Medication info
Melatonin Sustained Release Tablets 2 mg

Melatonin Sustained Release Tablets 2 mg

Prescription medicationTablet경구
Ingredient · strength
Melatonin›2mg / 1 tablet
Manufacturer / importer
동광제약(주)
Appearance
White to grayish-white, double-convex round tablets
Packaging
30 tablets/box [(15 tablets/PTP × 2)]
Approval status
Active

MFDS item code 202006554 · Approved 2020.09.23

Summary

Main use
Improvement of sleep quality in patients over 55 years suffering from insomnia
Who takes it
Adults
Adult dose
Take 1 tablet orally once a day, 1 to 2 hours before bedtime after meals, without chewing or crushing.

Ingredients

Manufacturer
동광제약(주)

Efficacy & effects

Improvement of sleep quality in patients over 55 years suffering from insomnia

  • Decreased sleep quality
  • insomnia
View approved original text

This medication is used short-term for patients over 55 years who experience poor sleep quality and insomnia. It helps improve sleep patterns temporarily, inducing deep and comfortable sleep while reducing occurrences of waking up during the night. This alleviates fatigue and concentration problems the following day. It helps with sleep safely while minimizing side effects, allowing for reassurance when taking it. It aids in enhancing overall sleep quality, contributing to increased vitality in daily life.

How to take

Adult dose

Take 1 tablet orally once a day, 1 to 2 hours before bedtime after meals, without chewing or crushing.

Precautions

This medication should not be used by patients who are allergic to specific ingredients or have a genetic lactose metabolism disorder. Patients with kidney or liver function issues should exercise caution when using this medication, and those with autoimmune diseases or women who are pregnant or breastfeeding should take it with care. Taking this medication may result in various side effects including headache, nasopharyngitis, lower back pain, and joint pain; rare side effects may include blood disorders, psychiatric disorders, gastrointestinal issues, and skin rashes. Particularly, it may cause drowsiness, so caution is needed when driving or operating machinery. Since this medication is metabolized by specific enzymes in the liver, interactions may occur when taken with other medications. For instance, when taken with certain antidepressants, antibiotics, hormones, smoking, or alcohol, the effects or side effects of this medication may change, so it is essential to consult with a physician or pharmacist. Women who are pregnant or breastfeeding should avoid this medication as its safety has not been fully established. For children under the age of 18, it is recommended not to use it since its safety and effectiveness have not been established. The medication should be kept out of reach of children and stored in its original container; although no specific cases have been reported for overdose, it is safest to consult a healthcare professional immediately.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • oral edema
  • tongue swelling
  • difficulty breathing
  • angina
  • high bilirubinemia
  • thrombocytopenia
  • leukopenia
  • Wernicke's encephalopathy
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  • tremor
  • pneumonia
  • vestibular neuritis
  • appendicitis
  • Clostridium difficile infection
  • small bowel bleeding
  • duodenal ulcer
  • tinnitus
  • lumbar fracture
  • cataract surgery.

Mild side effects

  • Headache
  • nasopharyngitis
  • lower back pain
  • joint pain
  • leukopenia
  • thrombocytopenia
  • hypertriglyceridemia
  • hypocalcemia
  • hyponatremia
  • hypersensitivity
Show 21 more
  • neuroexcitability
  • anxiety
  • insomnia
  • abnormal dreams
  • nightmares
  • mood changes
  • aggression
  • crying
  • stress symptoms
  • spatial disorientation
  • early morning awakening
  • increased libido
  • depressive mood
  • depression
  • migraine
  • hypersomnia
  • psychomotor hyperactivity
  • dizziness
  • drowsiness
  • fainting
  • memory impairment.

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

Storage

This medication is sensitive to light and should be stored in a container that blocks light. Additionally, to maintain its efficacy, it is important to store it at room temperature, below 25 degrees.

Appearance and packaging

Appearance

White to grayish-white, double-convex round tablets

Package unit

30 tablets/box [(15 tablets/PTP × 2)]

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

No questions yet.

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.