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Fenolip®
Disodium Chromoglicate Collyrium
Name
of the medical product
Fenolip
Qualitative
and quantitative composition
Active substance (1 ml of solution contains:) Disodium Chromoglicate:
20.0 mg
Pharmaceutical
form
Collyrium
Pharmacotherapeutic
class
XVI-1 Etyotropics and adstringents
Name
or designation of the Responsible for the M.A.
L. Lepori, Lda
Rua João Chagas 53, Piso 3,
1495-072 Algés
Therapeutic
indications
Allergic conjunctivitis (acute and chronic): Hay fever conjunctivitis
([kerato] seasonal conjunctivitis); non-specific conjunctival irritations).
Contraindications
and side effects
Hypersensitivity to any of the product’s components. In rare cases
it may occur ocular irritation. Allergic reactions may be observed in
isolated cases, following a treatment with chromoglycic acid/sodium chromoglicate.
Drug
interactions and other forms of interactions
There are no references.
Special
precautions for use
People should not be wearing hydrophilic contact lens during the application
of Fenolip collyrium.
Effects
on pregnant women, breast-feeding women, children, elderly patients and
patients with special pathologies
Although there is no evidence of embryotoxic effects, avoid the use of
Fenolip collyrium during the first three months of the pregnancy.
There are no references regarding the other groups. Consult your doctor.
Effects
on the ability to drive and use machines
No limits to the driving of vehicles or to the use of machines are known.
List
of excipients
Benzalcomium chloride, Disodium Edetate, Polisorbate 80, Sorbitol, sterilized
water,Sodium hydroxide solution 1N for pH adjustment.
Posology
and administration mode
Instil 4 drop in each eye, 4 times a day. The dosage is equally applied
to both adults and children. Treatment with Fenolip collyrium should be
continued, even after the disappearance of the symptoms, in situations
in which the patient is exposed to the allergen (pollen, dust, fungal
spores, etc).
Indication
of the most favourable moment for the administration of the medicine
Consult
your doctor.
Warnings
If
you forget to administer one or more doses, treatment must be continued.
No
special precaution is necessary to suspend the treatment and overdosage
is not to be considered.
If
you notice any side effect not mentioned in this leaflet, please inform
your doctor or pharmacist.
Check if the product is within the expiry date mentioned in the package.
Always keep medicines out of reach and sight of children.
Date
of the revision of the leaflet
February 2004
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