Pharmaniaga Flumazenil

Pharmaniaga Flumazenil Side Effects



Pharmaniaga LifeScience


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Full Prescribing Info
Side Effects
Any side effects associated with Flumazenil usually subside rapidly without the need for special treatment.
Immune systems disorders: Common: Allergic reactions.
Rare: Severe hypersensitivity reactions (including anaphylaxis).
Psychiatric disorders: Common: Anxiety*, emotional lability, insomnia, somnolence.
Uncommon: Fear.
Unknown: Withdrawal symptoms, (e.g. agitation, anxiety, emotional lability, confusion, sensory distortions, tachycardia, dizziness, sweating), following rapid injection of doses of 1 mg or more in patients with high-dose and/or long-term exposure to benzodiazepines ending at any time within the weeks preceding flumazenil administration panic attacks (in patients with a history of panic reactions); abnormal crying, agitation, aggressive reactions (the side effect profile in children is generally similar to that in adults. When Flumazenil has been used for the reversal of conscious sedation, abnormal crying, agitation and aggressive reactions have been reported).
Nervous system disorders: Common: Vertigo, headache, agitation*, tremor, dry mouth, hyperventilation, speech disorder, paresthesia.
Uncommon: Convulsions (in patients suffering epilepsy or severe hepatic insufficiency, mainly after long-term treatment with benzodiazepines or multiple medicinal products abuse).
Eye disorders: Common: Diplopia, strabismus, lacrimation increased.
Ear and labyrinth disorders: Uncommon: Abnormal hearing.
Cardiac disorders: Common: Palpitations*.
Uncommon: Tachycardia or bradycardia, extrasystole.
Vascular disorders: Common: Flushing, hypotension, orthostatic hypotension, transient increased blood pressure (on awakening).
Respiratory, thoracic and mediastinal disorders: Uncommon: Dyspnoea, cough, nasal congestion, chest pain.
Gastrointestinal disorders: Very common: Nausea (during anaesthesia).
Common: Vomiting (during anaesthesia), hiccup.
Skin and subcutaneous tissue disorders: Common: Sweating.
General disorders and administration site conditions: Common: Injection site pain. Uncommon: Shivering.
Rare: Severe hypersensitivity reactions (including anaphylaxis).
*: following rapid injection, generally did not require treatment.
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