Psoriderm Emulsion 40% w/v Bath Additive

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:

40 percent weight/volume

Pharmaceutical form:

Bath additive

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Tars

Authorization status:

Marketed

Authorization date:

1980-12-01

Patient Information leaflet

IN THIS LEAFLET:
1. What Psoriderm Emulsion Bath Additive is and
what it is used for
2. Before you use Psoriderm Emulsion Bath
Additive
3. How to use Psoriderm Emulsion Bath Additive
4. Possible side effects
5. How to store Psoriderm Emulsion Bath
Additive
6. Further information
1. WHAT PSORIDERM EMULSION BATH
ADDITIVE IS AND WHAT IT IS USED FOR
•
Psoriderm Emulsion Bath Additive is a
treatment for you to add to your bath water
when bathing.
•
It helps treat a particular type of psoriasis
that doctors refer to as sub-acute or chronic
plaque psoriasis.
•
This type of psoriasis involves areas of raised,
red, sometimes itchy, patches of skin, covered
with silvery scales (WITHOUT any blistering or
tenderness). The patches often occur on the
elbows, knees, lower back and scalp.
•
This product is recommended for use by
ADULTS, THE ELDERLY AND CHILDREN.
•
The active ingredient in this product is
DISTILLED COAL TAR, which stops itching and
restores normal skin development.
2. BEFORE YOU USE PSORIDERM
EMULSION BATH ADDITIVE
DO NOT USE PSORIDERM EMULSION BATH
ADDITIVE:
•
if you are ALLERGIC (HYPERSENSITIVE)
to distilled coal tar or any of the other
ingredients of Psoriderm Emulsion Bath
Additive 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.
TAKE SPECIAL CARE when using this product:
•
Do not use it undiluted.
•
Avoid spilling it.
•
Keep it away from the eyes, and broken or
inflamed skin.
USING OTHER MEDICINES
This product is not known to affect,
or to be affected by, any other medicines.
PREGNANCY AND BREAST-FEEDING
This product can be used during pregnancy and
whilst breast-feeding. The ingredients have been
in widespread use in this and similar preparations
for many years, without reports of problems.
However, safety trials have not been conducted.
DRIVING AND USING MACHINERY
Using this product is not known to affect your
ability to drive or use machi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Psoriderm Emulsion 40% w/v Bath Additive
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Distilled Coal Tar 40.0% w/v.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Bath additive.
Buff-coloured liquid bath additive.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use topically as an aid in the treatment of subacute and chronic
psoriasis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_For adults, children and the elderly_: add 30 ml of the emulsion to a
standard bath of warm water. Soak for 5 minutes, pat
dry.
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
Do not use product undiluted.
Keep away from the eyes and broken or inflamed skin.
Replace cap after use.
Avoid spillage.
For external use only.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6 FERTILITY, PREGNANCY AND LACTATION
No special precautions.
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4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
4.8 UNDESIRABLE EFFECTS
Local side-effects do not normally occur. In the rare event of skin
irritation, acne-like eruptions or photosensitivity,
discont