Stilnoct 10mg

1 Stilnoct leaflet: information for the patient STILNOCT 10 mg film-coated tablets zolpidem hemitartrate Read this leaflet carefully before taking this medicine because it contains important information for you. Save this leaflet. You may have to read it again. If you have any further questions, ask your doctor or pharmacist. This medication has been prescribed for you. Don’t give this to anyone else. It could harm them, even if their signs of illness are the same as yours. If you experience any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. See section WHAT IS STILNOCT AND WHAT IS IT USED FOR? 2. WHAT INFORMATION BEFORE YOU TAKE STILNOCT? 3. HOW TO TAKE STILNOCT? 4. WHAT ARE THE POSSIBLE SIDE EFFECTS? 5. CONSERVATION OF STILNOCT? 6. CONTENTS OF THE PACKAGING AND ADDITIONAL INFORMATION 1. WHAT IS STILNOCT AND WHAT IS IT USED FOR? Stilnoct is a sleeping medication. It is prescribed for the short-term treatment of insomnia in patients over 18 years of age in situations where insomnia is debilitating or causes great distress to the patient. Do not use Stilnoct for a long time. Treatment should be as brief as possible because the risk of addiction increases with the duration of treatment. However, not all sleep disorders need to be treated with medication. Sleep disorders that are secondary to a physical or mental illness can be treated with a disease-specific approach. 2. WHAT INFORMATION BEFORE YOU TAKE STILNOCT? Do not take Stilnoct if you are allergic to zolpidem hemitartrate or any of the other ingredients of this medicine (listed in section 6). Stilnoct Pharma.be Page 1 of 7

2If you have severe liver failure. If you suffer from an acute and/or severe respiratory tract disease. In children and adolescents under 18 years of age because safety and efficacy could not be demonstrated in this population. As a long-term treatment. Treatment should be as brief as possible, since the risk of addiction increases with the duration of treatment. If you have ever experienced sleepwalking or other unusual sleep behaviors (such as driving, eating, having a telephone conversation, or having sex, etc.) without being fully awake, after taking Stilnoct or other medicines containing zolpidem. Warnings and Precautions Your doctor will inform you of the risks associated with the use of sleeping pills and will discuss alternative non-pharmaceutical treatments with you. Consult your doctor or pharmacist before using Stilnoct. Impairment of psychomotor functions the next day (see also Driving and using machines) The day after taking Stilnoct, the risk of difficulty in coordinating certain movements (impaired psychomotor functions), including a reduction in the ability to drive, may increase, especially if: you take this medication less than 8 hours before activities that require mental alertness you take more than the recommended dose you are taking zolpidem while you are already using another medication that is sedating or that increases the amount of zolpidem in the blood, or alcoholic beverages or medicines containing alcohol, or illicit substances. Take Stilnoct tablet as a single dose immediately before bedtime. Do not take another dose during the same night. If you suffer from myasthenia gravis (a rare autoimmune disease characterized by severe muscle weakness). If you suffer from sleep apnea syndrome (breathing stops during sleep). If you have breathing problems (see “Possible side effects” in section 4), liver disease or muscle disease (myasthenia gravis). In this case, always inform your doctor. As with any sleep medication, long-term use of Stilnoct is generally neither helpful nor advisable. In people taking Stilnoct who were not fully awake, cases of sleepwalking and other associated behaviors have been reported, such as: driving while asleep, preparing and eating meals, making phone calls, or having sexual intercourse, without remembering doing these actions. Consumption of alcohol or certain other medications appears to increase this risk. Using more than the maximum recommended dose of Stilnoct also appears to increase the risk of developing these behaviors. If this happens to you, see your doctor. The use of Stilnoct may cause dependence (tolerance). Therefore, the soporific effect may decrease, especially after repeated use for a few weeks. Use of Stilnoct may result in the development of physical and mental abuse and/or dependence. The risk of addiction depends on the dose you take and the duration of treatment. Talk to your doctor or pharmacist if you have a history of medical illness.