Vistamethasone 0.1% ear/eye/nose drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betamethasone sodium phosphate

Available from:

Martindale Pharmaceuticals Ltd

ATC code:

S03BA03

INN (International Name):

Betamethasone sodium phosphate

Dosage:

1mg/1ml

Pharmaceutical form:

Ear/eye/nose drops solution

Administration route:

Auricular; Ocular; Nasal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11040100; GTIN: 5014124574014 5014124574007

Patient Information leaflet

VISTAMETHASONE DROPS
TM
IN THIS LEAFLET:
1. What Vistamethasone Drops are and what they
are used for
2. Before you use Vistamethasone Drops
3. How to use Vistamethasone Drops
4. Possible side effects
5. How to store Vistamethasone Drops
6. Further information
.
1. WHAT VISTAMETHASONE DROPS ARE AND
WHAT THEY ARE USED FOR
.
Vistamethasone Drops contain Betamethasone
Sodium Phosphate which belongs to a group of
medicines called corticosteroids. These are used
relieve redness and swelling.
.
Vistamethasone Drops are used to treat
redness and swelling of the eyes, nose and ears.
.
2. BEFORE YOU USE VISTAMETHASONE
DROPS
.
DO NOT USE VISTAMETHASONE DROPS IF YOU ARE:
•
allergic (hypersensitive) to Betamethasone
Sodium Phosphate or to any of the other
ingredients of this medicine, listed in section 6
of this leaflet
.
DO NOT USE IN YOUR EYES IF YOU:
•
have a viral infection of the eye
•
have a fungal infection of the eye
•
have tuberculosis of the eye
•
have an eye infection that is producing pus
•
suffer from raised pressure in your eye(s)
(glaucoma)
•
suffer from herpes in your eye(s)
•
have undiagnosed red eye(s)
•
are wearing soft contact lenses. These should
be removed whilst you are using
Vistamethasone Drops.
.
DO NOT USE IN YOUR EARS IF YOU HAVE:
•
a hole in your ear drum
.
If any of the above apply please tell your doctor or
pharmacist.
.
TAKE SPECIAL CARE WITH VISTAMETHASONE DROPS:
•
Do not use Vistamethasone Drops for a
prolonged period of time (more than 7 days) as
this may cause serious side effects, particularly
in children. (see section 4 of this leaflet)
•
You should be aware that if you are using
Vistamethasone Drops in your eyes your doctor
may need to check your eyes frequently during
your treatment.
.
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, before you use this medicine.
If you have any doubts about whether this
medicine is suitable for you, cons

Summary of Product characteristics

OBJECT 1
VISTAMETHASONE DROPS OR BETAMETHASONE DROPS
Summary of Product Characteristics Updated 10-Oct-2014 | Martindale
Pharma
1. Name of the medicinal product
Vistamethasone Drops or Betamethasone Drops.
2. Qualitative and quantitative composition
Betamethasone Sodium Phosphate 0.1% w/v
3. Pharmaceutical form
Eye, ear or nose drops.
4. Clinical particulars
4.1 Therapeutic indications
For the topical treatment of inflammatory non-infected conditions of
the eye, ear or nose.
4.2 Posology and method of administration
_DOSAGE SCHEDULE:_
ADMINISTRATION FOR TOPICAL OCULAR USE.
_Adults, Elderly and Children:_
Initially one or two drops to be instilled into the affected eye(s)
every two hours. Frequency of
administration should be reduced once the condition is under control.
ADMINISTRATION FOR TOPICAL OTIC USE.
_Adults, Elderly and Children:_
Initially two or three drops to be instilled into the affected ear(s)
every three to four hours. Frequency of
administration should be reduced once the condition is under control.
ADMINISTRATION FOR TOPICAL NASAL USE.
_Adults, Elderly and Children:_
Two or three drops to be instilled into each nostril twice daily as
required.
4.3 Contraindications
Hypersensitivity to any of the preparations components. Viral, fungal,
tuburculous or purulent conditions
of the eye. Use is contraindicated if Glaucoma is present or Herpetic
keratitis (e.g. dendritic ulcer), is
considered a possibility. Use of topical steroids in this condition
can lead to extension of the ulcer and
marked visual deterioration. Otitis externa should not be treated when
the eardrum is perforated due to the
risk of ototoxicity.
4.4 Special warnings and precautions for use
Topical corticosteroids should never be given for an undiagnosed red
eye as inappropriate use is
potentially blinding.
Prolonged use may lead to the risk of adrenal suppression in infants.
Ophthalmological treatment with
corticosteroid preparations should not be repeated or prolonged
without regular review to exclude raised
intraocular pressure, catarac