Minims Tetracaine Hydrochloride 1% w/v Eye Drops, Solution

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Tetracaine hydrochloride

Saadav alates:

Bausch + Lomb Ireland Limited

ATC kood:

S01HA; S01HA03

INN (Rahvusvaheline Nimetus):

Tetracaine hydrochloride

Ravimvorm:

Eye drops, solution

Terapeutiline ala:

Local anesthetics; tetracaine

Volitamisolek:

Marketed

Loa andmise kuupäev:

1980-04-01

Infovoldik

Bausch & Lomb
MINIMS® TETRACAINE HYDROCHLORIDE 0.5% W/V
MINIMS® TETRACAINE HYDROCHLORIDE 1% W/V
EYE DROPS, SOLUTION
TETRACAINE HYDROCHLORIDE
Read all this leaflet carefully BEFORE you start using your medicine.
It contains a summary of the
information available on your medicine. If you have any questions or
are not sure about anything, ask
your doctor or pharmacist.
Remember this medicine is for you. Do not give it to someone else.
IN THIS LEAFLET:
1. What Minims® Tetracaine Hydrochloride eye drops are and what they
are used for
2. Before you use your eye drops
3. How to use your eye drops
4. Possible side effects
5. How to store your eye drops
6. Further information
1. WHAT MINIMS® TETRACAINE HYDROCHLORIDE EYE DROPS ARE AND WHAT ARE
THEY USED FOR
Minims® Tetracaine Hydrochloride contains a local anaesthetic. It is
used to numb the eye
temporarily. Your doctor or eye specialist may use it to examine or
treat your eye without it being
painful.
This medicine should be avoided in premature babies.
2. BEFORE YOU USE YOUR EYE DROPS
DO NOT USE THESE DROPS IF
if you are allergic to the active substance (tetracaine) or any of the
other ingredients (refer to the end
of this leaflet).
if you are allergic to other similar types of local anaesthetic.
if you are taking medicines used to treat bacterial infection or
diabetes called “sulphonamides”.
in premature babies.
TAKE SPECIAL CARE
Your eye drops are not intended for long term use. Frequent use of
local anaesthetic in the eye over
long periods of time may severely affect your eyesight.
DO YOU USE ANY OF THESE MEDICINES?
medicines called “sulphonamides” used to treat bacterial infection
or diabetes.
If the answer to any of these questions is yes, tell your doctor or
eye specialist.
IF YOU ARE PREGNANT, MAY BE PREGNANT, OR ARE BREASTFEEDING
Tell your doctor or eye specialist, he/she may decide to use these
drops or to prescribe you an
alternative.
CONTACT LENSES
Your doctor will ask you to remove your contact lenses prior to the
administration of the drops. The

Toote omadused

Health Products Regulatory Authority
03 June 2022
CRN00CTZD
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Tetracaine Hydrochloride 1% w/v Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains Tetracaine hydrochloride 1% w/v solution.
Each unit (0.5ml) contains Tetracaine hydrochloride 5mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
Clear, colourless, aqueous, sterile, single dose eye drop solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ocular anaesthetic for topical instillation into the conjunctival sac.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children
One drop or as required. Each Minims unit should be discarded after
use.
4.3 CONTRAINDICATIONS
Not to be used in patients with a known hypersensitivity to the
product.
Tetracaine is hydrolysed in the body to p-amino-benzoic acid and
should not therefore be used in patients being treated with
sulphonamides.
In view of the immaturity of the enzyme system which metabolises the
ester type local anaesthetics in premature babies,
tetracaine should be avoided in these patients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The anaesthetised eye should be protected from dust and bacterial
contamination.
Use with caution in an inflamed eye, as hyperaemia greatly increases
the rate of systemic absorption through the conjunctiva.
Tetracaine may give rise to dermatitis in hypersensitive patients.
On instillation an initial burning sensation may be experienced. This
may last for up to 30 seconds.
The cornea may be damaged by prolonged application of anaesthetic eye
drops.
Systemic absorption may be reduced by compressing the lacrimal sac at
the medial canthus for a minute during and following
the instillation of the drops. (This blocks the passage of the drops
via the nasolacrimal duct to the wide absorptive area of the
nasal and pharyngeal mucosa. It is especially advisable in children.)
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS