Imovane is used under medical prescription for the treatment of severe sleep disturbances, in particular disorders related to difficulty falling asleep, continuity of sleep and early awakening.

It should only be taken in the presence of marked sleep disturbances and for a short period (for a total of no more than 10 days). If your doctor exceptionally considers prescribing it for a longer period, he will explain to you if you need to continue the treatment, which you will need to check regularly afterwards.

What must also be taken into account during treatment?

Sleep disturbances often only need to be treated temporarily with medicines. If you suffer from sleep disturbances, we also advise you not to consume caffeinated drinks in the evening, have a light dinner, enjoy a relaxing activity or go for a walk.

Do not consume alcoholic beverages while taking Imovane.

When can’t imovane be used?

People who are hypersensitive to the active substance zopiclone or to one of its components, with extremely poor lung function, severe diseases of the respiratory organs, severe liver function disorders or myasthenia gravis (a very rare pathological muscle weakness) or concomitant severe psychiatric illnesses cannot take it.

Children and young people under the age of 18 cannot take the tablet as they lack experience in this regard.

When is caution required in the administration / use of Imovane?

If you suffer from liver function disorders, kidney disease and breathing difficulties, Imovane should be taken with caution and the dosage determined by your doctor.

Other medications with a calming and sedative effect on the brain (central nervous system) can strengthen the effect of Imovane. These include, for example, tranquilizers (including natural or herbal preparations containing hypericum), other sleeping pills, certain painkillers, medicines for mental disorders (psychotropic drugs), antiepileptics, anesthetics, sedative antihistamines and alcoholic beverages. Certain antibiotics or mycosis medications can enhance the effectiveness of it.

Risk of addiction: The active substance in Imovane belongs to a class of chemicals that act like other sleeping pills, such as the very popular benzodiazepines that can cause addiction. The risk of dependence is greater in case of prolonged use of this tablet and in people who have already suffered from psychiatric disorders, alcoholism or drug addiction, and causes, in case of abrupt discontinuation of the drug, withdrawal symptoms: agitation, anxiety, insomnia, impaired concentration, headache and sweating. These symptoms generally disappear after 2 – 3 weeks.

Concomitant intake of Imovane with narcotic analgesics may increase the euphoric effect.

To minimize the risk of addiction, observe the following rules:

Take it only on prescription.

Never increase the dose prescribed by your doctor.

Tell your doctor if you intend to stop taking the medicine.

Prolonged use (more than 10 days) should only be done under strict medical supervision.

After discontinuing the preparation, even after a short period of intake, temporary sleep disturbances may reappear for a few nights which can be avoided by gradually discontinuing the intake.

If you experience changes in mood or behavior, contact your doctor immediately.

Takinthis tablets may increase the risk of suicide if you have a depressive disorder or not.

There have been reports of people who, after taking Imovane or a similar medicine, act while sleeping (sleepwalking) or not fully awake and do not remember. Behaviors observed included sleepwalking when driving, preparing meals, eating, telephoning or during sexual intercourse and isolated cases of self-harming behavior. The intake of alcohol and other central nervous system medicines in combination with Imovane appears to increase the risk of such behaviors. If such behavior occurs, stop treatment and inform your doctor.

The effect of Imovane is very rapid; it should therefore be taken just before going to sleep. It is important not to resume Imovane on the same night as this should allow for a normal sleep duration of 7-8 hours. It is also possible to carry out daily activities of which no memory is retained afterwards.

Particularly sensitive people may experience tiredness or sleepiness (as happens with all sleeping pills) even the next day, especially at the beginning of treatment. This medicine can reduce reactions, the ability to drive a vehicle and the ability to use tools or machines. You should avoid driving a vehicle when:

• Imovane has been employed for less than 12 hours;
• Imovane is taken at the same time as alcohol or other medicines that have a sedative effect on the brain.

Concomitant intake of Imovane with opioids can cause sedation and respiratory failure which can lead to coma or death. It is important to identify any signs or symptoms of respiratory failure and sedation and notify your doctor immediately.

Tell your doctor or pharmacist if

• suffer from other diseases,
• suffer from allergies or
• takes or applies other medications externally (even purchased on his own initiative!).

Can Imovane be given during pregnancy or breastfeeding?

Imovane can have harmful consequences for the unborn or newborn baby. For safety reasons, do not take Imovane if you are pregnant or breastfeeding.

If you are taking Imovane if you are pregnant or suspected, or if you intend to become pregnant, contact your doctor immediately to find out how to proceed with treatment.

How to use Imovane?

In general, the lowest effective dose is always used for the shortest possible period. Imovane should not be used for prolonged periods as the risk of addiction increases with the duration of treatment.

The exact dosage is decided by the doctor. Unless otherwise prescribed, the usual dosage for adults is 1 tablet per day (7.5 mg). In the elderly or patients with reduced hepatic function or chronic respiratory insufficiency ½ tablet (3.75 mg) may be sufficient.

Take Imovane with some water or a non-alcoholic drink just before bedtime.

Your doctor will decide how long you should take Imovane for.

Do not change the prescribed dosage on your own. If you think that the action of the medicine is too weak or too strong, talk to your doctor or pharmacist.

Imovane side effects

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.

What else needs to be taken into account?

Store Imovane at room temperature (15-25 ° C), in the original package, and out of the reach of children.

The medicinal product should not be used beyond the date indicated with “EXP” on the container.

Your doctor or pharmacist, who have detailed professional information, can give you further information.

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