ABRIDGED PRESCRIBING INFORMATION

Composition:
Benzydamine Hydrochloride BP 0.15% w/v

Pharmacology:
It selectively binds to inflamed tissues (Prostaglandin synthetase inhibitor) and is normally free of adverse systemic effects. Unlike other NSAIDs, it does not inhibit cyclooxygenase or lipooxygenase, and is not ulcerogenic. It has powerful reinforcing effect and has cross sensitization with drugs of abuse such as heroin and cocaine in animals. It is hypothesized that it has cannabinoid agonistic activity.

Indication:
Orobenz Pain Gargle is a locally acting analgesic and anti-inflammatory treatment for the relief of painful inflammatory conditions of the mouth and throat including:
Traumatic conditions: Pharyngitis following tonsillectomy or the use of a naso-gastric tube.
Inflammatory conditions: Pharyngitis, aphthous ulcers and oral ulceration due to radiation therapy.
Dentistry: For use after dental operations to relieve pain, discomfort and inflammation of the mouth and gums. It provides relief from pain, swelling and aids in speeding up the healing process.

Dosage and Administration:
Rinse or gargle with 15 ml solution (Dilute with water if stinging occurs) for 20-30 seconds and spit it. Do not swallow. Avoid eating, drinking or smoking for at least 30 minutes after rinsing. Every 2-3 hours as required for pain relief or as directed by the physician.

Contra-indication:
Orobenz Pain Gargle is contraindicated if anyone in patient with known allergic to benzydamine or any of the other ingredients of this mouthwash.

Warning and Precaution:
It is usually safe with little or no side effects. However, it may cause burning sensation and skin irritation at the site of application in some people. These are usually temporary and resolve with time. If one do not get better with time or worsen, one should let doctor know. Doctor may be able to suggest ways of preventing or reducing the symptoms.

Side-effects:
No common side effects seen. Most side effects do not require any medical attention and disappear as body adjusts to the medicine. Consult doctor if they persist or if worried about them. Stinging feeling or numbness in the mouth, Tightening of the throat. Allergic reactions like rash, difficulty breathing, swelling of the face, mouth, and lips.

Use in pregnancy and lactation:
Orobenz Pain Gargle should not be used in pregnancy and lactation unless considered essential by the physician. There is no evidence of a teratogenic effect in animal studies.
throat. Allergic reactions like rash, difficulty breathing, swelling of the face, mouth, and lips.

Use in Children & adolescents:
This mouthwash should not be used by children aged 12 years or under. Children over 12 should follow the instructions given above for adults.

Drug Interaction:
Certain medicines can affect the way of Orobenz Pain Gargle works or Orobenz Pain Gargle itself can affect the action of other medicines taken at the same time. Consult with doctor about all the medicines, supplements or herbals patients are currently taking or might take to avoid any possible interactions.

Overdose:
There are no known cases of overdosage with Benzydamine Mouthwash. Since no specific antidote for benzydamine is available, cases of excessive ingestion of the liquid should receive supportive symptomatic treatment aimed at rapid elimination of the drug.

Storage:
Store at a temperature not exceeding 30°C.

Packing:
Each PET bottle contains 250 ml Mouthwash with a measuring cup.