Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Cardiovascular


Attent FW 08-2024 Notification
Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction.
There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System
Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, aggression, anger, logorrhea, dermatillomania, tremor, motor and verbal tics,.

Eye Disorders
Vision blurred, mydriasis.

Gastrointestinal
Dryness of the mouth, unpleasant taste, diarrhea, constipation, intestinal ischemia and other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.

Allergic
Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported.

Endocrine
Impotence, changes in libido, frequent or prolonged erections

Skin
Alopecia
Musculoskeletal
Rhabdomyolysis

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

DRUG ABUSE AND DEPENDENCE
Abuse
Attent tablets have a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction. Attent tablets can be diverted for non- medical use into illicit channels or distribution.

Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.

Misuse and abuse of amphetamines may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed 

Attent FW 08-2024 Notification
with CNS stimulants abuse and/or misuse.          Misuse and abuse of CNS stimulants, including Attent tablets, can result in overdose and death [see OVERDOSE], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Dependence
Physical Dependence
Attent tablets may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.

Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of CNS stimulants including Attent tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

Tolerance
Attent tablets may produce tolerance. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).