Manufacturer
Hemofarm AD

Treatment
Belbien film tablets are used to treat insomnia.

Ingredients
The active substance is zolpidem.
Each tablet contains 10 mg of zolpidem tartrate.
Other ingredients are:
Core: lactose, monohydrate, cellulose, microcrystalline, sodium starch glycolate (Type A), magnesium-stearate, hypromellosis.
Movie: hypromellose, titanium dioxide (E 171), macrogol 400.

Before taking Belbien
Always take Belbien exactly as your doctor has told you. If you are not quite sure, check with your doctor or pharmacist.
You must not take Belbien if:
• you are allergic (hypersensitive) to zolpidem or to the other ingredients in the medication. The signs of an allergic reaction are: smallpox, difficulty swallowing or breathing, swelling lips, face, throat or tongue;
• you have severe respiratory failure;
• have severe liver failure (severe impairment of liver function);
• you have sleep apnea syndrome;
• you suffer from myasthenia gravis;
• you suffer from psychosis (mental illness).
Do not take this medicine if any of the above apply to you. If you are not sure, consult your doctor or pharmacist before taking Belbien.
Belbien should not be used in children and adolescents under 18 years of age.

Addiction
With high doses or long-term administration of Belbien, psychiatric and physical symptoms dependencies may occur. The risk is higher for those people who have misused alcohol or drugs. If addiction occurs, discontinuation of Belbien should be gradual. If you have any further questions, please contact your doctor.

Administration of other drugs
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those ones that can be purchased without a doctor's prescription, homeopathic remedies or high doses of vitamins.

Taking Belbien with food or drink
You must not consume alcohol during treatment with Belbien! Alcohol alters and enhances the effects of Belbien in an unpredictable way.
Taking Belbien with food or non-alcoholic beverages does not affect the effect of the medicine.

Administration of Belbien during pregnancy and lactation
There are insufficient data to evaluate the safety of Belbien administration during pregnancy and lactation. If you are pregnant or think you are pregnant, do not take Belbien without your doctor's advice, especially in the first three months of pregnancy.
If you are pregnant or planning to become pregnant while taking Belbien, consult your doctor. They will decide whether you should continue or stop Belbien treatment.
If Belbien is used for an extended period of time during the last months of pregnancy, it may cause abstinence symptoms (withdrawal symptoms) in the newborn.
If Belbien is used for medically justified reasons at a later stage of pregnancy or during childbirth, hypothermia (decrease in body temperature), hypotonia (weakened muscles) and respiratory depression (respiratory distress) may occur in the newborn.
Since Belbien is excreted in breast milk in small amounts, do not take Belbien in breastfeeding period.
If you have any further questions, ask your doctor.

Impact of Belbien on motor vehicle operation and machine operation
If drowsiness, dizziness or confusion occur within the next day after taking Belbien, you must not operate a motor vehicle or operate machinery. To reduce the risk of side effects, it is recommended that there must be a time between taking Belbien and performing these activities at least 7 - 8 hours.

If you have taken more Belbien than you should
If you have taken a higher dose of the medication than you were advised to or if someone else accidentally took your medicine, contact your doctor, pharmacist or your nearest healthcare facility immediately.
Belbien overdose can lead to a disorder of consciousness, which can manifest as drowsiness, confusion, deep sleep or a fatal coma.

If you forget to take Belbien
Never take a double dose to make up for skipping to take the medicine!
Belbien must be taken exclusively in the evening before bedtime. If you forget to take your tablet in the evening, do not take it at any other time as it may cause drowsiness, dizziness and confusion during the day.

If you suddenly stop taking Belbien
If you do not feel any improvement, do not discontinue Belbien without your doctor’s advice.
Never stop Belbien treatment abruptly as insomnia and worsening may cause abstinence symptoms (withdrawal symptoms), such as: anxiety (anxiety), nervousness, irritability, confusion, headache, depression, rapid or irregular heartbeat, nightmares, hallucinations (perception of non-existent objects, phenomena or events), hypersensitivity to light, noise or physical touch, derealization (a disorder of perception of the outside world that becomes strange or unrealistic), depersonalization (feeling of losing your identity, feeling that your own personality no longer exists, loss relationship with your body), feeling of tingling or tingling in your arms or legs, muscle aches, stomach problems. In rare cases, epileptic seizures may occur.
Contact your doctor immediately if you notice any of these symptoms.

Storing Belbien
Keep out of the reach and sight of children!
Do not take Belbien after the expiry date which is stated on the pack. Shelf life expires on the last day of that month.
Store the medicine in the original package.