Medication info

Bispentin Controlled Release Capsule 10mg (Methylphenidate Hydrochloride)

Prescription medicationApproval withdrawn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Approval withdrawn

MFDS item code 201503880 · 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This product's status changed to Approval withdrawn on 2023.05.19.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

  • Lack of attention
  • hyperactivity
  • impulsivity
  • restlessness
  • fidgeting
  • inability to sit still
  • inappropriate running
  • climbing
  • difficulty in engaging in quiet activities
  • constant activity
  • excessive talking
  • delayed responses
View approved original text

This medication is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients aged 6 years and older. ADHD is a condition characterized by persistent symptoms such as lack of attention, hyperactivity, and impulsivity that continuously appear in various environments, affecting social and academic functioning. This medication is one of the pharmacological treatment methods used alongside psychological, educational, and social therapies as needed, and it improves the symptoms of patients as part of a comprehensive treatment program rather than as a standalone treatment. Pharmacological treatment is not necessarily required for all patients, and the decision is made after a comprehensive evaluation of the patient's condition and the presence of other disorders. This medication is particularly applied in cases where ADHD symptoms are chronic and severe, helping to improve the patient's attention and behavioral control abilities.

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 should not be used in individuals with heart problems. It may be particularly dangerous for children or adolescents with structural heart abnormalities or arrhythmias, as well as adults with heart disease. Individuals with high blood pressure should frequently monitor their blood pressure and heart rate when using this medication, and caution is necessary for those with poor heart conditions. Patients with psychosis or bipolar disorder should be closely monitored by a psychiatrist as symptoms may worsen with this medication. This medication may affect growth, so regular monitoring of children's growth is essential, and if growth issues arise, temporary discontinuation may be warranted. Patients with a history of seizures or abnormal EEG may experience an increased risk of seizures while taking this medication, so caution is advised. This medication has not been proven safe and effective for children under the age of 5 and should not be used in this age group. Patients with a history of substance dependence or alcohol abuse should be closely monitored as they may be at risk of misuse. Persistent and painful erections may occur while taking this medication; if this symptom occurs, immediate medical attention should be sought. Symptoms of peripheral vascular disease, such as cold or pale hands and feet, may develop, and in these cases, medical consultation is necessary. This medication should not be used in patients with specific disorders, such as severe anxiety, glaucoma, Tourette syndrome, cardiovascular disease, or cerebrovascular disorders. During treatment, regular checks of blood tests, heart condition, mental state, weight, and height should be performed, and careful monitoring for drug abuse is necessary. This medication may interact with other medications; therefore, patients should inform their doctor or pharmacist about any other medications they are taking, especially when used with MAO inhibitors, antihypertensive drugs, antidepressants, and antipsychotic medications. Women who are pregnant or breastfeeding should carefully consider the risks and benefits of using this medication, and nursing mothers may need to consider discontinuing either the medication or breastfeeding. Caution is required as symptoms such as dizziness may occur while driving or operating machinery. This medication should be kept out of the reach of children and stored in its original container to maintain quality. In case of overdose, severe symptoms such as central nervous system overstimulation, arrhythmias, seizures, etc., may occur, requiring immediate emergency treatment.

Side effects

  • headache
  • abdominal pain
  • influenza syndrome
  • pain
  • infection
  • weakness
  • fatigue
  • phototoxic reaction
  • chills
  • fever
Show 80 more
  • allergic reaction
  • hypertension
  • vasodilation
  • insomnia
  • drowsiness
  • irritability
  • depression
  • apathy
  • emotional instability
  • obsessive behavior
  • speech tics
  • language disorders
  • motor tics
  • rebound
  • sleep disorders
  • dizziness
  • anxiety
  • abnormal sense of happiness
  • stereotypy
  • visual disturbances
  • conjunctivitis
  • corneal lesions
  • otitis media
  • palpitations
  • hyperesthesia
  • loss of appetite
  • nausea
  • increased appetite
  • vomiting
  • diarrhea
  • pharyngitis
  • asthma
  • increased coughing
  • rhinitis
  • bronchitis
  • rash
  • eczema
  • skin discoloration
  • itching
  • dysmenorrhea
  • persistent painful erection
  • Raynaud's phenomenon
  • distal ulcers
  • soft tissue damage
  • hallucinations
  • agitation
  • tremor
  • rebound
  • muscle spasm
  • seizure
  • sense of well-being
  • confusion
  • delirium
  • sweating
  • flushing
  • abnormal high fever
  • tachycardia
  • palpitations
  • deep vein thrombosis
  • mydriasis
  • mucosal dryness
  • vomiting
  • agitation
  • tremor
  • rebound
  • muscle spasm
  • seizure
  • sense of well-being
  • confusion
  • hallucinations
  • delirium
  • sweating
  • flushing
  • abnormal high fever
  • tachycardia
  • palpitations
  • deep vein thrombosis
  • hypertension
  • mydriasis
  • mucosal dryness

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

Storage

This medication should be stored in a sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 25 degrees Celsius at room temperature. This will help to safely preserve the effectiveness of the medication.

Appearance and packaging

Appearance

A hard capsule with a light teal upper part and a white lower part, 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.