Medication info

Parma Eszopiclone Tablet 3 mg

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Eszopiclone›3mg / 1 tablet
Manufacturer / importer
Korea Pharma Co., Ltd.
Appearance
Blue round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202103385 · Approved 2021.04.26

This product's status changed to Approval withdrawn on 2024.03.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of insomnia
Who takes it
Adults
Adult dose
Use the lowest effective dose of this medication. The recommended daily dose for adults is 1mg. If clinically necessary, the dose may be increased to 2-3mg. Because taking this medication may impair driving or other activities that require full alertness the following day, take it once immediately before bedtime and allow at least 7-8 hours between taking the medication and getting up. Do not exceed the recommended dose of 3mg; take once immediately before bedtime. For elderly or debilitated patients, do not exceed 2mg per day. For patients with severe hepatic impairment or those taking potent CYP3A4 inhibitors, do not exceed 2mg per day. (See Interactions.) For patients taking central nervous system depressants, dosage adjustment may be necessary because of the potential for additive effects. Taking this medication with or immediately after a high-fat/high-calorie meal is expected to slow its absorption and reduce its effect on sleep latency.

Ingredients

Manufacturer
Korea Pharma Co., Ltd.

Efficacy & effects

Treatment of insomnia

  • Insomnia
View approved original text

This medication is used for insomnia, specifically difficulty falling asleep or frequent awakenings.

How to take

Adult dose

Use the lowest effective dose of this medication. The recommended daily dose for adults is 1mg. If clinically necessary, the dose may be increased to 2-3mg. Because taking this medication may impair driving or other activities that require full alertness the following day, take it once immediately before bedtime and allow at least 7-8 hours between taking the medication and getting up. Do not exceed the recommended dose of 3mg; take once immediately before bedtime. For elderly or debilitated patients, do not exceed 2mg per day. For patients with severe hepatic impairment or those taking potent CYP3A4 inhibitors, do not exceed 2mg per day. (See Interactions.) For patients taking central nervous system depressants, dosage adjustment may be necessary because of the potential for additive effects. Taking this medication with or immediately after a high-fat/high-calorie meal is expected to slow its absorption and reduce its effect on sleep latency.

Precautions

This drug acts on the central nervous system to induce sedation and sleep. As drowsiness may occur after taking the medication, caution should be exercised during dangerous activities such as driving or operating machinery the next day. Taking it with other central nervous system depressants or alcohol can enhance its effects and pose risks, so it is advisable not to combine them. The dosage is designated to be taken right before bedtime, and taking it while awake may result in memory impairment, hallucinations, dizziness, etc. Elderly or frail patients may react more sensitively to this drug, so the dosage should be adjusted downwards and monitored closely. If sleep disturbances persist, there may be other physical or mental disorders, thus consulting a physician is necessary. If allergic reactions such as swelling of the tongue or throat, or difficulty breathing occur while taking this medication, stop taking it immediately and seek emergency treatment. Complex sleep behaviors, such as driving while asleep or eating while in this state, may occur, and if such symptoms arise, the medication should be discontinued. This drug has the potential for abuse and dependence, so prescribed dosages and usage must be strictly adhered to, particularly in patients with a history of substance abuse. Patients with impaired liver or kidney function, respiratory diseases, or depression require careful observation and dosage adjustment when using this medication. Pregnant or nursing women should consult a doctor before taking this medication, as its safety has not been established. This drug is not to be used in pediatric patients under 18 years of age, and those over 65 years need reduced dosages. Overdose may result in serious symptoms such as decreased consciousness and respiratory depression, so it is crucial to adhere strictly to the prescribed dosage, and in case of abnormal symptoms, immediate medical attention should be sought. Store this medication out of the reach of children, and it is safe to keep it sealed in the original container.

Side effects

  • Central nervous system suppression
  • behavioral disturbances
  • drowsiness
  • decreased level of consciousness
  • angioedema
  • anaphylactic reactions
  • respiratory distress
  • throat obstruction
  • nausea
  • vomiting
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  • abnormal thoughts and behavioral changes
  • reduced inhibition
  • aggression
  • extroversion
  • bizarre behavior
  • restlessness
  • hallucinations
  • depersonalization
  • sleepwalking
  • sleep driving
  • complex sleep behaviors
  • amnesia
  • anxiety
  • unusual dreams
  • nausea
  • gastrointestinal disturbances
  • headache
  • viral infections
  • dry mouth
  • dyspepsia
  • nausea
  • confusion
  • depression
  • dizziness
  • hallucinations
  • decreased libido
  • irritability
  • drowsiness
  • infections
  • rashes
  • unpleasant taste
  • dysmenorrhea
  • gynecomastia
  • accidental injuries
  • pain
  • diarrhea
  • abnormal dreams
  • neuralgia
  • pruritus
  • urinary tract infections
  • chest pain
  • allergic reactions
  • cellulitis
  • facial swelling
  • fever
  • halitosis
  • heatstroke
  • hernia
  • discomfort
  • neck stiffness
  • photosensitivity
  • migraines
  • hypertension
  • thrombophlebitis
  • anorexia
  • cholelithiasis
  • increased appetite
  • bloody stools
  • oral ulcers
  • thirst
  • ulcerative stomatitis
  • colitis
  • dysphagia
  • gastritis
  • hepatitis
  • hepatomegaly
  • liver damage
  • gastric ulcers
  • stomatitis
  • tongue swelling
  • rectal bleeding
  • anemia
  • lymphadenopathy
  • peripheral edema
  • hypercholesterolemia
  • weight gain
  • weight loss
  • dehydration
  • gout
  • hyperlipidemia
  • hypokalemia
  • arthritis
  • bursitis
  • joint diseases
  • leg cramps
  • myasthenia gravis
  • convulsions
  • arthrosis
  • myopathy
  • ptosis
  • tremors
  • asthma
  • bronchitis
  • respiratory distress
  • epistaxis
  • hiccups
  • laryngitis
  • acne
  • alopecia
  • contact dermatitis
  • dry skin
  • eczema
  • skin discoloration
  • sweating
  • urticaria
  • erythema multiforme
  • lichen planus
  • herpes zoster
  • hirsutism
  • granuloma annulare rash
  • contact dermatitis rash
  • conjunctivitis
  • dry eyes
  • ear pain
  • otitis externa
  • otitis media
  • tinnitus
  • vestibular disorders
  • auditory hypersensitivity
  • iritis
  • pupil dilation
  • photophobia
  • amenorrhea
  • mastitis
  • breast enlargement
  • breast tumors
  • breast pain
  • cystitis
  • urination disorders
  • breastfeeding in women
  • hematuria
  • kidney stones
  • kidney pain
  • mastitis
  • menorrhagia
  • uterine bleeding
  • frequency of urination
  • urinary incontinence
  • uterine bleeding
  • vaginal bleeding
  • vaginitis
  • oliguria
  • pyelonephritis
  • urethritis
  • olfactory dysfunction

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

Storage

This drug is sensitive to air and moisture, so it must be stored in a tightly closed container. It is important to maintain storage temperatures between 1 to 30 degrees Celsius. This helps ensure the drug's effectiveness is preserved safely.

Appearance and packaging

Appearance

Blue round film-coated tablet

Package unit

30 tablets/bottle, 100 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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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.