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The product code(s) for this leaflet is: PL 47848/0042.
Lunivia film-coated tablets
Lunivia 1 mg film-coated tablets
Lunivia 2 mg film-coated tablets
Lunivia 3 mg film-coated tablets
eszopiclone
For use in adults
1. What Lunivia is and what it is used for
2. What you need to know before you take Lunivia
3. How to take Lunivia
4. Possible side effects
5. How to store Lunivia
6. Contents of the pack and other information
Lunivia belongs to a group of medicines called hypnotics, which are used to help you sleep. Lunivia is used in adults to treat insomnia, usually for short term duration. Lunivia is used only when the disorder is severe, disabling or causing great distress.
Talk to your doctor or pharmacist before taking Lunivia:
Before taking Lunivia:
During treatment with Lunivia:
Do not give eszopiclone to children and adolescents under the age of 18 years.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Lunivia may affect or be affected by certain medicines.
These include:
Combination with the medicines above may result in increased chance of getting side effects. Tell your doctor if you are taking any of the medicines above. Your doctor may need to adjust the dose of Lunivia.
Concomitant use of Lunivia and opioids (strong pain killers, medicines for substitution therapy (e.g., levomethadone, methadone or buprenorphine) and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor does prescribe Lunivia together with opioids, the dose and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all opioid medicines you are taking and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
Lunivia may take longer to work if you take it with or immediately after eating a high-fat or large meal.
Do not drink alcohol while taking Lunivia because alcohol can increase the side effects of Lunivia.
The consumption of grapefruit juice should be avoided (see section 2, ‘Other medicines and Lunivia’).
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Lunivia is not recommended during pregnancy because it may be harmful to your baby.
Do not take Lunivia if you are breast-feeding, as it may pass into breast milk.
Do not drive, operate machinery or do any harzardous activities requiring complete mental alertness for 12 hours after you take Lunivia. Drowsiness, blurred vision, and difficulty with concentration, memory and coordination may affect your ability to perform such activities.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Duration of treatment
The duration of treatment should be as short as possible and should not exceed four weeks including the stepwise withdrawal process (see section ‘If you stop taking Lunivia’).
In certain cases, you may be required to take Lunivia for longer than 4 weeks. In this case, your doctor will tell you how long you need to take Lunivia.
Taking this medicine
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Take Lunivia by mouth just before you go to bed. Swallow the tablets whole. Do not crush or break the tablet.
Do not take more than one dose in a single night.
Adults
The usual starting dose of eszopiclone is 1 mg at night. The dose may be increased to 2 or 3 mg if needed.
Elderly aged 65 or older
The recommended starting dose of eszopiclone is 1 mg at night. The dose may be increased to 2 mg if needed.
Patients with severe kidney problems
The maximum recommended dose of eszopiclone is 2 mg each night.
Patients taking CYP3A4 inhibitors such as certain antibiotics or antifungals
The maximum recommended dose of eszopiclone is 2 mg each night. If you are 65 years or older, you must not take Lunivia with CYP3A4 inhibitors.
If you have taken too many tablets, you should seek medical advice urgently. Take the Lunivia pack with you, so the doctor knows what you have taken.
Eszopiclone overdose can be very dangerous. If you take too much Lunivia, the following effects may happen:
Eszopiclone must only be taken at bedtime. If you forget to take your tablet at bedtime, you should not take it at any other time. Just take your next tablet at the usual time the following evening. Do not take a double dose to make up for a forgotten dose.
Do not stop taking Lunivia suddenly, but tell your doctor if you want to stop. Your doctor will need to lower your dose and stop your tablets over a period of time. It is possible that your difficulty in sleeping may return for one or two nights when you stop taking Lunivia. Occasionally, unpleasant effects such as stomach pain, headache, and increased appetite may occur after you stop taking Lunivia. In rare cases, seizures may occur after you stop taking medicines like Lunivia. Tell your doctor if any of these happen to you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon side effects (may affect 1 to 10 users in 1000):
Rare side effects (may affect 1 to 10 users in 10000):
Common side effects (may affect 1 to 10 users in 100):
Uncommon side effects (may affect 1 to 10 users in 1000):
Rare side effects (may affect 1 to 10 users in 10000):
Side effects of not known frequency (frequency cannot be estimated from the available data):
Very common side effect (may affect more than 1 in 10 people):
Common side effects (may affect 1 to 10 users in 100):
Uncommon side effects (may affect 1 to 10 users in 1000):
Rare side effects (may affect 1 to 10 users in 10000):
Very rare side effects (may affect less than 1 in 10000 people):
Side effects of not known frequency (frequency cannot be estimated from the available data):
There have been some reports of people doing things while asleep that they do not remember when waking up after taking a sleep medicine. This includes sleep-driving and sleep-walking. Alcohol and some medicines for depression or anxiety can increase the chance that this serious effect will happen.
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
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 carton and blister after EXP. The expiry date refers to the last day of that month.
[For 1 mg packed in PVC/PCTFE-Aluminium and OPA/Alu/PVC-Aluminium blisters and for 2 mg and 3 mg packed in PVC/PCTFE-Aluminium, OPA/Alu/PVC-Aluminium and PVC/PVdC/PVC-Aluminium blisters]
This medicine does not require any special storage conditions.
[For 1 mg packed in PVC/PVdC/PVC-Aluminium blisters]
Do not store above 30°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.
Lunivia 1 mg film-coated tablets are light blue, round, biconvex and marked with “1” on one side.
Lunivia 2 mg film-coated tablets are white, round, biconvex and marked with “2” on one side.
Lunivia 3 mg film-coated tablets are blue, round, biconvex and, marked with “3” on one side.
Lunivia is available in blisters; packs containing 10, 14, 20 or 30 film-coated tablets.
Not all pack sizes may be marketed.
This leaflet was last revised in December 2023.
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