Minims Cyclopentolate Hydrochloride 1%, Single-use sterile eye drops

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

CYCLOPENTOLATE HYDROCHLORIDE

Dostupno od:

Bausch Health Ireland Limited 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland

ATC koda:

S01FA04

INN (International ime):

CYCLOPENTOLATE HYDROCHLORIDE

Farmaceutski oblik:

EYE DROPS, SOLUTION

Sastav:

CYCLOPENTOLATE HYDROCHLORIDE 1 percent weight/volume

Tip recepta:

POM

Područje terapije:

OPHTHALMOLOGICALS

Status autorizacije:

Authorised

Datum autorizacije:

2005-10-04

Uputa o lijeku

MINIMS® CYCLOPENTOLATE HYDROCHLORIDE 0.5% W/V
MINIMS® CYCLOPENTOLATE HYDROCHLORIDE 1% W/V
EYE DROPS, SOLUTION
_Cyclopentolate Hydrochloride _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
- 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 Minims® Cyclopentolate Hydrochloride eye drops are and what
they are used for
2. What you need to know before you use Minims® Cyclopentolate
Hydrochloride eye drops
3. How to use Minims® Cyclopentolate Hydrochloride eye drops
4. Possible side effects
5. How to store Minims® Cyclopentolate Hydrochloride eye drops
6. Contents of the pack and other 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.
WHAT YOU NEED TO KNOW BEFORE YOU USE MINIMS® CYCLOPENTOLATE
HYDROCHLORIDE EYE DROPS
DO NOT USE MINIMS® CYCLOPENTOLATE HYDROCHLORIDE EYE DROPS
• if you are allergic to the active substance (cyclopentolate
hydrochloride) or any of the other
ingredients (listed in section 6).
• if you have high pressure of liquid inside the eye (closed angle
glaucoma)
• in babies under 28 days old (unless your doctor decides that it

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
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 and adolescents _
< 3 months: Not recommended
3 months - 12 years: 1 drop of 0,5% solution to each eye.
12 years – 18 years: 1 drop of 0.5% solution to each eye repeated
after 10 minutes if necessary.
Children should be observed for 45 minutes after instillation.
It is recommended to use the 0.5% strength in children and adolescents
under 18 years.
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 is also