Minims dexamethasone 0.1% eye drops 0.5ml unit dose

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dexamethasone sodium phosphate

Available from:

Bausch & Lomb UK Ltd

ATC code:

S01BA01

INN (International Name):

Dexamethasone sodium phosphate

Dosage:

1mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11040100; GTIN: 5027519006205

Patient Information leaflet

MINIMS® DEXAMETHASONE SODIUM PHOSPHATE 0.1% W/V
EYE DROPS, SOLUTION
DEXAMETHASONE SODIUM PHOSPHATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as yours.
-
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.
WHAT IS IN THIS LEAFLET:
1.
What Minims
®
Dexamethasone Sodium Phosphate eye drops are and what they are used
for
2.
What you need to know before you use your eye drops
3.
How to use your eye drops
4.
Possible side effects
5.
How to store your eye drops
6.
Contents of the pack and other information
1.
WHAT MINIMS® DEXAMETHASONE SODIUM PHOSPHATE EYE DROPS ARE AND WHAT
THEY ARE USED FOR
Minims
®
Dexamethasone Sodium Phosphate contains a corticosteroid. It is used
to treat inflamed eyes (red and painful).
The part of the eye affected will vary depending on the cause of the
inflammation.
Your doctor may sometimes prescribe other drugs at the same time to
make sure that the inflammation is treated effectively.
This medicine is indicated for children, adults and the elderly.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE YOUR EYE DROPS
DO NOT USE THESE DROPS IF:
•
you are allergic to the active substance (dexamethasone sodium
phosphate) or any of the other ingredients of this medicine (listed in
section 6).
•
you have high pressure inside the eye or you are at risk of developing
glaucoma. Your doctor will have checked for this.
•
you currently have conditions affecting your cornea.
•
it is intended for long term continuous therapy in children (at the
discretion of the physician).
WARNING AND PRECAUTIONS
Talk to your doctor if you experience swelling and weight gain around
the trunk an

Summary of Product characteristics

OBJECT 1
MINIMS DEXAMETHASONE SODIUM PHOSPHATE 0.1%
W/V, EYE DROPS SOLUTION
Summary of Product Characteristics Updated 14-Jun-2017 | Bausch & Lomb
U.K Limited
1. Name of the medicinal product
Minims Dexamethasone sodium phosphate 0.1% w/v Eye Drops, solution.
2. Qualitative and quantitative composition
Dexamethasone sodium phosphate Ph Eur 0.1% w/v.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Single-use, sterile eye drops.
A colourless solution when examined under suitable conditions of
visibility, practically clear and
practically free from particles.
4. Clinical particulars
4.1 Therapeutic indications
Non-infected, steroid responsive, inflammatory conditions of the eye.
4.2 Posology and method of administration
Posology
_Adults and the elderly _
One or two drops should be applied topically to the eye up to six
times a day. _Note:_ In severe conditions
the treatment may be initiated with 1 or 2 drops every hour, the
dosage should then be gradually reduced
as the inflammation subsides.
_Paediatric population_
At the discretion of the physician.
4.3 Contraindications
Use is contra-indicated in herpes simplex and other viral diseases of
the cornea and conjunctiva, fungal
disease, ocular tuberculosis, untreated purulent infections and
hypersensitivity to any component of the
preparation.
In children, long-term, continuous corticosteroid therapy should be
avoided due to possible adrenal
suppression.
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 Special warnings and precautions for use
Care should be taken to ensure that the eye is not infected before
Minims Dexamethasone sodium
phosphate 0.1% w/v Eye Drops, solution is used.
These drops should be used cautiously in patients with glaucoma and
should be considered carefully in
patients with a family history of this disease.
This medicinal product contains phosphates which may lead to corneal
deposits or corneal opacity when
topically administered. It should be used with caution in patients
p