MAXIDEX 0.1 %w/w Eye Ointment

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

DEXAMETHASONE

Sẵn có từ:

Novartis Pharmaceuticals UK Ltd

Mã ATC:

S01BA01

INN (Tên quốc tế):

DEXAMETHASONE

Liều dùng:

0.1 %w/w

Dạng dược phẩm:

Eye Ointment

Loại thuốc theo toa:

Product subject to prescription which may be renewed (B)

Khu trị liệu:

Corticosteroids, plain

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2017-05-05

Tờ rơi thông tin

1
PACKAGE LEAFLET - INFORMATION FOR THE USER
MAXIDEX
® 0.1 % W / W EYE OINTMENT
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 called corticosteroids.
IT IS USED TO TREAT
allergy and inflammation of the eye.
It helps to relieve the symptoms of allergy and 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,
fungal, untreated parasitic eye
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 is not recommended for use
IN CHILDREN UNDER 2 YEARS
.

MAXIDEX should not be used for
MORE THAN ONE WEEK
, unless advised by your doctor. Use
of MAXIDEX
FOR LONG PERIODS OF TIME
, may cause:
o
INCREASED PRESSURE
in your eye(s). If you already have high pressure in your eye(s) or
an eye disease such as
GLAUCOMA
. You should have your eye pressure checked
regularly while using MAXIDEX. Ask your doctor for advice. This is
especially
important in paediatric patients, as the risk of
corticosteroid-induced increased
pressure in the eye may be greater in children and may occur earlier
than in adults.
The ris

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Maxidex 0.1% w/w Eye Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1g of ointment contains 1mg dexamethasone
Excipients: Also contains Methyl parahydroxybenzoate (E218) 0.05% w/w
Propyl parahydroxybenzoate (E216) 0.01% w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye ointment
A colourless to pale straw coloured slightly transparent ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indicated for the treatment of allergic and inflammatory conditions of
the eye.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults, adolescents and children (2 years of age and above)
Apply a small amount into the conjunctival sac 3-4 times daily for 3-4
days or until a satisfactory response occurs.
Method of Administration
For ocular use only.
Do not let the tip of the tube touch the eye.
Paediatric patients
The safety of this product has not been established in children below
2 years of age
Elderly population
No overall differences in safety or effectiveness have been observed
between elderly and younger patients.
Hepatic and renal impairment
The safety and efficacy of MAXIDEX in patients with hepatic or renal
impairment have not been established.
4.3 CONTRAINDICATIONS
Ocular viral infections such as vaccinia, varicella
Herpes simplex keratitis.
Fungal disease of ocular structures or untreated parasitic eye
infections and mycobacterial ocular infections.
Acute, untreated bacterial infections.
Hypersensitivity to dexamethasone or to any of the excipients listed
in section 6.1.
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