Difflam/Difflam Solution/Difflam-C/Difflam Forte

Difflam/Difflam Solution/Difflam-C/Difflam Forte Special Precautions

benzydamine

Manufacturer:

iNova

Distributor:

Metro Drug
Full Prescribing Info
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.
The clinical efficacy of an antibacterial agent in lozenges and an antiseptic agent in oral solutions in reducing the severity or duration of throat infections have not been clinically established.
Difflam Solution contains methylhydroxybenzoate as a preservative. This has been known to cause sensitization. Hypersensitivity reactions due to Difflam Solution or any of its components may occur in susceptible individuals.
Excess consumption of products containing isomalt may have a laxative effect.
Difflam-C is not intended for prolonged use except under dental or medical supervision.
Patients with Renal Impairment: Since absorbed benzydamine and its metabolites are excreted in the urine, the possibility of systemic effects should be considered in patients with severe renal impairment.
Patients with Hepatic Impairment: Since absorbed benzydamine is highly metabolized in the liver, the possibility of systemic effects should be considered in patients with severe hepatic impairment.
Use in pregnancy: Category B2. Studies in animals are inadequate or may be lacking, but available data showed no evidence of an increased occurrence of fetal damage. The safety of benzydamine HCl has not been established in pregnant patients. Risk to benefit ratio should be established if Difflam is to be used in these patients.
Use in children: Because of the lack of sufficient clinical experience, Difflam is not recommended in children <6 years.
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