Adverse reactions : תופעות לוואי

8. Adverse Reactions
(1) Summary of adverse reactions
There has been no research, such as a treatment outcome study, to determine the incidence of occurrence of adverse reactions.
(2) Serious of adverse reactions and initial symptoms
Serious adverse reactions
1) Respiratory arrest, respiratory depression (incidence unknown): Respiratory arrest and respiratory depression may occur, and there are also reports of symptoms resulting in cardiopulmonary arrest, so respiratory conditions must be monitored carefully and appropriate measures taken in case of abnormality.
2) Shock, anaphylaxis, (incidence unknown): Shock and anaphylaxis may occur, so patient must be monitored carefully and in case pruritus, edema, respiratory distress, decreased blood pressure, cyanosis, etc. occur, discontinue administration and take appropriate measures.
3) Dependence (incidence unknown): Since prolonged administration may cause drug dependency, monitor patient carefully and take careful care in dosage and duration of administration. Furthermore, sudden dosage reduction or discontinuation after prolonged use may cause withdrawal symptoms such as convulsive seizure, delirium, tremors, anxiety, etc. In case of discontinuing administration, carefully reduce dosage gradually.
(3) Other adverse reactions
Other adverse reactions
In case any of the following adverse reactions occur, take appropriate measures based on symptoms.
Frequency unknown
HypersensitivityNote)                             Rash, erythema, blister, fixed drug eruption, pruritus, fever
Circulatory system                                Bradycardia
Liver                                             Increase in AST (GOT) and ALT (GPT) BloodNote)                                        Eosinophilia, leukopenia Digestive system                                  Nausea/vomiting, flatulence, stomachache
Neuropsychiatric                                  Headache, dizziness, lightheadedness, ataxia, erethism, depression, dysarthria,
delayed awakening
Other                                             Edema, decreased urine volume, ketonuria
Note) In these cases, discontinue administration.
(4) List of adverse event frequency and abnormalities in clinical laboratory values by category
The incidence of adverse reactions in combination with tablets* was 202 cases (6.33%) out of 3,189 cases.

Cases    Incidence (%)                               Cases      Incidence (%) Headache                  11       0.34               Lack of restraint        1          0.03 Vomiting                  3        0.09               Elation                  1          0.03 Nausea                    5        0.16                 Hyperactivity           1           0.03 Abdominal pain            1        0.03                 Fear                    1           0.03 Gastric irritation        12       0.38                 Nightmares              1           0.03 Stomach discomfort        1        0.03                 Nervousness             1           0.03 Reflux                    2        0.06                 Insomnia                1           0.03 Heartburn                 2        0.06                 Incoordination          1           0.03 Flatulence                3        0.09                 Ataxia                  3           0.09 Mental desensitization 1           0.03                 Sluggish movement       1           0.03 Fatigue/drowsiness        32       1.00                 Hangover-like feeling   3           0.09 Dizziness, light-         14       0.44                 Residual action         9           0.28 headedness
Aftertaste                1        0.03
* triclofos sodium tablets were taken off the market in 1975

(5) Incidence of adverse reactions by background, including underlying disease, complications, severity and whether or not surgery was performed
No applicable data

(6) Precautions and study methods for drug allergy
1) Patients with a history of hypersensitivity to the components of TRICLONAM or chloral hydrate.
2) Shock and anaphylaxis may occur as major adverse reactions, so patient must be monitored carefully and in case pruritus, edema, respiratory distress, decreased blood pressure, cyanosis, etc. occur, discontinue administration and take appropriate measures.
3) Rash, erythema, blister, fixed drug eruption, pruritus or fever may occur. If such symptoms occur, discontinue administration.

Reporting of suspected adverse reactions:
Reporting of 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/ 
9. Use in the Elderly
TRICLONAM may cause respiratory depression in elderly patients. Since adverse reactions are likely to occur in general, administer drug carefully, for example by starting with minimal dosage.

10. Use during Pregnancy, Delivery or Lactation, etc.
Preferably, TRICLONAM should not be administered to pregnant women or woman who may be pregnant. [Safety in administration during pregnancy has not been established] 
11. Pediatric Use, etc.
(1) In general, children have a higher drug sensitivity than adults, so administer drug carefully, for example by starting with minimal dosage (there have been many reports of respiratory arrest, respiratory depression and convulsions children with low birth weight, newborns, and infants) (2) There are reports of respiratory arrest and respiratory depression occurring, leading to heart failure, so drug must be administered carefully and patient must be monitored closely. (See 6.
Important Precautions, Reasons and Measures)
(3) Convulsions (clonic convulsions, partial attacks, etc.) may occur, so administer carefully.

12. Effects in clinical test results
No applicable data