Mydrilate 1% solution

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Cyclopentolate hydrochloride

Tilgjengelig fra:

Esteve Pharmaceuticals Ltd

ATC-kode:

S01FA04

INN (International Name):

Cyclopentolate hydrochloride

Dosering :

10mg/1ml

Legemiddelform:

Eye drops

Administreringsrute:

Ocular

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 11050000; GTIN: 5039021059853

Informasjon til brukeren

REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard. By reporting side effects you
can help provide more information on the safety of this medicine.
5. HOW TO STORE MYDRILATE EYE DROPS
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not freeze. Store in the original package in order to protect from
light.
Before first opening:
Store in a refrigerator (between 2°C - 8°C).
Prior to first opening:
Remove from refrigerator and store at room temperature for 30 minutes.
After first opening:
Do not store above 25°C. Do not refrigerate. Discard 28 days after
first opening.
Do not use the eye drops after the expiry date which you will find
printed on the packaging.
6. FURTHER INFORMATION
WHAT MYDRILATE EYE DROPS CONTAIN:
Mydrilate eye drops 5 ml dropper bottle contain either 0.5% or 1% of
the active ingredient Cyclopentolate Hydrochloride.
Each solution also contains the inactive ingredients: boric acid,
potassium chloride, benzalkonium chloride solution and purified water.
WHAT MYDRILATE EYE DROPS LOOK LIKE:
The eye drops are available in 5 ml dropper bottles.
MARKETING AUTHORISATION HOLDER AND EU BATCH RELEASE SITE: Intrapharm
Laboratories Ltd. The Granary, The Courtyard Barns,
Choke Lane, Cookham Dean, Maidenhead, Berkshire SL6 6PT
MANUFACTURER: Holopack Verpackungstechnik GmbH, Bahnhofstrasse, 74429
Sulzbach-Laufen, Germany
This leaflet was last revised in March 2018.
Like all medicines, Mydrilate eye drops can cause side effects
although not everybody gets them.
If you experience the following side effects, you should stop using
Mydrilate Eye Drops immediately and seek urgent medical advice:
•
irregular heart rate
•
urinary retention (difficulty passing urine)
The following side effects have been observed in children or infants.
If they occur, treatment should be stopped immediately and
urgent medical

Preparatomtale

OBJECT 1
MYDRILATE 1.0% EYE DROPS
Summary of Product Characteristics Updated 04-Apr-2018 | Intrapharm
Laboratories Limited
1. Name of the medicinal product
Mydrilate 1.0% Eye Drops
Cyclopentolate Hydrochloride 1.0% w/v Eye Drops, Solution
2. Qualitative and quantitative composition
Cyclopentolate Hydrochloride BP 1.0 % w/v.
3. Pharmaceutical form
Eye drops.
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
_(I) REFRACTION / FUNDOSCOPY _
_ADULTS (AND THE ELDERLY):_
One drop of 0.5% 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% solution.
N.B. Maximum effect is reached after 30-60 minutes.
_CHILDREN 6-16 YEARS:_
One drop of 1% 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% 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% solution instilled into the eye, up to 4
times daily or as required.
Deeply pigmented eyes may require the use of a 1% solution.
_CHILDREN:_
At the discretion of the physician.
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.
Cycloplegia following administration is quick in onset and
short-lived. Maximal cycloplegia is achieved
within 15-45 minutes of instillation and lasts on average about 20
minutes. Recovery normally takes place
in about 4 hours, but very occasionally some effect persists for up to
24 hours.
Mydriasis is produced very rapidly and an aver