Fenolip, 20 mg/ ml, inhalation solution by nebulization, 15 ml

Name of the medical product
Fenolip, 20 mg/ ml, inhalation solution by nebulization.

Fenolip, inhalation solution by nebulization, contains disodium chromoglicate, which regularly used avoids the occurrence of allergic manifestations since it prevents histamine release.
Disodium chromoglicate is poorly absorbed (in man 1%) by the gastrointestinal tract.

Fenolip, inhalation solution by nebulization, should be used prophylactically but it is also effective when allergic symptoms are already evident.
It is indicated in prolonged treatments.

The application mechanism of the nebulizer assures the constant release of similar doses and the uniform spraying in the nasal cavity.
Fenolip, inhalation solution by nebulization, does not cause any sensation of tiredness or hyperaemia of the nasal mucosa.

The swelling of the mucosa decreases rapidly and nasal fossa remain free of obstructions.

Qualitative and quantitative composition
1ml of, inhalation solution by nebulization contains:
Active substance: Disodium Chromoglicate: 20 mg

Pharmaceutical form and content
Vial with 15 ml of inhalation solution by nebulization

Pharmacotherapeutic class
Pharmacotherapeutic group: 14.1.4 – Prophylactic drugs used in allergic rhinitis
ATC code: R01AC01

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

Therapeutic indications
Sporadic allergic rhinitis, seasonal allergic rhinitis (hay fever).

Contraindications and side effects
Hypersensitivity to any of the components present in this medicine.
A moderate irritation of the nasal mucosa may occur.

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

Warnings and special precautions for use
Benzalcomium chloride, which is one of the ingredients of Fenolip, inhalation solution by nebulization, may cause the swelling of the nasal mucosa (especially in cases of long-term use). If you suspect this reaction (permanent nasal congestion) you should replace this medicine, if possible, by other similar medicine not containing any preservatives. If there are no preservative-free nasal administration medicines, the use of other pharmaceutical form should be considered.

Fenolip, inhalation solution by nebulization is a prophylactic drug used in allergic rhinitis, thus, its use does not induce the immediate relief of the symptoms and, on the other hand, it should be continued even after the disappearance of the symptoms, in situations in which the patient is exposed to the allergen.

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

There are no studies on the use of Fenolip, inhalation solution by nebulization, 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
Not known.

List of excipients
Benzalcomium chloride, Disodium Edetate, Polisorbate 80, Sorbitol, water for Injectable preparations and sodium hydroxide.

Posology and administration mode
Except if otherwise indicated, the dose for adults and children of more than 4 years old is 1 inhalation of solution in each nostril, 4 times a day.

Treatment with Fenolip, inhalation solution by nebulization, 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).

Keep the package in the vertical position. Insert the tip inside the nostril and press the nebulizer one time.

Indication of the most favourable moment for the administration of the medicine
To be defined by the doctor

Duration of the average treatment when it should be limited
To be defined by the doctor, depending on the severity of the disease.

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.

Special precautions for storage
Do not store above 25ºC

Date of the revision of the leaflet
January 2006

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