Medication info
Pregabalin Oral Disintegrating Tablets 50 mg (Pregabalin)

Pregabalin Oral Disintegrating Tablets 50 mg (Pregabalin)

Prescription medicationOrally disintegrating Tablet
Ingredient · strength
Pregabalin›50mg / 1 tablet
Manufacturer / importer
한올바이오파마(주)
Appearance
Yellow round oral disintegrating tablet
Packaging
30 tablets/PTP [10 tablets/PTP x 3], 100 tablets/PTP [10 tablets/PTP x 10]
Approval status
Active

MFDS item code 202600532 · Approved 2026.02.24

Summary

Main use
Treatment of peripheral and central neuropathic pain, adjunctive treatment for partial epilepsy, improvement of fibromyalgia
Who uses it
Adults · Children
Adult dosage
This medication, consisting of pregabalin, should be taken orally in divided doses twice daily without regard to food, placed on the tongue to disintegrate and swallowed without water. 1. Neuropathic pain - Peripheral neuropathic pain: Starting dose of 150 mg once daily; may be increased to 300 mg once daily after 3 to 7 days, with potential further titration to a maximum of 600 mg every 7 days if necessary. - Central neuropathic pain
Children's dosage
The safety and efficacy data for children under 12 years of age and adolescents aged 12-17 are insufficient, and therefore administration is not recommended.

Ingredients

Manufacturer
한올바이오파마(주)

Efficacy & effects

Treatment of peripheral and central neuropathic pain, adjunctive treatment for partial epilepsy, improvement of fibromyalgia

  • Peripheral neuropathic pain
  • central neuropathic pain
  • partial seizures
  • fibromyalgia
View approved original text

This medication is used for the treatment of peripheral and central neuropathic pain in adults. It is also used as an adjunctive treatment for partial seizures in patients with epilepsy and is effective whether or not there are secondary general symptoms. Additionally, it helps in the treatment of fibromyalgia. In summary, it is used to improve symptoms of neuropathic pain, partial seizures in epilepsy, and fibromyalgia.

Dosage and Administration

Adult dosage

This medication, consisting of pregabalin, should be taken orally in divided doses twice daily without regard to food, placed on the tongue to disintegrate and swallowed without water. 1. Neuropathic pain - Peripheral neuropathic pain: Starting dose of 150 mg once daily; may be increased to 300 mg once daily after 3 to 7 days, with potential further titration to a maximum of 600 mg every 7 days if necessary. - Central neuropathic pain

Children's dosage

The safety and efficacy data for children under 12 years of age and adolescents aged 12-17 are insufficient, and therefore administration is not recommended.

Precautions

This medication may increase the risk of suicidal thoughts or behavior, so if symptoms of depression or mood changes occur during treatment, it must be reported to a healthcare professional immediately. It should not be used if there is an allergy to this medication's components. Diabetic patients may need to adjust their blood sugar control medications due to weight gain after taking this medication. If allergic reactions such as angioedema occur, discontinue use immediately and consult a healthcare professional. Elderly patients need to be cautious of falls or injuries due to dizziness or drowsiness and should refrain from activities if these symptoms occur. This medication may cause blurred vision, so any changes in vision should be reported to a healthcare professional. Halting this medication suddenly can cause withdrawal symptoms such as insomnia, headache, and anxiety, so it should be gradually reduced after consulting a healthcare professional. Patients with a history of drug abuse should be especially cautious of misuse or dependence on this medication. Patients with decreased kidney function may require dose adjustments of this medication. Patients with severe heart disease should use this medication cautiously and consult a healthcare professional immediately if symptoms of heart failure occur. Taking this medication with other central nervous system depressants or opioid analgesics can increase the risk of respiratory depression, so caution is needed. During early pregnancy, there is a risk of fetal malformations, so women who are pregnant or planning to become pregnant should consult a healthcare professional before taking this medication and use effective contraception. Breastfeeding women should discuss with a healthcare professional regarding the potential transfer of this medication into breast milk and its effects on the infant. It is advisable to avoid dangerous activities such as driving or operating machinery until dizziness or drowsiness symptoms subside. Severe skin reactions may occur, so if symptoms such as rash, redness, or blisters arise, discontinue use immediately and inform a healthcare professional. In cases of overdose, symptoms such as drowsiness, confusion, depression, and seizures may occur, so immediate medical attention should be sought for appropriate treatment. This medication must be stored out of reach of children and should not be transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • breathing difficulties
  • skin peeling
  • pain in mouth/eye mucosa
  • skin or eyes turning yellow (jaundice)
  • severe lethargy
  • sudden and severe headaches
  • seizures
  • confusion
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  • visual disturbances
  • paralysis
  • significantly reduced urine output
  • severe swelling of the body
  • increased blood pressure
  • angioedema
  • severe skin adverse reactions
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • anaphylaxis-like symptoms

Mild side effects

  • Dizziness
  • drowsiness
  • nasopharyngitis
  • increased appetite
  • decreased appetite
  • hypoglycemia
  • confusion
  • spatial disorientation
  • irritability
  • depression
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  • euphoria
  • decreased libido
  • insomnia
  • derealization
  • sexual arousal disorder
  • restlessness
  • anxiety
  • mood swings
  • emotional lability
  • difficulty finding appropriate terms
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • impulsivity
  • apathy
  • ataxia
  • abnormal motor coordination
  • balance disorders
  • memory impairment
  • attention deficit
  • memory loss

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round oral disintegrating tablet

Package unit

30 tablets/PTP [10 tablets/PTP x 3], 100 tablets/PTP [10 tablets/PTP x 10]

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.