to be used for acute, sore or pustular psoriasis or in the
presence of infection.
Not to be used in cases of sensitivity to any of the ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Keep away from the eyes and mucous membranes.
Replace cap after use.
Avoid spillage.
For external use only.
If there is no improvement after 4 weeks, or the scalp condition seems
to look or feel worse, discontinue treatment and tell
your doctor, pharmacist or nurse.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None known.
4.6 FERTILITY, PREGNANCY AND LACTATION
No special precautions.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
Health Products Regulatory Authority
06 January 2020
CRN00927L
Page 2 of 3
4.8 UNDESIRABLE EFFECTS
Local side-effects do not normally occur. In the rare event of skin
irritation, acne-like eruptions or photosensitivity,