Flogoral, Mouth wash solution, 240 ml

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
Flogoral®

Qualitative and quantitative composition
Each 100 ml contains:
Active substance: Benzidamine hydrochloride: 0.15 g
(Equivalent to 0.134 g of benzidamine)

Pharmaceutical form and content
Mouth wash solution.

Glass vial containing 240 ml of mouth wash solution at 0.15%, with a dosing cup.

Pharmacotherapeutic class
Pharmacotherapeutic group: 6.1.1 – Topical application medicines for the mouth and oropharynx.

Market authorisation holder
L. Lepori, Lda
Rua João Chagas 53, Piso 3,
1495-072 Algés

Therapeutic indications
Symptomatic treatment of inflammatory and irritative states, associated to painful conditions of the oropharyngeal cavity, such as:
gingivites, stomatitis and pharyngitis, or as consequence of a stomatological therapy, like in the extraction and maintenance of teeth.

Contraindications and side effects
Hypersensitivity to the product’s components.
In the therapeutic doses used, no undesirable effects were reported.

Compliance with the instructions contained in the patient leaflet reduces the risk of undesirable effects. These effects are normally transient.

However, when they occur, you should consult your doctor or pharmacist.

Drug interactions and other forms of interaction
If you are taking other medicines, you should ask the advice of your doctor or pharmacist.

Warnings and special precautions for use
The long term use of Flogoral, mouth wash solution, may lead to sensitivity phenomena. In these cases, treatment should be interrupted and adequate therapeutic measures adopted.

Effects on pregnant women, breast-feeding women, children, elderly patients and patients with special pathologies
In pregnant and breast-feeding women, Flogoral mouth wash solution should only be used after consulting the doctor who will assess the risk-benefit relationship for each case.

Consult your doctor if you suspect you are pregnant or if you are planning to become pregnant.

Effects on the ability to drive and use machines
The use of Flogoral, mouth wash solution, when administered in the recommended doses does not impair the ability to drive or use machines.

List of excipients
Glycerin, sodium saccarine, sodium bicarbonate, Ethanol 96%, methyl p-hydroxybenzoate, mint flavour, Polisorbate 20, Quinolein yellow (E104), Patented Blue V (E131), purified water.

Usual posology, with reference to maximum dose
Pour 15 ml of Flogoral mouth wash solution, in the dosing cup and apply it 2 to 3 times a day, pure or diluted in water.

Pure form: Used as a gargle for the treatment of the inflammatory processes.

Diluted form with 15 ml of water, up to the 30 ml mark of the dosing cup; used in daily oral hygiene.

Do not exceed the indicated dose, without the advice of the doctor.

If after a short period of treatment, the obtained results are not significant, contact the doctor.

Indication of the most favourable moment for the administration of the medicine
Some environmental conditions, such as temperature decrease or temperature changes, inhalation of humidity, etc. may cause the inflammation of the upper airways, thus, favouring the attack of pathogenic germs.

The syntomatology characteristic of the inflammation of upper airways, mouth, nose and throat is manifested by burning sensation and sore throat with difficulty to swallow.

Therefore, so that these symptoms are not worsened some irritative factors should be avoided such as smoke, dry air, closed places full of people, among others.

Although gingivas may be the source of inflammation, this could be a manifestation of a stomatological problem (in the initial stage) and, in this case, the control of the dentist is recommended.

Besides, after stomatological therapy (conservative type), tooth extraction, small stomatological surgeries, etc, the gingivas and the oral cavity may present redness, inflammation and pain.

All these conditions may be rapidly solved using a mouth wash solution with specific anti-inflammatory, analgesic and surface anaesthetic activity.

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

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

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

Measures to adopt in case of overdosage and/or intoxication, emergency symptoms and antidotes.
In case of accidental ingestion of high doses of Flogoral mouth wash solution, contact your doctor immediately or go to the nearest hospital taking this leaflet with you.

Advice to the patient
This product is a medicine used for SELF-MEDICATION, to cure mild and transient disorders, easily recognized and solved, without the need to consult a doctor.

Therefore, it can be acquired without prescription but it should be correctly used in order to ensure the effectiveness of the product and reduce adverse effects.

Flogoral, mouth wash solution, is a non-steroidal anti-inflammatory drug with analgesic properties, which improves the pain that accompanies the inflammation of the throat, mouth and gingivas.

Flogoral, mouth wash solution, also possesses disinfectant properties and surface anaesthetic action.

You should see the doctor, if the problem repeats or if you notice any recent change in its characteristics.

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 medicines out of reach and sight of children.

Special precautions of storage and indication of visible signs of deterioration if they exist
Store at a temperature below 25ºC

Date of the revision of the leaflet
May 2005


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