Para Shampoo Special Lice and Nits

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PIPERONYL BUTOXIDE, DEPALLETHRINE

Available from:

Laboratoires Omega Pharma France 2 rue Chaintron, BP 850, 92542 Montrouge, France

ATC code:

P03AC52

INN (International Name):

PIPERONYL BUTOXIDE 4.4 % (W/W) DEPALLETHRINE 1.1 % (W/W)

Pharmaceutical form:

CUTANEOUS LIQUID

Composition:

PIPERONYL BUTOXIDE 4.4 % (W/W) DEPALLETHRINE 1.1 % (W/W)

Prescription type:

OTC

Therapeutic area:

ECTOPARASITICIDES, INCL. SCABICIDES, INSECTICIDES AND REPELLENTS

Authorization status:

Withdrawn

Authorization date:

2007-04-12

Patient Information leaflet

Réserve Vernis
DIRECTIONS FOR USE
PRECAUTIONS
COMPOSITION
BP 850 - 92542 MONTROUGE Cédex
FRANCE
EB 0HH 30/B
LABORATOIRES OMEGA PHARMA FRANCE
DATE :
SIGNATURE :
CONTACT : JAMILA
FORMAT : 100%
FORMAT  :  95X125 MM 
TÉL. PAO  04 66 81 89 61/ FAX  [phone] - POUR NE PAS
RETARDER LE DELAI CONVENU POUR L'IMPRESSION, VEUILLEZ RENVOYER CE BON
A TIRER PAR FAX DANS LES 3 JOURS AU PLUS TARD. MERCI
A L'ATTENTION DE MME KATHLEEN DECROP - STÉ MEDGENIX - 
 CI-DESSOUS BON À TIRER
LE 12 OCTOBRE 2006
IMPRESSION 3 COUL. : VERT PANTONE 374C - VERT PANTONE 347C - NOIR 
SUPPORT : VINYLE TRANSPARENT BRILLANT
OPTION : VERNIS PARTIEL BRILLANT
COINS : 1
RÉF. : 9 08 31 83 835/2
BAT 1 : 1 série 

Summary of Product characteristics

 
Page 1 of 3 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.  TRADE NAME OF THE MEDICINAL PRODUCT   

PARA SHAMPOO SPECIAL LICE AND NITS 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 

Depallethrine ....................................................................................................................1.1
g 
Piperonyl
Butoxyde...........................................................................................................4.4g 

per 100 g of solution. 

3.  PHARMACEUTICAL FORM 

Shampoo 

4.  CLINICAL PARTICULARS 

4.1  Therapeutic Indications 

Treatment of pediculus humanus capitis (head lice). 

4.2  Dosage and Method of Administration 

_First day: _apply shampoo to wet hair, and massage the
scalp thoroughly (pre-shampoo). 
Rinse with a lot of water. Repeat the operation and allow shampoo to
remain on scalp for 
five minutes. Rinse. Use a fine-tooth comb to remove dead nits. 
_Second day:_ repeat the operation in the same conditions. 

In order to avoid recontamination, we advise you to: 
–  treat other members of your family as well 
–  decontaminate clothes, sheets and objects that have come into
direct contact with your 
hair, by washing them at 60°C. If you cannot wash them, put
them into a plastic bag for 
48 hours with an insecticide or for 8 days without an insecticide.

4.3  Contraindications 

Hypersensitivity or intolerance to one of the components. 

4.4  Special Warnings and Precautions for Use 

Avoid contact with eyes and mucous membranes. 

Page 2 of 3 
4.5  Interactions with other drugs and other forms of interaction 

Not applicable 

4.6  Pregnancy and Lactation 

Not applicable 

4.7  Effects on Ability to Drive and Use Machines 

Not applicable 

4.8  Adverse Reactions 

Rarely observed: red spots and dandruff. 
Due to the presence of propyl and
methyl parahydroxybenzoate, exceptional risk of conta