INTRODUCTION
ZOPIREST 7.5MG TABLET contains Zopiclone which belongs to the group of medicines known as Hypnotics and Sedatives. It is indicated for the short-term treatment and symptomatic relief of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings and or early morning awakenings.
Insomnia is a common sleep disorder that can make it hard to fall asleep, hard to stay asleep, or cause you to wake up too early and not be able to get back to sleep. You may still feel tired when you wake up. It also affects your health, work performance and quality of life.
ZOPIREST 7.5MG TABLET is not recommended for use in patients suffering from myasthenia gravis (muscle weakness), severe liver diseases, severe breathing problems, sleep apnoea (serious breathing problem while sleeping) and in patients who had stroke. Consult your doctor before taking.
ZOPIREST 7.5MG TABLET should be used with caution in patients suffering from depression or any other mental illness, personality disorder, kidney disease, somnambulism (sleep walking), thyroid disorder, epilepsy (seizures). Consult your doctor before taking.
ZOPIREST 7.5MG TABLET is not recommended for use in pregnant and breast-feeding women. Contact your doctor before taking.
ZOPIREST 7.5MG TABLET is not recommended for use in children and adolescents below 18 years of age. Consult your doctor before taking.
ZOPIREST 7.5MG TABLET should be used with caution in elderly patients above age 65 years. Consult your doctor before taking.
The most common side effects of taking ZOPIREST 7.5MG TABLET are dry mouth, bitter or metallic taste, feeling sleepy or drowsy, headache and fatigue, dizziness, lightheadedness and difficulty with coordination. Contact your doctor if you get any side effects. Specific serious side effects include suicidal thoughts in some patients. Consult your doctor immediately if you experience such thoughts.
USES OF ZOPIREST 7.5MG TABLET
- Treats insomnia
HOW ZOPIREST 7.5MG TABLET WORKS
ZOPIREST 7.5MG TABLET helps to improve your sleep by binding to benzodiazepine receptors in brain and increases the level of a chemical in the brain called GABA (a neurotransmitter helps to transfer messages in the brain) and produces a calming effect on the brain. Thus, helps to treat sleep disorders.
DIRECTIONS FOR USE
Take ZOPIREST 7.5MG TABLET as advised by your doctor. Do not crush or chew the medicine while consuming it with water. Your doctor will decide the correct dosage and duration for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF ZOPIREST 7.5MG TABLET
COMMON
- dry mouth
- metallic or bitter taste
- feeling sleepy or drowsy
- headache, fatigue
- dizziness, lightheadedness
- difficulty with coordination
- falling (especially in elderly patients)
UNCOMMON
- nausea, vomiting
- diarrhoea, constipation
- increased or loss of appetite
- epigastric pain, indigestion, heart burn
- weakness
- confusion, depression
- palpitations (especially in elderly patients)
- amnesia (memory loss)
- difficulty breathing
- coated tongue or bad breath
- severe itching, tingling sensation, rashes
- reduced sexual drive, impotence, ejaculation failure
- feeling of drunkenness
- euphoria
- hypotonia
- speech disorder
- tremor
- rebound insomnia
- muscle pain
- rages
- psychoses (mental illness)
RARE
- itchy, lumpy rash (urticaria)
Stop taking ZOPIREST 7.5MG TABLET and consult your doctor immediately in case you experience any of following:
- severe allergic reaction such as rash, itching, breathing difficulty and swallowing, swelling in throat, tongue, lips, and face
- fainting
- sleepwalking or other unusual behaviour (such as driving, eating, making a phone call, or having sex) while not being fully awake
- psychiatric and paradoxical reactions like restlessness, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, inappropriate behaviour
- suicidal thoughts or are experiencing changes in your behaviour
- symptoms of withdrawal effects such as abdominal pain, muscle cramps, vomiting, sweating, tremor, and fits
HOW TO MANAGE SIDE EFFECTS
Headache:
Take rest and plenty of water. Avoid taking alcohol and skipping meals. Do not strain your eyes by watching screen for long time. Consult your doctor if the condition persists for long or gets worsened.
Dizziness:
Lie down until the dizziness passes and get up slowly. Do not bend down suddenly. Get a lot of rest. Walk slowly and carefully. Take plenty of fluids. Avoid drinking coffee, alcohol, or smoking. Consult your doctor if the condition persists for long or gets worsened.
Dry mouth:
Drinking water and staying hydrated can help relieve dry mouth. Chew sugar-free gum or suck on sugar-free hard candies to stimulate the flow of saliva. If this persists for a long time, consult your doctor.
WARNING & PRECAUTIONS
PREGNANCY
ZOPIREST 7.5MG TABLET is not recommended for use in pregnant women as it may cause harm to the unborn baby. Consult your doctor before taking.
BREASTFEEDING
ZOPIREST 7.5MG TABLET is not recommended for use in breast feeding women as it may pass into the breast milk. Consult your doctor before taking.
DRIVING AND USING MACHINES
ZOPIREST 7.5MG TABLET may cause drowsiness which can affect your ability to drive and operate machines. Do not drive or operate machines after taking ZOPIREST 7.5MG TABLET.
ALCOHOL
ZOPIREST 7.5MG TABLET is not recommended for use in patients who have history of alcohol abuse. Consumption of alcohol is not advised while taking this medicine as it increases sleepiness. Consult your doctor before taking.
KIDNEY
ZOPIREST 7.5MG TABLET should be used with caution in patients suffering from kidney disease. Consult your doctor before taking.
LIVER
ZOPIREST 7.5MG TABLET is not recommended for use in patients with severe liver disease. It should be used with caution in patients with mild to moderate liver diseases. Consult your doctor before taking.
ALLERGY
Do not take ZOPIREST 7.5MG TABLET if you are allergic to Zopiclone or to other ingredients of medicine.
LUNGS
ZOPIREST 7.5MG TABLET is not recommended for use in patients suffering from sleep apnoea (severe breathing disorder in sleep) and in patients suffering from severe respiratory disorders. Consult your doctor before taking.
OTHERS
ZOPIREST 7.5MG TABLET is not recommended for use if you:
- have myasthenia gravis (muscle weakness)
- had stroke
- ever experienced sleepwalking or other unusual behaviour while not being fully awake after taking ZOPIREST 7.5MG TABLET
Before taking ZOPIREST 7.5MG TABLET inform your doctor if you have:
- personality disorder
- depression and any other mental illness such as psychoses, schizophrenia
- a history of drug abuse
- periodic limb movement disorder (involuntary moving the limbs in sleep)
- restless legs syndrome (an urge to move legs constantly)
- surgery or anaesthesia
- somnambulism (sleep walking)
- thyroid disorder
- epilepsy (seizures)
Use in paediatrics:
ZOPIREST 7.5MG TABLET is not recommended for use in children and adolescents below 18 years of age. Consult your doctor before taking.
Use in geriatrics:
ZOPIREST 7.5MG TABLET should be used with caution in elderly patients as they are more susceptible to the sedative effects of this medicine associated with giddiness, ataxia and confusion, which may increase the possibility of a fall. Consult your doctor before taking.
INTERACTIONS
A. Drug-Drug interactions:
Before taking ZOPIREST 7.5MG TABLET inform your doctor if you are taking any of the following medicine:
- clozapine, haloperidol, chlorpromazine (medicines used for treatment of mental illness)
- imipramine, moclobemide (medicines used for treatment of depression)
- phenobarbital, phenytoin, carbamazepine, trimethadione (medicines used for treatment of epilepsy)
- anaesthetics such as hexobarbital (medicines used during surgery)
- medicines to calm or reduce anxiety or for sleep problems (hypnotics) ex. diazepam, alprazolam
- St. John’s Wort (medicine used for depression and mood swings)
- skeletal muscle relaxants Ex. baclofen (medicine used to relax muscles)
- chlorphenamine, promethazine (medicines used for treatment for hay fever or allergies)
- opioids such as codeine, methadone, tramadol, pethidine, oxycodone, morphine (medicines used as strong pain killers)
- rifampicin (medicine used in treatment of tuberculosis)
- ketoconazole, itraconazole (medicines used for treatment of fungal infections)
- clarithromycin, erythromycin (medicines used for treatment of infections)
- ritonavir (medicines used for HIV infection)
Overdosage:
If you or anybody else accidently takes too much ZOPIREST 7.5MG TABLET, consult your nearest hospital immediately. Symptoms of mild overdosage are drowsiness, dizziness, lightheaded or faint, falling over or losing your balance, confusion, lethargy, sleeping deeply and possibly falling into a coma.
Symptoms of severe overdosage are low blood pressure, respiratory disorder or shallow breathing or difficulty breathing, weak muscle tone, methemoglobinemia (increased methaemoglobin in blood), ataxia (impaired coordination). Consult your doctor.
SYNOPSIS
| Drug | : | Zopiclone |
| Pharmacological Category | : | Hypnotic and Sedatives |
| Therapeutic Indication | : | Insomnia |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep ZOPIREST 7.5MG TABLET out of reach of children
- Store the medicine at room temperature below 25°C
FAQs ABOUT ZOPIREST 7.5MG TABLET
Can i take alcohol with ZOPIREST 7.5MG TABLET?
ZOPIREST 7.5MG TABLET is not recommended for use in patient who have history of alcohol abuse. Consumption of alcohol is not advised while taking ZOPIREST 7.5MG TABLET as it can increase sleepiness. Consult your doctor before taking.
Is ZOPIREST 7.5MG TABLET safe in pregnancy?
ZOPIREST 7.5MG TABLET is not recommended for use in pregnant women as it may cause harm to unborn baby. Consult your doctor before taking.
Which pain killers I should avoid while taking ZOPIREST 7.5MG TABLET?
Strong painkillers such as codeine, methadone, tramadol, pethidine, oxycodone, morphine should be taken only after consultation from your doctor.
Is ZOPIREST 7.5MG TABLET a strong sleeping Pill?
ZOPIREST 7.5MG TABLET belongs to group of medicines called Hypnotics and Sedatives. It is used for short term treatment of sleep disorders such as insomnia. It helps you fall asleep more quickly and helps stop you waking up during the night. It helps you sleep by affecting a calming chemical in your brain called gamma-aminobutyric acid (GABA).
What are the side effects of taking ZOPIREST 7.5MG TABLET?
The most common side effects of taking ZOPIREST 7.5MG TABLET are dry mouth, bitter or metallic taste, feeling sleepy or drowsy, headache and fatigue, dizziness, difficulty coordination. Contact your doctor if you get any of the above side effects.
Does ZOPIREST 7.5MG TABLET cause liver damage?
No, ZOPIREST 7.5MG TABLET has not been reported to cause liver damage and rarely causes serum enzyme elevations. Contact your doctor before taking.
REFERENCES
1. KD Tripathi. Drugs Acting on Central Nervous System. Essentials of pharmacology, 7th edition.2013 page 406.
2. Adoble, T Canton, C Malgouris, J Stutzmann, O Piot, M Bardone, C Pauchet, J Blanchard. The mechanism of action of Zopiclone. European Psychiatry. 1995. [Accessed on 27th August 2022] https://pubmed.ncbi.nlm.nih.gov/19698408/#:~:text=The%20mechanism%20of%20action%20of%20the%20cyclopyrrolone%20hypnotic%20drug%20zopiclone,%5B(35)S%5D%2DTBPS.
3. Accord. Electronic Medicines Compendium (EMC). [Revised in August 2021] [Accessed on 27th August 2022] https://www.medicines.org.uk/emc/files/pil.5894.pdf
4. Teva Pharma Limited. Zopiclone. [Revised in September 2017] [Accessed on 27th August 2022] https://www.medsafe.govt.nz/profs/datasheet/z/zopicloneactavistab.pdf
5. Sanofi-Aventis. Zopiclone. [Revised in September 2018] [Accessed on 27th August 2022] https://pdf.hres.ca/dpd_pm/00047617.PDF
6. Sanofi-Aventis. Zopiclone. [Revised in June 2022] [Accessed on 27th August 2022] https://www.medsafe.govt.nz/Consumers/cmi/i/imovane.pdf
PRODUCT DETAILS
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