ZOPICLONE 7.5 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Zopiclone 7.5 mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others.

It may harm them, even if their signs of illness are the same as yours.

- if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. see section 4.

What is in this leaflet :

• 1. What Zopiclone is and what it is used for

• 2. What you need to know before you take Zopiclone

• 3. How to take Zopiclone

• 4. Possible side effects

• 5. How to store Zopiclone

• 6. Contents of the pack and other information

1. what zopiclone is and what it is used for

Zopiclone is a sedative-hypnotic drug with zopiclone as active substance. Zopiclone induces sleep and helps you to relax.

Zopiclone is used in adults for the short-term treatment of sleeplessness which causes you extreme distress. The treatment can take a few days to 2 weeks and usually does not take longer than 4 weeks.

2. what you need to know before you take zopiclonedo not take zopiclone if you are allergic to zopiclone or any of the other ingredients of this medicine (listed in section 6. “contents of the pack and other information” at the end of this leaflet)

• – if you suffer from a serious muscle-weakness called myasthenia gravis (an autoimmune disease)

• – if you suffer from severe respiratory insufficiency (a condition in which the gas exchange in the lungs is insufficient to meet the body's needs)

• – if you suffer from sleep apnoea syndrome (a sleep disorder characterized by pauses in breathing during sleep)

• – if you suffer from severe liver impairment

• if you are a child or adolescent under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Zopiclone.

• If you suffer from depression, liver or kidney disease, severe respiratory failure (a condition in which the gas exchange in the lungs is insufficient to meet the body's needs caused by breathing or heart problems), impairment of the liver, psychoses (severe mental disorders characterized by disturbance of personality and loss of contact with reality) or if you have a history of alcohol or drug abuse.
• Dependence can occur. The risk increases with higher doses and with longer periods of treatment and in patients with a history of alcohol or drug abuse. If physical dependence occurs, stopping the treatment suddenly may lead to withdrawal symptoms such as: headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases following symptoms may occur: an alteration in the perception of the world so that it seems strange or unreal (derealisation), loss of your own personal identity followed by feelings of unreality and strangeness (depersonaliza­tion), oversensitivity to sound (hyperacusis), numbness and tingling of arms and legs, hypersensitivity to light, noise or physical contact, seeing, hearing or feeling things that don't really exist (hallucinations) and epileptic seizures
• Memory loss (amnesia) can occur.
• The effect of zopiclone may decrease after repeated use for a few weeks (this process is called tolerance).
• When stopping the treatment with zopiclone, a temporary syndrome called rebound insomnia (return of sleep problems) may occur. Sleeplessness (insomnia) may return in a more severe form. Other symptoms may be mood changes, anxiety and restlessness. The risk of withdrawal or rebound symptoms is higher if you stop the treatment suddenly. Therefore, your doctor will advise you to reduce your dose of Zopiclone gradually.
• Your treatment with Zopiclone should be as short as possible. In general, it should last between a few days to 2 weeks. Treatment with hypnotics should not exceed four weeks.
• Sleep walking and other associated behaviours such as “sleep driving”, preparing and eating food, or making phone calls, with memory loss (amnesia) of the event, have been reported in patients who have taken zopiclone and were not fully awake. Concomitant use of alcohol or certain other medicines (such as strong painkillers, tranquilizers, sleeping pills or antianxiety agents/sedatives) and taking zopiclone at doses exceeding the maximal recommended dose increase the risk of such behaviour.
• It is known that reactions such as restlessness, agitation, irritability, aggression, false beliefs (delusions), outbursts of rage, nightmares, seeing, hearing or feeling things that don't really exist (hallucination), severe mental disorders characterized by disturbance of personality and loss of contact with reality (psychoses), unsuitable behaviour and other behavioural disturbances may occur. The risk of these reactions is higher in elderly patients. If you feel any of the symptoms listed above, you should stop taking Zopiclone.
• Due to the muscle relaxing effect of Zopiclone, there is a risk of fall, especially in the elderly when they get up during the night.
• Zopiclone should not be used in children and adolescent under the age of 18. The safety and efficacy in children and adolescents aged less than 18 years have not been established.

Please tell your doctor if you have or have had any medical conditions or illnesses from above list.

Take Zopiclone just before retiring for the night. Make sure you will be able to have an uninterrupted sleep of 7–8 hours. If you slept too short or your sleep has been interrupted, you may experience short term memory loss.

Other medicines and Zopiclone

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines, herbal remedies, health foods or supplements that you have obtained without a prescription.

The following medicines may increase the effect of Zopiclone:

• antipsychotic­s/neuroleptics (used to treat psychoses), anxiolytics (used to treat anxiety), sedatives/tran­quilizers (used to induce calmness and reduce anxiety), hypnotics (used to treat sleeplessness), antidepressants (used to treat depression), antiepileptic­s/anticonvulsan­ts (used to prevent epileptic seizures),
• strong painkillers, such as morphine and morphine-like substances (used to relieve pain). They may additionally cause an abnormal feeling of happiness (euphoria). This may promote psychological dependence,
• some sedative antihistamines (used to treat allergic reactions),
• some antimycotics (used to treat fungal infections) and antibiotics (used to treat bacterial infections),
• some medicines to treat HIV infection,
• anaesthetics (used to block pain sensation, for example during surgeries)

The combination of Zopiclone with muscle relaxants may enhance the muscle relaxing effect.

The following medicines may reduce the effect of Zopiclone:

• Medicines like phenobarbital and phenytoin (used to treat seizures), carbamazepine (used to treat seizures and mood disorders) and rifampicin (antibiotic)
• products containing St. John's wort (herb used to treat depression and anxiety).
• Do not drink alcohol while you are taking Zopiclone. Alcohol can increase the effects of Zopiclone and make you sleep very deeply so that you do not breathe properly or have difficulty waking.
• You should not take the tablets with grapefruit juice as this will influence the effect of Zopiclone in an unpredictable manner.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The use of Zopiclone is not recommended during pregnancy.

If zopiclone is used during the last three months of pregnancy or during labour, some effects on the newborn child may arise. These include low body temperature (hypothermia), and low blood pressure (hypotension), decreased muscle tone (hypotonia), very slow or shallow breathing (respiratory depression) and decreased suckling reflex (“floppy infant syndrome”).

Withdrawal symptoms may occur in newborns. This has been observed in children of mothers who have used zopiclone for long periods during the last months of pregnancy.

You should not take Zopiclone if you are breast-feeding. Zopiclone is excreted in breast milk in a small amount.

Driving and using machines

You should not drive or operate machines until the treatment has finished or it has been established that your performance is not impaired. Zopiclone may cause side effects which affect your ability to drive and use machines. Common side effects are feeling numb (sedation), loss of memory (amnesia), impaired concentration and impaired muscle function.

The risk of these effects increases with alcohol intake and is even higher when the sleep duration is insufficient (7–8 hours). Do not drive, operate machinery or perform other tasks requiring mental alertness, directly after taking this medicine or in the following 12 hours. The symptoms may affect you also in the next day. You should therefore not drive or operate machines unless you are certain that these symptoms are gone.

Zopiclone contains milk sugar (lactose). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. how to take zopiclone

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your treatment with Zopiclone should be as short as possible. In general, it should last between a few days to 2 weeks. Treatment with hypnotics should not exceed four weeks.

Take Zopiclone just before bedtime. Each tablet should be swallowed without sucking or chewing.

The tablets can be divided into equal doses:

• – lay the tablet on a desk

• – take the left and right thumb or forefinger and press on both sides of the scoring line.

Do not use more than 1 tablet per day.

Elderly and patients with impaired liver or kidney function or severe respiratory failure (a condition in which the gas exchange in the lungs is insufficient to meet the body's needs) should start the treatment with half a tablet per day.

Use in children and adolescents

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

If you take more Zopiclone than you should

If you have taken too many tablets, contact your doctor, pharmacist or nearest hospital casualty department immediately for advice.

The following effects may happen:

• Feeling drowsy, confused, sleeping deeply and possibly falling in to a coma.
• Floppy muscles (hypotonia).
• Feeling dizzy, light headed or faint. These effects are due to low blood pressure.
• Falling over or losing your balance (ataxia).
• Shallow breathing or difficulty breathing (respiratory depression).

If you forget to take Zopiclone

If you still have time to sleep for 7 to 8 hours, you should take the dose immediately.

If there is less time, ignore the forgotten dose and do not take another dose until the following day before going to sleep.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Zopiclone

Stopping the treatment suddenly may lead to withdrawal or rebound symptoms. See section 2 “ Warnings and precautions”.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most commonly reported adverse effects are: sleepiness during the day, a bitter taste, a dry mouth and a reduced alertness. These affect 1 to 10 users in 100.

Coordination problems or double vision occurs in 1 to 10 users in 10,000, especially at the beginning of the treatment. These symptoms usually disappear spontaneously so that the treatment doesn't need to be stopped.

Stop using Zopiclone and contact your doctor immediately if you develop one or more of following symptoms:

• swelling of the face, lips or tongue
• difficulty breathing
• sudden high fever
• joint pain
• blistering or peeling of the skin

These symptoms can be signs of severe allergic reactions which can be life-threathening.

Other severe adverse effects which rarely occur are (particularly in the elderly):

• loss of memory (amnesia) (sometimes in combination with inappropriate behaviour)
• risk of fall

The risk for memory loss is greater when high doses are used.

The following side effects have been observed in patients treated with zopiclone.

Uncommon (1 to 10 users in 1,000):

• nightmares
• agitation
• headache
• dizziness
• gastro-intestinal problems, including feeling sick (nausea) and vomiting
• tiredness.
• dulling of sensitivity
• confusion
• depression
• restlessness
• irritability
• aggression
• false beliefs (delusions)
• outbursts of rage
• seeing, hearing or feeling things that don't really exist (hallucinations)
• severe mental disorders characterized by disturbance of personality and loss of

contact with reality (psychoses)

• change in sexual desire (decreased libido).
• physical and psychological dependence
• inappropriate behaviour and other behavioral disturbances.
• sleepwalking
• dreaming more frequently
• difficulties in concentrating
• short of breath
• indigestion (dyspepsia)
• slight to moderate increases of certain liver enzymes (serum transaminases and/or alkaline phosphatase)
• allergic reactions including itching and skin reactions
• muscle weakness
• unusual skin sensations such as tickling, itching and tingling
• withdrawal symptoms like:

o anxiety

o tremor

o palpitations

o tension

o loss of feeling who and where you are

o oversensitivity to sound

o hypersensiti­vity to light, noise and physical contact

o hearing or feeling things that don't really exist

o epileptic seizures

Very rare (less than 1 user in 10,000):

• skin rash with irregular red spots (erythema multiforme)

Not known (frequency cannot be estimated from available data)

• difficulty breathing

During treatment with Zopiclon pre-existing depression can be unmasked.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in. By reporting side-effects you can help provide more information on the safety of this medicine.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5. how to store zopiclone

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

Do not use this medicine after the expiry date which is stated on the box after “EXP”. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other informationwhat zopiclone containsthe active substance is zopiclone.

Each Zopiclone 7.5 mg tablet contains 7.5 mg of zopiclone.

The other ingredients are:

• – calcium hydrogen phosphate dihydrate

• – lactose monohydrate

• – maize starch

• – sodium starch glycolate

• – magnesium stearate (E470b)

• – hypromellose (E464)

• – propylene glycol (E1520)

• – titanium dioxide (E171)

• – talc (E553B)

What Zopiclone tablets look like and contents of the pack

Zopiclone 7.5 mg tablets are white, round, biconvex film-coated tablets, scored on one side and divisible.

The tablet can be divided in equal doses.

Zopiclone is available in packs containing 10, 20, 28, 30 or 100 film-coated tablets in PVC/PVDC/Al blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder

Jubilant Pharmaceuticals nv

Axxes Business Park

Guldensporenpark 22 – Block C

9820 Merelbeke

Belgium

Manufacturer

PharmaS d.o.o.

Industrijska cesta 5

Potok

Popovaca, 44317

Croatia

This leaflet was last revised in 12/2017.