Stilnox 10mg/20 tbl

Information for use, read carefully!

STILNOX

zolpidem tartrate
 

film-coated tablets


Manufacturer:

Sanofi Winthrop Industrie, Tours, France

Chinoin Pharmaceutical and Chemical Works Private Co.. Ltd.., Veresegyház, Hungary

Composition

Active substance:

Zolpidem tartrate 10 mg per tablet

Excipients:

Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, macrogol 400, titanium dioxide.
 

Indication group

Hypnotic

 

Characteristic

Zolpidem shortens sleep onset, reducing the number of awakenings, total sleep time, prolongs and improves the quality of restoring physiological structure of sleep.

 

Indication

Zolpidem use adult patients aged 18 years suffering from insomnia.

It is intended for short-term administration, treatment duration should not exceed 4 weeks.

 

Contraindication

It must not be used for children and adolescents under 18 years of age and patients with hypersensitivity to the active substance zolpidem or other ingredients.

Stilnox not be used in patients with acute or severe shortness of breath, stops breathing during sleep, or myasthenia gravis (a disease characterized by marked muscle weakness), pregnancy and lactation.

Regarding use in patients with hepatic insufficiency must be decided by your doctor.

 

Side effects

The common reported side effects include drowsiness, headache, dizziness, increased insomnia, memory loss sometimes associated with inappropriate behavior, hallucinations, agitation, nightmares, fatigue, diarrhea, nausea, vomiting, abdominal pain.

Less frequently reported were confusion, irritability, double vision.

Reported a decreased level of consciousness, nervousness, aggression, anger, inappropriate behavior, somnambulism, dependence (withdrawal of treatment with hypnotics may again experience symptoms that led to treatment, and even increased in intensity. It is important that the patient knew about this option and had concerns after drug withdrawal this occurs), changes in libido, abnormal gait, medication tolerability, treatment failure, muscle weakness, rash, pruritus, urticaria, increased sweating.

 

The use of the product may lead to the development of physical and psychological dependence. The risk increases with dose and duration of treatment and is higher in patients who were or are addicted to alcohol or drugs. In dependence of the abrupt termination of treatment accompanied by withdrawal symptoms such as headaches, muscle pain, extreme anxiety and tension, restlessness, confusion and irritability. They can also occur cramps. For these reasons, the appropriate treatment of any addiction under medical supervision.

If you notice any side effects, tell your doctor.

Interaction

The effects of Stilnox and the effects of other concomitant drugs can interact. Your doctor should therefore be informed about all the medicines you are currently taking, or taking, on the prescription without it. Before you begin simultaneously with the use of Stilnox use an OTC medicine, talk to your doctor

 

When submitting central nervous system together with zolpidem may deepen the effect of this.

They are as neuroleptics - drugs affecting the central nervous system, hypnotics - sleep inducing drugs, anxiolytics - antianxiety drugs, antidepressants - antidepressants, antiepileptics - medicines for epilepsy, alcohol.

The sedative effect may also be increased with the use of zolpidem with ketoconazole (medicines used to treat fungal infections).


Dosage

The dose should be individualized.

The usual dose in patients under 65 years is 1 tablet (10 mg) at bedtime. For patients over 65 years is recommended to start half tablet (5 mg).

The dose should be increased spontaneously.

The highest dose should not exceed 10 mg.

 

Stilnox should be administered just before bedtime or in bed, washed down with a small amount of liquid.

The product should be used only if they can provide 7-8 hours sleep.

The duration of treatment should not exceed 4 weeks.


Notice

As with other hypnotics is not recommended for long-term use.

Most often several hours after taking this medicine may cause memory loss or sleepwalking and related behavior, unless the patient fully awake.

The product may adversely affect activities requiring mental alertness, coordination and quick decision-making (eg driving, operating machinery, working at heights, etc.), because there is a potential risk of morning sleepiness.

The risk of amnesia, sleepwalking and morning sleepiness can be reduced by ensuring uninterrupted sleep for 7-8 hours.

The product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact us before taking this medicine your doctor.

Overdose
In case of overdose or accidental ingestion by a child could lead to disturbances of consciousness from somnolence to light coma, significantly heavier manifestations were observed in combination with other substances, central nervous system depressants including alcohol.
You should always consult a doctor promptly.