Name of the medical product
Oxolamina (oxolamine citrate)

Qualitative and quantitative composition
Each 100 ml syrup contains:

Active substance:
Oxolamine citrate ...................... 1 g
(equivalent in pure base to 0.56 g)

Pharmaceutical form
Syrup. Glass vial with 250 ml of syrup.

Pharmacotherapeutic class
VI-4, Fluidificants, Anticough and Expectorants

Name or designation of the Responsible for the M.A.
L. Lepori, Lda
Rua João Chagas 53, Piso 3,
1495-072 Algés

Therapeutic indications
Symptomatic treatment of the cough.

Contraindications and side effects
Hypersensitivity to any of the product’s components.

The ingestion of Oxolamina, may cause (rare) a sensation of weight in the stomach and pyrosis. These disorders can be eliminated if the drug is administered when the stomach is full.

The administration of the syrup may cause a mild sensation of anaesthesia in the oral cavity, which quickly disappears.

Drug interactions and other forms of interactions
In patients on treatment with anticoagulants, Oxolamina should be used with the knowledge of the doctor.

Special precautions for use
The product contains saccarosis, thus it should be administered with caution in patients with diabetes or undergoing hypocaloric diets.

Effects on pregnant women, breast-feeding women, children, elderly patients and patients with special pathologies
Although there are no contraindications to the use of Oxolamina in pregnant or breast-feeding women, the product should only be used with the knowledge of the doctor.

Effects on the ability to drive and use machines
No effects on the ability to drive and use machines were observed.

List of excipients
Citric acid, saccarosis, methylparabene, raspberry flavour, cochineal red A, indigotine, Purified water.

Usual posology, with reference to maximum dose
Adults: 10 ml in the measurement cup every 4 hours
Children: 5 ml in the measurement cup every 4 hours

Indication of the most favourable moment for the administration of the medicine
According to the doctor’s indication.

Duration of the average treatment when it should be limited
The duration of the treatment depends on the clinical situation and its evolution.

Indication of how to discontinue the treatment when its discontinuation causes withdrawal effects
If you forget to administer one or more doses, treatment must be continued.

No special precaution is necessary to suspend the treatment.

Measures to adopt in case of overdosage and/or intoxication, emergency symptoms and antidotes
No overdosage cases were reported with Oxalamine.

In case of accidental ingestion, please go to the nearest hospital and that this leaflet with you. Treatment must be symptomatic.

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.
Always keep medicines out of reach and sight of children.
Contains saccarosis. Contains parabenes.

Special precautions for storage and indication of visible signs of deterioration, if they exist
Do not store above 25ºC.

Date of the revision of the leaflet
February 2004

 

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