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 (2-4 weeks) of insomnia. It is not recommended for use for more than 4 weeks at a time.
Your doctor, however, may prescribe Imovane for another purpose.
Do not take Imovane if you have:
- 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
- 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 you are allergic to it 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.
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.
What side effects can Imovane have?
The side effects of Imovane depend on the dosage and individual sensitivity.
The following side effects may occur with the intake or application of Imovane:
A bitter but harmless taste can often be found on the tongue, dry mouth, and residual sleepiness. Occasionally, headaches, dizziness, nausea, or fatigue may appear.
Rarely, reactions due to hypersensitivity such as hives, rash, itching or acute allergic edema of the face, larynx or tongue or even dyspnoea and drop in blood pressure may occur. Cases of falls have been reported mainly in the elderly.
Very rarely have been observed: muscle weakness, ataxia, visual disturbances (double vision), difficult and painful digestion, disturbances in liver function (increase in serum transaminases and / or alkaline phosphatase).
Psychic side effects appeared after taking benzodiazepine-based sleeping pills. Nightmares, agitation, confusional states, more rarely changes in libido, irritability, hallucinations and cases of aggression have occasionally been reported. There have been isolated reports of restlessness, hallucinations, pins and needles, anger, abnormal behavior (sometimes associated with memory disturbances), sleepwalking, addiction and withdrawal syndrome.
The use of benzodiazepine-based sleeping pills has also been very rarely linked to the accentuation of depressive states.
If you notice any side effects not described here, you should inform your doctor or pharmacist.
