Pill Identifier App

FULL MARKS PHENOTHRIN LIQUID

Active substance: PHENOTHRIN

View full screen / Print PDF » Download PDF ⇩

Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Full Marks Phenothrin Liquid

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenothrin 0.5% w/w

3

PHARMACEUTICAL FORM
Cutaneous Emulsion

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the treatment of head lice infestations.

4.2

Posology and method of administration
For topical external use only.
The source of infestation should be sought and treated.
Adults, the elderly and children aged 6 months and over:
Rub the emulsion into the scalp until all the hair and scalp are thoroughly
moistened. Leave the hair to dry naturally in a warm but well ventilated room.
After 12 hours, or the next day, if preferred, shampoo the hair in the normal
way.
Rinse the hair and comb whilst wet to remove dead lice and eggs (nits) using a
nit comb.
Treatment should be repeated after 7 days.

Children under 6 months:
Under medical supervision only.

4.3

Contraindications
Known sensitivity to pyrethroid insecticides. Not to be used on infants less
than 6 months except on medical advice.

4.4

Special warnings and precautions for use
Avoid contact with the eyes. For external use only. Keep out of the reach of
children. If inadvertently swallowed, a doctor or casualty department should
be contacted at once.
Children under the age of six months should be treated under medical
supervision.
When used by a school nurse or other health officer in the mass treatment of
large numbers of children, it is advisable that protective plastic or rubber
gloves be worn.
Continued prolonged treatment with this product should be avoided. It should
not be used more than once a week for more than three consecutive weeks.
The treatment may affect permed, pre-rinsed, bleached or coloured hair.

4.5

Interaction with other medicinal products and other forms of interaction
None stated.

4.6

Pregnancy and lactation
No known effects in pregnancy and lactation. However, as with all medicines,
use with caution.

4.7

Effects on ability to drive and use machines
None stated.

4.8

Undesirable effects
Very rarely skin irritation has been reported.

4.9

Overdose
It is most unlikely that a toxic dose will be ingested. Treatment consists of
gastric lavage, assisted respiration and, if necessary in the event of massive
ingestion, administration of Atropine together with Pralidoxime.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Phenothrin is a synthetic pyrethroid insecticide, highly effective against human
lice but with an exceptionally low mammalian toxicity.

5.2

Pharmacokinetic properties
Full Marks Phenothrin Liquid is applied topically to the affected area. A
pharmacokinetic study has shown absorption of the active constituent is
negligible.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Potassium Citrate EP
Citric Acid Monohydrate EP
Emulsifying Wax (Lanette Wax SX) BP
Methyl Hydroxybenzoate EP
Propyl Hydroxybenzoate EP
Perfume HT 52
Diethylene Glycol
Dimethyl Phthalate BP
Purified Water EP

6.2

Incompatibilities
None stated.

6.3

Shelf life
36 months.

6.4

Special precautions for storage
Store below 25°C and do not refrigerate

6.5

Nature and contents of container
Amber glass sirop bottle fitted with a polypropylene tamper evident lined cap
containing 50, 100 and 200m1 of product.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
Shake the bottle before use.

7

MARKETING AUTHORISATION HOLDER
SSL International plc
Venus
No 1 Old Park Lane
Trafford Quays
Urmston
Manchester
M41 7HA

8

MARKETING AUTHORISATION NUMBER(S)
PL 17905/0062

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
19/1/98

10

DATE OF REVISION OF THE TEXT
May 2009

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)