Difflam Anti-Inflammatory Loz (with cough suppressant)

Difflam Anti-Inflammatory Loz (with cough suppressant) Adverse Reactions

Manufacturer:

iNova

Distributor:

Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Difflam in topical oral preparations is generally well tolerated and side effects are minor.
Benzydamine: The following adverse reactions have been reported after use of benzydamine hydrochloride in solution form.
Local Adverse Reactions: The most commonly reported reaction is oral numbness (2.6%). Occasional burning or stinging may occur and has been reported in 1.4% of treated cases. Other local adverse effects were less common and included dryness or thirst (0.2%), tingling (0.2%), warm feeling in mouth and altered sense of taste (<0.1%).
Systemic Adverse Reactions: These were very uncommon and never of a serious nature. They consisted mainly of nausea, vomiting, retching, gastro-intestinal disorders (0.4%), dizziness (0.1%), headache and drowsiness (<0.1%). Hypersensitivity reactions occur very rarely but may be associated with pruritus, rash, urticaria, photodermatitis and occasionally laryngospasm or bronchospasm.
Pholcodine: Pholcodine may occasionally cause nausea and vomiting. After large doses, drowsiness, restlessness, excitement, ataxia and respiratory depression may occur.
Postmarketing Experience: Serotonin syndrome: (See Precautions).
Adrenal insufficiency: (See Precautions).
Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids. Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and physiological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date. Patients presenting with symptoms of androgen deficiency should undergo laboratory evaluation.
Infertility: Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible.
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