Ametop 4% gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tetracaine

Available from:

Forum Health Products Ltd

ATC code:

N01BA03

INN (International Name):

Tetracaine

Dosage:

40mg/1gram

Pharmaceutical form:

Cutaneous gel

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15020100; GTIN: 5000223420734 5000223420734

Patient Information leaflet

NON-PRINT AREA
READ THIS ENTIRE LEAFLET CAREFULLY BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription.
However, you still need to use AMETOP Gel
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.
•
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
1.
What AMETOP Gel is and what it is used for.
2.
Before you use AMETOP Gel.
3.
How to use AMETOP Gel.
4.
Possible side effects.
5.
How to
store AMETOP Gel.
6.
Further information.
1.
WHAT AMETOP GEL IS AND WHAT IT IS
USED FOR
AMETOP Gel is a local anaesthetic which numbs
the skin.
AMETOP GEL IS USED:
•
when needles are inserted into a vein for
giving an injection or taking a blood sample.
•
to relieve the pain of inserting small plastic
tubes (cannulae) into veins for putting up
drips.
2.BEFORE YOU USE AMETOP GEL
DO NOT USE AMETOP GEL:
•
if you are allergic (hypersensitive) to
tetracaine or any of the other ingredients of
AMETOP Gel (see Section 6 ).
•
if you are allergic (hypersensitive) to any other
local anaesthetics.
•
if you are pregnant or breast-feeding.
•
if the patient is less than 1 month old.
•
If the patient is a premature baby up until one
month after the expected delivery date
(44 weeks gestation).
•
on wounds
•
on broken skin
•
on lips, mouth or tongue
•
on eyes or ears
•
on anal and genital regions.
TAKE SPECIAL CARE WITH AMETOP GEL
•
if you suffer from epilepsy.
DO NOT swallow AMETOP Gel
IMPORTANT INFORMATION ABOUT SOME OF THE OTHER
INGREDIENTS IN AMETOP GEL:
AMETOP Gel contains Sodium methyl
parahydroxybenzoate (E219) and Sodium propyl
parahydroxybenzoate (E217) as excipients which
may cause allergic reactions (possibly delayed).
USING OTHER MEDICINES
Tell your doctor
or pharmacist if you are taking or
have recently taken any medicines, including
medicines obtained

Summary of Product characteristics

OBJECT 1
AMETOP
Summary of Product Characteristics Updated 12-Mar-2018 | Alliance
Pharmaceuticals
1. Name of the medicinal product
Ametop Gel 4% w/w
2. Qualitative and quantitative composition
Tetracaine base 4.0% w/w
3. Pharmaceutical form
Topical, white opalescent gel, each gram containing 40mg of tetracaine
base.
4. Clinical particulars
4.1 Therapeutic indications
Percutaneous local anaesthetic to produce anaesthesia of the skin
prior to venepuncture or venous
cannulation.
4.2 Posology and method of administration
Adults (including the elderly) and children over 5 years: A maximum of
5 tubes (approximately 5g) can
be applied.
Children over 1 month of age and under 5 years: No more than 1 tube
should be applied.
Apply the contents of the tube to the centre of the area to be
anaesthetised and cover with an occlusive
dressing. The contents expellable from 1 tube (approximately 1 gram)
are sufficient to cover and
anaesthetise an area of up to 30 sq.cm. (6x5cm). Smaller areas of
anaesthetised skin may be adequate in
infants and small children. Each tube is intended for use on a single
occasion only.
Adequate anaesthesia can usually be achieved following a thirty minute
application time for
venepuncture, and a forty-five minute application time for venous
cannulation, after which the gel should
be removed with a gauze swab and the site prepared with an antiseptic
wipe in the normal manner.
It is not necessary to apply Ametop gel for longer than 30-45 minutes
and anaesthesia remains for 4-6
hours in most patients after a single application.
Application of Ametop gel can be repeated after a minimum of 5 hours
if necessary.
The maximum cumulative dose in a 24 hour period should not exceed 7
tubes for adults and 2 tubes for
children.
NOT RECOMMENDED FOR INFANTS UNDER 1 MONTH OF AGE.
4.3 Contraindications
Use in premature babies or in full term infants less than 1 month of
age, where the metabolic pathway for
Tetracaine may not be fully developed. For premature babies use of
Ametop is not recommended before 1
month after