ZOPICLONE 7.5 MG TABLETS - package leaflet, side effects, dosage | patient information (2023)

What is this medicine and what is it for?

2. What you need to know before you start taking this medicine

3. How to take this medication

4. Possible side effects

5. How to store this medicine

What is this medicine and what is it for?

This medicine belongs to a group of medicines known as hypnotics or sleep aids, which cause drowsiness.

This medication is used for the short-term treatment of severe sleeping difficulties (insomnia) in adults.

2^

What you need to know before taking this medicine

do not take this medicine

• if you are allergic to zopiclone or any of the other ingredients (seesection 6). An allergic reaction may include a rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.
• if you are allergic to other benzodiazepines or benzodiazepine-like hypnotics, such as nitrazepam or diazepam
• if you have severe liver problems. In patients with severe liver problems, encephalopathy (a brain disorder) may develop.
• if you have myasthenia gravis (a condition where muscles tire and weaken easily)
• if you have breathing problems, especially during sleep (sleep apnoea)
• if you are pregnant, intend to become pregnant or are breast-feeding
• if the patient is under 18 years of age.

Warnings and Cautions

Consult your doctor or pharmacistbefore taking zopiclone tablets if you:

• are elderly or frail. Due to the muscle relaxant effect of zopiclone, there is a danger of falls, especially for the elderly when waking up at night.
• have a kidney problem
• have mild or moderate liver problems
• have trouble breathing
• suffer from or have a history of depression or anxiety (as suicidal thoughts may occur)
• have psychiatric problems or mental illness (including personality disorders)
• have recently taken zopiclone or other similar medications for more than 4 weeks.

Tell your doctor if you have any of the conditions listed above.

Tell your doctor before taking this medicine:

• if you have any problems with your liver, kidneys or lungs
• If you have received or are receiving treatment for drug or alcohol abuse.

Zopiclone and other drugs:

Tell your doctor if you are taking or have recently taken any of the following medicines, including medicines obtained without a prescription:

• drugs to treat mental illness (antipsychotics)
• medicines to treat depression, e.g. amitriptyline, fluoxetine and what are known as monoamine oxidase inhibitors (MAOIs), e.g. phenelzine
• other benzodiazepines or benzodiazepine-like hypnotics used to treat insomnia or anxiety, e.g. nitrazepam, diazepam
• other tranquilizers, e.g. chlorpromazine strong pain relievers such as codeine, morphine. They can increase the feeling of excitement (euphoria), which in turn increases the possibility of physical or mental dependence.
• medicines used to treat epilepsy, e.g. carbamazepine
• anesthetics (used during surgery)
• Antihistamine medicines that cause drowsiness, e.g. Alimemazine, Chlorphenamine
• erythromycin (an antibiotic).

Concomitant use of zopiclone and opioids (strong analgesics, substitution therapy drugs and some cough medicines) increases the risk of drowsiness, shortness of breath (respiratory depression), coma and can be fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes zopiclone along with opioids, he should limit the dose and duration of concomitant treatment.

Tell your doctor about all opioid medications you are taking and strictly follow your doctor's dosage recommendations. It may be helpful to tell friends or family so they are aware of the signs and symptoms listed above. Contact your doctor when experiencing such symptoms.

The following medications may increase your risk of side effects when taken with zopiclone. To make this less likely, your doctor may lower your dose of zopiclone by:

• some medicines for yeast infections like ketoconazole and itraconazole
• some antibiotics, including erythromycin and clarithromycin
• ritonavir (a protease inhibitor) used to treat HIV infections.

The following medications can make zopiclone work less well:

• some epilepsy medicines, such as carbamazepine, phenobarbital, or phenytoin
• rifampicin (an antibiotic) – for infections
• St. John's wort (an herbal medicine): for mood swings and depression.
• The effect of the following medicines is enhanced when taken with zopiclone: ​​muscle relaxants, e.g. baclofen

General information about the effects observed after using this medication:

• Dependence (need to continue taking the medicine): When taking this type of medicine, there is a risk of dependence, which increases with the dose and duration of treatment. It can be a physical dependence, in which the body gets used to the presence of the drug. and the suspension of treatment causes withdrawal symptoms and/or mental dependence, where the desire for the medication develops. There is an increased risk in patients with a history of alcohol or drug abuse of suffering from a personality disorder.
• Suicidal ideation/suicide attempt/suicide: Some studies have shown an increased risk of suicidal ideation, suicide attempt, and suicide in patients taking certain sedatives and hypnotics, including this medication. However, it has not been established if this is caused by the drug or if there could be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for further medical advice.
• Depression: This medication should not be used as a treatment for depression. All causes of sleep disturbances must be clarified and addressed prior to treatment with this medication. This is to avoid treatment for the possible serious effects of depression.
• Withdrawal: treatment should be discontinued gradually. Withdrawal effects are unlikely when treatment duration is limited to 4 weeks. Withdrawal effects can also occur between doses, especially if you are taking a high dose of zopiclone. See Section 3, If you stop taking zopiclone.
• Amnesia: Zopiclone tablets can cause memory loss. To reduce this risk, you need to get 7 to 8 hours of uninterrupted sleep.
• Behavioral effects may occur while using zopiclone (see Section 4, Possible Side Effects).

zopiclone with alcohol

DO NOT drink alcohol when taking zopiclone tablets as it may increase the sedative effect.

Pregnancy and lactation

• Talk to your doctor before taking this medication if you are pregnant, might become pregnant, or think you may be pregnant.
• Do not take zopiclone during the last 3 months of pregnancy or during labor and delivery as it may harm your baby.
• Do not breast-feed if you are taking zopiclone. This is because small amounts can pass into breast milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking zopiclone.

Consult your doctor or pharmacist before taking any medicine if you are pregnant or breastfeeding.

Driving and using machines.

• Zopiclone may cause drowsiness, loss of concentration or muscle weakness. DO NOT drive or operate machinery after taking a dose of zopiclone
• DO NOT drive or operate machinery the day after taking zopiclone until you are sure you are not affected by zopiclone.
• If Zopiclone is taken with alcohol, the effects of Zopiclone may increase the next morning. DO NOT drive or operate machinery until you are sure you are not affected.

Important information about some of the ingredients of Zopiclone

Lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine (seesection 6).

Sodium

This medicine contains less than

1 mmol sodium (23 mg) per film-coated tablet, i.e. essentially “sodium-free”.

j3^

How to take this medicine

Always take this medicine exactly as directed by your doctor. Talk to your doctor or pharmacist if you are not sure.

This medicine should be swallowed whole with water.

Dose

Adults:

• the usual dose is 7.5 mg, taken in an upright position 30 to 60 minutes before bedtime

Geezer:

• your doctor may direct you to take 3.75 mg per day initially and then gradually increase this dose to 7.5 mg per day

children and teenagers

Zopiclone should not be used in children and adolescents under 18 years of age. The safety and efficacy of zopiclone in children and adolescents less than 18 years of age have not been established.

Patients with kidney and liver problems:

• if you have mild kidney or liver problems you should not take more than 7.5 mg per day
• If you have more severe kidney or liver problems, you should not take more than 3.75mg per day.

This medicine should not be given to children.

Treatment with this medicine usually lasts up to a maximum of four weeks, including the taper period. Prolonged use is not recommended.

It is important to continue taking the pills for as long as your doctor tells you to. You should not stop taking the pills suddenly without your doctor's advice. Do not change the dose of your medicine unless you have discussed it with your doctor.

If you forget to take this medicine:

• if you forget to take a dose before bed, take it as soon as you remember. Only take the dose if it is still possible to sleep through the night, if this is not possible, take the next dose before going to bed the next day. If your sleep is interrupted or delayed, you may experience memory loss of recent events (anterograde amnesia), this does not affect your long-term memory, only newer, more recent events.
• Do not take two doses at the same time.

If you take more of this medicine than you should:

• If you accidentally take too many tablets, contact the nearest emergency department or inform your doctor or pharmacist immediately. Symptoms may include ataxia, hypotonia, hypotension, respiratory depression, and rarely coma.

To stop taking this medicine:

• Some patients may experience withdrawal symptoms when they stop taking this medication, these symptoms may include: headaches
• muscle pain
• extreme anxiety
• variety
• concern
• confusion and irritability.

In severe cases, the following symptoms may occur:

• derealization
• depersonalization
• increased sensitivity in hearing (hyperacusis)
• numbness and tingling sensation in the hands and feet
• increased sensitivity to light, noise, and physical contact
• hallucinations or epileptic seizures.

In rare cases, reports of abuse have been reported.

Although patients are unlikely to experience withdrawal symptoms when using this medication, patients may benefit from reducing the dose before stopping treatment.

possible side effects

Like all medicines, Zopiclone can cause side effects, although not everybody gets them. Side effects are more common at the start of treatment, within the first hour after taking the tablet.

If you experience the following rare but very serious side effects, stop taking Zopiclone tablets and tell your doctor straight away or contact the nearest hospital emergency department:

• an allergic reaction: rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.
• signs of life-threatening rashes (Stevens-Johnson, erythema multiforme, necrolysis), initially as reddish target-shaped spots or circular spots, often with central blisters on the trunk. Additional signs may include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red, puffy eyes). These life-threatening rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling skin.

This is a very serious but very rare side effect. You may need urgent medical attention or hospitalization.

Tell your doctor as soon as possible if you experience any of the following side effects. You may want to discontinue zopiclone treatment.

Strange(affects less than 1 in 1,000 people who take the drug):

• poor memory (amnesia) since taking zopiclone
• hallucinations (seeing or hearing things that are not real).

not known(frequency cannot be estimated from available data):

• depressed mood (feeling depressed or sad) false beliefs (delusions).

These effects are more likely to occur in the elderly.

Tell your doctor or pharmacist if any of the following side effects last more than a few days or become severe:

Very common(affects more than 1 in 10 people who take the drug)

• a bitter (metallic) taste in the mouth.

common(affects less than 1 in 10 people who take the drug):

• stomach pain (including feeling sick (nausea) or dizziness)
• drowsiness (next day)
• reduced alert status
• dizziness headache

Strange(affects less than 1 in 1,000 people who take the drug):

• confusion
• fatigue
• numb emotions
• dry mouth
• dizziness
• loss of coordination
• difficulty controlling movements (predominantly at the beginning of treatment; usually disappears after repeated administration)
• vision problems (double vision)
• sleepwalking (somnambulism)
• fall (predominantly in older people)
• indigestion (dyspepsia)
• muscle weakness
• rash
• abnormal blood test results for liver function
• restlessness, agitation, or irritability
• aggression or anger
• Nightmares

Very strange(affects less than 1 in 10,000 people who take the drug):

• reduced sexual desire

not known(frequency cannot be estimated from available data):

• physical and mental dependence.

Sleepwalking and other strange behaviors

There have been some reports of people (during sleep) performing tasks that they don't remember upon waking up after taking a sleeping medication. This includes driving while sleeping, eating and walking while sleeping. Alcohol and some medications for depression or anxiety can increase the chance of this serious effect. If you are concerned about this side effect occurring after taking zopiclone, tell your doctor as soon as possible.

side effect notification

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not mentioned in this leaflet. You can also report side effects directly through the Yellow Card Program at: or search for MHRYellow Card on Google Play or Apple AppStore

By reporting side effects you can help provide more information about the safety of this medication.

How to store this medicine

Keep this medicine out of the sight and reach of children.

This medicine should not be stored above 25°C. Store in the original container.

The expiry date for this product is printed on the carton and blister. Do not use this medication after this date.

Package contents and other information

Your doctor has prescribed you zopiclone tablets. Your medicine is available in two strengths:

• Zopiclone 3.75 mg tablets: Round, orange tablets engraved with "ZOC 3.75" on one side and containing 3.75 mg of zopiclone, which is the active ingredient.
• Zopiclone 7.5 mg tablets: Round, white tablets, scored on both sides and debossed "ZOC 7.5" on one side, containing 7.5 mg of zopiclone, which is the active ingredient.
• Zopiclone tablets also contain the following ingredients: lactose monohydrate, calcium hydrogen phosphate, corn starch, pregelatinized starch, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, titanium dioxide (E171) and hypromellose. In addition, the 3.75 mg tablets contain: iron oxide yellow (E172) and iron oxide red (E172).