Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The following convention has been used for the classification of the adverse reactions: 
Very common              ≥1/10

Common                   ≥1/100 to <1/10
Uncommon                 ≥1/1,000 to <1/100

Rare                     ≥1/10,000 to <1/1,000

Very rare                <1/10,000
Not known                cannot be estimated from the available data


Immune systems disorders
Common                   Allergic reactions.
Not known                Hypersensitivity reactions, including anaphylaxis 
Psychiatric disorders
Common                           Anxiety*, emotional lability, insomnia, somnolence.
Uncommon                         Fear
Not known                        Withdrawal symptoms (see below); panic attacks (in patients with a history of panic reactions); abnormal crying, agitation,
aggressive reactions

Nervous system disorders
Common                   Vertigo, headache, agitation*, tremor, dry mouth, hyperventilation, speech disorder, paresthesia.
Uncommon                 Convulsions (in patients suffering from epilepsy or severe hepatic insufficiency, mainly after long-term treatment with benzodiazepines or mixed drug overdose (see section 4.4)).

Ear and labyrinth disorders
Uncommon                    Abnormal hearing.

Eye disorders
Common                           Diplopia, strabismus, lacrimation increased.
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 postoperative use).
Common                            Vomiting (during postoperative use), hiccup.
Skin and subcutaneous tissue disorders
Common                    Sweating.

General disorders and administration site conditions
Common                             Fatigue, injection site pain.
Uncommon                           Shivering*.
*: after rapid injection, not requiring treatment

Following rapid injection of doses of 1 mg or more or in patients treated for long periods and/or high dose with benzodiazepines flumazenil can induce withdrawal symptoms. The symptoms are: tension, agitation, anxiety, emotional lability as well as confusion and sensory distortions, hallucinations, tremor and convulsions.

In general the undesirable effect profile in children is generally similar to that in adults. When using flumazenil for the reversal of conscious sedation abnormal crying, agitation and aggressive reactions have been reported.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il and emailed to the Registration Holder's Patient Safety Unit at: drugsafety@neopharmgroup.com.