Fenolip, 10 mg / 0.5 ml, collyrium, solution

Read this leaflet carefully before taking the medicine

• Keep this leaflet. You may need to read it again.
• If you have any doubts, ask your doctor or pharmacist.
• This medicine was prescribed to you. You should not give it to others; the medicine may be harmful to them, even if they have the same symptoms.

Name of the medical product
Fenolip, 10 mg / 0.5 ml, collyrium, solution

Qualitative and quantitative composition
1 ml of collyrium solution contains:

Active substance: Disodium Chromoglicate: 20 mg

Pharmaceutical form and content
Collyrium, solution, 20 monodoses of 0.5 ml

Pharmacotherapeutic class
Pharmacotherapeutic group: 15.2.3 – Medicines used in ophthalmic affections; Anti-inflammatory drugs; Other Anti-inflammatory, decongestionants and antiallergics.

ATC code: S01GX01

Market authorisation holder
L. Lepori, Lda
Rua João Chagas 53, Piso 3,
1495-764 Cruz Quebrada - Dafundo

Therapeutic indications
Allergic conjunctivitis (acute and chronic): Hay fever conjunctivitis ([kerato] seasonal conjunctivitis).

Contraindications and side effects
Hypersensitivity to any of the components present in this medicine. In rare cases, it may occur burning sensation, foreign body eye sensation or conjunctival hyperaemia. Allergic reactions may be observed in isolated cases, following a treatment with sodium chromoglicate.

Drug interactions and other forms of interaction
There are no references.

Special precautions for use
Not known.

Effects in pregnant women, breast-feeding women, children, elderly patients and patients with special pathologies
Although no embryotoxic effects have been observed, Fenolip collyrium solution should not be used (if possible) during the first three months of pregnancy.

There are no studies on the use of disodium chromoglicate by breast-feeding mothers thus, its prescription should be carefully weighted after the assessment of the risk-benefit relationship.

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
Sorbitol, hydroxypropylmethylcellulose, water for injectable preparations and chloridric acid.

Posology and administration mode
Instil 1 drop in each eye, 4 times a day. The dosage is equally applied to both adults and children older than 4 years old.

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.

Instructions about what to do if you forget to administer one or more doses
If you forget to administer one or more doses, treatment must be continued.

Indication of how to discontinue the treatment when its discontinuation causes withdrawal effects
Normally, no special precaution is necessary to suspend the treatment.

Measures to adopt in case of overdosage and/or intoxication, symptoms, emergency measures and antidotes
Overdosage is not to be considered.

Advice to the patient
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.

Keep the medicine out of reach and sight of children.

Date of the revision of the leaflet
January 2006

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