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Takeda Chemical Industries, Ltd.
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The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
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Brand name :
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Rozerem Tablets 8mg
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Dosage form:
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pale orangish yellow tablets, φ7.1 mm, thickness 3.6 mm
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Print on wrapping:
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(Face) ロゼレム 8mg 157 (Back) ロゼレム8mg
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Effects of this medicine
This medicine brings the brain and body into “a state of readily going to sleep” by regularizing the sleep-awake rhythm via its acting upon the receptor for “melatonin,” a hormone deeply involved in the sleep mechanism.
Usually, used for treatment of insomnia.
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Before using this medicine, be sure to tell your doctor and pharmacist
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If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
If you have liver disorder, sleep apnea syndrome, or brain disorder.
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If you are pregnant or breastfeeding.
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If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
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Dosing schedule (How to take this medicine)
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Your dosing schedule prescribed by your doctor is << to be written by a healthcare professional>>
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General dosage regimen: for adults, take 1 tablet (8 mg of the active ingredient) at a time, once a day, at bedtime. Do not increase the prescribed dose at your own discretion just because you still remain awake. Strictly follow the instructions of your doctor/pharmacist.
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Do not take the medicine while eating a meal or immediately after a meal.
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Do not take the medicine if you are intending to get up partway and do some work.
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If you missed a dose at bedtime, awoke halfway and remained wakeful, you may take a dose if there is a considerable time until your getting up the following morning. If the remaining time is insufficient, you may be bothered by oversleeping, or experience some carryover effect of the medicine such as sleepiness or light-headedness on arising. DO NOT take double doses to make up for the missed dose.
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If you took too much of the medicine (more than ordered), check with your doctor/pharmacist.
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Do not stop taking the medicine without the instructions of your doctor.
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Precautions while taking this medicine
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As some carryover effect of the medicine may persists the following morning and thereafter, avoid operating dangerous machinery such as driving a car.
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Refrain from alcohol drinking while taking the medicine because the effect of the medicine may be potentiated by alcohol.
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Possible adverse reactions to this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: dizziness, headache, sleepiness, rash, constipation, nausea, malaise, etc.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
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rash, swelling of the face/tongue/throat, breathlessness [anaphylactic symptoms (hives, angioedema, etc.)]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
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Storage conditions and other information
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Keep out of the reach of children. Store away from direct sunlight, heat and humidity.
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Discard the remainder. Do not store them. If you dispose of unused medicines, seek advice of your pharmacist about proper disposal of drugs.
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