Difflam Forte Anti-Inflammatory Throat Spray

Difflam Forte Anti-Inflammatory Throat Spray

benzydamine

Manufacturer:

iNova

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Benzydamine HCl.
Description
Each mL of spray contains benzydamine HCl 3 mg. Each spray delivers approximately 0.5 mg of benzydamine HCl. It also contains the following excipients: Ethanol, saccharin sodium, methylparahydroxybenzoate, glycerol, PEG-40 hydrogenated castor oil, purified water and mint flavouring.
It does not contain gluten, lactose, sugar or colour.
Action
Benzydamine HCl is an anti-inflammatory and analgesic agent. It helps to reduce swelling and pain.
Indications/Uses
Temporary relief of painful conditions of the mouth and throat including tonsillitis, sore throat, radiation mucositis, aphthous ulcers, pharyngitis, swelling, redness, inflammatory conditions, post orosurgical and periodontal procedures.
Dosage/Direction for Use
Adults and Children >12 years: 2-4 sprays (1-2 mg) directly onto the sore/inflamed area and swallow gently. Repeat every 1½ to 3 hrs as necessary.
Children (6-12 years): 2 sprays (1 mg) directly onto sore/inflamed area and swallow gently. Repeat every 1½ to 3 hrs as necessary.
Children <6 years: Not recommended. Uninterrupted treatment should not exceed 7 days unless under medical supervision.
Overdosage
There are no known cases of overdosage. Adverse central nervous system effects have been reported following overdosage with high doses of benzydamine HCl in solution form. There is no specific antidote for benzydamine HCl and should excessive quantities be ingested, the treatment should be symptomatic.
Contraindications
Patients with known hypersensitivity to benzydamine HCl or to any other ingredients of Difflam Forte Anti-inflammatory Throat Spray.
Special Precautions
If a sore throat is either caused or complicated by a bacterial infection, appropriate antibacterial therapy should be considered in addition to the use of Difflam Forte Anti-inflammatory Throat Spray.
Caution should be applied in patients with hepatic and renal impairment.
Use in pregnancy: The safety of benzydamine HCl has not been established in pregnant patients. Medical advice should be seek if pregnant or planning to become pregnant during the course of medication.
Use in lactation: Use of benzydamine HCl during lactation has not been established in humans. Medical advice should be seek if breastfeeding or likely to breastfeed during the course of medication.
Use in children: Because of the lack of sufficient clinical experience, Difflam Forte Anti-inflammatory Throat Spray is not recommended in children <6 years.
Adverse Reactions
Difflam Forte Anti-inflammatory Throat Spray is generally well tolerated and side effects are minor.
The most commonly reported reaction is oral numbness and has been reported in 2.6% of treated cases. Occasional burning or stinging sensation may occur (1.4%). Other local adverse effects are less common and included dryness or thirst (0.2%), tingling (0.2%), warm feeling in mouth and altered sense of taste (0.1%).
Systemic side effects are rare. These include nausea, vomiting, retching, gastrointestinal disorders (0.4%), dizziness (0.1%), headache and drowsiness (0.1%). Hypersensitivity reactions occur very rarely but may be associated with rash, urticaria, photodermatitis and occasionally laryngospasm or bronchospasm.
Drug Interactions
There are no known drug interactions with Difflam Forte Anti-inflammatory Throat Spray.
Caution For Usage
Cleaning Instructions: After use, wipe the nozzle with a clean tissue to prevent blockage.
Storage
Store at or below 30°C.
Shelf-Life: 4 years.
ATC Classification
A01AD02 - benzydamine ; Belongs to the class of other agents for local oral treatment.
Presentation/Packing
Oromucosal spray (w/ extended nozzle) (metered-dose pump) 3 mg/mL x 15 mL x 1's.
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