Capasal Therapeutic Shampoo

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Salicylic acid; Coconut oil; Coal tar

Available from:

Dermal Laboratories Ltd

ATC code:

D05AA

INN (International Name):

Salicylic acid; Coconut oil; Coal tar

Dosage:

0.5%w/w +1%w/w+1 percent weight/weight

Pharmaceutical form:

Shampoo

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Tars

Authorization status:

Marketed

Authorization date:

1991-01-10

Patient Information leaflet

salicylic acid, coconut oil, distilled coal tar
PACKAGE LEAFLET _Information for the user_
continued…
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.
FP35/20/1 202086
TM
IN THIS LEAFLET:
1. What Capasal Therapeutic Shampoo is and
what it is used for
2. What you need to know before you use
Capasal Therapeutic Shampoo
3. How to use Capasal Therapeutic Shampoo
4. Possible side effects
5. How to store Capasal Therapeutic Shampoo
6. Contents of the pack and other information
1. WHAT CAPASAL THERAPEUTIC
SHAMPOO IS AND WHAT IT IS USED FOR
•
Capasal Therapeutic Shampoo is a treatment
for dry, scaly scalp conditions such as:
•
seborrhoeic eczema / seborrhoeic
dermatitis (patches of red, scaly, itchy skin);
•
pityriasis capitis (severe dandruff);
•
cradle cap (thick, yellowish, scaly scalp
rash in babies and infants), and;
•
psoriasis (areas of raised, red, sometimes
itchy, patches of skin, covered with
silvery scales, WITHOUT any blistering or
tenderness).
•
Capasal Therapeutic Shampoo can also be
used to remove other medicines applied to
the scalp.
•
Capasal Therapeutic Shampoo is for use by
ADULTS, THE ELDERLY, CHILDREN, INFANTS AND
BABIES.
•
This product contains three active ingredients:
• SALICYLIC ACID to remove scaly, flaky skin;
• COCONUT OIL to soften, moisturise and
lubricate the scalp, and;
• DISTILLED COAL TAR to stop itching and
restore normal skin development.
2. WHAT YOU NEED TO KNOW BEFORE
YOU USE CAPASAL THERAPEUTIC
SHAM

Summary of Product characteristics

Health Products Regulatory Authority
20 July 2020
CRN00927N
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Capasal Therapeutic Shampoo
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Salicylic Acid 0.5% w/w
Coconut Oil 1.0% w/w
Distilled Coal Tar 1.0% w/w
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Shampoo
Golden brown foaming shampoo.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use as a shampoo in the treatment of dry, scaly scalp conditions
such as seborrhoeic eczema, seborrhoeic dermatitis,
pityriasis capitis, psoriasis and cradle cap in children. It may also
be used to remove previous scalp applications.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For adults, children and the elderly.
Use as a shampoo, once or twice weekly until the condition improves.
Thereafter, occasional use may be necessary. After
thoroughly wetting the hair, massage a small amount of shampoo into
the scalp (approximately a quantity the size of a two
Euro piece for short hair, adjusting up depending on length/thickness
of hair), and leave for a few minutes before washing out.
If necessary, repeat, giving a thick lather.
Rinse the hair well and dry.
4.3 CONTRAINDICATIONS
Not to be used in cases of sensitivity to any of the ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Protect the eyes from the shampoo.
Keep out of the sight and reach of children.
If there is no improvement after 4 weeks, or the condition is
aggravated, discontinue treatment and consult your doctor,
pharmacist or nurse.
For external use only.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None known.
4.6 FERTILITY, PREGNANCY AND LACTATION
There is inadequate evidence of safety in pregnant and lactating women
but coal tar preparations have been in use for many
years without apparent ill-consequence and no harmful effects on the
health of the child is anticipated with the proper use of
Health Products Regulatory Authority
20 July 2020
CRN00927N
Page 2 of 3
this product.