Medication info

Bispentin Extended-release Capsule 60mg (Methylphenidate Hydrochloride)

Prescription medicationApproval withdrawn
Ingredient · strength
Methylphenidate Hydrochloride›Strength being verified
Manufacturer / importer
Mundipharma Korea Ltd.,
Appearance
A hard capsule with the upper part in dark gray and the lower part in white, containing white spherical particles.
Packaging
30 capsules
Approval status
Approval withdrawn

MFDS item code 201503882 · Approved 2015.06.15

This product's status changed to Approval withdrawn on 2023.05.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 years and older
Who uses it
Adults
Adult dosage
Start this medicine at the lowest possible dose and adjust the dose individually according to the patient's response and tolerability. This medicine or its contents should be taken intact with water. Do not chew or crush the contents of this medicine. Administer this medicine once daily in the morning. The initial dose is 10 - 20mg once daily. Increase the daily dose by 10mg each week according to the patient's response to treatment and tolerability. The maximum daily dose of this medicine is 60mg. The efficacy of this medicine for treatment lasting longer than 4 weeks has not been systematically evaluated in placebo-controlled clinical trials. When prescribing this medicine for long-term use in patients with ADHD, periodically reevaluate its long-term efficacy by temporarily interrupting drug treatment and assessing the patient's social functioning. If symptoms worsen or other adverse reactions occur, reduce the dose and, if necessary, discontinue this medicine. If symptoms do not improve within one month after adjustment to an appropriate dose, discontinue this medicine.

Ingredients

Importer
Mundipharma Korea Ltd.,

Efficacy & effects

Treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 years and older

  • Inattention
  • hyperactivity
  • restlessness
  • fidgeting
  • inability to stay seated
  • inappropriate running
  • climbing
  • difficulty with quiet activities
  • constant activity
  • excessive talking
  • blunt responses
  • inability to wait for one's turn
View approved original text

This medication is used for patients aged 6 and older who have been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a condition characterized by symptoms such as inattention, hyperactivity, and impulsivity that begin before the age of 7 and persist across various environments, causing impairment in social and academic functioning. Pharmacotherapy should be conducted alongside psychological, educational, and social treatments and aids in alleviating the patient's symptoms as part of this approach. It is not necessary for all patients and should be prescribed by a physician based on the patient's condition and symptom severity. This drug is used effectively to control ADHD symptoms in conjunction with the appropriate treatment program.

Dosage and Administration

Adult dosage

Start this medicine at the lowest possible dose and adjust the dose individually according to the patient's response and tolerability. This medicine or its contents should be taken intact with water. Do not chew or crush the contents of this medicine. Administer this medicine once daily in the morning. The initial dose is 10 - 20mg once daily. Increase the daily dose by 10mg each week according to the patient's response to treatment and tolerability. The maximum daily dose of this medicine is 60mg. The efficacy of this medicine for treatment lasting longer than 4 weeks has not been systematically evaluated in placebo-controlled clinical trials. When prescribing this medicine for long-term use in patients with ADHD, periodically reevaluate its long-term efficacy by temporarily interrupting drug treatment and assessing the patient's social functioning. If symptoms worsen or other adverse reactions occur, reduce the dose and, if necessary, discontinue this medicine. If symptoms do not improve within one month after adjustment to an appropriate dose, discontinue this medicine.

Precautions

This medication is not recommended for children or adolescents with heart problems, or for adults. Patients with a history of heart disease or a family history should consult a physician before taking it. Patients with high blood pressure or heart disease should regularly monitor their blood pressure and heart rate while taking this medication. Caution is needed as it may burden the heart. Patients with a history of psychiatric problems or previous psychotic symptoms should use this medication with caution as symptoms may worsen. Immediate consultation with a physician is required if new psychotic symptoms or manic symptoms appear. This medication may affect growth, so for children, growth status should be regularly monitored, and if growth delays are suspected, use may be temporarily discontinued. Patients with a history of epilepsy or seizures should consult a physician before taking this medication as it may increase the risk of seizures. Due to the risk of drug abuse, care should be taken not to increase the dosage or misuse the medication without proper guidance. Persistent and painful erections may occur, and if this symptom arises, medical attention should be sought immediately. Symptoms of peripheral vascular disease may emerge, so if there are changes such as cold or discolored hands and feet, consultation with a physician is advised. The safety and efficacy of this medication in children under 5 years of age have not been established and it is advisable not to use it. Patients with specific conditions or on certain medications, such as severe anxiety, glaucoma, Tourette’s syndrome, or those on MAO inhibitors, should not take this medication. Monitoring of blood pressure, heart rate, weight, kidney function, and mental status should be performed regularly during treatment, and immediate consultation with a physician is required if side effects or abnormal reactions occur. This medication may interact with other drugs; therefore, inform the physician or pharmacist of any other medications being taken. Pregnant or breastfeeding women should consult a physician before taking this medication, as it may affect the baby during breastfeeding. Caution is needed when driving or operating machinery due to potential dizziness or drowsiness. Severe side effects may occur in cases of overdose, so strictly adhere to the prescribed dosage and contact a healthcare facility immediately if in doubt.

Side effects

  • Headache
  • abdominal pain
  • influenza syndrome
  • pain
  • infection
  • weakness
  • lethargy
  • photosensitivity reaction
  • chills
  • fever
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  • allergic reaction
  • hypertension
  • vasodilation
  • insomnia
  • drowsiness
  • irritability
  • depression
  • apathy
  • emotional instability
  • obsessive behavior
  • language tic
  • speech disorder
  • motor tic
  • rebound
  • sleep disorder
  • dizziness
  • anxiety
  • euphoric sensation
  • stereotypy
  • visual disturbances
  • conjunctivitis
  • corneal lesions
  • otitis media
  • palpitations
  • drowsiness
  • dizziness
  • depersonalization
  • vocal tic
  • vertigo
  • appetite loss
  • nausea
  • increased appetite
  • vomiting
  • diarrhea
  • pharyngitis
  • asthma
  • increased cough
  • rash
  • eczema
  • skin discoloration
  • itching
  • dysmenorrhea
  • persistent painful erection
  • Raynaud's phenomenon
  • hallucinations
  • agitation
  • tremors
  • rebound insomnia
  • muscle spasms
  • seizures
  • euphoria
  • confusion
  • delirium
  • sweating
  • flushing
  • abnormal fever
  • palpitations
  • deep vein thrombosis
  • pupillary dilation
  • mucosal dryness
  • serotonin syndrome
  • hypersensitivity
  • urticaria
  • fever
  • arthralgia
  • exfoliative dermatitis
  • necrotizing vasculitis
  • thrombocytopenic purpura
  • dyskinesia
  • changes in blood pressure and pulse
  • increase and decrease
  • tachycardia
  • angina
  • weight loss during long-term use
  • Tourette syndrome
  • toxic psychosis
  • hepatic coma
  • cerebral vascular arteritis
  • obstruction
  • anemia
  • transient depressive mood
  • rare hair loss
  • malignant neuroleptic syndrome

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, maintaining a storage temperature between 1 and 25 degrees Celsius. Therefore, it is important to avoid direct sunlight and not to place it in excessively hot or cold locations.

Appearance and packaging

Appearance

A hard capsule with the upper part in dark gray and the lower part in white, containing white spherical particles.

Package unit

30 capsules

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.