Hypromellose 0.3% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hypromellose

Available from:

Alliance Healthcare (Distribution) 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

Patient Information leaflet

HYPROMELLOSE 0.3% W/V EYE DROPS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECASUE IT CONTAINS
IMPORTANT INFORMATION FOR YOU. ALWAYS USE THIS MEDICINE EXACTLY AS
DESCRIBED IN THIS LEAFLET OR AS
YOUR DOCTOR OR PHARMACIST HAS TOLD YOU.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects
not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel
worse.
PACKAGE LEAFLET: INFORMATION FOR THE USER
D04397
Hypromellose
(Referred to as Hypromellose Eye Drops in this leaflet)
_Continued overleaf_
100MM MEASUREMENT VERIFICATION BAR
D04397
WHAT IS IN THIS LEAFLET:
1.
What Hypromellose Eye Drops are and what
they are used for
2. What you need to know b efore you use
Hypromellose Eye Drops
3. How to use Hypromellose Eye Drops
4. Possible side effects
5. How to store Hypromellose Eye Drops
6. Contents of the pack and other 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. WHAT YOU NEED TO KNOW 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.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using
Hypromellose
• If you develop an eye infection during this
treatment

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