Vividrin 2% eye drops

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Sodium cromoglicate

Disponível em:

Bausch & Lomb UK Ltd

Código ATC:

S01GX01

DCI (Denominação Comum Internacional):

Sodium cromoglicate

Dosagem:

20mg/1ml

Forma farmacêutica:

Eye drops

Via de administração:

Ocular

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 11040200

Folheto informativo - Bula

VIVIDRIN
®
Eye Drops
PATIENT INFORMATION
Please read this leaflet carefully before you start to take your
medicine. This leaflet
only provides a summary of the information available on your medicine.
If you have
any questions or are not sure about anything ask your doctor or
pharmacist.
The name of your medicine is Vividrin (sodium cromoglycate) Eye Drops.
WHAT IS IN YOUR MEDICINE?
Vividrin Eye Drops contain sodium cromoglycate 2% w/v as the active
ingredient,
a presevative called benzalkonium chloride, disodium edetate,
sorbitol, sodium
hydroxide, polysorbate 80 and water. It is supplied in bottles of
13.5ml.
HOW DOES YOUR MEDICINE WORK?
Vividrin Eye Drops work to prevent allergic reactions (e.g. hayfever).
PRODUCT LICENCE HOLDER Pharma Global Limited,
Hudson Road, Sandycove, Co Dublin, Ireland PL 11185/0004
MANUFACTURER Dr.Mann Pharma, 13581 Berlin, Germany.
WHAT ARE VIVIDRIN EYE DROPS USED FOR?
The sodium cromoglycate in Vividrin Eye Drops is used for the
prevention and
treatment of chronic allergic conjunctivitis and hayfever (acute
allergic conjunctivitis).
Put directly into the eye, Vividrin Eye Drops prevent the itching,
inflammation and
watering eyes often experienced with hayfever.
CAUTIONS – PLEASE READ THIS SECTION BEFORE USING VIVIDRIN EYE DROPS
In common with all medicines, if you are pregnant you should only use
Vividrin Eye
Drops if it is absolutely necessary and then only on your doctor’s
advice.
Do not use Vividrin Eye Drops if you are hypersensitive to sodium
cromoglycate or
benzalkonium chloride.
Soft contact lenses should not be worn while you are using Vividrin
Eye Drops.
If vision becomes blurred, do not drive or operate hazardous machinery
until proper
vision is restored.
This medicine is only for you and should never be given to someone
else.
HOW TO USE VIVIDRIN EYE DROPS
To work most effectively, Vividrin Eye Drops should be used every day
during the
hayfever season, even when you are not suffering from any symptoms. If
your
symptoms are only caused by pollen, you should continue to

Características técnicas

OBJECT 1
VIVIDRIN EYE DROPS 2% SODIUM CROMOGLICATE
Summary of Product Characteristics Updated 20-Sep-2007 | Bausch & Lomb
U.K Limited
1. Name of the medicinal product
Vividrin Eye Drops
Vividrin Hay Fever Eye Drops
2. Qualitative and quantitative composition
Active
Sodium cromoglycate EP 2.00% w/v.
3. Pharmaceutical form
Sterile Preserved Multidose Eye Drops.
4. Clinical particulars
4.1 Therapeutic indications
Vividrin Eye Drops are for the prophylaxis and symptomatic treatment
of acute allergic conjunctivitis,
chronic allergic conjunctivitis and vernal kerato conjunctivitis.
Vividrin Hay Fever Eye Drops are for the treatment of acute seasonal
allergic conjunctivitis.
4.2 Posology and method of administration
Route of Administration:
For topical administration to the eye.
Adults, Children and the Elderly
One or two drops into each eye up to four times daily.
4.3 Contraindications
Known hypersensitivity to benzalkonium chloride, sodium cromoglycate
or other constituents.
4.4 Special warnings and precautions for use
The solution should be discarded 1 month after first opening the
bottle or if any turbidity develops. Do
not use if the bottle has been opened prior to receipt. Vividrin Eye
Drops and Vividrin Hay Fever Eye
Drops contain benzalkonium chloride. Do not wear soft contact lenses
during the period of use.
4.5 Interaction with other medicinal products and other forms of
interaction
None known.
4.6 Pregnancy and lactation
Use in Pregnancy_: _Vividrin Eye Drops and Vividrin Hay Fever Eye
Drops should be used cautiously
during pregnancy and lactation. The widespread use of sodium
cromoglycate has yet to reveal any
adverse effects to mother or child during pregnancy.
Use in Lactation_:_ It is not known whether sodium cromoglycate is
excreted in human breast milk but on
the basis of its physicochemical properties, this is considered
unlikely. There is no information to suggest
that the use of sodium cromoglycate has any undesirable effects on the
baby
4.7 Effects on ability to drive and use machines
Transient stin