5 mg, 7.5 mg tablets
zopiclone
1. What Imovane is and what it is used for
Imovane is a sleeping pill for the treatment of various forms of sleep disorders in adults e.g. difficulty falling asleep, waking up prematurely, or many nocturnal awakenings. Imovane is used for temporary and short-term sleep disorders and for a limited time for chronic sleep disorders.
Imovane contains the active substance zopiclone, which affects the centers in the brain that allow us to sleep and usually have an effect within 30 minutes.
Please note that the doctor may have prescribed the medicine for another use and/or with a different dosage than that stated in the package leaflet. Always follow your doctor’s prescription and the instructions on the medicine pack.
2. What you need to know before taking Imovane
Do not take Imovane
- 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 liver disease
- sleep apnea (sleep disturbance with temporary breathing pauses during sleep)
- myasthenia gravis (a serious muscle disease)
- respiratory failure (severe difficulty breathing)
Warnings and cautions
Generally
Talk to your doctor, pharmacist, or nurse before taking Imovane.
Before starting treatment with Imovane, the cause of your sleep problems should be investigated and any other underlying disease treated.
Tell your doctor if you have had any illness or other medical condition, especially if you suffer from impaired liver function, chronic respiratory impairment, impaired general condition, or are elderly (in elderly people, medicines stay longer in the body). Your doctor may then prescribe a lower dose. Also tell your doctor if you have/have previously had problems with alcohol, drug, or drug abuse before starting Imovane.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
If you suffer from the following rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, you should not take this medicine.
Imovane can cause dry mouth, which can increase the risk of cavities. You should therefore be extra careful with dental hygiene. Toothbrushing with fluoride toothpaste twice a day is recommended.
About addiction and withdrawal symptoms
The use of drugs such as Imovane may lead to physical or mental dependence or abuse of these drugs. The risk of this increases with dose one and the treatment time. The risk is higher in patients who abuse or have abused alcohol or drugs.
If a physical dependence has arisen, a sudden interruption in treatment will lead to withdrawal symptoms.
About insomnia that recurs after completion of treatment
If treatment is stopped abruptly after prolonged use, it sometimes leads to restless sleep for a few nights. This is a temporary syndrome called “rebound insomnia”. To avoid any problems with discontinuation after long-term treatment, it is recommended to gradually reduce dose one. See also the section on side effects.
About tolerance development
The effect of Imovane may be reduced if the medicine is used repeatedly for a number of weeks. This is called tolerance development. If you have the impression that the effect is diminished, talk to your doctor.
About memory gaps, so-called anterograde amnesia
Imovane may cause a decrease in short-term memory, especially a few hours after taking the tablet. To reduce the risk of this, you should take Imovane just before or after going to bed and make sure that you can sleep undisturbed throughout the night.
About psychic and “paradoxical reactions”
When using Imovane, certain mental reactions, such as worry and anxiety, nightmares, irritability, aggression, inappropriate behavior, hallucinations (seeing and hearing things that are not real), confusion, and difficulty concentrating may occur.
About sleepwalking, so-called somnambulism, and similar behaviors
Sleepwalking and other similar behaviors, such as driving a car, cooking and eating, or making phone calls without being really awake and without remembering the event afterward, have been reported for patients taking zopiclone which is the active substance in Imovane.
The risk of such behavior increases if Imovane is combined with alcohol or certain other specific medicines (eg drug-classified painkillers, antipsychotics, sleeping pills, or antianxiety / sedatives).
The risk also increases if Imovane is taken in a higher dose than the highest recommended dose.
Contact a doctor immediately if you experience any of the above symptoms.
Children and young people
Imovane should not be used by children and adolescents under 18 years of age. Safety and efficacy in children and adolescents under 18 years of age have not been established.
Other medicines and Imovane
The treatment effect can be affected if Imovane is taken at the same time as certain other medicines, which means that dose one of Imovane may need to be adjusted.
Therefore, tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular any of the following medicines:
- Medicines for certain mental illnesses (antipsychotics / neuroleptics)
- Hypnotics ( hypnotics )
- Medicines for anxiety ( anxiolytics )
- Sedatives ( sedatives )
- Antidepressants (antidepressants)
- Drug-classified opioid-type painkillers, e.g. morphine and morphine-like substances.
- Antiepileptic drugs ( antiepileptics )
- Anesthetics ( anesthesia )
- Antiallergic drugs ( antihistamines )
- Certain agents for bacterial and fungal infections (containing eg erythromycin or itraconazole)
- Medicines used in the treatment of HIV infection er
- Medicines used to treat epilepsy (containing phenytoin , phenobarbital and carbamazepine
- Medicines for tuberculosis (containing rifampicin)
- Products containing St. John’s wort (herbal medicine used to treat depression and anxiety)
Concomitant use of Imovane with opioid medicines (strong painkillers such as morphine, opioid-dependent medicines, and certain cough medicines) increases the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and may be life-threatening. Due to this, concomitant use should only be considered by your doctor when other treatment options are not possible.
If your doctor prescribes Imovane at the same time as opioid medicines, the dose and treatment time should be limited by your doctor.
Tell your doctor if you are taking any opioid medication and carefully follow your doctor’s dose recommendations. It may be helpful to inform friends or relatives about being aware of the signs and symptoms listed above. Contact your doctor if you experience any of these symptoms.
Imovane with drinks and alcohol
Alcohol should be avoided when using Imovane as alcohol may increase the effects of Imovane. The effect may persist until the next morning, which may adversely affect your ability to drive or use machines.
Grapefruit and grapefruit juice should be avoided when taking Imovane. Grapefruit can increase the effect of Imovane.
Pregnancy and breastfeeding
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 taking this medicine.
Pregnancy
You should not take Imovane if you are pregnant. If Imovane is taken during the last three months of pregnancy or during childbirth, there is a risk that the newborn baby will be affected. Symptoms of effects on the baby include low blood pressure ( hypotension ), effects on breathing, and low body temperature.
Breast-feeding
Imovane should not be taken during breastfeeding. Zopiclone passes into breast milk.
Driving and using machines
You should not drive or use machines until your Imovane treatment has ended, or until it has been established that your ability is not impaired. The effect can also persist until the next day.
You are responsible for assessing whether you are fit to drive a 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Side effects of Imovane that may affect your ability to drive are:
- Fatigue and drowsiness the following day (residual somnolence )
- Dizziness
- Memory gaps (anterograde amnesia )
- Impaired ability to concentrate
The risk of suffering from the above side effects is greater if you have drunk alcohol and if you have not had enough sleep.
Imovane contains lactose (milk sugar) and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free.
3. How to take Imovane
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dosage one and the duration of treatment should be determined by the doctor who adapts it individually for you.
The recommended dose for adults is one 5 mg or 7.5 mg tablet at bedtime.
The recommended dose for the elderly is half an Imovane 7.5 mg tablet, equivalent to 3.75 mg zopiclone. The doctor may increase the dose to 5 mg or 7.5 mg after the dose.
The tablet can be divided into two equal doses.
Use for children and adolescents
Imovane should not be used by children and adolescents under 18 years of age.
If you have renal impairment, hepatic impairment, or chronic respiratory failure (respiratory failure), you should start treatment with half an Imovane 7.5 mg tablet, equivalent to 3.75 mg zopiclone.
As the tablets usually work within half an hour, it is important to take them in connection with going to bed or only when there has been no natural sleep. Make sure you can sleep undisturbed all night. To get the effect fast enough, the tablets should be taken in an upright position together with a glass of water.
Your treatment with Imovane should be as short-lived as possible. To reduce the risk of withdrawal symptoms or recurring sleep problems when treatment is stopped, your doctor may explain how to gradually reduce dose one at the end of treatment, so-called tapering.
If you take more Imovane than you should
If you have ingested too much medicine or if e.g. a child has ingested the medicine by mistake, always contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
Overdose of Imovane with certain other substances or medicines that have an inhibitory effect on the central nervous system can cause life-threatening symptoms such as difficulty breathing. This also includes alcohol.
If you forget to take Imovane
Do not take a double dose to make up for a forgotten dose.
If you still have the opportunity to sleep undisturbed for a whole night, take the missed dose immediately. If you do not have the opportunity for a full night’s sleep, skip the missed dose and do not take a new dose until you go to bed the next night.
If you stop taking Imovane
If you suddenly stop taking Imovane, your sleep difficulties may return for a temporary period. You may also have withdrawal symptoms. Withdrawal symptoms include difficulty sleeping, headaches, sweating, hallucinations, and increased heart rate. In more severe and very rare cases, seizures may occur.
The risk of withdrawal symptoms increases with dose one and the treatment time and therefore the doctor can give you information on how to gradually reduce dose one.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (affects more than 1 user in 100): Dry mouth, bitter/metallic taste in the mouth (often transient). Drowsiness, which depends on the size of the dose.
Uncommon (affects less than 1 user in 100): Headache, nightmares, nausea, anxiety, dizziness.
Rare (affects less than 1 user in 1,000): Sleepwalking, anxiety, aggression, inappropriate behavior that may be associated with memory lapses, confusion, irritation, difficulty concentrating, memory lapses, hallucinations. Stomach upset ( dyspepsia ). Skin rash, itching, hives. Severe allergic reactions. Effects on liver enzymes.
If you stop treatment suddenly after long-term treatment, so-called withdrawal symptoms may occur. Examples of such symptoms may be insomnia, nightmares, headaches, tremors, sweating, confusion ( delirium ), hallucinations, palpitations and increased heart rate. You may also feel anxious, irritated, and upset. In very rare cases, seizures have also occurred.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Imovane
Keep this medicine out of the sight and reach of children.
Do not store above 30 ° C
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance in Imovane is zopiclone . One tablet contains 5 mg and 7.5 mg zopiclone respectively .
- The other ingredients are: Lactose monohydrate , calcium hydrogen phosphate dihydrate , maize starch, hypromellose, sodium starch glycollate, magnesium stearate and titanium dioxide (E171).
What the medicine looks like and contents of the pack
Imovane 5 mg are white, round, and slightly cupped tablets.
Imovane 7.5 mg are white, oval, slightly cupped tablets with a score line on one side.
Imovane is available in blister packs (PVC / PVDC-Al or PVC-Al) with 10, 30, or 100 tablets, plastic cans with 250 tablets, and single-dose packs with 100×1 tablets
Marketing Authorization Holder and Manufacturer
Meda AB
Box 906
107 09 Solna