Imovane Tablets 7.5MG Pack Of 30

Imovane(R)

Zopiclone
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Imovane. It does not contain all the information that is known about Imovane.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Imovane against the benefits they expect it will have for you.

If you have any concerns about taking this medicine ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Imovane is used for

Imovane is used to help you fall asleep and to reduce the number of times you wake up during the night. It is used for short term treatment (2-4 weeks) of sleeplessness.

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.

Before you take Imovane

When you must not take it

Do not take Imovane if you :

  • have ever had an allergic reaction to:
  • zopiclone
  • any of the tablet ingredients listed at the end of this leaflet
  • If you have an allergic reaction you may get a skin rash, have difficulty in breathing, get symptoms of hayfever or feel faint.

    Do not take Imovane if you:

  • have had a stroke
  • have severe muscle weakness
  • have breathing problems during the day or the night
  • have severe liver problems
  • Do not take Imovane after the expiry date (EXP) printed on the blister pack.

    It may have no effect at all, or an entirely unexpected effect if you take it after the expiry date.

    Do not take Imovane if the package shows signs of having been tampered with.

    Do not take Imovane to treat any other complaints unless your doctor has instructed you to do so.

    Before you start to take it

    Your doctor must know about all the following before you start to take Imovane.

  • 1.You must tell your doctor if you are allergic to any other medicines or any foods, dyes or preservatives.
  • 2.You must tell your doctor about any other medical conditions for which you receive other medicines, such as thyroid problems, depression and epilepsy.
  • 3.You must tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
  • 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 you may need to take different medicines. Your doctor or pharmacist has a more complete list of medicines to avoid while taking Imovane.

    Your doctor or pharmacist can tell you what to do if you are taking any of these or other medicines.

  • 4.You must tell your doctor if you are pregnant or plan to become pregnant.
  • Do not take Imovane if you are pregnant unless you and your doctor have discussed the risks and benefits involved.
  • It is recommended that you do not breastfeed while taking Imovane.
  • If you have not told your doctor about any of these things, tell them before you take Imovane.
  • Use in children

    Imovane must not be used by children. The safety and effectiveness of Imovane has not been established in children.

    Use in elderly

    Elderly patients may be more sensitive to the effects or side effects of Imovane.

    How to take Imovane

    How much to take and when to take it

    Your doctor will tell you how much Imovane to take. Take the amount your doctor tells you to.

    The recommended dose of Imovane is one tablet just before you go to bed. For elderly patients and patients with liver disease, the recommended starting dose is half a tablet at night.

    Imovane can be taken with or without food.

    How long to take it

    Your doctor will tell you how long to take Imovane. Usually Imovane should not be taken for more than 2 to 4 weeks, but your doctor may tell you that you should take it for longer than 2 to 4 weeks.

    What to expect

    Individuals will vary greatly in their response to Imovane. Your doctor will check your progress at regular intervals.

    If you forget to take it

    If you miss a dose, simply take Imovane again the next night. You do not have to make up for the missed dose.

    If you have been taking Imovane for several weeks or have been taking another drug which promotes sleep before you started taking Imovane, do not suddenly stop taking Imovane. Discuss with your doctor the best way to stop taking Imovane.

    If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

    If you take too much (Overdose)

    Immediately telephone your doctor or Poisons Information Centre (In Australia call 13 11 26, in New Zealand call 0800 POISON, 0800 764766) for advice, or go to Accident & Emergency at your nearest hospital if you think that you or anyone else may have taken too much Imovane. Do this even if there are no signs of discomfort or poisoning. Keep telephone numbers for these places handy.

    While you are taking Imovane

    Things you must do

  • Take Imovane exactly as your doctor has prescribed.
  • If you do not follow your doctor`s instructions, you may not get improvement in your sleeplessness. Try not to miss any doses.
  • Tell your doctor if your condition returns or becomes worse after your dose of Imovane has been reduced or treatment has been stopped.
  • Tell your doctor immediately if you become pregnant while taking Imovane.
  • Tell all doctors, dentists and pharmacists who are treating you that you are taking Imovane, especially if you are being started on any new medicines.
  • Things you must not do

  • Do not give this medicine to anyone else even if their symptoms seem similar to yours.
  • Things to be aware of

  • Imovane can cause drowsiness and increase the effects of alcohol and other drugs. If affected, do not drive or operate machinery.
  • Side effects

  • Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Imovane.
  • Imovane helps most people who take it, but it may have unwanted side effects in some people.
  • All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
  • The side effects that occur most often with Imovane are headaches, dry mouth, bitter taste and drowsiness.
  • Other less commonly reported side effects include:
  • heartburn
  • diarrhoea
  • change in appetite
  • nausea
  • vomiting
  • rash
  • bad breath
  • agitation
  • depression
  • confusion
  • anxiety
  • dizziness
  • change in frequency of urination
  • blurred vision
  • impotence
  • throbbing of the heart (in elderly patients)
  • Imovane may have other unwanted effects which have not been described here. If you notice any change in your health while taking Imovane, tell your doctor or pharmacist.

    Ask your doctor or pharmacist to answer any questions you may have.

    After using Imovane

    Storage

    Keep Imovane tablets in a cool dry place where the temperature stays below 25 degrees C.

    Do not store Imovane or any other medicine in the bathroom or near a sink or stove.

    Heat and dampness can destroy some medicines.

    Keep Imovane where young children cannot reach it.

    A locked cupboard at least one-and-a-half metres above ground is a good place to store medicines.

    Do not leave it in the car on hot days.

    Disposal

    Dispose of the tablets where children cannot reach them.

    Ask your pharmacist what to do with any Imovane you may have left over if your doctor tells you to stop taking them, or you find that the tablets have passed the expiry date.

    Product description

    What it looks like

    Imovane is an oval, film-coated white tablet with a break-line on one side.

    Imovane is available in blister packs of 30 tablets. In Australia there is also a pack of 10 tablets as well as a sample pack of 2 tablets.

    Ingredients

    Active ingredient

    Each tablet contains 7.5 mg of zopiclone.

  • Additives

    Imovane tablets also contain:

  • calcium hydrogen phosphate
  • starch-wheat (gluten)
  • sodium starch glycollate
  • lactose
  • magnesium stearate
  • hypromellose
  • titanium dioxide
  • Manufacturer

  • Imovane is made in France and supplied by:
  • Aventis Pharma Pty Limited
  • 27 Sirius Road, Lane Cove 2066
  • Australia
  • Aventis Pharma Limited
  • Auckland, New Zealand
  • This leaflet was last updated in December 2002
  • Australian Registration Number:
  • Imovane – AUST R 48020
  • ENQUIRE

    1800 200 736