5 mg film-coated tablets
Zopiclone
What Zopiclone Pilum is and what it is used for
Zopiclone Pilum is a sleep aid that affects the centers in the brain that enable us to sleep. Zopiclone Pilum usually takes effect within 30 minutes.
Zopiclone Pilum is used for the treatment of various forms of sleep disorders, e.g. difficulty falling asleep, early awakening, or many night awakenings in adults. Zopiclone Pilum is used for temporary and short-term sleep disorders and for a limited time for chronic sleep disorders in adults.
The zopiclone contained in Zopiclone Pilum 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 you use Zopiclone Pilum
Do not use Zopiclone Pilum
- if you are allergic to zopiclone or any of the other ingredients of this medicine (listed in section 6)
- if you have severe liver disease,
- if you have the disease myasthenia gravis (muscle disease),
- if you have pronounced breathing stops during sleep ( sleep apnea ),
- if you have severely impaired breathing.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Zopiklon Pilum:
- if you have impaired liver function,
- if you have impaired respiratory function,
- if you are older,
- if you have previously been addicted to drugs or alcohol.
Before starting treatment with Zopiclone Pilum, the cause of your sleep difficulties should be investigated and any other underlying disease treated.
Zopiclone Pilum can cause dry mouth, which can increase the risk of tooth decay. You should therefore be extra careful with dental hygiene. Brushing with fluoride toothpaste twice a day is recommended.
Addiction and withdrawal symptoms
The use of drugs such as Zopiclone Pilum can lead to physical and psychological dependence. 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, a sudden interruption of the treatment may lead to withdrawal symptoms (see section 3 “If you stop taking Zopiclone Pilum”).
Insomnia that returns after the end of treatment
If the treatment is stopped suddenly after a long period of use, it sometimes leads to restless sleep for a few nights. This is a temporary syndrome called “rebound insomnia”. To avoid possible problems at termination after long-term treatment, it is recommended to gradually reduce the dose. See also the section dealing with side effects.
Tolerance development
The effect of Zopiclone Pilum may decrease if the medicine is used repeatedly over several weeks. This is called tolerance development. If you feel that the effect has decreased, talk to your doctor.
Memory gaps, so-called anterograde amnesia
Zopiclone Pilum can cause short-term memory loss, especially a few hours after taking the tablet. To reduce the risk of this, take Zopiclone Pilum just before or after you go to bed, and make sure you have an undisturbed sleep throughout the night.
Psychic and “paradoxical” reactions
When using Zopiclone Pilum, certain psychological reactions such as worry and anxiety, nightmares, irritability, aggressiveness, inappropriate behavior, hallucinations (seeing and hearing things that are not real), confusion, and difficulty concentrating may occur.
Bedtime
Sleepwalking and other similar behaviors, 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 certain other drugs (e.g. narcotics, pain relievers, antipsychotics, anxiolytic/sedative drugs, or sleeping aids) are used during treatment with Zopiclone Pilum
- if Zopiclone Pilum is used in higher doses than those recommended.
If you experience any of the above symptoms, contact your doctor immediately. Your doctor may decide to stop treatment with Zopiclone Pilum.
Children and young people
Zopiclone Pilum should not be used by children and adolescents under the age of 18.
Other medicines and Zopiclone Pilum
Some other medicines can affect or be affected by Zopiclone Pilum. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The doctor needs to know if you are already being treated with:
- drugs for depression, anxiety, and insomnia (antidepressants, anxiolytics, hypnotics )
- medicines for certain mental illnesses (antipsychotics/neuroleptics)
- sedatives _ _
- narcotic pain-relieving drugs of the opioid type, e.g. morphine and morphine-like substances
- anesthetics _ _
- allergy medicine ( antihistamines )
- agents against bacterial and fungal infections containing erythromycin, itraconazole, and rifampicin
- medicines used in the treatment of epilepsy that contain phenytoin, phenobarbital, or carbamazepine
- certain medicines used in the treatment of HIV infection,
- herbal remedies containing St. John’s wort.
Concomitant use of Zopiclone Pilum and opioid medicines (strong painkillers, medicines for the treatment of opioid dependence, and certain cough medicines) increases the risk of drowsiness, breathing difficulties ( respiratory depression ), and coma and can be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
If the doctor prescribes Zopiklon Pilum at the same time as opioid drugs, dose one and
the treatment time is 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 helpful to inform friends or relatives to be aware of the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.
Zopiclone Pilum with food, drink, and alcohol
Alcohol should be avoided when using Zopiclone Pilum as alcohol can increase the effect of Zopiclone Pilum. The effect may persist until the next morning, which may hurt your ability to drive or operate machinery.
Grapefruit and grapefruit juice should be avoided while taking Zopiclone Pilum. Grapefruit may increase the effect of Zopiclone Pilum.
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 using this medicine.
Pregnancy
You should not take Zopiclone Pilum if you are pregnant. If Zopiclone Pilum is taken during the last three months of pregnancy or childbirth, there is a risk that the newborn baby will be affected. Symptoms of impact on the child include low blood pressure ( hypotension ), impact on breathing, and low body temperature.
Breast-feeding
Zopiclone Pilum should not be taken during breastfeeding. Zopiclone Pilum passes into breast milk.
Driving ability and use of machinery
You should not drive or operate machinery until your treatment with Zopiclone Pilum has finished, or until it has been established that your ability is not impaired. The effect can also last until the following day.
Side effects of Zopiclone Pilum 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 you suffering from the above side effects is greater if you have drunk alcohol and if you have not had enough sleep.
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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Zopiclone Pilum contains lactose
Zopiclone Pilum contains lactose. If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
How to use Zopiclone Pilum
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The dose and duration of treatment must be determined by the doctor who adapts it individually for you. The duration of treatment should be as short as possible and the treatment should be phased out gradually.
The recommended dose for adults: One tablet of 5 mg or 7.5 mg at bedtime.
The recommended dose for the elderly is half a tablet of Zopiclone Pilum 7.5 mg, which corresponds to 3.75 mg of zopiclone. The doctor may then increase the dose to 5 mg or 7.5 mg.
If you have reduced kidney function, you should start the treatment with half a tablet of Zopiclone Pilum 7.5 mg, which is equivalent to 3.75 mg of zopiclone.
If you have impaired liver function or chronic respiratory insufficiency (respiratory failure), you should start the treatment with half a tablet of Zopiclone Pilum 7.5 mg, which corresponds to 3.75 mg of zopiclone. Dose one can later be increased to 5 mg and if necessary up to 7.5 mg.
Since the tablets usually work within half an hour, it is important to take them at bedtime or only when a natural fall asleep has not occurred. To get the effect quickly, the tablets should be taken in an upright position together with 1/2 glass of water.
Use for children and adolescents
Zopiclone Pilum should not be given to children and adolescents under 18 years of age.
If you have taken too much Zopiclone Pilum
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Zopiclone Pilum
Do not take a double dose to make up for a missed dose.
If you are still able to sleep undisturbed for a whole night, take the missed dose right away. If you are unable to get a full night’s sleep, skip the missed dose and do not take another dose until you go to bed the following evening.
If you stop taking Zopiclone Pilum
If you suddenly stop taking Zopiclone Pilum, your sleep problems may return for a temporary period. You may also experience withdrawal symptoms. Withdrawal symptoms include difficulty sleeping, headaches, sweating, hallucinations, and increased heart rate. In more serious and very rare cases, convulsions may occur.
The risk of withdrawal symptoms increases with the dose and the duration of treatment, and therefore the doctor can give you information on how to gradually reduce the dose.
If you have further questions about this medicine, contact your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if the following serious side effects occur:
Stop taking Zopiclone Pilum and contact a doctor immediately if you experience a severe allergic reaction with any of the following symptoms ( angioedema, anaphylactic shock ) (rare side effects: may occur in up to 1 in 1,000 users):
– swelling of the face, tongue, or throat
– difficulty swallowing
– hives and difficulty breathing
– drop in blood pressure
Other side effects may occur:
Common side effects ( may affect up to 1 in 10 users): Dry mouth, bitter/metallic taste in the mouth (often transient). Drowsiness, which is dependent on the size of the dose.
Uncommon side effects ( may affect up to 1 in 100 users): Headache, nightmares, nausea, restlessness, dizziness.
Rare side effects ( may affect up to 1 in 1,000 users): Somnolence, anxiety, aggressiveness, irritability, inappropriate behavior possibly associated with memory lapses, hallucinations, confusion, and difficulty concentrating. Stomach upset ( dyspepsia ). Skin rash, itching, hives. Effect on liver enzymes.
If you stop the treatment suddenly after long-term treatment, so-called withdrawal symptoms may occur. Examples of such symptoms can 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, convulsions have also occurred.
How to store Zopiclone Pilum
Keep this medicine out of the sight and reach of children.
Store at a maximum of 25 °C.
Store in the original packaging. Light sensitive and moisture sensitive.
Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
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. One tablet contains 5 mg of zopiclone.
- Other ingredients are:
Tablet core: anhydrous calcium hydrogen phosphate, potato starch, magnesium stearate, colloidal hydrated silicon dioxide, sodium starch glycolate.
The film coating: hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol, and triacetin.
Appearance and package sizes of the medicine
Appearance
White, round, film-coated biconvex tablet. Diameter 6 mm.
Package sizes
Blisters: 10, 30, or 100 tablets.
Plastic jar 250 or 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pilum Pharma A/S, Energivej 15, 5260 Odense S, Denmark
Local Representative
Orifarm Generics AB, Box 56048, 102 17 Stockholm, info@orifarm.com
Manufacturer
AS Grindeks, Krustpils iela 53, LV-1057 Rīga, Latvia