Medizol 0.005% eye drops

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Latanoprost

Tilgængelig fra:

Medicom Healthcare Ltd

ATC-kode:

S01EE01

INN (International Name):

Latanoprost

Dosering:

50microgram/1ml

Lægemiddelform:

Eye drops

Indgivelsesvej:

Ocular

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 11060000; GTIN: 50606119660569

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
LATANOPROST 0.005% W/V
EYE DROPS, SOLUTION
drop is not recommended. There
have been reports of raised pressure
in the eye when two prostaglandin
analogues are used together.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or
breast-feeding, think you may be
pregnant or are planning to have a
baby, ask your doctor for advice. Do
not use Latanoprost when you are
pregnant or breast-feeding.
DRIVING AND USING MACHINES
As with other eye drops, if your
vision is blurred when you first put
your drops in, wait until this wears
off before you drive or operate
machinery.
LATANOPROST CONTAINS
BENZALKONIUM CHLORIDE
Latanoprost contains a preservative
called benzalkonium chloride.
This preservative may cause eye
irritation or disruption to the surface
of the eye. Benzalkonium chloride
can be absorbed by contact lenses
and is known to discolour soft
contact lenses. Therefore, avoid
contact with soft contact lenses.
If you or your child wear contact
lenses, they should be removed
before using Latanoprost . See the
instructions for contact lens wearers
in Section 3.
3. HOW TO USE LATANOPROST
Always use Latanoprost exactly as
your doctor or the doctor treating
your child has told you until they
tell you to stop. Check with your
doctor or pharmacist if you are not
sure.
The recommended dose for adults
(including elderly) and children is
ONE DROP ONCE A DAY in the
affected eye(s). The best time to do
this is IN THE EVENING.
Do not use Latanoprost more than
once a day, because the
effectiveness of the treatment can
be reduced if you administer it
more often.
CONTACT LENS WEARERS
If you or your child wear contact
lenses, you should remove these
before using Latanoprost . After
using Latanoprost you should wait
15 minutes before putting the
contact lenses back into the eyes.
USING WITH OTHER EYE DROPS:
If you have to use other eye drops
you should WAIT FOR AT LEAST FIVE
MINUTES before using them.
HOW TO USE LATANOPROST .
FOLLOW THE STEPS BELOW to help
you use Latanoprost properly:
1. Wash you

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Medizol 0.005% w/v eye drops, solution
.
Latanoprost 0.005% w/v Eye Drops, Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre (ml) of eye drops, solution contains 50 mcg of
latanoprost.
One drop contains approximately 1.5 micrograms latanoprost.
Excipient with known effect: Benzalkonium chloride 0.02% w/v as a
preservative.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Eye drops, solution.
The solution is a clear colourless liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in patients with open angle
glaucoma and ocular hypertension.
Reduction of elevated intraocular pressure in paediatric patients with
elevated
intraocular pressure and paediatric glaucoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Recommended dosage for adults (including the elderly): _
Recommended therapy is one eye drop in the affected eye(s) once daily.
Optimal
effect is obtained if Medizol/ Latanoprost is administered in the
evening.
The dosage of Medizol/ Latanoprost should not exceed once daily since
it has been
shown that more frequent administration decreases the intraocular
pressure lowering
effect.
If one dose is missed, treatment should continue with the next dose as
normal.
_Paediatric population _
Medizol/ Latanoprost may be used in paediatric patients at the same
posology as in
adults. No data are available for preterm infants (less than 36 weeks
gestational age).
Data in the age group < 1 year (4 patients) are limited (see section
5.1).
Method of administration
As with any eye drops, to reduce possible systemic absorption, it is
recommended
that the lachrymal sac be compressed at the medial canthus (punctal
occlusion) for
one minute. This should be performed immediately following the
instillation of each
drop.
Contact lenses should be removed before instillation of the eye drops
and may be
reinserted after 15 minutes.
If more than one topical ophthalmic drug is be