Difflam Anti-Inflammatory Loz (with cough suppressant)

Difflam Anti-Inflammatory Loz (with cough suppressant) Special Precautions

Manufacturer:

iNova

Distributor:

Zuellig Pharma
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 Anti-Inflammatory Lozenges with Cough Suppressant.
For use in patients with hepatic or renal impairment see Dosage & Administration.
Excess consumption of products containing isomalt may have a laxative effect.
Risks from Concomitant Use with Benzodiazepines: Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Difflam Anti-inflammatory Lozenges with Cough Suppressant with benzodiazepines. Observational studies have demonstrated that concomitant use of opioids and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
If the decision is made to newly prescribe a benzodiazepine and an opioid together, prescribe the lowest effective dosages and minimum durations of concomitant use.
If the decision is made to newly prescribe a benzodiazepine in a patient already receiving an opioid, prescribe a lower initial dose of the benzodiazepine than indicated in the absence of an opioid, and titrate based on clinical response.
If the decision is made to prescribe an opioid in a patient already taking a benzodiazepine, prescribe a lower initial dose of the opioid, and titrate based on clinical response.
Follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when Difflam Anti-inflammatory Lozenges with Cough Suppressant is used with benzodiazepines. Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warm them of the risk for overdose and death associated with the use of benzodiazepines (see Interactions).
Serotonin Syndrome with Concomitant Use of Serotonergic Drugs: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concurrent use of Difflam Anti-inflammatory Lozenges with Cough Suppressant with serotonergic drugs (See Interactions). This may occur within the recommended dosage range.
Serotonin syndrome symptoms may include mental-status changes (e.g. agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) and can be fatal (See Interactions). The onset of symptoms generally occurs within several hours to a few days of concomitant use, but may occur later than that. Discontinue Difflam Anti-inflammatory Lozenges with Cough Suppressant if serotonin syndrome is suspected.
Adrenal Insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, decreased appetite, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement dosing of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tired as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioid as being more likely to be associated with adrenal insufficiency.
Sexual Function/ Reproduction: Long term use of opioids may be associated with decreased sex hormones levels and symptoms such as low libido, erectile dysfunction, or infertility (see Postmarketing Experience under Adverse Reactions).
Use in Pregnancy: Benzydamine: Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of foetal damage.
The safety of benzydamine hydrochloride has not been established in pregnant patients. Risk to benefit ratio should be established if Difflam Anti-Inflammatory Lozenges with Cough Suppressant are to be used in these patients.
Pholcodine: Pholcodine has been taken by a large number of pregnant women and women of child bearing age without an increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
Use in Lactation: Pholcodine: No information is available as to whether pholcodine is excreted in breast milk nor whether it has a harmful effect on the newborn. Therefore it is not recommended for nursing mothers unless the expected benefit to the mother outweighs any potential risks to the infant.
Use in Children: Because of the lack of sufficient clinical experience Difflam Anti-Inflammatory Lozenges with Cough Suppressant are not recommended in children under 6 years of age.
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