Medication info

Pharmaes Zopiclone Tablet 2mg

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Eszopiclone›2mg / 1 tablet
Manufacturer / importer
Korea Pharma Co., Ltd.
Appearance
Pale blue round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202103387 · 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This product's status changed to Approval withdrawn on 2024.03.27.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 to improve insomnia, specifically difficulty falling asleep or frequently waking up.

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 medication has a central nervous system depressant effect, therefore drowsiness may occur after taking it; caution is advised when performing activities requiring alertness such as driving or operating machinery the next day. Moreover, it is advisable not to take it in conjunction with other central nervous system depressants or alcohol, as the depressant effect may be intensified. Taking this medication with other sleeping pills just before bedtime or in the middle of the night is not recommended. If sleep disturbances persist for more than 7–10 days, there may be an underlying physical or mental health issue, necessitating consultation with a specialist. If symptoms such as swelling of the tongue or throat, difficulty breathing, nausea, or vomiting occur during the use of this medication, it should be discontinued immediately and emergency treatment sought. During treatment, abnormal behavior, aggression, hallucinations, or sleep-related behaviors may occur; if these symptoms arise, the use of this drug must be stopped immediately. This medication carries a risk of abuse and dependence; those with a history of substance abuse or mental health issues should exercise extra caution and use the minimum effective dose possible. It should be taken immediately before bedtime, as taking it while awake can lead to memory loss, hallucinations, coordination disorders, and other issues. This medication should not be used in patients under 18 years of age, those with acute respiratory failure, or specific congenital lactose intolerant patients. Elderly or frail patients may be more sensitive to this medication, requiring careful dose adjustments and monitoring. Patients with significantly impaired liver function should have their dosage limited; however, those with reduced kidney function do not require special dose adjustments. Pregnant or breastfeeding women should make careful decisions regarding the use of this medication, considering potential effects on the fetus or infant. In case of overdose, decreased consciousness or coma may occur; immediate medical assistance should be sought, and an antidote may be administered if necessary. This medication must be kept out of reach of children and stored in its original container to maintain quality.

Side effects

  • Central nervous system suppression
  • behavioral disturbances
  • drowsiness
  • decreased level of consciousness
  • vascular swelling
  • anaphylactic reactions
  • respiratory distress
  • pharyngeal obstruction
  • nausea
  • vomiting
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  • abnormal aggression
  • extroversion
  • bizarre behavior
  • agitation
  • 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
  • unusual dreams
  • neuralgia
  • pruritus
  • urinary tract infections
  • chest pain
  • allergic reactions
  • cellulitis
  • facial swelling
  • fever
  • halitosis
  • heat stroke
  • hernia
  • discomfort
  • neck stiffness
  • photosensitivity
  • migraine
  • hypertension
  • thrombophlebitis
  • anorexia
  • cholelithiasis
  • increased appetite
  • blood in stool
  • oral ulcers
  • thirst
  • ulcerative stomatitis
  • colitis
  • dysphagia
  • gastritis
  • hepatitis
  • hepatomegaly
  • liver damage
  • gastric ulcer
  • 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
  • tremor
  • asthma
  • bronchitis
  • respiratory distress
  • epistaxis
  • hiccups
  • laryngitis
  • acne
  • alopecia
  • contact dermatitis
  • dry skin
  • eczema
  • skin discoloration
  • sweating
  • urticaria
  • multiforme erythema
  • necrobiosis
  • herpes zoster
  • hypertrichosis
  • granuloma annulare rash
  • dust mite rash
  • conjunctivitis
  • dry eyes
  • ear pain
  • otitis externa
  • otitis media
  • tinnitus
  • vestibular disorders
  • hyperacusis
  • iritis
  • pupillary dilation
  • photophobia
  • amenorrhea
  • mastitis
  • breast enlargement
  • breast tumors
  • breast pain
  • cystitis
  • voiding disorders
  • female lactation
  • hematuria
  • kidney stones
  • kidney pain
  • mastitis
  • menorrhagia
  • uterine bleeding
  • urinary frequency
  • incontinence
  • uterine bleeding
  • vaginal bleeding
  • vaginitis
  • oliguria
  • pyelonephritis
  • urethritis
  • anosmia

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is also advisable to store it at room temperature between 1°C and 30°C. Proper storage will help ensure the safety and efficacy of the medication.

Appearance and packaging

Appearance

Pale 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.