Imovane contains the active ingredient zopiclone. Zopiclone, a cyclopyrrolone derivative, is a short-acting hypnotic agent. Zopiclone belongs to a novel chemical class which is structurally unrelated to existing hypnotics. The pharmacological profile of zopiclone is similar to that of the benzodiazepines.

        In sleep laboratory studies of 1 to the 21-day duration in man, zopiclone reduced sleep latency, increased the duration of sleep and decreased the number of nocturnal awakenings. Zopiclone delayed the onset of REM sleep but did not reduce consistently the total duration of REM periods. The duration of stage 1 sleep was shortened, and the time spent in stage 2 sleep increased. In most studies, stage 3 and 4 sleep tended to be increased, but no change and actual decreases have also been observed. The effect of zopiclone on stage 3 and 4 sleep differs from that of the benzodiazepines which suppress slow-wave sleep. The clinical significance of this finding is not known.

        Each tablet contains 7.5 mg of zopiclone as the active ingredient. It also contains the inactive ingredients calcium hydrogen phosphate dihydrate, wheat starch (gluten), sodium starch glycollate, lactose monohydrate, magnesium stearate, hypromellose, titanium dioxide, macrogol 6000.

• Been drinking alcohol or you believe that you may have alcohol in your bloodstream;

• Sleep apnoea (a condition where you temporarily stop breathing while you sleep);

• Myasthenia gravis (a condition in which the muscles become weak and tire easily);

• Severe liver problems;

• Acute and/or severe lung problems;

• Had a stroke.

        Do not take Imovane if you are allergic to it or any of the ingredients listed here. 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.

        Do not give Imovane to children or adolescents. There is no experience with its use in children or adolescents.

        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.

        Do not take Imovane after the expiry date (EXP) printed on the pack. If you take it after the expiry date has passed, it may not work as well.

        Do not take Imovane if the packaging is damaged or shows signs of tampering.

Tell your doctor or pharmacist if you have allergies to:

• Any of the ingredients listed here;

• Any other substances such as foods, dyes or preservatives.

• Tell your doctor if you are pregnant or intend to become pregnant. Like most medicines of this kind, Imovane is not recommended to be used during pregnancy. Your doctor will discuss the risks and benefits of taking it if you are pregnant.

• Tell your doctor if you are breastfeeding or planning to breastfeed. Your doctor will discuss the risks of taking it if you are breastfeeding or planning to breastfeed.

• Tell your doctor if you have any problems with your breathing or if you often snore while you are asleep.

• Tell your doctor if you 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.

• 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.