Medication info
Meltone Sustained-release Tablet 2 mg (Melatonin)

Meltone Sustained-release Tablet 2 mg (Melatonin)

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

MFDS item code 202006555 · Approved 2020.09.23

Summary

Main use
Improvement of sleep quality in patients with insomnia aged 55 and above
Who takes it
Adults
Adult dose
Administer 1 tablet orally once daily after meals, 1-2 hours before bedtime, without chewing or crushing.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Improvement of sleep quality in patients with insomnia aged 55 and above

  • Decreased sleep quality
  • insomnia
View approved original text

This medication is developed for short-term use for patients aged 55 and above who experience insomnia due to decreased sleep quality. It primarily improves difficulties in falling asleep and symptoms of not being able to sleep deeply, leading to more comfortable sleep. This helps alleviate fatigue and enhances vitality in daily life. It can be used safely for short-term treatment and must be taken under the guidance of a healthcare professional. It is effective for overall sleep improvement and treats insomnia symptoms.

How to take

Adult dose

Administer 1 tablet orally once daily after meals, 1-2 hours before bedtime, without chewing or crushing.

Precautions

This medication should not be taken by individuals who are allergic to this drug or its ingredients. This medication contains lactose, thus individuals with hereditary issues such as lactose intolerance, congenital lactase deficiency, or glucose-galactose malabsorption should not take it. Patients with kidney or liver function issues should use this medication with caution, and those with autoimmune diseases or women who are pregnant or breastfeeding should also take it cautiously. Various side effects such as headaches, throat pain, muscle pain, insomnia, dizziness, and indigestion may occur when taking this medication, and some patients have reported rare incidents of skin rashes or blood abnormalities. This medication may cause drowsiness; therefore, caution should be exercised when driving or operating hazardous machinery. Additionally, this medication may interact with various drugs, so if you are taking other medications, it is crucial to consult with a healthcare professional. Particularly, taking it with fluvoxamine, methoxsalen, or estrogen preparations may increase the blood concentration of this medication, so caution is needed. Avoid taking it with alcohol as it may reduce the sleep effect of this medication. It is recommended that women who are pregnant or breastfeeding do not take this medication. Children under 18 years old should avoid using this medication as its safety and efficacy have not been established.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • oral edema
  • tongue swelling
  • angina
  • thrombocytopenia
  • leukopenia
  • high bilirubinemia
  • blood electrolyte abnormalities
  • Wernicke's encephalopathy
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  • pneumonia
  • vestibular neuritis
  • appendicitis
  • Clostridium difficile infection
  • small intestine bleeding
  • duodenal ulcer
  • tinnitus
  • lumbar vertebral fracture
  • congestive dermatitis
  • hives
  • angioedema
  • oral edema
  • tongue swelling
  • hives
  • angioedema
  • oral edema
  • tongue swelling.

Mild side effects

  • Headache
  • nasopharyngitis
  • low back pain
  • joint pain
  • hypertriglyceridemia
  • hypocalcemia
  • hyponatremia
  • hypersensitivity
  • nervousness
  • anxiety
Show 22 more
  • insomnia
  • abnormal dreams
  • nightmares
  • mood changes
  • aggression
  • crying
  • stress symptoms
  • disorientation
  • early morning awakening
  • increased libido
  • depressed mood
  • depression
  • migraine
  • drowsiness
  • excess psychomotor activity
  • dizziness
  • drowsiness
  • fainting
  • memory impairment
  • attention deficit
  • muddled state
  • and others.

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 does not allow light in. Additionally, it is important to store it in a cool room temperature, specifically below 25 degrees Celsius, to maintain the drug's effectiveness.

Appearance and packaging

Appearance

White to grayish white, double convex, round sustained-release tablets

Package unit

30 tablets/box [(15 tablets/PTP) x 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

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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.