Hypromellose 0.3% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hypromellose

Available from:

Martindale Pharmaceuticals Ltd

ATC code:

S01XA20

INN (International Name):

Hypromellose

Dosage:

3mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11080100; GTIN: 5014124374164

Patient Information leaflet

HYPROMELLOSE EYE DROPS 0.3%W/V
IN THIS LEAFLET:
1.
What Hypromellose Eye Drops are and what
they are used for
2.
Before you use Hypromellose Eye Drops
3.
How to use Hypromellose Eye Drops
4.
Possible side effects
5.
How to store Hypromellose Eye Drops
6.
Further information
1. WHAT HYPROMELLOSE EYE DROPS
ARE AND WHAT THEY ARE USED FOR
The active ingredient hypromellose belongs to
a group of medicines known as eye lubricants
(ocular lubricants).
Hypromellose Eye Drops are used to treat
conditions where not enough tears are
made to keep the eye lubricated and clean.
Hypromellose Eye Drops lubricate the surface
of the eye (including artificial eyes) in the same
way as natural tears. It can therefore be used
to relieve the dryness and pain associated with
reduced or abnormal tear production.
2. BEFORE YOU USE HYPROMELLOSE EYE
DROPS
DO NOT USE HYPROMELLOSE EYE DROPS IF:
• you are allergic (hypersensitive) to
Hypromellose or any of the other ingredients
of this medicine, which are listed in section 6
of this leaflet.
• you are wearing soft contact lenses.
TAKE SPECIAL CARE WITH HYPROMELLOSE EYE
DROPS IF:
• your eye irritation persists or worsens,
• you have a headache or eye pain,
• your vision changes
• you have permanently red eyes
If any of the above apply to you, stop using
Hypromellose Eye Drops and contact your
doctor immediately.
If you are unsure about taking this medicine
or you have any questions, go and talk to your
doctor first and follow the advice given.
TAKING OTHER MEDICINES
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
PREGNANCY AND BREAST-FEEDING
You should not use Hypromellose Eye Drops
if you are pregnant, trying for a baby or
breast-feeding, unless your doctor believes it is
necessary.
DRIVING AND USING MACHINES
Hypromellose Eye Drops can cause mild
stinging or blurring of vision after application.
Wait until your vision is clear before driving or
using machines.
IMPORTANT INFORMAT

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hypromellose 0.3% w/v Eye Drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hypromellose 0.3%
Excipients of known effect:
Benzalkonium Chloride
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Eye drops, Solution.
Clear to slightly opalescent colourless, slightly viscous solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
To provide tear-like lubrication for the symptomatic relief of dry
eyes and eye
irritation associated with deficient tear production.
As an ocular lubricant for artificial eyes.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults, children and the elderly
The recommended dosage for adults, children and elderly is one or two
drops
topically instilled into the eye three times daily as needed, or as
directed by a
physician.
Method of administration
For ocular use only.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance, Hypromellose or to any of
the
excipients listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
May cause transient mild stinging or temporary blurred vision. If
irritation
persists or worsens, or headache, eye pain, vision changes or
continuous
redness occur, patients should discontinue use and consult a physician
or
pharmacist.
In order to preserve the sterility, the dropper should not be allowed
to touch
any part of the eye or any other surface.
The product contains benzalkonium chloride and should not be used if
soft
contact lenses are being worn.
Remove contact lenses prior to application and wait at least 15
minutes before
reinserting. Benzalkonium chloride is known to discolour soft contact
lenses.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Hypromellose prolongs the contact time of topically applied drugs
commonly
used in ophthalmology.
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