Mydrilate 0.5% w/v Eye Drops

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cyclopentolate hydrochloride

Available from:

Esteve Pharmaceuticals GmbH

ATC code:

S01FA; S01FA04

INN (International Name):

Cyclopentolate hydrochloride

Dosage:

0.5 percent weight/volume

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

Anticholinergics; cyclopentolate

Authorization status:

Not marketed

Authorization date:

1979-04-01

Patient Information leaflet

PATIENT INFORMATION LEAFLET
MYDRILATE
®
0.5% W/V EYE DROPS
MYDRILATE
®
1.0% W/V EYE DROPS
cyclopentolate hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
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. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
•
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist. This includes any possible side
effects not listed in this
leaflet. See section 4.
IN THIS LEAFLET:
1. What Mydrilate eye drops are and what they are used for
2. Before you use Mydrilate eye drops
3. How to use Mydrilate eye drops
4. Possible side effects
5. How to store Mydrilate eye drops
6. Further information
1. WHAT MYDRILATE EYE DROPS ARE AND WHAT THEY ARE USED FOR
Mydrilate eye drops are prescription eye drops containing the active
ingredient cyclopentolate
hydrochloride. They are available in two strengths, 0.5% and 1%.
They belong to a group of medicines known as mydriatic (used for pupil
dilation) and cycloplegic
(used to block the muscles of the eye that control the shape of the
lens).
Mydrilate eye drops are applied on the surface of the eyes for
diagnostic purposes during eye
examinations and refraction tests.
They can also be used to treat some types of eye inflammation (iritis
and uveitis).
2. BEFORE YOU USE MYDRILATE EYE DROPS
DO NOT USE MYDRILATE EYE DROPS
•
if you are ALLERGIC (HYPERSENSITIVE) TO CYCLOPENTOLATE HYDROCHLORIDE,
BENZALKONIUM CHLORIDE or
any other ingredients listed in section 6
•
if you suffer from GLAUCOMA (high pressure in the eyeball) or if you
are at risk of having it (i.e.
your close family suffered from glaucoma, you are over 60, you have
increased pressure in the
eye, you had an eye injury)
•
if you wear SOFT CONTACT LENSES - wait at least 15 minutes after
removal of contact l

Summary of Product characteristics

Health Products Regulatory Authority
24 May 2022
CRN00CXWV
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mydrilate 0.5% w/v Eye Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cyclopentolate Hydrochloride 0.5% w/v.
Contains 5 mg cyclopentolate hydrochloride per 1 ml.
Excipient(s)with known effect
Each millilitre contains 0.1 mg benzalkonium chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye Drop Solution. (Eye Drops).
Clear colourless or almost colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
(i) Diagnostic purposes for fundoscopy and cycloplegic refraction.
(ii) Dilating the pupil in inflammatory conditions of the iris and
uveal tract.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_(I)_ _REFRACTION / FUNDOSCOPY_
_ADULTS (AND THE ELDERLY):_
One drop of 0.5% w/v solution instilled into the eye, repeated after
15 minutes if necessary, approximately 40 minutes before
examination.
Deeply pigmented eyes may require the use of a 1% w/v solution. NB:
maximum effect is reached after 30-60 minutes.
_CHILDREN _6-16 _YEARS:_
One drop of 1% w/v solution instilled into the eye, repeated after 15
minutes if necessary, approximately 40 minutes before
examination.
_CHILDREN UNDER _6 _YEARS:_
One or two drops of 1% w/v solution instilled into the eye, repeated
after 15 minutes if necessary, approximately 40 minutes
before examination.
_(II)_ _FOR UVEITIS, IRITIS AND IRIDOCYCLITIS_
_ADULTS AND THE ELDERLY:_
One or two drops of 0.5% w/v solution instilled into the eye up to 4
times daily or as required.
Health Products Regulatory Authority
24 May 2022
CRN00CXWV
Page 2 of 5
Deeply pigmented eyes may require the use of a 1% w/v solution.
_CHILDREN:_
At the discretion of the physician.
_Paediatric population _
Do not use during the first three months of life due to possible
association between the cycloplegia produced and the
development of amblyopia and also the increased risks of systemic
toxicity in neonates.
The lowest possible dose and