Maxidex 0.1% eye drops

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Dexamethasone

Inapatikana kutoka:

Novartis Pharmaceuticals UK Ltd

ATC kanuni:

S01BA01

INN (Jina la Kimataifa):

Dexamethasone

Kipimo:

1mg/1ml

Dawa fomu:

Eye drops

Njia ya uendeshaji:

Ocular

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 11040100; GTIN: 5015664006157 5015664014022

Taarifa za kipeperushi

1
PACKAGE LEAFLET - INFORMATION FOR THE USER
MAXIDEX
® EYE DROPS, SUSPENSION
Dexamethasone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
KEEP THIS LEAFLET.
You may need to read it again.
•
IF YOU HAVE ANY FURTHER QUESTIONS,
ask your doctor or your pharmacist.
•
This medicine has been prescribed for you.
DO NOT PASS IT ON TO OTHERS.
It may harm them, even if their symptoms are the same as yours.
•
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 MAXIDEX IS AND WHAT IT IS USED FOR
2.
BEFORE YOU USE MAXIDEX
3.
HOW TO USE MAXIDEX
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE MAXIDEX
6.
FURTHER INFORMATION
1.
WHAT MAXIDEX IS AND WHAT IT IS USED FOR
MAXIDEX
belongs to a group of medicines known as corticosteroids.
IT IS USED TO TREAT
inflammation of the eye surface and the front portion inside the eye
(anterior
segment) and to prevent or treat inflammation following surgery to the
eye. It helps to relieve the
symptoms of inflammation such as redness, soreness and swelling.
2.
BEFORE YOU USE MAXIDEX
DO NOT USE MAXIDEX...
•
If you think that you have any
TYPE OF INFECTION,
including viral and fungal infections and
tuberculosis of the eye.
•
If you are
ALLERGIC
to dexamethasone or any of the other ingredients listed in section 6.
If any of these apply, ask your doctor for advice.
TAKE SPECIAL CARE...
•
Only use MAXIDEX in your eye(s). MAXIDEX should be used
WITH CAUTION IN CHILDREN
UNDER 2 YEARS
of age.
•
Use of MAXIDEX
FOR LONG PERIODS OF TIME,
may cause
INCREASED PRESSURE
in your eye(s)
and/or the development of
CATARACTS.
MAXIDEX should not be used for
MORE THAN ONE WEEK,
unless advised by your doctor. The risk of increase in eye pressure
and/or cataract formation is
higher in susceptible patients (e.g. patients with diabetes) using
steroids.
•
If you already have high pressure in your eye(s) or an eye disease
such as
GLAUCOMA,
you should
have your eye pressure c

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
MAXIDEX 0.1% w/v, eye drops, suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dexamethasone 0.1% w/v
Excipient with known effect in suspension:
Benzalkonium Chloride 0.01% w/v.
For the full list excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Eye drops, suspension
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indicated for treatment of steroid responsive inflammatory conditions
of the
conjunctiva, cornea and anterior segment of the eye such as: anterior
uveitis,
iritis,
cyclitis,
allergic
and
vernal
conjunctivitis,
herpes
zoster
keratitis,
superficial punctate keratitis and non-specific superficial keratitis.
Also indicated for the treatment of corneal injury from chemical,
radiation or
thermal burns or following penetration by foreign bodies. Indicated
for post-
operative use to reduce inflammatory reactions and suppress graft
reaction.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults, adolescents, and children (2 years of age and above)
The
frequency
of
instillation
of
drops
and
the
duration
of
treatment
will
vary
depending upon the severity of the underlying condition and the
response to treatment.
Severe inflammations require one to two drops instilled into the eye
every thirty to
sixty minutes until a satisfactory response occurs.
Subconjunctival or systemic steroid therapy should be considered if
there is no
response. When a favourable response has been observed reduce the
dosage towards
one drop every four hours.
Method of Administration
For ocular use only.
Shake the bottle well before use.
After cap is removed, if tamper evident snap collar is loose, remove
before using
product.
Do not let the tip of the dropper touch the eye.
Nasolacrimal
occlusion
or
gently
closing
the
eyelid
after
administration
is
recommended.
This
may
reduce
the
systemic
absorption
of
medicinal
products
administered via the ocular route and result in a decrease in systemic
adverse reactions.
Paediatric patients
The safety and efficacy of this product has