Medication info
Sileno Tablets 3mg (Doxepin Hydrochloride)

Sileno Tablets 3mg (Doxepin Hydrochloride)

Prescription medicationTabletOral
Ingredient · strength
Doxepin Hydrochloride›3.39mg / 1 tablet
Manufacturer / importer
HK Inno.N Co., Ltd.
Appearance
Blue oval tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201310842 · Approved 2013.12.24 · Insurance code 640006660

Summary

Main use
Short-term treatment of insomnia characterized by difficulty maintaining sleep
Who takes it
Adults
Adult dose
Adults: The recommended dose is 6mg once daily; for some patients, 3mg once daily may be appropriate as prescribed by a physician. Older adults 65 years of age and older: The recommended initial dose is 3mg once daily. A maximum of 6mg daily may be administered as prescribed by a physician. Do not exceed the maximum daily dose of 6mg. Take this medicine within 30 minutes before bedtime. To minimize effects on the following day, do not take it within 3 hours after a meal.

Ingredients

Manufacturer
HK Inno.N Co., Ltd.

Efficacy & effects

Short-term treatment of insomnia characterized by difficulty maintaining sleep

  • Insomnia with difficulty maintaining sleep
View approved original text

This medication is used short-term for patients with insomnia who have difficulty maintaining sleep, helping to relieve insomnia symptoms and promote restful sleep. It helps reduce the frequency of waking during the night, allowing for better overall sleep quality. It is effective in improving sleep quality when used for a short period.

How to take

Adult dose

Adults: The recommended dose is 6mg once daily; for some patients, 3mg once daily may be appropriate as prescribed by a physician. Older adults 65 years of age and older: The recommended initial dose is 3mg once daily. A maximum of 6mg daily may be administered as prescribed by a physician. Do not exceed the maximum daily dose of 6mg. Take this medicine within 30 minutes before bedtime. To minimize effects on the following day, do not take it within 3 hours after a meal.

Precautions

This medication should only be used after a thorough evaluation of the patient's condition, as sleep disturbances may be symptoms of physical or mental disorders. If insomnia does not improve within 7 to 10 days of starting treatment, a consultation with a specialist is necessary as there may be other underlying conditions. During the use of this medication, there may be sudden changes in behavior or abnormal thoughts, so caution is necessary. Especially, complex behaviors such as driving or preparing food may occur while not fully awake after taking this medication, and the patient may not remember these actions. Taking this medication with alcohol or other central nervous system depressants increases the risk of such behaviors; therefore, it should not be taken together. Patients with depression may experience an increase in suicidal thoughts or actions after taking this medication, necessitating close monitoring of mental state. This medication may suppress the central nervous system, leading to drowsiness or sedation; therefore, driving vehicles or operating hazardous machinery should be avoided after taking it. Caution is advised when using this medication in combination with alcohol, antihistamines, or other central nervous system depressants as the sedative effect may be enhanced. Patients with hypersensitivity to this medication, those taking MAO inhibitors, or those with untreated glaucoma or severe urinary retention should not take this medication. Pregnant or breastfeeding women should carefully consider the potential effects on the fetus or infant before using this medication. Safety in children has not been established, so it is advisable not to use it in this population. The elderly may be more sensitive to this medication, thus starting at a lower dose and monitoring closely is advised. Patients with poor liver function may experience elevated blood concentrations, requiring dose adjustment and careful monitoring. Patients with severe sleep apnea should not use this medication, and those with compromised respiratory function should also be cautious. This medication has a low potential for abuse and dependence, but careful observation of any history of drug use and behavioral changes is necessary. In case of overdose, serious side effects may occur, and immediate medical attention is necessary. In the event of overdose, gastric lavage and monitoring of cardiac and central nervous system function is required, with emergency treatment for seizures or cardiac issues being important.

Side effects

drowsiness, sedation, upper respiratory infection, pharyngitis, gastroenteritis, nausea, hypertension, anemia, thrombocytosis, heart block, palpitations, tachycardia, ventricular extrasystole, ear pain, hearing loss, motion sickness, tinnitus, tympanic membrane perforation, congestion, blurred vision, eyelid twitching, double vision, eye pain, decreased urination, abdominal pain, dry mouth, gastroesophageal reflux, vomiting, indigestion, constipation, gum swelling, bloody stools, oral vesicles, weakness, chest pain, fatigue, chills, gait abnormalities, peripheral edema, hyperbilirubinemia, hypersensitivity reaction, bronchitis, fungal infection, laryngitis, sinusitis, dental infection, urinary tract infection, viral infection, soft tissue infection, eye infection, folliculitis, viral gastroenteritis, herpes zoster, tenosynovitis, influenza, lower respiratory infection, onychomycosis, pharyngitis, pneumonia, abdominal injury, falls, joint sprain, fracture, skin laceration, increased blood sugar, elevated ALT, decreased blood pressure, increased blood pressure, ECG ST-T segment abnormality, ECG QRS complex abnormality, decreased heart rate, decreased neutrophil count, ECG QRS axis abnormality, increased aminotransferase, loss of appetite, decreased appetite, hyperkalemia, hypermagnesemia, increased appetite, hypokalemia, arthralgia, back pain, myalgia, cervical pain, limb pain, decreased joint range of motion, muscle cramps, lethargy, stage 1 lung adenocarcinoma, malignant melanoma, dizziness, taste disturbances, somnolence, paresthesia, syncope, loss of taste, ataxia, cerebrovascular accident, attention deficit, migraine, sleep paralysis, vascular vagal syncope, tremor, abnormal dreams, adjustment disorder, anxiety, depression, confusion, euphoric mood, insomnia, decreased libido, nightmares, breast cyst, dysmenorrhea, dysuria, nocturia, hematuria, night urination, congestion, sore throat, sinus congestion, wheezing, cough, bad breath, pharyngeal disturbances, runny nose, difficulty breathing, skin irritation, cold sweats, dermatitis, erythema, hyperhidrosis, pruritus, rash, rosacea, pallor, uncontrolled blood pressure, hematoma, facial flushing, constipation, urinary retention, disorientation, hallucinations, numbness, sensory disturbances, extrapyramidal symptoms, seizures, delayed onset movement disorders, aphthous stomatitis, indigestion, increased libido, scrotal swelling, gynecomastia, galactorrhea, breast enlargement, increased blood sugar, decreased blood sugar, inappropriate antidiuretic hormone secretion syndrome, tinnitus, weight gain, sweating, flushing, jaundice, hair loss, exacerbation of asthma, high fever, confusion, concentration difficulties, transient visual hallucinations, pupil dilation, agitation, hyperactive reflexes, stupor, drowsiness, rigidity, vomiting, hypothermia, high fever

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, preferably at a temperature between 1°C and 30°C. This will preserve the efficacy and ensure safe use of the medication.

Appearance and packaging

Appearance

Blue oval tablet

Package unit

30 tablets/bottle

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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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.