Medication info
Melatonin Extended Release 2 mg

Melatonin Extended Release 2 mg

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

MFDS item code 202106894 · Approved 2021.10.13

Summary

Main use
Improvement of sleep quality in patients with insomnia aged 55 and older
Who takes it
Adults
Adult dose
1 tablet taken orally once daily after a meal, 1 to 2 hours before going to sleep, without chewing or crushing.

Ingredients

Manufacturer
한올바이오파마(주)

Efficacy & effects

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

  • Decreased sleep quality
  • insomnia
View approved original text

This medication is used for the short-term improvement of insomnia symptoms in patients aged 55 and older with decreased sleep quality. Specifically, it helps temporarily alleviate insomnia issues such as difficulty falling asleep or frequent awakenings, promoting comfortable sleep. This treatment leads to an overall improvement in sleep patterns, reducing fatigue and stress during daily activities.

How to take

Adult dose

1 tablet taken orally once daily after a meal, 1 to 2 hours before going to sleep, without chewing or crushing.

Precautions

This medication should not be taken by individuals who are allergic to this medication or its components. Additionally, because this medication contains lactose, those with hereditary disorders that prevent lactose digestion should also avoid taking it. Individuals with kidney or liver function issues should exercise particular caution when using this medication. Those with autoimmune diseases or who are pregnant or breastfeeding should consult a healthcare professional before taking this medication. This medication can cause various side effects such as headache, dizziness, and insomnia; if any abnormal symptoms occur during use, contact medical personnel immediately. As this medication may cause drowsiness, caution is needed when driving or operating machinery. Moreover, taking this medication alongside certain other drugs may alter drug concentrations, so any concurrent medications should be disclosed. Pregnant or breastfeeding women are advised to avoid using this medication. The safety and efficacy in children have not been adequately established, so use in this population is not recommended. This medication should be kept out of reach of children and properly sealed in its original container for storage.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • oral edema
  • tongue swelling
  • dermatitis
  • generalized rash
  • pruritic rash
  • congestive dermatitis
  • hyperbilirubinemia
  • angina pectoris
Show 11 more
  • pneumonia
  • small intestine bleeding
  • duodenal ulcer
  • Wernicke's encephalopathy
  • tremor
  • tachycardia
  • tinnitus
  • orthostatic hypotension
  • facial swelling
  • fever
  • dyspnea

Mild side effects

  • Headache
  • nasopharyngitis
  • low back pain
  • joint pain
  • hypertriglyceridemia
  • hypocalcemia
  • hyponatremia
  • hypersensitivity
  • neuromuscular hyperactivity
  • restlessness
Show 22 more
  • insomnia
  • abnormal dreams
  • nightmares
  • anxiety
  • mood changes
  • aggression
  • crying
  • stress symptoms
  • disorientation
  • early morning awakening
  • increased libido
  • depressed mood
  • depression
  • migraine
  • drowsiness
  • excessive psychomotor activity
  • dizziness
  • sleepiness
  • memory impairment
  • attention deficit
  • stupor
  • restless legs syndrome

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

Storage

This medication is sensitive to light, so it should be stored in a container that prevents light exposure. It is also advisable to store it in a cool place at or below room temperature (25 degrees Celsius).

Appearance and packaging

Appearance

White to grayish-white, double-convex round extended-release tablet

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.