Minims Tropicamide 1%

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TROPICAMIDE

Available from:

Bausch & Lomb UK Limited

ATC code:

S01FA06

INN (International Name):

TROPICAMIDE

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

TROPICAMIDE 1 % (W/V)

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Authorised

Authorization date:

2005-10-04

Patient Information leaflet

TROPICAMIDE
1%
w/v
Eye Drops, Solution
®
TROPICAMIDE
1%
w/v
Eye Drops, Solution
®
85884
C1UKIE01
Manufacturer:
Laboratoire Chauvin
Z.I. Ripotier Haut
07200 Aubenas - France
TROPICAMIDE
1%
w/v
Eye Drops, Solution
®
20 Single-dose containers
Preservative-free
Active ingredient:
Each unit (0.5ml) contains tropicamide 5mg.
Excipients:
Purified water, hydrochloric acid and sodium hydroxide (for
pH-adjustment).
British Pharmacopoeia Evocative Code: TRO 1.0
DOSAGE
Use as directed by medical practitioner.
DIRECTIONS FOR USE
1 Peel the overwrap apart and withdraw the Minims
®
unit.
2 Twist cap and pull off.
3 Squeeze the unit to obtain the number of drops required.
4 FOR SINGLE USE ONLY. DISCARD ANY UNUSED SOLUTION.
For ocular use.
20 sterile single-dose containers of 0.5 ml.
Bausch & Lomb UK Ltd, 106 London Road,
Kingston-Upon-Thames, Surrey KT2 6TN, United Kingdom
Minims is a registered trademark of Bausch & Lomb Incorporated or its
affiliates.
PL 03468/0085 PA 555/15/2 HK-14987
MAL19871633A SIN4202P MA147/00110
10694GB
TROPICAMIDE
1%
w/v
Eye Drops, Solution
®
One
MINIMS UNIT
One patient
Do not store above 25°C.
Do not freeze.
STORE IN ORIGINAL CONTAINER
TO PROTECT FROM LIGHT.
Keep out of the reach
and sight of children.
5 027519 002603
minims
tropicamide
#1% w/v
Eye drops,
solution
minims
tropicamide
#1% w/v
Eye drops,
solution
DO NOT DISPENSE
IF SEAL IS BROKEN
BN: A99999
DOM: 99-9999
EXP: 99-9999
DO NOT DISPENSE
IF SEAL IS BROKEN
BN: A99999
DOM: 99-9999
EXP: 99-9999
KARTONIK CARTON
Nazwa produktu Product name
Kraj Country (ISO)
Wymiar komponentu Component size
Kolory nadruku Colours
Dane techniczne Technical data
Krój czcionki Fonts Used
Kod kreskowy Barcode _(EAN, PZN etc.)_
Wielkość opakowania Pack size
Kod farmaceutyczny Pharmacode
Kod wersji Valeant code version
Nr Wykrojnika Spec. No.
Kod Wytwórcy Manufacturer code
Data Date
Nr korekty Proof Nr
Komentarze Comments
_(Reason for the change)_
Rozmiar czcionki Font size
MINIMUM 5,84 PT
Graphics&Packing Technology Section
ICN Polfa Rzeszów S.A.
_MAH transfe

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1.   
TRADE NAME OF THE MEDICINAL PRODUCT   

Minims Tropicamide 1%.   

2.   
QUALITATIVE AND QUANTITATIVE COMPOSITION   

Clear, colourless, sterile eye drops containing Tropicamide Ph.
Eur. 1% w/v.   

3.   
PHARMACEUTICAL FORM   

Single-use, sterile eye drops.   

4.   
CLINICAL PARTICULARS   

4.1 THERAPEUTIC INDICATIONS   

As a topical mydriatic and cycloplegic.   

4.2 POSOLOGY AND METHOD OF ADMINISTRATION   

_     _
_Adults (including the elderly):_   

1  drop  followed  by  a  second  drop  after  an  interval  of  5  minutes.    A  further  1  drop  may  be 
instilled after 30 minutes, if required.   

_Children:_   

At the discretion of the physician.   

4.3 CONTRAINDICATIONS   

Do not use in patients with a known hypersensitivity to
tropicamide.   

Tropicamide  is  contraindicated  in  narrow  angle  glaucoma  and  in  eyes      where  the  filtration 
angle is narrow, as an acute attack of angle
closure      glaucoma may be precipitated.   

4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE   

Use  with  caution  in  an  inflamed  eye,  as  hyperaemia  greatly  increases  the      rate  of  systemic 
absorption through the conjunctiva.   

Care should be exercised in small children.   

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 drops 
via  the  naso-lacrimal      duct  to  the  wide  absorptive  ar