5 mg and 7.5 mg film-coated tablets
zopiclone
What Zopiclone Actavis is and what it is used for
Zopiclone Actavis is a sleep aid, which affects the centers in the brain that allow us to sleep. It helps you fall asleep faster and sleep longer. Zopiclone Actavis is used in adults as a sleep aid for various types of sleep problems, e.g. difficulty falling asleep, waking up too early, or many nighttime awakenings. Zopiclone Actavis is used for temporary and short-term sleep disorders and for a limited time for chronic sleep disorders. Zopiclone Actavis usually starts working within 30 minutes and leaves the body relatively quickly. This means that the risk of feeling drowsy the day after taking the tablet is small.
The zopiclone contained in Zopiclone Actavis 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 take Zopiclone Actavis
Do not take Zopiclone Actavis
- 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 severe muscle weakness ( myasthenia gravis )
- if you have breathing problems ( respiratory insufficiency )
- if you have severe breathing stops during sleep ( sleep apnea )
Warnings and precautions
Talk to your doctor or pharmacist before taking Zopiclone Actavis. Talk to your doctor before treatment if you:
- have problems with the liver
- have breathing problems (respiratory problems)
- have previously had problems with alcohol or drug abuse
- have recently taken Zopiclone Actavis or other similar medicines for more than 4 weeks
- feel that you cannot stop taking Zopiclone Actavis or other medicines for sleep problems
- has reduced general condition
Sleepwalking and similar behaviors
Sleepwalking and other similar behaviors, such as driving or eating while asleep without remembering the event afterward, have been reported in patients who have taken zopiclone and have not been fully awake.
The risk of such behaviors increases
- if alcohol or certain other medicines (eg narcotic painkillers, antipsychotic medicines, sleeping pills, or anxiolytics/sedatives) are used during treatment with zopiclone.
- if zopiclone is taken in a higher dose than the highest recommended dose a.
Contact a doctor immediately if you develop any of the above behaviors. Your doctor may discontinue treatment with zopiclone.
Older
Caution should be exercised when treating the elderly.
Children and young people
Zopiclone Actavis should not be used by children and adolescents under the age of 18. The safety and efficacy of zopiclone in children and adolescents under 18 years of age have not been established.
Other medicines and Zopiclone Actavis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines, including herbal medicines, as Zopiclone Actavis can affect the effectiveness of certain other medicines. Other medicines can also affect the effect of Zopiclone Actavis.
Zopiclone Actavis can increase the effect of the following medicines:
- medicines for mental illnesses (antipsychotics)
- medication for depression
- anesthetics _ _
- drugs for anxiety or sleep disorders ( hypnotics )
- medicines for hay fever, rashes, or other allergies that can make you sleepy ( sedative antihistamines )
- certain medicines for moderate to severe pain (narcotic analgesics )
The following medicines may increase the effect of Zopiclone Actavis:
- certain antibiotics such as erythromycin
- certain medicines against fungal infections such as itraconazole
The simultaneous use of Zopiclone Actavis 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 Zopiclone Actavis at the same time as opioid drugs, the dose and duration of treatment must 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 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.
Certain antibiotics for infection, such as rifampicin, can make Zopiclone Actavis work less well.
Zopiclone Actavis with alcohol
Do not use alcohol while taking Zopiclone Actavis. Alcohol can increase the effect of Zopiclone Actavis and cause you to sleep very deeply so that you do not breathe properly.
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.
During pregnancy, there is a risk that the fetus will be affected. Zopiclone Actavis should therefore not be used during pregnancy.
Zopiclone passes into breast milk. Use of Zopiclone Actavis while breastfeeding is not recommended.
Driving ability and use of machinery
Zopiclone Actavis may impair responsiveness. This should be taken into account when increased attention is required, e.g. when driving and precision work. For more information about possible side effects that may affect your ability to drive, see section 4 of this leaflet.
You are responsible for assessing whether you are fit to drive vehicles 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 Actavis contains lactose and sodium
Zopiclone Actavis contains lactose
If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
Zopiclone Actavis contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, i.e. it is almost “sodium-free”.
How to take Zopiclone Actavis
The duration of treatment should be as short as possible and should not exceed 4 weeks, including the gradual taper.
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Ingestion of the drug
- Take this medicine by mouth.
- Take this medicine in an upright position, otherwise, the effect may be delayed.
- Take the tablet before going to bed or before going to sleep.
- Zopiclone Actavis usually works within 30 minutes.
The recommended dose for adults is one tablet (5 mg) at bedtime. Your doctor may decide to increase the dose by one Zopiclone Actavis tablet (7.5 mg) if necessary.
If you have taken too much Zopiclone Actavis
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.
If you have taken too much Zopiclone Actavis, contact a doctor or go to the hospital. Take the medicine package with you, so the doctor knows what you have taken.
Taking too much Zopiclone Actavis can have the following effects:
- drowsiness, confusion, deep sleep, and possibly coma
- fatigue (exhaustion)
- rapid heartbeat
- dizziness, lightheadedness, or fainting
- changes in blood test results
- stomach and intestinal problems
- shallow breathing or difficulty breathing ( respiratory depression )
If you forget to take Zopiclone Actavis
Do not take a double dose to make up for a missed tablet. Zopiclone Actavis should only be taken at bedtime.
If you stop taking Zopiclone Actavis
If you suddenly stop taking Zopiclone Actavis, your sleep problems may return and you may experience withdrawal symptoms. If this happens, you may experience some of the effects listed below. Talk to a doctor immediately if you experience any of the following effects:
- headache
- muscle pain ( myalgia )
- muscle tension
- severe anxiety
- irritation
- hallucinations (seeing and hearing things that are not real)
- increased sensitivity to light, sound, and touch than normal
- numbness and tingling in the hands and feet
- epileptic seizures
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.
Common (may affect up to 1 in 10 users):
- Dry mouth (careful oral hygiene is therefore important)
- Bitter taste in the mouth (often transient)
- Drowsiness
These side effects depend on the size of the dose and generally disappear or decrease when the dose is lowered.
Uncommon (may affect up to 1 in 100 users):
- Headache
- Strange dreams
- General discomfort
- Concern
- Dizziness
Rare (may affect up to 1 in 1,000 users):
- Aggressiveness
- Confusion
- Irritation
- Concentration difficulties
- Memory shutters
- Hallucinations
- Anxiety
- Rash
- Severe allergic reactions
- Effect on liver enzymes
Has been reported: occurring in an unknown number of users:
- For sleepwalking and other similar behaviors, see section 2 “Warnings and Precautions”.
How to store Zopiclone Actavis
Keep this medicine out of the sight and reach of children.
Store at a maximum of 25°C.
Store in the original packaging.
Use before the expiry date stated on the packaging. 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.
- Other ingredients are: lactose monohydrate, calcium hydrogen, phosphate dihydrate, corn starch, carmellose sodium, magnesium stearate, titanium dioxide (E171), hypromellose
Zopiclone Actavis 5 mg film-coated tablets also contain yellow iron oxide (E172) and macrogol.
Appearance and package sizes of the medicine
Zopiclone Actavis 5 mg film-coated tablets: yellow, marked “ZOC5”.
Zopiclone Actavis 7.5 mg film-coated tablets: White, with the partial score on both sides, marked “ZOC7.5”.
PVC/PVDC/aluminum blisters: 10, 30, 100, and 50×1 film-coated tablets (single dose).
HDPE plastic container: 500 film-coated tablets (for dose dispensing and hospital use only).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavikurvegi 76-78
IS-220 Hafnarfjordur
Iceland
Manufacturer
Synthon Hispania SL
Castelló 1
Polígono Las Salinas
08830 Sant Boi de Llobregat
Spain
(only applies to 5 mg)
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria