Imovane®
| Consumer Medicine Information (CMI) summary |
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
| 1. Why am I using Imovane? |
Imovane contains the active ingredient zopiclone. Imovane is used to help people over 18 years of age with sleeping difficulties, also called insomnia. It can help you fall asleep and to reduce the number of times you wake up during the night. It is used for short term treatment (7-14 days) of insomnia. For more information, see Section 1. Why am I using Imovane? in the full CMI.
| 2. What should I know before I use Imovane? |
Do not use if you have ever had an allergic reaction to Imovane or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Imovane? in the full CMI.
| 3. What if I am taking other medicines? |
Some medicines may interfere with Imovane and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
| 4. How do I use Imovane? |
- Imovane should only be taken when you are able to get a full night's sleep (7 to 8 hours) before you need to be active again.
- The standard adult dose of Imovane is one tablet just before you go to bed.
More instructions can be found in Section 4. How do I use Imovane? in the full CMI.
| 5. What should I know while using Imovane? |
| Things you should do |
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| Things you should not do |
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| Driving or using machines |
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| Drinking alcohol |
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| Looking after your medicine |
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For more information, see Section 5. What should I know while using Imovane? in the full CMI.
| 6. Are there any side effects? |
- Common side effects include headache, bitter taste in your mouth, dry mouth and drowsiness. Serious side effects include allergic reaction symptoms such as swelling of the face, lips, mouth or throat, which may cause difficultly in swallowing or breathing. Other serious side effects include fainting, depression, suicidal thoughts or changes in your behaviour.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
Imovane®
Active ingredient: zopiclone
| Consumer Medicine Information (CMI) |
This leaflet provides important information about using Imovane. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Imovane.
Where to find information in this leaflet:
1. Why am I using Imovane?
2. What should I know before I use Imovane?
3. What if I am taking other medicines?
4. How do I use Imovane?
5. What should I know while using Imovane?
6. Are there any side effects?
7. Product details
| 1. Why am I using Imovane? |
Imovane contains the active ingredient zopiclone.
Imovane belongs to the class of medications called sedative-hypnotics.
Imovane is used to help people over 18 years of age with sleeping difficulties, also called insomnia. It can help you fall asleep and to reduce the number of times you wake up during the night. It is used for short term treatment (7-14 days) of insomnia.
Your doctor, however, may prescribe Imovane for another purpose. Ask your doctor if you have any questions about why Imovane has been prescribed for you.
| 2. What should I know before I use Imovane? |
Warnings
Do not use Imovane if you:
- are allergic to zopiclone, or any of the ingredients listed at the end of this leaflet.
Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.
Always check the ingredients to make sure you can use this medicine. - have been drinking alcohol or you believe that you may have alcohol in your bloodstream
- have sleep apnoea (a condition where you temporarily stop breathing while you sleep)
- have myasthenia gravis (a condition in which the muscles become weak and tire easily)
- have severe liver problems
- have acute and/or severe lung problems
- have had a stroke
- have ever experienced sleep-walking or other unusual behaviour (such as driving, eating, making a phone call or having sex etc.) while not being fully awake after taking Imovane.
- Do not take Imovane as a long term treatment
- Do not take Imovane if the packaging is damaged or shows signs of tampering.
- Do not give Imovane to children or adolescents.
- Do not take it if you are pregnant or intend to become pregnant.
- Do not take it if you are breastfeeding or planning to breastfeed.
Check with your doctor if you:
- take any medicines for any other condition.
- have allergies to any of the ingredients listed at the end of this leaflet or any other substances such as foods, dyes or preservatives.
- have any problems with your breathing or if you often snore while you are asleep.
- have ever been addicted to alcohol or any drug or medicine, or if you have ever suffered from a mental illness. If you have, you may be at risk of getting into a regular pattern or habit of taking Imovane.
- ever had a history of sleep-walking or other unusual behaviour (such as driving, eating, making a phone call, or having sex etc.) while not being fully awake after taking Imovane.
Imovane may cause sleep walking or other unusual behaviour (such as driving, eating, making a phone call, or having sex etc.) while not being fully awake, some of which have been associated with serious injuries and death. The next morning, you may not remember that you did anything during the night. These activities may occur whether or not you drink alcohol or take other medicines that make you drowsy with Imovane. If you experience any of the above, stop the treatment with Imovane immediately and contact your doctor or health-care provider.
Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:
- thyroid problems
- depression, psychosis or schizophrenia
- epilepsy
- addiction to drugs or medicines
Tell your doctor if you plan to have surgery.
If you have not told your doctor or pharmacist about any of the above, tell them before you take Imovane.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Do not take it if you are pregnant or intend to become pregnant.
It may affect your developing baby if you take it during pregnancy. Your doctor will discuss the risks and benefits of taking it if you are pregnant.
Do not take it if you are breastfeeding or planning to breastfeed.
Imovane passes into breast milk and there is a possibility your baby may be affected. Your doctor will discuss the risks and benefits of using it if you are breastfeeding or planning to breastfeed.
Use in children
- Do not give Imovane to children or adolescents.
- There is no experience with its use in children or adolescents.
| 3. What if I am taking other medicines? |
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with the absorption of Imovane. These include:
- medicines to treat depression, anxiety and mental illness
- St John's wort, (hypericum), a herbal remedy for depression
- other medications which may cause drowsiness
- benzodiazepines (medicines used as sedatives or to treat anxiety)
- pain relievers, such as opioids or narcotic analgesics
- alcohol, (ethanol), contained in some medicines eg cough syrups
- muscle relaxants
- antihistamines
- medicines used to treat epilepsy
- antiviral medication
- rifampicin, erythromycin or clarithromycin (medicines used to treat infections)
- ketoconazole or itraconazole (medicines used to treat fungal infections)
These medicines may be affected by Imovane or may affect how well it works. You may need to take different amounts of your medicine or different medicines. Your doctor or pharmacist will advise you.
Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking Imovane.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Imovane.
| 4. How do I use Imovane? |
How much to take
- Imovane should only be taken when you are able to get a full night's sleep (7 to 8 hours) before you need to be active again.
- The standard adult dose of Imovane is one tablet just before you go to bed.
- Imovane should be taken in a single intake and not readministered during the same night.
- If you are over 65 years of age the dose is half a tablet taken just before you go to bed.
- If you have a liver or kidney problem, the usual recommended dose is half a tablet taken just before you go to bed.
- Your doctor may have prescribed a different dose.
- Ask your doctor if you are unsure of the correct dose for you. They will tell you exactly how much to take. Follow the instructions they give you.
- If you take the wrong dose, Imovane may not work as well.
- Imovane should not be given to children or adolescents less than 18 years of age.
When to take Imovane
- Take Imovane immediately before you go to bed. Imovane should be taken as a single intake and not be readministered during the same night.
- It helps put you to sleep quite quickly. If you take Imovane on an empty stomach it may work more quickly.
- If you are not sure when to take it, ask your doctor or pharmacist.
How long to take Imovane
- Imovane should only be used for short periods (e.g.7-14 days). Continuous long term use is not recommended.
- Ask your doctor or pharmacist if you are not sure how long to take the medicine for.
How to take Imovane
- Swallow the tablet with a full glass of water.
If you forget to use Imovane
If you forget to take the tablet before you go to bed, and you wake up late in the night or very early in the morning, do not take it.
You may have trouble waking at your normal time.
After taking Imovane
Sometimes when medicines are stopped suddenly, after being used for a long time, withdrawal symptoms may occur. Symptoms of withdrawal may include abdominal and muscle cramps, vomiting and sweating.
In some cases your insomnia may appear worse for a short time; speak to your doctor if this occurs.
Tell your doctor if you have any problems when you stop taking Imovane.
If you have any queries about any aspect of your medicine, or any questions regarding the information in this leaflet, discuss them with your doctor or pharmacist.
If you use too much Imovane
If you think that you have used too much Imovane, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(by calling 13 11 26 in Australia or 0800 764 766 in New Zealand), or - contact your doctor, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
| 5. What should I know while using Imovane? |
Things you should do
- Tell all the doctors, dentists and pharmacists who are treating you that you are taking Imovane.
- If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Imovane.
- If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine.
- If you become pregnant while you are taking this medicine, stop taking it and tell your doctor or pharmacist immediately.
Things you should not do
- Do not take more than the recommended dose unless your doctor tells you to.
This can increase the risk of side effects. - Do not give this medicine to anyone else, even if they have the same condition as you.
- Do not use this medicine to treat any other complaints unless your doctor tells you to.
- Do not drink alcohol before or after taking this medicine.
This can increase the risk of side effects.
Driving or using machines
Because Imovane will make you sleepy, you should not operate dangerous machinery or drive motor vehicles for 12 hours after you take it. You should also be careful the next morning when you wake up.
Make sure you know how you react to Imovane before you drive a car or operate machinery. This is very important if you are taking other drugs that also make you drowsy.
Impairment can occur despite feeling fully awake, in absence of symptoms or if you are feeling better.
Use in Elderly (over 65 years)
Be careful if you are over 65 and unwell or taking other medicines.
You may be more sensitive to some of the side effects of Imovane.
Drinking alcohol
You should not drink alcohol while you are taking Imovane.
The effects of alcohol could be made worse while taking Imovane.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out of the box or the blister pack they may not keep well.
Store below 25°C.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:
- in the bathroom or near a sink, or
- in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
| 6. Are there any side effects? |
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
| Less serious side effects | What to do |
General
These are the most common side effects of this medicine. Less common side effects include: Gut related
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
Alcohol can increase the risk of sleep walking or other behaviours such as driving or eating food whilst asleep. This risk is also increased if you take more than the recommended dose.
Some sleep medicines may cause a short-term memory loss. When this occurs, a person may not remember what has happened for several hours after taking the medicine. This is usually not a problem since most people fall asleep after taking the medicine.
Sleep medicines should in most cases, be used only for short periods of time. If your sleep problems continue, consult your doctor.
Some sleep medicines can cause dependence, especially when they are used regularly for longer than a few weeks. People who have been dependent on alcohol or other drugs in the past may have a higher chance of becoming addicted to sleep medicines. If you have been addicted to alcohol or drugs in the past, it is important to tell your doctor before starting Imovane.
Serious side effects
| Serious side effects | What to do |
Allergy related
| Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
These are very serious side effects. If you have them, you may have had a serious allergic reaction to Imovane. You may need urgent medical attention or hospitalisation.
These side effects are very rare.
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems in Australia or in New Zealand at https://nzphvc.otago.ac.nz/reporting
By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
| 7. Product details |
This medicine is only available with a doctor's prescription.
What Imovane contains
| Active ingredient (main ingredient) |
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| Other ingredients (inactive ingredients) |
Coating (Opadry white OY-S-38906):
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Do not take this medicine if you are allergic to any of these ingredients.
What Imovane looks like
Imovane is a white, elliptical biconvex film-coated tablet with a score line on one side.
Australia: Imovane is available in blister packs of 2, 10, 14 and 30 tablets.
New Zealand: Imovane is available in blister packs of 10, 14 and 30 tablets.
** Not all pack sizes marketed.
AUST R 165934.
New Zealand Ref: TT50-3976
Who distributes Imovane
Distributed in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Email: medinfo.australia@sanofi.com
Distributed in New Zealand by:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
Email: medinfo.australia@sanofi.com
This leaflet was prepared in October 2022.
® Registered Trademark
Imovane-ccdsv13-cmiv18-06oct22
Published by MIMS November 2023