SODIUM PYRROLIDONE CARBOXYLATE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SODIUM PYRROLIDONE CARBOXYLATE

Available from:

Alliance Pharmaceuticals Ltd.

ATC code:

D02AX

INN (International Name):

SODIUM PYRROLIDONE CARBOXYLATE

Dosage:

2.5 %w/w

Pharmaceutical form:

Cream

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other emollients and protectives

Authorization status:

Not marketed

Authorization date:

2006-08-11

Patient Information leaflet

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Magenta text, keylines and shading are NOT to be printed
Product Title:
Hydromol Cream leaflet
Date:
12-05-15
Product Size:
126mm x 150mm
Label Number:
15-048
Version 3
Colours Used:
PMS 291, PMS 292, PMS 274
Fonts Used:
Swiss 721, Palatino
Font size (min):
6.5pt
XXXXX
© Alliance Pharmaceuticals Limited. 2015
Hydromol cream is manufactured by: Dales Pharmaceuticals Limited,
Skipton, North Yorkshire, BD23 2RW, UK.
The active ingredient in this medicine is sodium pyrrolidone
carboxylate 2.5%.
The other ingredients are liquid paraffin, isopropyl myristate, sodium
lactate solution, cetomacrogol emulsifying wax, myristyl myristate,
macrogol cetostearyl ether, hydroxybenzoates (parabens)
(E218, E214, E216), phenoxyethanol and purified water.
THIS LEAFLET WAS LAST REVISED: April 2015.
Alliance Pharmaceuticals Limited.
Hydromol is a registered trade mark of Alliance Pharmaceuticals
Limited.
The product licence holder is: Alliance Pharmaceuticals Limited,
C R E A M
Sodium Pyrrolidone Carboxylate
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via HPRA Pharmaccovigilance,
Earlsfort Terrace, IRL - Dublin 2; Tel: [phone]; Fax: +353 1
6762517. Website: www.hpra.ie; E-mail: [e-mail]. By
reporting side effects you can help provide more information on the
safety of this medicine.
If your condition worsens consult your doctor or pharmacist.

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium pyrrolidone carboxylate 2.5 % w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Pyrrolidone Carboxylate 2.50 % w/w.
Excipients:
Contains cetostearyl alcohol 4%w/w.
Contains hydroxybenzoates (parabens) approximately 1%w/w: methyl
(E218), ethyl (E214), propyl (E216) and butyl
parahydroxybenzoates.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
Soft, white oil-in-water cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a lubricant and hydrating agent in the management of dry skin
conditions such as certain types of eczema,
ichthyosis and senile pruritus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration
For topical use only.
ADULTS, CHILDREN AND THE ELDERLY:
Apply liberally to the affected area and massage well into the skin.
Sodium pyrrolidone carboxylate 2.5 % w/w Cream may be used as often as
required.
Sodium pyrrolidone carboxylate 2.5 % w/w Cream is especially
beneficial when used immediately after washing or
bathing, when the resultant warmth of the skin enhances absorption.
4.3 CONTRAINDICATIONS
There are no contraindications except true hypersensitivity to any of
the ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If there is aggravation of the condition consult the doctor.
The formulation is not designed for use as a diluent.
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