STILNOX 10X10MG Coated tablets
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sp.zn.sukls331305/2018 Package information: information for users
Stilnox 10 mg coated tablets
Read the entire package leaflet carefully before you start taking this medicine because
contains important information for you.
- Keep the leaflet in case you need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed exclusively for you. Do not give it to anyone else. He could hurt her, even if she has the same symptoms as you.
- If you experience any of the side effects, tell your doctor or pharmacist. Proceed in the same way in case of any side effects not listed in this leaflet. See point 4.
What you will find in this leaflet
- What Stilnox is and what it is used for
- What you need to pay attention to before you start taking Stilnox
- How to take Stilnox
- Possible side effects
- How to store Stilnox
- Package contents and other information
1. What Stilnox is and what it is used for
The preparation Stilnox belongs to the so-called hypnotics, i.e. drugs that induce sleep. The active ingredient in Stilnox is zolpidem. Zolpidem shortens the time of onset of sleep, reduces the number of awakenings, prolongs the total time of sleep and improves its quality by restoring the physiological structure of sleep. Stilnox is intended for the short-term treatment of insomnia in adults that debilitates them or leads to severe agitation. Do not use long term. Treatment should be as short as possible, as the risk of addiction increases with the duration of treatment.
2. What you need to pay attention to before you start taking Stilnox
Do not take Stilnox
- If you are allergic to zolpidem or any of the other ingredients of this medicine (listed in section 6).
- If you have severe liver disease.
- If you have acute and/or severe breathing problems.
- If you have severe muscle weakness.
- If you have sleep apnea syndrome.
Special caution is required when using Stilnox
- If you have serious breathing problems, because hypnotics can suppress the activity of the respiratory center and your breathing problems can get worse.
- If you have liver disease or are elderly (over 65 years), your doctor may need to reduce your dose of Stilnox.
- If you suffer from depression, your doctor will check you more often. Pre-existing depression may be detected during treatment with zolpidem. Because insomnia can be a symptom of depression, if insomnia persists, your doctor will reevaluate your treatment. Where possible, the doctor will determine the cause of the insomnia before starting treatment. If insomnia does not subside after 7-14 days of treatment, consult your doctor.
Taking zolpidem can lead to its abuse and/or the development of physical and psychological dependence. The risk of addiction is greater if zolpidem is taken for more than 4 weeks. The risk of abuse and dependence is higher in patients with a history of mental illness and/or dependence on alcohol, drugs, or medications. Tell your doctor if you have ever had a mental illness or have been addicted to alcohol, drugs, or medications.
Warnings and precautions
General information related to the known effects of hypnotics is also provided.
Psychiatric and „paradoxical“ reactions
Symptoms such as restlessness, increased insomnia, restlessness, irritability, aggression, delusions, rage, nightmares, hallucinations, psychosis, unusual behavior and other unwanted behavior disorders may occur when zolpidem and similar substances are administered. If these occur, see a doctor. These manifestations are more likely in older patients.
Sleepwalking and related behaviors
Drowsiness and associated behaviors such as „driving“, preparing and eating food, talking on the phone, or having intercourse have been reported in patients taking zolpidem who were not fully awake. The patient does not remember this activity retrospectively (amnesia). The risk of such behavior increases when taking zolpidem with other central nervous system depressants (including alcohol), as well as when exceeding the maximum recommended dose of zolpidem. If such behavior occurs, seek immediate medical attention to decide on further treatment.
Zolpidem and similar substances can cause memory loss (anterograde amnesia), which most often occurs a few hours after administration of the drug. The risk is reduced if you get 8 hours of uninterrupted sleep.
With repeated use of zolpidem and similar substances, a certain loss of effect may develop over several weeks.
Administering the product can lead to the development of physical and psychological dependence. The risk increases with dose and duration of treatment and is higher in patients who have been or are dependent on alcohol or drugs. When addiction occurs, the sudden cessation of treatment is accompanied by withdrawal symptoms such as headache, muscle pain, extreme anxiety and tension, restlessness, confusion and irritability. In severe cases, the following symptoms may occur: psychological disorders (feelings of unreality, strangeness of the surrounding world and feelings of alienation in relation to the environment or oneself), increased hearing sensitivity (hyperacusis), tingling or tingling in the limbs, hypersensitivity to light, noise and physical contact, hallucinations. Cramps may also occur. If these symptoms occur, see a doctor, as addiction treatment must be done under medical supervision.
Return of insomnia
When zolpidem is stopped, the symptoms that led to the treatment may reappear, with increased intensity. Other side effects may also be present, including mood changes, anxiety, and restlessness.
Zolpidem can cause drowsiness and decrease alertness, which can cause a fall and possibly serious injury.
Suicide and depression
Some studies show an increased risk of suicidal thoughts, suicide attempts and suicide in patients taking certain sedatives (tranquilizers) and hypnotics, including this product. However, it has not been determined whether it is caused by the medicinal product or there is another reason. If you have suicidal thoughts, contact your doctor immediately for advice.
Heart rhythm disorder (long QT syndrome)
If you have a heart rhythm disorder called congenital long QT syndrome, which can be detected on an ECG, your doctor will consider whether this medicine is suitable for you.
Impairment of psychomotor functions appearing the next day
(see also point „Driving means of transport and operating machines“). The day after taking Stilnox, there may be an increased risk of impaired psychomotor functions, including impaired driving ability, if:
- you take the product less than 8 hours before activities that require alertness,
- you take a higher than recommended dose,
- you take zolpidem at the same time as other medicines that depress the central nervous system or medicines that increase the level of zolpidem in the blood, or you consume alcohol or illicit substances at the same time. Take the preparation once immediately before going to bed. Do not take another dose during the same night.
In the case of zolpidem and similar short-acting substances, withdrawal symptoms may occur even during the interval between doses.
Other medicines and Stilnox
When taking zolpidem with the following preparations, the next day there may be an increased risk of drowsiness and impairment of psychomotor functions, including impaired ability to drive vehicles.
- Preparations for the treatment of certain mental disorders (antipsychotics).
- Preparations for the treatment of sleep disorders (hypnotics).
- Medications to calm or reduce anxiety.
- Preparations for the treatment of depression.
- Preparations for the treatment of moderate to severe pain (opioid analgesics).
- Preparations for the treatment of epilepsy.
- Preparations used for anesthesia (numbing).
- Medicines to treat hay fever, rashes or other allergies that can cause drowsiness (sedating antihistamines). You may see things that are not real (hallucinations) when taking zolpidem in combination with antidepressants including bupropion, desipramine, fluoxetine, sertraline and venlafaxine.
Zolpidem is not recommended for use with St. John’s wort, fluvoxamine and ciprofloxacin.
Substances that suppress or induce the production of certain liver enzymes can increase the effect of some hypnotics. If zolpidem is used simultaneously with ketoconazole (a medicine used to treat fungal diseases), the sedative effects may be increased.
Concomitant use of Stilnox and opioids (strong pain relievers, opioid replacement therapy medications, and certain cough medications) increases the risk of drowsiness, difficulty breathing (shortness of breath), coma, and can be life-threatening. For this reason, simultaneous administration is intended only for cases where no other treatment is possible. However, if your doctor prescribes Stilnox together with opioids, the dosage and duration of concomitant treatment must be limited by your doctor. Tell your doctor about all opioids you are taking and carefully follow the dosage recommended by your doctor. It is advisable to inform friends or relatives so that they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.
Tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take.
Stilnox with food, drink and alcohol
Stilnox can be taken with or without food. Do not drink alcohol while taking Stilnox as this may increase the sedative effect of the product.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, talk to your doctor or pharmacist before taking this medicine.
The use of Stilnox during pregnancy is not recommended. If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor.
If the product is used during pregnancy, there is a risk that the baby will be affected. Some studies have shown that a newborn may be at increased risk of cleft lip and palate (sometimes called „cleft lip“).
When using Stilnox during the second and/or third trimester of pregnancy, there may be a decrease in the mobility of the fetus and changes in its heart rhythm.
If Stilnox is used at the end of pregnancy or during labour, the baby may experience muscle weakness, a drop in body temperature, feeding difficulties and breathing problems (respiratory depression).
If the product is used regularly in late pregnancy, the child may develop physical dependence and is at risk of withdrawal symptoms such as restlessness or tremors. In such a case, the newborn must be carefully monitored in the postpartum period.
Breast-feeding Because a small amount of zolpidem passes into breast milk, it is not recommended that women who are breast-feeding use the product.
Driving vehicles and operating machines
The preparation Stilnox has a significant effect on the ability to drive or operate machines, it can cause microsleep. The day after taking Stilnox (as with other hypnotic drugs) it is necessary to take into account that:
- you may feel drowsy, sleepy, dizzy or confused,
- decision-making speed may slow down,
- you may have blurred or double vision,
- attention may be impaired. To reduce the side effects mentioned above, an interval of at least 8 hours is recommended between taking zolpidem and driving vehicles, operating machinery and working at heights.
Do not drink alcohol or take other psychoactive substances while taking Stilnox, as this may increase the side effects listed above.
Stilnox contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicinal product.
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially ‚sodium-free‘.
3. How to take Stilnox
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is 10 mg of Stilnox per 24 hours. A lower dose may be prescribed for some patients. Stilnox should be administered:
- in one dose,
- right before bed.
It is important that you do not perform activities that require increased attention for at least 8 hours after taking the product. Do not exceed a dose of 10 mg in 24 hours.
Take Stilnox just before or after lying down, with a small amount of liquid. The preparation should only be used if 8 hours of sleep can be ensured.
Duration of treatment Treatment should be as short as possible. The duration of treatment usually ranges from a few days to two weeks. The maximum duration of administration, including the gradual withdrawal of the product, is 4 weeks. Your doctor will choose a gradual withdrawal regimen depending on your specific needs.
If you take more Stilnox than you should
In case of overdose or accidental ingestion of the product by a child, disturbances of consciousness may occur, ranging from drowsiness to light unconsciousness, significantly more severe manifestations were observed when combined with other substances that suppress the central nervous system, including alcohol. If you have taken too much, contact your doctor or hospital immediately. Take the box with the remaining tablets with you. Do not seek help alone.
If you forget to take Stilnox
If you forget to take a tablet just before going to bed and only remember during the night, take it only if you have a sufficient period of continuous sleep (8 hours). If this is not possible, do not take the next tablet until the next day before going to bed. Do not double the next dose to make up for a missed tablet.
If you have stopped taking Stilnox
Do not change your dosage without consulting your doctor.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can have side effects, but not everyone gets them.
If you develop a rash, itching, swelling, breathing problems or severe mental problems, see a doctor.
Commonly reported side effects (affecting 1 to 10 patients in 100) include:
- worsening insomnia,
- memory lapses sometimes associated with unusual behavior,
- motion sickness,
- abdominal pain,
- back pain,
- upper and lower respiratory tract infections.
Uncommon side effects (affects 1 to 10 patients in 1,000) are:
- euphoric (excessively happy) mood,
- attention deficit disorder
- speech disorder,
- double vision,
- increase in liver enzyme values,
- increased sweating,
- muscle weakness.
Rare side effects (occur in 1 to 10 patients in 10,000) are:
- changes in libido (sexual desire),
- reduced level of consciousness,
- liver damage
- gait disorder
- falls (mainly in elderly patients and if zolpidem was not taken in accordance with the recommended dosage).
Very rare side effects (occurring in less than 1 patient in 10,000) are:
- drug addiction
- respiratory depression.
Other side effects, the frequency of which cannot be determined from the available data, are:
- angioneurotic edema (swelling occurring in different places, causing difficulties depending on the affected place),
- unusual behavior
- drug tolerance (loss of therapeutic effect),
- blurred vision,
- decrease in appetite.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. Adverse event reporting
If you experience any of the side effects, tell your doctor, pharmacist or nurse. Do the same for any side effects not listed in this leaflet. You can also report side effects directly to:
State Institute for Drug Control Šrobárova 48 100 41 Prague 10 website: www.sukl.cz/nahlasit-nezadouci-ucinek
By reporting side effects, you can help by sending more information about the safety of this product.
5. How to store Stilnox
Keep this medicine out of the sight and reach of children. This product does not require any special storage conditions.
Do not use this product after the expiration date stated on the packaging after the abbreviation „EXP“. The period of validity refers to the last day of the specified month.
Do not dispose of any medicinal products in sewage or household waste. Ask your pharmacist how to dispose of products you are no longer using. These measures help protect the environment.
6. Package contents and other information What Stilnox contains
- The active substance is zolpidemi tartras 10 mg in one coated tablet.
- Excipients are in the core of the tablet lactose monohydrate (90.4 mg in one coated tablet), microcrystalline cellulose, hypromellose, sodium carboxymethyl starch (type A), magnesium stearate and in the coating layer: hypromellose, macrogol 400, titanium dioxide (E 171 ).
What Stilnox looks like and what this pack contains
Stilnox is white to off-white oblong film-coated tablets, scored on one side and debossed with „STILNOX“ on the other side. The tablet can be divided into equal doses. The preparation is packed in a colorless transparent PVC blister closed with aluminum foil and in a box. Pack size: 10 or 20 tablets. Not all pack sizes may be on the market.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder: sanofi-aventis, s.r.o., Evropska 846/176a, 160 00 Prague 6, Czech Republic
Manufacturer: Sanofi Winthrop Industrie, Tours, France Chinoin Pharmaceutical and Chemical Works Private Co. Ltd., Veresegyház, Hungary
This leaflet was last revised: