Special Warning : אזהרת שימוש

4.4     Special warnings and precautions for use

Attent FW 08-2024 Notification
Abuse, Misuse, and Addiction
Attent tablets have a high potential for abuse and misuse. The use of Attent tablets exposes individuals to the risks of 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 (see DRUG ABUSE and DEPENDENCE). 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.

Before prescribing Attent tablets, assess each patient’s risk for abuse, misuse, and addiction.
Educate patients and their families about these risks and proper disposal of any unused drug.
Advise patients to store Attent tablets in a safe place, preferably locked, and instruct patients to not give Attent tablets to anyone else. Throughout Attent tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

Risk to Patients with Serious Cardiovascular Events
Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulant treatment at the recommended ADHD dosages.

Avoid Attent tablets use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.

Increased Blood Pressure and Heart Rate
CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mmHg) and heart rate (mean increase about 3 to 6 bpm). Some patients may have larger increases.
Monitor all Attent tablets-treated patients for potential tachycardia and hypertension.

Psychiatric Adverse Events
Exacerbation of Pre-Existing Psychosis
CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychotic disorder.
Induction of a Manic Episode in Patients with Bipolar Disorder
CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).
New Psychotic or Manic Symptoms
CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared with 0% of placebo-treated patients. If such symptoms occur, consider discontinuing Attent tablets.
Long-Term Suppression of Growth in Pediatric Patients
CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients.
Closely monitor growth (weight and height) in Attent tablets -treated pediatric patients.
Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted.
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Seizures


Attent FW 08-2024 Notification
There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizure, in patients with prior EEG abnormalities in absence of seizures, and very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

Peripheral Vasculopathy, Including Raynaud’s Phenomenon
Stimulants, including ATTENT (Mixed Amphetamine Salts), used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in postmarketing reports and at the therapeutic doses of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant. Careful observation for digital changes is necessary during Attent tablets treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for Attent tablet-treated patients who develop signs or symptoms of peripheral vasculopathy.

Serotonin Syndrome
Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort [see Drug Interactions]. The coadministration with cytochrome P450 (CYP2D6) inhibitors increase the risk with increased exposure to ATTENT tablets. In these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6 [see Drug Interactions].
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
Concomitant use of ATTENT tablets with MAOI drugs is contraindicated [see Contraindications].
Discontinue treatment with dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of ATTENT tablets with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate ATTENT tablets with lower doses, monitor patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the increased risk for serotonin syndrome.

Motor and Verbal Tics, and Worsening of Tourette’s Syndrome
CNS stimulants, including amphetamine sulfate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported. Before initiating Attent tablets, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome with Attent tablets, and discontinue treatment if clinically appropriate
Other Precautions


Excipients with Known Effect


Attent FW 08-2024 Notification
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially "sodium-free".
This medicine contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Attent 20 mg and 30 mg tablets contain FD & C Yellow No. 6 Aluminium lake that may cause allergic reactions.

Effects on Driving

4.7 Effects on ability to drive and use machines
This product may affect your or your child’s ability to drive or do other dangerous activities.