ZOLSANA 10 mg. 20 tablets

KRKA
ZOLSANA 10 mg. 20 tablets
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WHAT ZOLSANA AND WHAT IT IS USED FOR?
Zolsana 10 mg was soporific, the group of benzodiazepines and benzodiazepine-like drugs. It applies to short-term treatment of insomnia.
Treatment with benzodiazepines and benzodiazepine-like drugs has been shown only in sleep disorders in clinically severe cases.

2. BEFORE YOU TAKE ZOLSANA 10 MG
Do not take Zolsana 10 mg:
  - If you have an allergy (hypersensitivity) to Zolpidem tartrate or any of the excipients of the tablet 10 mg Zolsana
- If you suffer from severe pathological muscle weakness (myasthenia gravis)
- In the case of short-term cessation of breathing during sleep (sleep apnea syndrome in sleep)
- If you have severe breathing problems (respiratory failure);
- If you have severe liver disease (liver failure)

Children and adolescents under 18 years of age should not take Zolpidem tartrate 10 mg.
Be especially cautious with Zolsana 10 mg
General
Before starting treatment with 10 mg Zolsana
- Need to clarify the reasons for insomnia
- Must treat the underlying cause of insomnia
If the treatment of insomnia is not successful after 7-14 days should contact a psychiatrist or doctor to discuss the underlying disease.
General information on the effects observed after the use of benzodiazepines and benzodiazepine-like drugs (such as Zolpidem tartrate 10 mg) or other sedatives that prescribers should consider are:

familiarization
After repeated use over several weeks may develop some loss of efficiency in terms of hypnotic effects.

dependence
Use can lead to development of mental and physical dependence on these drugs. The risk of dependence increases with dose and duration of treatment and is greater in patients with a history of psychiatric illness and / or abuse of alcohol or drugs.
Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms.
Withdrawal symptoms (insomnia resumption) upon discontinuation of treatment with hypnotics may cause transient syndrome whereby sleep disorders, to reappear in an enhanced form, (rebound phenomenon). It may be accompanied by other reactions including headaches or muscle pain, anxiety and tension, restlessness, confusion, irritability and sleep disorders and severe cases of derealization, depersonalization, hearing impairment (hyperacusis), numbness and tingling of teapots, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
It is important to realize the possibility of developing these symptoms when curing your insomnia.

Memory problems (amnesia)
May show memory problems (anterograde amnesia). This condition generally occurs several hours after taking Zolpidem tartrate 10 mg. To minimize this risk, you should make sure that you can provide uninterrupted sleep of 7-8 hours (see 4. "Possible side effects").

Psychiatric and "paradoxical" reactions during treatment reactions may occur such as anxiety, inner tension, anxiety, agitation, irritability, aggression, delusions (psychosis), fits of rage, nightmares, hallucinations, psychoses, somnambulism, inappropriate behavior, increased insomnia and other adverse behavioral reactions. If this happens, use of Zolpidem tartrate 10 mg should be discontinued. More likely, these reactions occur in elderly patients.

Specific patient groups
Benzodiazepines and benzodiazepine-like drugs (such as Zolpidem tartrate 10 mg) should be administered with caution in:

Elderly or debilitated patients
They should receive a lower dose (see "How to take Zolpidem tartrate 10 mg").
Zolpidem tartrate 10 mg had muscle relaxant effects ... For this reason, especially in the elderly, there is a risk of falling and hip fracture relevant when
are overnight.
Patients c impaired renal function
However, that does not require dose adjustment is necessary caution.

Patients with chronic dyspnoea
It has been established that benzodiazepines can affect breathing. This must be taken into account. It should also be borne in mind and that anxiety or agitation are described as symptoms of dyspnea

Use in patients with a history of drug abuse and alcohol:
Should be used with extreme caution in these patients. These patients should be closely monitored during treatment with Zolpidem tartrate 10 mg, since they are at risk of habituation and psychological dependence. Benzodiazepines and benzodiazepine-like drugs (such as Zolpidem tartrate 10 mg) did not apply to:
- Patients with severe hepatic impairment There is a risk of brain damage (encephalopathy).
- Patients with psychosis for primary treatment
- To treat depression or anxiety accompanied by depression as a single agent (due to risk of suicide).

Taking other medicines
Zolpidem tartrate 10 mg should be used with caution in combination with other medicines that suppress the central nervous system (see "Before you take Zolpidem tartrate 10 mg").
Co-administration with other medicines can lead to mutual strengthening of the central depressive effect (see "Possible side effects");
- Medicinal products for the treatment of brain disorders (neuroleptics, antidepressants, antipsychotics)
- hypnotics
- Medicines against anxiety, tranquilizers (anxiolytics / sedatives)
- Strong painkillers (narcotic analgesics). May arise elevated euphoria and consequently to increase the psychological dependence.
- Muscle relaxants
- Anticonvulsant drugs (AEDs) anesthetics
- Medicines to treat allergies or common colds Simultaneously with sedative effect (sedative antihistamines).
Medicinal products that increase the activity of certain liver enzymes can reduce the effect of Zolpidem tartrate 10 mg: eg. Rifampicin (for tuberculosis).
Please note that these interactions may relate to medicinal products used some time ago or at the same time in the future!
Please tell your doctor or pharmacist if you have taken or are taking any medicines, including medicines without a prescription.

Adoption of Zolpidem tartrate 10 mg with food and drink
You should not drink alcohol during treatment as this will change and intensify the effect of Zolpidem in an unexpected way. Ability to fulfill certain obligations associated with increased concentration further reduced by this combination.

Pregnancy and lactation
Consult your doctor or pharmacist before taking any medicine.
Zolpidem tartrate 10 mg should not be taken during pregnancy and particularly during the first trimester of pregnancy, as there is insufficient data to assess the safety of prescribing Zolpidem tartrate 10 mg during pregnancy and lactation. Although Zolpidem tartrate 10 mg showed no development of any defects or any other effects teratogenic in animal studies, safety during human pregnancy has not been confirmed.
Please tell your doctor if you become pregnant during treatment with Zolpidem tartrate 10 mg or if you suspect that you are pregnant. He / she will decide whether treatment will continue or be changed.
If Zolpidem tartrate 10 mg was given continuously during the last months of pregnancy may develop withdrawal symptoms in the newborn after birth.
If Zolpidem tartrate 10 mg was taken in extremely compelling reasons at the end of pregnancy or during birth, the newborn may occur after excessive loss of body temperature (hypothermia), lowering of blood pressure (hypotension) and moderate respiratory depression.
As Zolpidem passes into breast milk in small quantities, Zolpidem tartrate 10 mg should not be used during breastfeeding.

Driving and using machines
The ability to drive or operate machinery may be damaged by sleepiness, amnesia, impaired concentration and impaired muscular function (see also "Taking Zolpidem tartrate 10 mg with food and drink"). This largely concerns and insufficient sleep duration.

Important information about some of the ingredients of Zolpidem tartrate 10 mg
Zolpidem tartrate 10 mg contains lactose. If your doctor told you that you have an intolerance to some sugars, talk to him before you start taking this medicine.

3. HOW TO TAKE ZOLPIDEM TARTRATE 10 MG?

Always take Zolpidem tartrate 10 mg exactly as your doctor tells you. If you are not sure, check with your doctor or pharmacist.
Film-coated tablet should be taken with fluid just before going to bed.

The usual dose is:
adults
The recommended daily dosage for adults is 1 tablet Zolpidem tartrate 10 mg (corresponding to 10 mg Zolpidem tartrate / day).
- Elderly and debilitated patients
The recommended dose in the elderly and debilitated patients is 1/2 tablet Zolpidem tartrate 10 mg (corresponding to 5 mg Zolpidem tartrate / day).
Only when the effect of treatment is insufficient and the drug was well tolerated, the dose may be increased to 1 coated tablets Zolpidem tartrate 10 mg (corresponding to 10 mg Zolpidem tartrate / day).

- Patients with impaired hepatic function
In patients with hepatic impairment, the recommended dose of 1 tablet Zolpidem tartrate 5 mg (corresponding to 5 mg Zolpidem tartrate / day).

Only in cases where the effect of treatment is inadequate and the drug is well tolerated, the dose may be increased to 1/2 tablet Zolpidem tartrate 10 mg (corresponding to 5 mg Zolpidem tartrate / day).

maximum dose
A daily dose of 1 tablet Zolpidem tartrate 10 mg (corresponding to 10 mg Zolpidem tartrate / day) should not be exceeded.

Children and adolescents
Zolpidem tartrate 10 mg should not be used in children and adolescents under 18 years of age.

How long should you take Zolpidem tartrate 10 mg?
The duration of intake should be as short as possible. In general, it can be from several days to 2 weeks and no more than 4 weeks, including the period of dose reduction.

The period of suspension should be determined individually.
Severe conditions may require a longer period of maximum treatment. Your supervising doctor will decide, after re-evaluation of your condition.

If you take more Zolpidem tartrate 10 mg than you should
In case of overdose, consult a doctor immediately.
Overdose of Zolpidem tartrate 10 mg alone, have been reported weight loss of consciousness, which has been under strong light drowsiness to coma.

If you forget to take Zolpidem tartrate 10 mg
Do not take a double dose to make up for forgotten! Continue to take Zolpidem tartrate 10 mg as prescribed by your doctor.

If you stop taking Zolpidem tartrate 10 mg
Since the risk of withdrawal symptoms is greater after abrupt discontinuation of treatment, your doctor will advise you to stop treatment after gradually reducing the dose.
If you have any questions about the use of this medicine, ask your doctor or pharmacist!

4. POSSIBLE SIDE EFFECTS

Like all medicines, Zolpidem tartrate 10 mg may cause side effects, although not everyone can develop them.
Assessment of adverse reactions is based on data for the following frequencies: Very common: more than 1 in 10 treated patients common: less than 1 in 10 but more than 1 in 100 treated patients uncommon; less than 1 in 100, but more than 1 per 1,000 treated patients rare: less than 1 in 1,000, but more than 1 per 10,000 treated patients very rare: less than 1 in 10,000 patients treated, including isolated cases.

psychiatric disorders
Uncommon: Paradoxical reactions: anxiety, agitation, irritability, aggression, delusions, fits of rage, nightmares, hallucinations, psychoses, somnambulism, inappropriate behavior, increased insomnia and other adverse behavioral effects (more likely that these reactions occur in patients with advanced age), memory problems (amnesia) to and is associated with inappropriate behavior (see section "Pay special attention to ZoIpidem tartrate 10 mg").
During the use of benzodiazepines and benzodiazepine-like agents may occur existing earlier depression. Use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of treatment may lead to withdrawal symptoms or phenomenon of termination (See "Careful use of Zolpidem tartrate 10 mg") - may appear psychological dependence. depending been reported in patients abusing many other drugs.
Decreased sexual desire (libido).

Nervous system disorders: Common: Sleepiness during the day, feelings of numbness, reduced alertness, confusion, fatigue, headache

Eye disorders: Double vision

ENT disorders:
Common: Dizziness, impaired movement (ataxia)
gastrointestinal disorders
Uncommon: Gastrointestinal disorders (diarrhea, nausea, vomiting)

Skin and subcutaneous tissue disorders: Skin reactions

Musculoskeletal. adjacent tissue and bone disorders Common: Muscle weakness

If you experience severe side effects or notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. how to store 10 MG TABLETS ZOLSANA

Be kept out of reach of children.
Do not use the tablets Zolpidem tartrate 10 mg after the expiry date stated on the pack and blister. The first two digits indicate the month and the last four digits indicate the year. Expiry date indicates the last day of that month.
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