Medication info

Slinaitomini Sustained-Release Tablets 5 mg (Melatonin)

Prescription medicationTablet경구
Ingredient · strength
Melatonin Micronized›5mg / 1 tablet
Manufacturer / importer
건일제약(주)
Appearance
A round, sustained-release film-coated tablet with a yellow color, convex on both sides, and a diameter of 3 millimeters.
Packaging
30 tablets/box [(30 tablets/blister packaging)]
Approval status
Active

MFDS item code 202303210 · Approved 2023.11.23

Summary

Main use
Treatment of insomnia in children and adolescents with autism spectrum disorder and Smith-Magenis syndrome.
Who takes it
Adults
Adult dose
The recommended initial dose is 2 mg once daily. If inadequate response is observed, it may be increased up to 5 mg, with a maximum daily dose of 10 mg. Administer orally with food 0.5 to 1 hour before bedtime, swallowing whole without chewing or crushing. This medication can be taken mixed with yogurt, orange juice, or ice cream and should be taken immediately after mixing.

Ingredients

Importer
건일제약(주)

Efficacy & effects

Treatment of insomnia in children and adolescents with autism spectrum disorder and Smith-Magenis syndrome.

  • Insomnia
View approved original text

This medication is used for the treatment of insomnia in children and adolescents aged 2 to 18 years with autism spectrum disorder and Smith-Magenis syndrome, where symptoms do not improve with sleep hygiene alone.

How to take

Adult dose

The recommended initial dose is 2 mg once daily. If inadequate response is observed, it may be increased up to 5 mg, with a maximum daily dose of 10 mg. Administer orally with food 0.5 to 1 hour before bedtime, swallowing whole without chewing or crushing. This medication can be taken mixed with yogurt, orange juice, or ice cream and should be taken immediately after mixing.

Precautions

This medication should not be used by individuals allergic to this drug or any of its components. This medication contains lactose, and individuals with genetic disorders that prevent lactose digestion should not take it. Patients with kidney or liver issues, autoimmune diseases, pregnant or breastfeeding women, and children under 2 years of age should use this medication with caution. This medication may cause side effects such as drowsiness, fatigue, mood changes, headaches, irritability, aggression, and hangover effects, so be careful with these symptoms. Particularly, caution is required during activities such as driving or operating machinery, as drowsiness may lead to accidents. This medication is metabolized in the liver by certain enzymes; taking it in conjunction with other drugs that affect these enzymes may lead to drug interactions. For example, taking it with certain antidepressants, sleeping pills, or alcohol can alter the effects of this medication, so consultation with a specialist is recommended. Pregnant or breastfeeding women should avoid this medication as its safety has not been sufficiently established. Children under 2 years should not use this medication as its safety and efficacy have not been established. In case of overdose, severe drowsiness may occur; however, this medication is rapidly eliminated from the body, so no special treatment is needed. Finally, this medication should be stored out of reach of children and kept in its original container to prevent misuse and quality degradation.

Side effects and when to seek care immediately

Serious side effects

Shortness of breath.

Mild side effects

  • Drowsiness
  • fatigue
  • mood swings
  • headaches
  • irritability
  • aggression
  • hangover
  • sinusitis
  • sudden sleep episodes
  • depression
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  • nightmares
  • restlessness
  • abdominal pain
  • constipation
  • decreased appetite
  • unusual sensations
  • abnormal behavior
  • neutropenia
  • nasal bleeding
  • facial swelling
  • skin lesions
  • visual disturbances.

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. Furthermore, it is important to store the medication at a temperature between 1°C and 30°C to maintain its efficacy.

Appearance and packaging

Appearance

A round, sustained-release film-coated tablet with a yellow color, convex on both sides, and a diameter of 3 millimeters.

Package unit

30 tablets/box [(30 tablets/blister packaging)]

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.