Minims cyclopentolate hydrochloride 1% eye drops 0.5ml unit dose

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cyclopentolate hydrochloride

Available from:

Bausch & Lomb UK Ltd

ATC code:

S01FA04

INN (International Name):

Cyclopentolate hydrochloride

Dosage:

10mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11050000; GTIN: 5027519000708

Patient Information leaflet

Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.
ULOTKA PIL
Nazwa produktu
Product Name
MINIMS CYCLOPENTOLATE
HYDROCHLORIDE 0,5% AND
1% DRP
Kolor nadruku Colours
Black
Kraj
Country (ISO)
UNITED KINGDOM (UK)
Nr wykrojnika
Spec No
5338
Opracowane przez
Designed by
Kod Wytwórcy
Manufacturer code
76897
Nr korekty
Proof No
1
Data
Date
24.07.2015
Kod farmaceutyczny
Pharmacode
-
Kod wersji
Valeant version code
P1UK01
Inny kod
Other code
76897 (DATA MATRIX)
Rozmiar czcionki
Font size
MINIMUM 8 PT
Wymiar ulotki
PIL size
160 X 240 MM
Krój czcionki
Font used
Frutiger Neue LT W1G
Condensed
FRUTIGER NEUE LT W1G
CONDENSED BOLD
Gramatura papieru
Paper weight
- G/M
2
Komentarze Comments (Reason for the change)
TEXT REPLACED WITH CORRECT PRODUCT NAME & FORMATTING CHANGES (ADDITION
OF BULLET)
PMR_ICN-15-0692-A AND PMR_ICN-14-0749-A.PDF
PACKING SITE: LABORATOIRE CHAUVIN, AUBENAS, FRANCE
Akceptacja Techniczna Technical Approval
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval
MINIMS® CYCLOPENTOLATE HYDROCHLORIDE 0.5% W/V
MINIMS® CYCLOPENTOLATE HYDROCHLORIDE 1% W/V
EYE DROPS, SOLUTION
CYCLOPENTOLATE HYDROCHLORIDE
IN THIS LEAFLET:
1.
What Minims® Cyclopentolate 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® CYCLOPENTOLATE HYDROCHLORIDE EYE DROPS ARE AND WHAT THEY
ARE USED FOR
Minims® Cyclopentolate Hydrochloride contains a mydriatic agent. It
is used to enlarge the pupil of the eye and to paralyse the lens
temporarily.
Your doctor or eye specialist may use it to examine your eye more
closely.
These eye drops are also used to treat some types of inflammation of
the eye.
This medicine is not indicated for babies under 28 days old.
However, your doctor or eye specialist can use it if he/she decides
that it is necessary.
2.
BEFORE YOU USE YOUR EYE DROPS
DO NOT USE THESE DROPS
•
if you are allergic to the active substance (cyclopentolate

Summary of Product characteristics

OBJECT 1
MINIMS CYCLOPENTOLATE HYDROCHLORIDE 1%, EYE
DROPS SOLUTION
Summary of Product Characteristics Updated 29-Jul-2015 | Bausch & Lomb
U.K Limited
1. Name of the medicinal product
Minims Cyclopentolate Hydrochloride 1%.
2. Qualitative and quantitative composition
Clear, colourless, sterile eye drops containing cyclopentolate
hydrochloride BP 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):_
Instil dropwise into eye according to the recommended dosage.
One or two drops as required. Maximum effect is induced in 30 - 60
minutes after instillation.
For refraction and examination of the back of the eye: 1 drop of
solution, which may be repeated after
five minutes, is usually sufficient.
For anterior and posterior uveitis (if associated with signs of
anterior uveitis) and for the breakdown of
posterior synechiae: 1 - 2 drops are instilled every 6 - 8 hours.
Resistance to cycloplegia can occur in young children, in patients
with dark skin and/or patients with dark
irides, therefore, the strength of cyclopentolate used should be
adjusted accordingly.
_Children _
< 3 months: Not recommended
3 months - 12 years: 1 drop of a 1% solution to each eye.
12 years - adult: 1 drop of 0.5% solution to each eye repeated after
10 minutes if necessary.
Children should be observed for 45 minutes after instillation.
4.3 Contraindications
Do not use in patients with a known hypersensitivity to any component
of the preparation.
Should not be used in neonates except where, on expert evaluation, the
need is considered to be
compelling.
Do not use in patients with confirmed or suspected narrow-angle
glaucoma as an acute attack may be
precipitated.
4.4 Special warnings and precautions for use
Recovery of accommodation occurs within 24 hours.
Use with caution in very young children and other patients at special
risk, such as debilitated or aged
patients.
Caution