Medication info

Narafil Oral Disintegrating Film 2.5 mg (Naratriptan Hydrochloride)

Prescription medicationOral
Ingredient · strength
Naratriptan Hydrochloride›2.78mg / 1 sheet
Manufacturer / importer
CMG Pharmaceutical Co., Ltd.
Appearance
White or yellowish rectangular oral disintegrating film (may have spots).
Packaging
6 sheets/box [1 sheet x 6 pieces]
Approval status
Active

MFDS item code 202400098 · Approved 2024.01.12 · Insurance code 648604690

Summary

Main use
Rapid relief of migraine, with or without aura
Who takes it
Adults · Children
Adult dose
This drug is an orally dissolving film. Remove it from its individual package and place it on the tongue immediately; allow it to dissolve and take it without water. This drug should not be used routinely for preventive purposes. It is preferable to use it as monotherapy rather than in combination with other migraine medications. Adults (18 ∼ 65 years): The recommended dose of naratriptan is 2.5 mg as a single dose. The total dose should not exceed 5.0 mg in 24 hours. If the migraine recurs after a single 2.5 mg dose of this drug, a further 2.5 mg dose may be taken after an interval of at least 4 hours. In patients who do not respond to this drug, do not repeat the dose for the same attack unless there is a therapeutic benefit; it may be used for subsequent attacks. Elderly patients (66 years and older): The safety and efficacy of this drug have not been established in patients 66 years and older; therefore, its use is not recommended. Pharmacokinetic data indicate that clearance decreases with age. Patients with renal impairment: Use with caution in patients with renal impairment. The maximum dose in 24 hours is 2.5 mg. Do not administer to patients with severe renal impairment (creatinine clearance < 10 mL/min). Patients with hepatic impairment: Use with caution in patients with hepatic impairment. The maximum dose in 24 hours is 2.5 mg. Do not administer to patients with severe hepatic impairment (Child-Pugh grade C).
Child dose
Adolescents (12 ∼ 17 years): In a placebo-controlled trial in adolescents, a single dose of this drug at 0.25 mg, 1.0 mg, or 2.5 mg was not shown to be more effective than placebo. Therefore, use of this drug is not recommended in patients under 18 years of age. Children (under 12 years): Clinical data on the use of this drug in children under 12 years of age are insufficient; therefore, its use is not recommended.

Ingredients

Manufacturer
CMG Pharmaceutical Co., Ltd.

Efficacy & effects

Rapid relief of migraine, with or without aura

  • Aura
  • migraine
View approved original text

This medication helps to quickly relieve symptoms of migraine, whether with or without aura. It reduces severe headaches caused by migraines, helping to make daily life more comfortable. It is effectively used by individuals suffering from migraines.

How to take

Adult dose

This drug is an orally dissolving film. Remove it from its individual package and place it on the tongue immediately; allow it to dissolve and take it without water. This drug should not be used routinely for preventive purposes. It is preferable to use it as monotherapy rather than in combination with other migraine medications. Adults (18 ∼ 65 years): The recommended dose of naratriptan is 2.5 mg as a single dose. The total dose should not exceed 5.0 mg in 24 hours. If the migraine recurs after a single 2.5 mg dose of this drug, a further 2.5 mg dose may be taken after an interval of at least 4 hours. In patients who do not respond to this drug, do not repeat the dose for the same attack unless there is a therapeutic benefit; it may be used for subsequent attacks. Elderly patients (66 years and older): The safety and efficacy of this drug have not been established in patients 66 years and older; therefore, its use is not recommended. Pharmacokinetic data indicate that clearance decreases with age. Patients with renal impairment: Use with caution in patients with renal impairment. The maximum dose in 24 hours is 2.5 mg. Do not administer to patients with severe renal impairment (creatinine clearance < 10 mL/min). Patients with hepatic impairment: Use with caution in patients with hepatic impairment. The maximum dose in 24 hours is 2.5 mg. Do not administer to patients with severe hepatic impairment (Child-Pugh grade C).

Child dose

Adolescents (12 ∼ 17 years): In a placebo-controlled trial in adolescents, a single dose of this drug at 0.25 mg, 1.0 mg, or 2.5 mg was not shown to be more effective than placebo. Therefore, use of this drug is not recommended in patients under 18 years of age. Children (under 12 years): Clinical data on the use of this drug in children under 12 years of age are insufficient; therefore, its use is not recommended.

Precautions

This medication should not be used in certain patients. For example, patients who have had allergic reactions to this medication or have heart diseases should not take it. Patients with cerebrovascular diseases, uncontrolled hypertension, or severe renal or liver dysfunction should also avoid this medication. Since this medication contains sulfonamide compounds, patients allergic to sulfonamides should take it with caution. When taking this medication, temporary side effects such as pain, dizziness, drowsiness, and nausea may occur, so activities requiring attention such as driving or operating machinery should be avoided. Women who are pregnant or may become pregnant should only take this medication when the benefits to the mother outweigh the risks to the fetus, and nursing mothers should also exercise caution. It is best to avoid using this medication in conjunction with other specific migraine treatments, as drug interactions can lead to serious side effects such as serotonin syndrome, so follow your doctor's instructions. In case of overdose, visit a medical institution immediately and undergo observation and treatment for at least 24 hours. Finally, this medication should be stored out of reach of children and not transferred to other containers for safety.

Side effects

  • Pain
  • visual impairment
  • nausea
  • vomiting
  • pressure sensation
  • bradycardia
  • tachycardia
  • palpitations
  • fatigue
  • lethargy
Show 17 more
  • dizziness
  • drowsiness
  • pain
  • numbness
  • warmth
  • sensation of tightness
  • skin hypersensitivity reaction
  • anaphylaxis
  • coronary artery spasm
  • transient ischemic changes in ECG
  • angina
  • myocardial infarction
  • peripheral vascular ischemia
  • ischemic colitis
  • headache
  • neck tension
  • loss of synergistic action

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

Storage

This medication should be kept in a tightly sealed container to protect it from air and moisture and should be stored at room temperature between 1 and 30 degrees Celsius. This way, the effectiveness of the medication can be well maintained and deterioration can be prevented.

Appearance and packaging

Appearance

White or yellowish rectangular oral disintegrating film (may have spots).

Package unit

6 sheets/box [1 sheet x 6 pieces]

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.

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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.