Vividrin Antiallergic Eye Drops, Solution 2% w/v

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Sodium cromoglycate

Disponível em:

Bausch Health Ireland Limited

Código ATC:

S01GX; S01GX01

DCI (Denominação Comum Internacional):

Sodium cromoglycate

Dosagem:

2 percent weight/volume

Forma farmacêutica:

Eye drops, solution

Área terapêutica:

Other antiallergics; cromoglicic acid

Status de autorização:

Marketed

Data de autorização:

1991-03-26

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
VIVIDRIN®
_ANTIALLERGIC EYE DROPS, SOLUTION 2% W/V _
SODIUM CROMOGLICATE
The name of your medicine is Vividrin Antiallergic Eye Drops, Solution
2% w/v and it is called
Vividrin Eye Drops in this leaflet.
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However you still
need to use Vividrin Eye Drops
carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve.
- If any of the side effects gets serious or if you notice any side
effects not listed in this leaflet, tell
your doctor or pharmacist.
IN THIS LEAFLET:
1. What Vividrin Eye Drops are and what they are used for
2. What you need to know before you use Vividrin Eye Drops
3. How to use Vividrin Eye Drops
4. Possible side effects
5. How to store Vividrin Eye Drops
6. Contents of the pack and other information
1. WHAT VIVIDRIN EYE DROPS ARE AND WHAT THEY ARE USED FOR
Your drops contain the active ingredient sodium cromoglicate, which
belongs to a group of medicines
called antiallergics. Your drops are used to prevent and treat chronic
allergic conjunctivitis and hay
fever (acute allergic conjunctivitis).
Allergic conjunctivitis is an inflammation of the thin skin that
covers the white parts of the eyes and
the inside of the eyelids. The most common cause is an allergy to
pollen during the hay fever season.
Other causes are less common such as allergies to house dust mites,
cosmetics or problems with
contact lenses. You may have red, watery and itchy eyes.
The sodium cromoglicate in your drops works to stop the allergic
reaction in your eyes and has a
soothing effect.
These drops can be used in children, adults and the elderly.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VIVIDRIN EYE DROPS
DO NOT USE THESE DROPS
• If you have been told, or know, that you are allergic

Características técnicas

Health Products Regulatory Authority
19 October 2021
CRN00CLFH
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vividrin Antiallergic Eye Drops, Solution 2% w/v
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 20.0 mg of sodium cromoglicate.
Excipient with known effect: Benzalkonium Chloride (0.01%)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops solution
Colourless to slightly yellow, clear, aqueous eye drops solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acute or chronic allergic conjunctivitis e.g. hay-fever conjunctivitis
(vernal [kerato-] conjunctivitis).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Instill one drop into each eye four times a day or as directed by the
physician in the case of high pollen challenge. The dose
applies equally to children and adults.
Treatment with Vividrin Antiallergic Eye Drops should be continued
even after the complaints have disappeared as long as the
patient is exposed to the allergizing substances (pollen, house dust,
fungus spores, etc.).
4.3 CONTRAINDICATIONS
Vividrin Antiallergic Eye Drops are contra-indicated in persons who
have shown hypersensitivity to any component of this
product.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
VIVIDRIN HAYFEVER EYE DROPS CONTAINS BENZALKONIUM CHLORIDE
This medicinal product contains 0.00306 mg benzalkonium chloride in
each drop (0.0306ml) which is equivalent to 0.1 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may
change the colour of the contact lenses. Patients
should remove contact lenses before using this medicine and put them
back 15 minutes afterwards.
Benzalkonium chloride has been reported to cause eye irritation,
symptoms of dry eyes and may affect the tear film and
corneal surface. Vividrin Hayfever Eye Drops should be used with
caution in dry eye patients and in patients where the cornea
may be compromised.
Patients should be monitored in case of prolonged use.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS A