7.5 mg film-coated tablet
Zopiclone
What Zopiclone STADA is and what it is used for
Zopiclone Stada belongs to a group of medicines called cyclopyrrolones. It has similar properties to benzodiazepines. You should only use benzodiazepines and benzodiazepine-like substances if you suffer from severe insomnia that causes you extreme discomfort.
Zopiclone, the active substance in Zopiclon Stada, is a hypnotic that induces sleep and is used in the short-term treatment of insomnia.
The zopiclone contained in Zopiclon Stada may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Zopiclone STADA
Do not use Zopiclone STADA
- if you are allergic to zopiclone or any of the other ingredients of this medicine (listed in section 6)
- if you suffer from any of the following diseases:
- a serious muscle disease called myasthenia gravis (an autoimmune disease)
- serious breathing problems ( respiratory insufficiency, a condition where the gas exchange in the lungs is not sufficient to meet the body’s needs)
- sleep disorder with temporary pauses in breathing while sleeping ( sleep apnea )
- if you have severely impaired liver function
- if you are a child or young person under the age of 18
Warnings and precautions
Talk to your doctor or pharmacist before taking Zopiclone Stada.
Generally
Before treatment with Zopiclone Stada:
- the cause of the sleep disturbances should be investigated
- underlying disease should be treated.
Tell your doctor if you have or have had any illness or medical condition, especially any of the following:
- chronic respiratory failure ( chronic respiratory insufficiency, caused by heart or lung problems). Your doctor may reduce the dose because of the risk of reduced breathing
- and impaired liver function. Your doctor may reduce the dose a
- psychosis (a serious mental condition with personality change and loss of contact with reality)
- Depression
- anxiety is associated with depression
- abuse of alcohol, drugs, or medicines.
Your doctor will decide whether you should take Zopiclone Stada or not. He/she will also monitor your treatment closely.
Addiction and withdrawal symptoms
The use of benzodiazepines or benzodiazepine-like substances can lead to physical and psychological dependence on these substances. The risk of addiction increases with the dose and duration of treatment. The risk is also higher in patients who abuse or have abused alcohol or drugs and/or have a pronounced personality disorder.
If physical dependence occurs, sudden discontinuation of treatment may lead to withdrawal symptoms (see section 3. How to use Zopiclone Stada).
Insomnia (recurring after the end of treatment, so-called “rebound insomnia”)
After treatment with benzodiazepines or a benzodiazepine-like substance has ended, a temporary syndrome called “rebound insomnia” may occur. Insomnia can then return to a more serious form. Other symptoms may include mood changes, anxiety, and restlessness. The risk of withdrawal – or so-called rebound symptoms – is greater if you stop treatment suddenly. Therefore, your doctor may advise you to reduce the dose of Zopiclone Stada gradually.
Tolerance development
The effect of benzodiazepines or benzodiazepine-like substances may decrease after repeated dosing over several weeks. The process is called tolerance development. Check with your doctor if you feel that the effect of Zopiclone Stada has decreased after repeated use for a few weeks.
Impaired short-term memory (Anterograde amnesia )
Benzodiazepines and benzodiazepine-like substances can lead to impaired short-term memory (anterograde amnesia ). This occurs especially a few hours after taking the medicine. To reduce the risk of this, you should make sure you get 7 to 8 hours of undisturbed sleep.
Psychic and “paradoxical” reactions
When using benzodiazepines and benzodiazepine-like substances, the following reactions may occur:
- restlessness
- indignation
- irritability
- aggressiveness
- delusions (illusions)
- temper tantrums
- nightmares
- seeing, hearing, or feeling things that are not real (hallucinations)
- serious mental condition with personality change and loss of contact with reality ( psychosis )
- inappropriate behavior
- other behavioral disorders.
The risk of these reactions is higher for elderly patients. If you experience any of the above symptoms, stop taking Zopiclone Stada and contact your doctor for advice.
Sleepwalking (somnambulism) and associated behavior
Sleepwalking and other associated behavior such as driving, cooking and eating, or making phone calls while asleep, without recalling the event afterward, have been reported in patients taking zopiclone who were not sufficiently awake.
The risk of these behaviors increases:
- if alcohol or other specific medications (e.g. narcotic pain relievers, antipsychotics, sleeping pills, or anxiolytics/sedatives) are used during treatment with Zopiclone Stada
- if Zopiclon Stada is used in a higher dose than the most recommended.
If you experience any of the above symptoms, contact your doctor immediately. Your doctor may decide to stop treatment with Zopiclone Stada.
Risk of falling accidents
As a result of the muscle relaxant effect of zopiclone, there is a risk of fall accidents, especially in the elderly when they get out of bed at night.
Other medicines and Zopiclone STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The following medicines may increase the effect of Zopiclone Stada:
- medicines for certain mental illnesses (antipsychotics/neuroleptics)
- drugs for insomnia ( hypnotics )
- anti-anxiety drugs ( anxiolytics )
- tranquilizers that reduce anxiety ( sedatives )
- medicines for depression (antidepressants)
- narcotic pain relievers of the opioid type, e.g. morphine and morphine-like substances. These can give an unnatural feeling of happiness ( euphoria ). This can lead to increased psychological dependence.
- Simultaneous use of Zopiclone Stada and opioid medicines (strong painkillers, medicines for the treatment of patients who have become addicted to opioids and certain cough medicines) increases the risk of drowsiness, breathing difficulties ( respiratory depression ), coma, and can be life-threatening. Because of this, concomitant use should only be considered by the physician when other treatment options are not possible. If the doctor prescribes Zopiclon Stada at the same time as opioid drugs, the dose and duration of treatment should be limited by the doctor.
- Tell your doctor if you are taking any opioid medication and follow your doctor’s dosage recommendations carefully. It may be good to inform friends or relatives about the risks described above. Contact a doctor if you experience any of these symptoms.
- medicines to prevent epileptic seizures (antiepileptic/anticonvulsant medicines)
- anesthetics (anesthetics, e.g. in operations)
- anti-allergy medicine (sedating antihistamines ).
A combination of Zopiclone Stada with muscle relaxants may increase the muscle relaxant effect.
The following medicines may increase the effect of Zopiclone Stada. It may be necessary to reduce the dose of Zopiclone Stada that you are going to take.
- antibiotics for the treatment of bacterial infections (so-called macrolide antibiotics, e.g. erythromycin)
- antifungals ( antimycotics belonging to the azole class)
- drugs against AIDS ( HIV protease inhibitors ).
The following medicines can reduce the effect of Zopiclon Stada:
- anticonvulsants (phenobarbital and phenytoin )
- medicines for seizures and mood changes (carbamazepine)
- antibiotic (rifampicin)
- products containing St. John’s wort (natural medicine used to treat depression and anxiety).
Zopiclon STADA with food, drink, and alcohol
You should not consume alcohol in connection with the use of Zopiclone Stada. Alcohol can increase the effect of the medicine. In particular, this may affect your ability to drive or use machines.
Avoid grapefruit juice during treatment. Grapefruit can increase the effect of Zopiclone Stada.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. It is not yet known whether it is safe to use zopiclone during pregnancy and breastfeeding.
Pregnancy
You should not take Zopiclone Stada if you are pregnant. If zopiclone is given during the last three months of pregnancy or labor, it may affect the newborn baby. Symptoms of this include low body temperature ( hypothermia ), low blood pressure ( hypotonia ), decreased muscle tone (the muscle’s normal resting state of tension), very short or shallow breathing ( respiratory depression ), and a decreased suction reflex.
Withdrawal symptoms may occur in newborns. This has been seen in children of mothers who used zopiclone for a long time during the last months of pregnancy.
Your doctor will only prescribe Zopiclone Stada after weighing the risks against the benefits.
Breast-feeding
Zopiclone Stada should not be used during breastfeeding. Zopiclone passes into breast milk.
Driving ability and use of machinery
You should not drive or operate machinery until your treatment has ended or it has been established that your ability is not impaired.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Zopiclone Stada can cause side effects that affect your ability to drive or use machines. These can be, for example:
- a feeling of numbness (sedation effect)
- memory impairment ( amnesia )
- impaired ability to concentrate
- impaired muscle function.
The risk of these effects increases with the simultaneous intake of alcohol, and even more in connection with lack of sleep. The symptoms may also persist until the following day.
Zopiclon STADA contains lactose and sodium
Zopiclon Stada contains lactose (milk sugar).
If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
Zopiclone Stada contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially “sodium-free”.
How to use Zopiclon STADA
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Adults
The recommended dose is 7.5 mg (1 tablet). This dose should not be exceeded.
Elderly and patients with impaired liver function, impaired kidney function, or chronic respiratory insufficiency (a condition with breathing difficulties when the gas exchange in the lungs is not sufficient to meet the body’s needs)
You should start treatment with a dose of 3.75 mg (half a tablet).
Highest dose
A daily dose of 1 film-coated tablet of Zopiclon Stada should not be exceeded.
The tablet can be divided in the following ways:
- place the tablet on a table
- press with the left and upper thumb or forefinger on both sides of the break notch.
Take Zopiclone Stada immediately before going to bed. Make sure you will get 7 to 8 hours of undisturbed sleep. Swallow the tablet with liquid (eg a glass of water), but avoid grapefruit juice.
Duration of treatment
Your treatment with Zopiclone Stada should be as short as possible. In general, it should be between a few days to two weeks. Your doctor can explain how to reduce the dose of Zopiclon Stada gradually at the end of treatment (tapering). That action reduces the risk of withdrawal symptoms or recurrent insomnia (see section 2. Warnings and precautions)
Use for children and adolescents
Zopiclone Stada should not be given to children under 18 years of age.
If you have used too much Zopiclon STADA
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Overdosing with zopiclone together with certain other substances can be life-threatening. These substances are those that have an inhibitory effect on the central nervous system, including alcohol.
Overdose with benzodiazepines or benzodiazepine-like substances usually leads to inhibition of the central nervous system, which manifests itself in forms from drowsiness to coma. The most common symptoms are dizziness, lack of energy ( lethargy ), and difficulty coordinating muscles ( ataxia ).
If you forget to use Zopiclon STADA
If you are still able to sleep undisturbed for 7 to 8 hours, you should take your dose right away.
If you have less time, ignore the missed dose and do not take a dose until the following day before going to bed. Don’t take a double dose, it’s worse than skipping a dose.
If you stop using Zopiclon STADA
If treatment is stopped suddenly, your sleep difficulties may return for a temporary period or give rise to withdrawal symptoms. The symptoms that may occur are:
- headache
- muscle pains
- extreme anxiety
- voltage
- restlessness
- confusion
- irritability.
In severe cases, the following withdrawal symptoms may occur:
- a distorted sense of the outside world so that it is perceived as alien or unreal
- losing grip on your own identity followed by a foreign or unreal feeling (depersonalization)
- hypersensitive to sound (hyperacusis)
- numbness and tingling in arms and legs
- hypersensitivity to light, sound, or physical contact
- seeing, hearing, or feeling things that are not real (hallucinations)
- epileptic seizures.
The risk of developing these symptoms increases the higher the dose and the longer the treatment lasts. Therefore, your doctor will advise you on how to gradually taper off the dose.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effect of zopiclone is a bitter or metallic taste in the mouth.
The following side effects have been reported in patients treated with zopiclone:
Very common (may affect more than 1 in 10 users)
- a bitter or metallic taste in the mouth ( dysgeusia ).
Common (may affect up to 1 in 10 users)
- drowsiness next day
- impaired attention
- headache
- dizziness
- stomach and intestinal problems including nausea and vomiting.
Rare (may affect up to 1 in 1,000 users)
- slight to moderate increase in specific liver enzymes (serum transaminases and/or alkaline phosphatases)
- memory impairment ( amnesia )
- lack of cooperation between body parts (incoordination)
- difficulty coordinating muscle movements ( ataxia ), which mainly occurs at the beginning of treatment and usually disappears after repeated use.
- dizziness/intoxication
- double vision, which mainly occurs at the beginning of treatment and usually disappears after repeated use.
- dry mouth
- skin reactions including hives ( urticaria )
- muscle weakness
- risk of fall accidents, especially in the elderly (see section 2. Warnings and precautions)
- fatigue
- depressed emotional state
- confusion
- Depression
- so-called paradoxical reactions such as:
- restlessness
- indignation
- irritability
- aggressiveness
- delusions (illusions)
- temper tantrums
- nightmares
- seeing, hearing, or feeling things that are not real (hallucinations)
- serious mental condition with personality change and loss of contact with reality ( psychosis )
- inappropriate behavior and other behavioral disorders.
Very rare (may affect up to 1 in 10,000 users)
- swelling of the face, lips, or tongue along with difficulty swallowing or breathing ( angioedema )
- severe allergic reactions (anaphylactic reactions)
- serious skin reactions ( Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell’s syndrome, erythema multiforme)
- altered sex drive (reduced libido ).
Has been reported (occurring in an unknown number of users)
- physical and psychological dependence
- somnambulism (sleepwalking and associated behavior, see also section 2 Take special care with Zopiclone Stada).
Even if Zopiclone Stada is taken as prescribed, amnesia (impaired short-term memory), sometimes along with inappropriate behavior, can occur. The risk increases with higher doses.
During treatment with Zopiclone Stada, a previously hidden depression may appear.
The use of Zopiclon Stada can lead to physical or psychological dependence, which can mean that a break in treatment can lead to withdrawal symptoms and recurring insomnia. See also section 2 Warnings and precautions.
How to store Zopiclon STADA
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the blister pack after EXP. The expiration date is the last day of the specified month.
Store at a maximum of 25 ºC.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is zopiclone. Each film-coated tablet contains 7.5 mg of zopiclone.
Other ingredients are:
lactose monohydrate
calcium hydrogen phosphate dihydrate
cornstarch
carmellose sodium
magnesium stearate
titanium dioxide (E171)
Appearance and package sizes of the medicine
Zopiclon Stada is white, round, biconvex film-coated tablets, debossed with “ZOC 7.5” on one side and scored on both sides.
Zopiclon Stada is available in pack sizes: 5, 10, 14, 18, 20, 28, 30, 50, 56, 60, 90, 100, 150, 200, 250, 300, 400, 500, or 1000 tablets in PVC/PVDC /Al blisters and PP cans containing 100, 250 or 1000 tablets.
Not all pack sizes may be marketed.
STADA Arzneimittel AG
Stadastrasse 2 – 18
61118 Bad Vilbel
Germany
Other manufacturers:
Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Local Representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark