Rozerem S

Rozerem S

ロゼレムS

Sleep Aids
Pharmacist-Guidance Drug β€” Sold only by a pharmacist
Drug Type

Sleep aid (ramelteon, acts on melatonin receptors)

Form

Film-coated tablets

Indication

Relief of the following symptom of temporary sleeplessness: difficulty falling asleep.

Active Ingredients (per 1 tablet (daily dose))

Ramelteon 8 mg

Inactive Ingredients

Lactose hydrate, corn starch, hydroxypropyl cellulose, magnesium stearate, hypromellose, copovidone, titanium oxide, red ferric oxide, macrogol

Instructions for Use

  • βœ“Take once daily, within 30 minutes before bedtime, with water or lukewarm water. Do not chew.
Age Dose per use Times per day
Adults (15 years and older) 1 tablet Once daily
Under 15 years Do not use β€”
  • βœ“Follow the recommended dosage strictly.
  • βœ•Do not take at any time other than bedtime.
  • βœ•Do not take with a meal or right after a meal (it may not work well enough).
  • βœ“To remove a tablet from the PTP sheet, press firmly on the raised side of the sheet with your fingertip to break the aluminum foil on the back, then take out the tablet. Do not swallow the PTP sheet, as it may puncture the esophageal lining and cause serious injury.
  • βœ•Do not use this product if you:
  • (1) Have ever had an allergic reaction to this product or any of its ingredients.
  • (2) Are under 15 years of age.
  • (3) Are pregnant or possibly pregnant.
  • (4) Are being treated at a medical institution for any of the following: sleep disorders such as sleep apnea syndrome; mental illnesses that come with sleeplessness (depression, mania, schizophrenia, neurosis, dementia, etc.); or liver disease.
  • (5) Are being treated with fluvoxamine maleate (Depromel, Luvox, etc.).
  • βœ•Do not use any of the following medicines while taking this product: other sleep aids or hypnotic sedatives, cold medicines, pain relievers/fever reducers, cough and phlegm medicines, or oral medicines containing antihistamines (such as medicines for rhinitis, motion sickness, or allergies).
  • βœ•Do not operate vehicles or machinery after taking this product (drowsiness or other effects may occur and cause an accident). If drowsiness or fatigue continues into the next day, do not operate vehicles or machinery until these symptoms are gone.
  • βœ•Do not take this product while breastfeeding. If you take it, do not breastfeed.
  • βœ•Do not drink alcohol before or after taking this product.
  • βœ•Do not take this product except when you have difficulty falling asleep.
  • βœ•Do not take for more than 2 weeks. If you need to take it for longer than 2 weeks, consult a doctor or pharmacist.
  • βœ“Seek immediate medical attention if any of the following serious symptoms appear:
  • β€’ Shock (anaphylaxis): Itching of skin, hives, hoarseness, sneezing, itchy throat, difficulty breathing, palpitations, or clouded consciousness immediately after use.
  • ⚠Consult a doctor or pharmacist before use if you:
  • (1) Are under medical treatment.
  • (2) Are elderly.
  • (3) Have any of the following symptoms in addition to difficulty falling asleep: strong sleepiness during the day, light sleep and waking up during the night, feeling depressed, feeling pessimistic, rarely feeling tired or sleepy, becoming easily excited, hallucinations (seeing or hearing things, including voices), delusions, declining memory, or not knowing the time or where you are.
  • (4) Have ever had any of the following: insomnia; sleep disorders such as sleep apnea syndrome; or mental illnesses that come with sleeplessness (depression, mania, schizophrenia, neurosis, dementia, etc.).
  • βœ“Stop use immediately and consult a doctor or pharmacist β€” bringing this package insert with you β€” if any of the following symptoms appear after taking this product, as they may be side effects:
  • Skin: Rash, redness, or itching
  • Gastrointestinal: Constipation or nausea
  • Nervous system: Dizziness, headache, daytime sleepiness, or nightmares
  • Other: General fatigue
  • βœ“Stop use and consult a doctor or pharmacist β€” bringing this package insert with you β€” if you notice symptoms such as menstrual problems, irregular periods, no periods, breast milk discharge in men or in women who are not breastfeeding, or decreased sex drive.
  • βœ“Stop use and consult a doctor or pharmacist β€” bringing this package insert with you β€” if symptoms do not improve after 2–3 doses, taken strictly as directed (1 tablet once daily).
  • βœ“Store in the box in a cool, dry place away from direct sunlight. Keep out of reach of children. Do not transfer to another container (this can cause mistaken use or affect quality). Do not use after the expiry date. Write the date you opened the aluminum pouch in the "opening date" box on the carton. Once the aluminum pouch is opened, use within about 6 months of opening, as soon as possible.

Additional Information

Contains no antihistamine. The only active ingredient is ramelteon.
Ramelteon acts on melatonin receptors in the brain. It adjusts the body clock, which switches between sleep and wakefulness, and tips the balance toward sleep to lead you into natural sleep.

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For informational purposes only. Always consult a doctor or pharmacist before taking any medication.