Sodium pyrrolidone carboxylate 2.5 % w/w Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium pyrrolidone carboxylate

Available from:

Alliance Pharma (Ireland) Limited

ATC code:

D02AX

INN (International Name):

Sodium pyrrolidone carboxylate

Dosage:

2.5 percent weight/weight

Pharmaceutical form:

Cream

Therapeutic area:

Other emollients and protectives

Authorization status:

Not marketed

Authorization date:

2006-08-11

Patient Information leaflet

Sodium pyrrolidone carboxylate 2.5% w/w Cream PIL ROI 009
LOGO
SODIUM PYRROLIDONE CARBOXYLATE 2.5% W/W CREAM
INFORMATION FOR PATIENTS
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR
YOU.
This medicine is available without prescription. However, you still
need to use
Sodium pyrrolidone carboxylate 2.5% w/w Cream carefully to get the
best results
from it.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
You must contact a doctor if your symptoms worsen or do not improve.
•
If any of the side effects gets serious, or if you notice any side
effect not listed in
this leaflet, please tell your doctor or pharmacist.
The information in this leaflet has been divided into the following
sections:
1.
SODIUM PYRROLIDONE CARBOXYLATE 2.5% W/W CREAM IS AND WHAT IT IS USED
FOR
2. CHECK BEFORE YOU USE SODIUM PYRROLIDONE CARBOXYLATE 2.5% W/W CREAM
3. HOW TO USE SODIUM PYRROLIDONE CARBOXYLATE 2.5% W/W CREAM
4. POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SODIUM PYRROLIDONE CARBOXYLATE 2.5% W/W CREAM
6.
FURTHER INFORMATION
1. WHAT SODIUM PYRROLIDONE CARBOXYLATE 2.5% W/W CREAM IS AND WHAT IT
IS USED
FOR
Sodium pyrrolidone carboxylate 2.5% w/w Cream is a soft, white cream
which
moisturises the skin.
Sodium pyrrolidone carboxylate 2.5% w/w Cream contains a naturally
occurring
moisturising agent as well as oils, which prevent moisture loss from
the skin. This
helps to relieve itch, lubricate and soften the skin.
Sodium pyrrolidone carboxylate 2.5% w/w Creamis used to treat any
condition in
which dry skin is a feature such as eczema, ichthyosis (hereditary dry
skin) and
senile pruritus (itching that may occur in old age).
2. CHECK BEFORE YOU USE SODIUM PYRROLIDONE CARBOXYLATE 2.5% W/W CREAM
DO NOT USE SODIUM PYRROLIDONE CARBOXYLATE 2.5% W/W CREAM:
•
if you are allergic (hypersensitive) to sodium pyrrolidone carboxylate
or any of the
ingredients of Sodium pyrrolidone carboxylate 2.5% w/w Cream (see
section 6
Further information).
Sodium p

Summary of Product characteristics

Health Products Regulatory Authority
26 March 2019
CRN008KJP
Page 1 of 3
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.
Health Products Regulatory Authority
26 March 2019
CRN008KJP
Page 2 of 3
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None known.
4.6 FERTILITY, PREGNANCY AND LACTATION
Sodium pyrrolidone carboxylate 2.5 % w/w Cream is not contra-indicated
in pregnancy or lactation.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not applicable.
4.8 UNDESIRABLE EFFECTS
Rarely a non serious allergic type reaction may be experienced, e.g.
rash.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after authorisation of the
medi