Ametop 40 mg/g Gel

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Tetracaine base

Dostupné z:

Alliance Pharma (Ireland) Limited

ATC kód:

N01BA; N01BA03

INN (Medzinárodný Name):

Tetracaine base

Dávkovanie:

40 milligram(s)/gram

Forma lieku:

Gel

Terapeutické oblasti:

Esters of aminobenzoic acid; tetracaine

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2018-07-06

Príbalový leták

Ametop PIL IE 004
PATIENT INFORMATION LEAFLET
AMETOP
® 40MG/G GEL
Tetracaine
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION
FOR YOU.
This medicine is available without prescription. Always use this
medicine
exactly as described in this leaflet or as your doctor or pharmacist
has told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This
includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What AMETOP Gel is and what it is used for
2. What you need to know before you use AMETOP Gel
3. How to use AMETOP Gel
4. Possible side effects
5.
How to store AMETOP Gel
6.
Contents of the pack and other information
1. WHAT AMETOP GEL IS AND WHAT IT IS USED FOR
AMETOP Gel contains the active substance tetracaine. Tetracaine is a
local
anaesthetic which numbs the skin.
AMETOP GEL IS USED:
•
to relieve the pain 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.
•
prior to non-ablative skin laser treatment to relieve the pain of the
procedure.
AMETOP Gel is used in adults and infants aged over 1 month.
Ametop PIL IE 004
2. WHAT YOU NEED TO KNOW 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.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using this me

Súhrn charakteristických

Health Products Regulatory Authority
11 November 2020
CRN00C109
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ametop 40 mg/g Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of gel contains 40 mg tetracaine (as hydrochloride)
equivalent to tetracaine base 4.0% w/w.
Excipients with known effect:
Sodium methyl parahydroxbenzoate (E219) 2 mg/g
Sodium propyl parahydroxybenzoate (E217) 0.2 mg/g
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gel
White, opalescent gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Percutaneous local anaesthetic to produce anaesthesia of the skin
prior to venepuncture, venous cannulation or non-ablative
dermal laser procedures.
Ametop is indicated in adults and infants aged over 1 month.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults (including the elderly): A maximum of 5 tubes (approximately
5g) can be applied at separate sites at a single time.
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.
_Paediatric population_
Ametop is contraindicated in premature babies or in full term infants
less than 1 month of age (see section 4.3).
Infants over 1 month and children under 5 years of age: A maximum of 1
tube (approximately 1 g) can be applied at separate
sites at a single time. 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 2 tubes.
Children over 5 years of age: A maximum of 5 tubes (approximately 5 g)
can be applied at separate sites at a single time.
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.
METHOD OF ADMINISTRATION
_Cutaneous route._
_Precautions to be taken before handling or administering the
medicinal product _
It may be advisable to use a finger cot or rubber glove during
application and