Ramely® (Ramelteon)

Dosage form:

Film coated tablets 8 mg

What is Ramely® (Ramelteon) used for?

RAMELY® is a hypnotic (sleep) medicine. RAMELY® is used in adults for the treatment of the symptom of trouble falling asleep from insomnia. RAMELY® is not for children.

Important notes before taking RAMELY® (Ramelteon):

RAMELY® may not be right for you. Before starting RAMELY®, tell your doctor about all of your health conditions, including if you:

have a history of depression, mental illness, or suicidal thoughts

have liver disease

have a lung disease or breathing problems

are pregnant, or planning to become pregnant

are breastfeeding or plan to breastfeed. RAMELY® may cause somnolence in a breastfed infant. You may consider interrupting breastfeeding and pumping and discarding breastmilk during treatment and for 25 hours after administration of RAMELY®.

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects.

Important notes while taking RAMELY® (Ramelteon):

Tell all of your doctors about taking this medicine.

You may still feel drowsy the next day after taking RAMELY®. Do not drive or do other activities that need your complete alertness after taking RAMELY® until you feel fully awake.

Do not take RAMELY® if you drink alcohol. Do not drink alcohol while using RAMELY®.

After taking RAMELY®, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. Activities may include:

driving a car (“sleep-driving”)

making and eating food

talking on the phone

sleep-walking

Do not take RAMELY® unless you are able to get a full night’s sleep (7-8 hours) before you must be active again.

Tell your doctor if you are pregnant or plan to become pregnant or breast-feeding while taking this medication.

RAMELY® (Ramelteon) side effects:

Along with its desired therapeutic effects, every medicine may cause some unwanted effects; although not all of these side effects are seen in every person. Consult your doctor or pharmacist if you experience the following most common side effects:

drowsiness

tiredness

dizziness

How do I store and/or throw out this drug?

Store RAMELY® tablets at room temperature, 15˚ to 30˚C. Keep the container tightly closed and protected from moisture and humidity.

Do not use RAMELY® after the expiry date stated on the package

Keep RAMELY® out of reach of children.

This medicine must be taken only as prescribed by a physician. Do not share RAMELY® with other people, even if you think they have the same symptoms that you have. It may harm them.