ZOLSANA 5 mg. 20 tablets

KRKA
ZOLSANA 5 mg. 20 tablets
€ 15.00
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What is Zolsana and what is it used?
Zolsana is soporific, from the group of 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
Do not take Zolsana
- If you are allergic (hypersensitive) to the active substance or to any of the excipients of the tablet 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 Zolsana.

Take special care with Zolsana
Before starting treatment with 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 Zolsana) 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. The risk of dependence increases with dose and duration of treatment and is greater in patients who abuse 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 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 the extremities, 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 the adoption of zolpidemov tartrate. 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"
During treatment reactions may occur such as anxiety, inner tension, irritability, aggression, delusions (psychosis), bouts of anger, nightmares, hallucinations, psychoses, somnambulism, inappropriate behavior, increased insomnia and other adverse behavioral reactions. If this happens, use of Zolsana should be discontinued. More likely, these reactions occur in the elderly.

Specific patient groups
Benzodiazepines and benzodiazepine-like drugs (such as Zolsana) should be prescribed with caution in:
Elderly or debilitated patients
They should receive a lower dose (see "How to take Zolsana mg"). Zolsana have muscle relaxant effects. For this reason, especially in the elderly, there is a risk of falling and hip fracture relevant when it overnight.

Patients with 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 anxiety are described as symptoms of dyspnea.

Use in patients with a history of drug abuse or alcohol:
Should be used with extreme caution in these patients. These patients should be closely monitored during treatment with Zolsana as they are at risk of habituation and psychological dependence.

Benzodiazepines and benzodiazepine-like drugs (such as Zolsana) shall not apply to:
patients with severe hepatic impairment. There is a risk of brain damage (encephalopathy).
patients with hallucinations (psychoses) for primary treatment
to treat depression or anxiety accompanied by depression as a single agent (due to risk of suicide).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Zolsana should be used with caution in combination with other medicines that suppress the central nervous system (see "Before you take Zolsana"). Concomitant use with other medicinal products can lead to mutually strengthen the central depressive effect (see 4 "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 with simultaneous
- A sedative effect (sedative antihistamines).
Medicinal products that increase the activity of certain liver enzymes can reduce the effect of Zolsana: 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!

Taking Zolsana 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. Zolsana 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 zolpidemov tartrate during pregnancy and lactation. Although zolpidemov tartrate 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 Zolsana or if you suspect that you are pregnant. He / she will decide whether treatment will continue or be changed. Zolsana if taken for long periods during the last months of pregnancy may develop withdrawal symptoms in the newborn after birth. If Zolsana accepted at 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. Since zolpidem passes into breast milk in small quantity Zolsana should not be taken during lactation.

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 Zolsana with food and drink"). This largely concerns and insufficient sleep duration.

Important information about some of the ingredients of Zolsana
The film-coated tablets contain 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 Zolsana
Always take zolpidemov Tartrate exactly as you have been told your doctor. 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 2 tablets Zolsana 5 mg or 1 tablet Zolsana 10 mg (caotvetstvashta to 10 mg zolpidem / day).

Elderly and debilitated patients
The recommended dose in the elderly and debilitated patients is 1 tablet Zolsana 5 mg (caotvetstvashta to 5 mg zolpidem / day).
Only when the effect of treatment is insufficient and the drug was well tolerated, the dose may be increased to 2 tablets per day Zolsana (corresponding to 10 mg zolpidem / day).

Patients with impaired hepatic function
In patients with impaired liver function, the recommended dose of 1 tablet Zolsana 5 mg or 1 tablet Zolsana 10 mg (corresponding to zolpidem 10 mg / day).
The dose should be increased to two tablets of Zolsana 5 mg or 1 tablet Zolsana 10 mg (corresponding to zolpidem 10 mg / day), if the effect is insufficient and the drug is well tolerated.

maximum dose
A daily dose of 2 tablets Zolsana 5 mg or 1 tablet Zolsana 10 mg (corresponding to 10 mg zolpidem / day) should not be exceeded.

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

How long should you take Zolsana?
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 than you should Zolsana
In case of overdose, consult a doctor immediately! Overdose of Zolsana alone have been reported weight loss of consciousness, which has been under strong light drowsiness to coma.

If you forget to take Zolsana
Do not take a double dose to make up for forgotten! Continue adoption of Zolsana as prescribed by your doctor.

If you stop taking Zolsana
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, Zolsana can cause side effects, although not everyone can develop them.

Adverse reactions are classified into the following groups in order of frequency:
Very common: Affects more than 1 user in 10
Common: Affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1000
Rare: affects 1 to 10 users in 10,000
Very rare: Affects less than 1 user in 10,000
Not known: frequency can not be made from the available data

common:
sleepiness during the day, weakened emotions, reduced alertness, confusion, fatigue, headache, double vision, dizziness, abnormal movements (ataxia), muscle weakness.
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 these reactions occur in the elderly) problems with memory (amnesia), which is associated with inappropriate behavior (see section "Take special care given Zolsana"). During the use of benzodiazepines and benzodiazepine-like agents may occur existing earlier depression.
physical dependence (even at therapeutic doses): interruption of treatment may lead to withdrawal symptoms or phenomenon of termination (See "Careful use of Zolsana").
May occur psychological dependence. Depending been reported in patients abusing many other drugs.
Decreased sexual desire (libido).
Gastrointestinal disorders (diarrhea, nausea, vomiting)
skin reactions
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Zolsana?
Be kept out of reach of children.
Do not use Zolsana after the expiry date stated on the pack. The expiry date refers to the last day of the month.
This medicinal product does not require any special storage conditions.
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