Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ZOPICLONE
DUOPHARMA (M) SDN. BHD.
ZOPICLONE
100 Tablet Tablets
DUOPHARMA (M) SDN. BHD.
_CONSUMER MEDICATION _ _INFORMATION_ _ LEAFLET (RIMUP) _ INSOPIN TABLET Zopiclone (7.5 mg) CCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCC 1 WHAT IS IN THIS LEAFLET 1. What INSOPIN TABLET is used for 2. How INSOPIN TABLET works 3. Before you use INSOPIN TABLET 4. How to use INSOPIN TABLET 5. While you are using INSOPIN TABLET 6. Side effects 7. Storage and disposal of INSOPIN TABLET 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT INSOPIN TABLET IS USED FOR INSOPIN TABLET is used in for short treatment of sleeping difficulties (insomnia) (2 to 4 weeks). HOW INSOPIN TABLET WORKS INSOPIN TABLET contains Zopiclone which is a short- acting hypnotic which work by acting on the brain to cause sleepiness. Zopiclone helps you fall asleep and reduces the number of times you wake up during the night. BEFORE YOU USE INSOPIN TABLET _-_ _ _ _When you must not use it _ Do not use INSOPIN TABLET if you: allergic to Zopiclone or any of the other ingredients listed at the end of the leaflet. suffer from severe muscle weakness have severe breathing problems suffer from breathing problems whilst sleeping have stroke _-_ _ _ _Before you start to use it _ Before taking INSOPIN TABLET, you must tell your doctor or pharmacist if you have, or have had, any of the following conditions: Long term breathing problems Impaired thyroid hormone or hormone imbalance Depression Had history of seizure Prone to drug abuse INSOPIN TABLET is not to be used in children. _Pregnancy _ ASK FOR YOUR DOCTOR’S ADVICE IF YOU ARE PREGNANT, OR LIKELY TO BECOME PREGNANT DURING YOUR COURSE OF MEDICATION. _Breastfeeding _ ASK FOR YOUR DOCTOR’S ADVICE IF YOU ARE BREASTFEEDING, OR LIKELY TO BREASTFEED DURING YOUR COURSE OF MEDICATION. INSOPIN TABLET IS SECRETED IN BREAST MILK THEREFORE USE IN NURSING MOTHER IS NOT RECOMMENDED. _-_ _ _ _Taking other medicines _ Inform your doctor or pharmacist before taking INSOPIN TABLET. Before using INSOPIN TA Soma hati kamili
[DUOPHARMA (M) SDN BHD] [Page 1/2] [Revision Date: 30.10.2020] INSOPIN 7.5MG TABLET DESCRIPTION: A yellow oval shaped tablet, scored on one side with marking '861' and marking 'DUO' on the other side. COMPOSITION: Each tablet contains Zopiclone BP 7.5 mg PHARMACODYNAMICS: Zopiclone, a cyclopyrrolone derivative, is a short-acting hypnotic agent. Zopiclone belongs to a novel chemical class which is structurally unrelated to existing hypnotics. The pharmacological profile of zopiclone is similar to that of the benzodiazepines. PHARMACOLOGY: In sleep laboratory studies of 1 to 21-day duration in man, zopiclone reduced sleep latency, increased the duration of sleep and decreased the number of nocturnal awakenings. Zopiclone delayed the onset of REM sleep but did not reduce consistently the total duration of REM periods. The duration of stage 1 sleep was shortened, and the time spent in stage 2 sleep increased. In most studies, stage 3 and 4 sleep tended to be increased, but no change and actual decreases have also been observed. The effect of zopiclone on stage 3 and 4 sleep differs from that of the benzodiazepines which suppress slow wave sleep. The clinical significance of this finding is not known. PHARMACOKINETICS: ABSORPTION, DISTRIBUTION AND BIOAVAILABILITY: Zopiclone is rapidly absorbed and distributed after oral administration, the time of maximum observed plasma concentration being about 1.75 hours. A study of 16 healthy volunteers receiving a single dose of 7.5 mg of zopiclone intravenously demonstrated the apparent volume of distribution of zopiclone to be 104 ± 15.5 L. Autoradiographic studies in the rat showed rapid distribution into the blood and peak tissue levels at 0.5 hours in the liver, small intestines, stomach, kidneys and the adrenals. After twenty four hours the total residual radioactivity in the body of the rat was 8%. The bioavailability of the 7.5 mg tablets in man is 76.3 ± 9.6%, a hepatic first pass effect has been demonstrated. In fresh human plasma, zopiclone is approximately 45% prote Soma hati kamili