Isopto Plain 0.5% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hypromellose

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

S01XA20

INN (International Name):

Hypromellose

Dosage:

5mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 11080100

Patient Information leaflet

Package Leaflet - Information for the User
ISOPTO
*
PLAIN 0.5 %
w/v eye drops, solution
Hypromellose
Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without a prescription. However, you still
need to use
ISOPTO PLAIN carefully to get the best results from it.
•
Keep this leaflet.
You may need to read it again.
•
Ask your pharmacist
if you need more information or advice.
• You must
contact a doctor
if your symptoms worsen or do not improve
after 3 days.
•
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.
IN THIS LEAFLET
1. What ISOPTO PLAIN is and what
it is used for
2. Before you use ISOPTO PLAIN
3. How to use ISOPTO PLAIN
4. Possible side effects
5. How to store ISOPTO PLAIN
6. Further information
WHAT ISOPTO
*
PLAIN IS AND WHAT IT IS USED FOR
1
ISOPTO PLAIN
is a slightly viscous solution that
acts as an artificial tear.
It is used to treat
dry eyes caused by a lack of
tears in the eye(s).
Replacement of the reduced natural tears with an
artificial tear helps to soothe and lubricate your
eyes and provide relief from irritation.
It can also be used
as a lubricant for artificial
eyes.
BEFORE YOU USE ISOPTO
*
PLAIN
2
Do not use ISOPTO PLAIN...
• If you are
allergic
to hypromellose or any of
the other ingredients listed in section 6.
Ask your doctor for advice.
Take special care...
This medicine is available without a
prescription.
However, you still need to use
ISOPTO PLAIN carefully to get the best results
from it.
Pregnancy and breast-feeding
If you are pregnant or might get pregnant, or
if you are breast-feeding a baby,
talk to your
doctor
before you use ISOPTO PLAIN.
Driving and using machines
You may experience blurred vision after using
ISOPTO PLAIN.
Do not drive or operate
hazardous machinery unless your vision is
clear.
Using other medicines
Tell your doctor or pharmacist
if you
are taking or have recently taken any other
medicines, including

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
2
Isopto Plain 0.5% eye drops, solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hypromellose Ph.Eur. 0.5% w/v
For excipients see 6.1.
3
PHARMACEUTICAL FORM
Eye Drops, Solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Used topically to provide tear-like lubrication for the symptomatic
relief of dry eyes
and eye irritation associated with deficient tear production. (Usually
in cases of
rheumatoid arthritis, keratoconjunctivitis sicca and xerophthalmia.)
Also used as an ocular lubricant for artificial eyes.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults, children and the elderly:
The dose depends on the need for lubrication. Usually one to two drops
to each eye
three times daily or as prescribed.
4.3
CONTRAINDICATIONS
Hypersensitivity to any component of the product.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If irritation persists or worsens, or headache, eye pain, vision
changes or continued
redness occur, discontinue use and consult a physician.
To preserve sterility do not allow the dropper to touch the eye or any
other surface.
The product contains benzalkonium chloride and should not be used when
soft
contact lenses are worn.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known
4.6
FERTILITY, PREGNANCY AND LACTATION
Fertility
Studies
have
not
been
performed
to
evaluate
the
effect
of
topical
ocular
administration of hypromellose on fertility. Hypromellose is a
pharmacologically
inert compound and it would not be expected to have any effect on
fertility.
Pregnancy
There are no or limited amount of data from the use of ophthalmic
hypromellose in
pregnant
women.
Systemic
exposure
to
hypromellose
following
topical
ocular
administration is negligible and the product has no pharmacological
properties.
Lactation
It is unknown whether topical hypromellose/metabolites are excreted in
human milk.
No
effects
on
the
breastfed
newborn/infant
are
anticipated
since
the
systemic
exposure of the breast-feeding