Diazepam. 5 mg. 30 tablets
Diazepam. table. 5 mg. 20 tablets
Diazepam WHAT IS AND WHAT IT IS USED ?
Actavis Diazepam is a long acting benzodiazepine with anticonvulsant , oppressive anxiety , sedative and muscle - relaxing effect . Its action is performed by the increased activity of gamma aminobutyric acid (GABA ), the most depressing chief agent in the brain.
Diazepam Actavis is applied for the treatment of:
• Short (2-4 weeks) symptomatic treatment of severe anxiety , leading to disability and stress, alone or in conjunction with insomnia or short psychosomatic , organic or mental illness ;
• short (2-4 weeks) treatment of conditions in which anxiety is an unlocking condition or aggravating factor (e.g., tension headache and migraine ) ;
• Symptomatic treatment of acute alcohol withdrawal ; »
• Treatment of muscle spasms , as an additional tool to control muscle spasms in tetanus ;
• For management of cerebral spasticity in certain cases;
• As an additional means to treat some forms of epilepsy - myoclonus ;
• Premedication .
• nightmares and somnambulism ;
• As an additional tool to control muscle spasms in tetanus ;
• In some cases it may have an effect in controlling the tension and irritability that accompany cerebral spasticity ;
• Premedication .
2 . WHAT YOU NEED TO KNOW BEFORE treatment with Diazepam ?
Diazepam Actavis does not apply to :
• Hypersensitivity to product , other benzodiazepines or to any of the excipients in the formulation of Diazepam Actavis ;
• Heavy breathing and severe hepatic impairment ;
• Inhibition of the function of the breathing ;
• apnea syndrome ( transient cessation of breathing during sleep ;
• Myasthenia gravis (a disease with muscle weakness
• Chronic psychosis ;
• phobia and mania ;
• Being self- treat depression or anxiety associated with depression, since such patients may trigger the emergence of suicidality . Benzodiazepines are not recommended for the primary treatment of mental illness ;
• Dependence on other compounds , including alcohol (except for use in acute withdrawal reactions ) .
In this medicinal product, please note the following:
This group of drugs may trigger anterograde amnesia (memory disturbance , thereby losing the ability to acquire new memory traces) . It can occur at therapeutic doses , but the risk increases with higher doses. Amnestic manifestations may be associated with inappropriate behavior . This condition usually occurs several hours after taking the drug and to reduce the risk of patients should provide 7-8 hours of uninterrupted sleep . Treatment with Diazepam Actavis may lead to the development of physical and psychological dependence . The risk increases with increasing dose and duration of treatment. This is typical especially for patients with a history of abuse of alcohol or drugs, or in patients with significant personal injuries. It is essential to follow these patients and should be avoided routine re- prescribing and treatment to be phased out . Once you become addicted , abrupt termination of treatment may be accompanied by phenomena of dependence. This is a transient syndrome whereby the symptoms that led to the initiation of treatment with diazepam appear in a stronger form. It is manifested by headache , muscle pain, severe onset anxiety, tension , restlessness , confusion and irritability. In severe cases develop loss of reality , personality and desensitization, tingling of the extremities , hypersensitivity to light, noise and touch , hallucinations or epileptic seizures.
With repeated performed for an extended period of time courses of Diazepam Actavis may be lost response to ongoing treatment .
Possible state of anxiety to reoccur , particularly when treatment is discontinued . This may be accompanied by other reactions including mood changes , anxiety and restlessness. Since the risk of recurrence of complaints or signs of addiction were more pronounced after abrupt discontinuation of treatment , a gradual dose reduction.
In bereavement , benzodiazepines may inhibit psychological adaptation.
Administration of benzodiazepines is known that may develop paradoxical reactions such as anxiety , agitation, irritability , aggressiveness , disorientation , anger , nightmares , hallucinations, psychoses, inappropriate behavior and other adverse behavioral effects in such cases, treatment with the product should be discontinued. Similar effects may occur more often in children and the elderly . In patients with chronic pulmonary disease , and patients with chronic liver diseases , it may be necessary to reduce the dosage . In renal insufficiency is necessary to change the dosage .
Application of Diazepam with food and drink
No evidence of a need for a special diet or restrictions on certain types of food and beverages during treatment with this product.
Before taking any medicines , consult your doctor or pharmacist
Actavis Diazepam not be used during pregnancy , especially during the first and last three months, unless there are good reasons for this.
If the product is administered to women of childbearing age , they should be warned that need doctor's advice if you intend to become pregnant or suspected pregnancy development . Administration of high doses or prolonged administration of low doses of the drug in the last three months of pregnancy causes disruption of fetal heart rate and low blood pressure , abnormal reflex intake , low body temperature and moderate respiratory depression in neonates. This is due to the underdeveloped enzyme system of the newborn for product degradation (especially in premature infants ) .
In addition, infants born to mothers who took Diazepam Actavis in the last months of pregnancy may have developed physical dependence and become at risk of developing symptoms of addiction in the postnatal period.
Before intake of any medicines consult your doctor or pharmacist
The drug is found in breast milk . Therefore, its application during lactation should be avoided .
Driving and using machines
Patients should be informed that, like other drugs of this type , Diazepam Actavis may alter the patient's ability to perform certain actions. Sedation , memory loss and impaired ability to concentrate, as well as impaired muscular function may further suppress the skills to drive and use machines . If insufficient sleep duration occurs, the likelihood of such injuries may increase .
Patients should be informed that alcohol may increase the extent of damage and therefore during treatment should be avoided .
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines soon , even if they have not been prescribed by your doctor.
If Diazepam Actavis combined with centrally acting drugs such as antipsychotics, anxiolytics / sedatives , antidepressants, hypnotics, anticonvulsants , narcotic analgesics , anesthetics ( anesthetic ) and antihistamines , it is possible to enhance the soothing effects. In applying painkillers ( analgesics ) heavy euphoria may also lead to increased psychological dependence. Elderly patients require special monitoring . Co-administration with alcohol use is not recommended due to enhancement of relaxing effect . This affects the ability to drive or operate machinery .
When co-administered with the Diazepam Actavis anticonvulsant can be observed as an increase and a reduction of drug levels or lack of such changes. When the product is administered simultaneously with anti-seizure agents, the side effects and toxicity may be more pronounced , particularly in hydantoins , barbiturates or combined preparations comprising them . This requires extra care when adjusting the dose in the initial phases of treatment.
It is known that inhibitors of proven liver enzymes , e. Cimetidine , fluvoxamine and omeprazole reduced the secretion of benzodiazepines and may potentiate their action. Meanwhile inducers of hepatic enzymes, eg . rifampicin may increase their separation .
Cisapride may temporarily increase the soothing effect of orally administered benzodiazepines due to faster absorption by the body .
3 . HOW TO USE Diazepam ?
Always take Diazepam Actavis exactly as your doctor !
For optimal effect , the dose should be individualized . Treatment should be initiated at the lowest effective dose corresponding to the specified state.
The duration of treatment should be as short . The patient should be regularly evaluated with regard to the need for continued treatment , especially in asymptomatic patients. Treatment should not last more than 2-3 months , including the period of suspension .
The patient should be informed of the duration of treatment in detail explain how will be gradually reduced the dose administered and the possibility of recurrence of symptoms at the time of discontinuation . When applying a long-acting benzodiazepines such as diazepam is important to know that, in the transition to the treatment with short-acting benzodiazepines may develop withdrawal symptoms , which manifests itself even in the interval between doses , particularly if it is large .
The usual dose of 5 mg daily maximum dose of 30 mg per day in divided doses, the dosage is individual .
Insomnia associated with anxiety - 5 to 15 mg at bedtime .
Maximum dose treatment should not last longer than four weeks .
Symptomatic treatment of acute alcohol withdrawal - 5-20 mg, repeated if necessary after 2-4 hours.
Nightmares and somnambulism
Children - up to 5 mg at bedtime.
Conditions accompanied with muscle spasm
Muscle spasm - up to 15 mg daily in divided doses . Harnessing cerebral spasticity - up to 60 mg daily divided doses.
Additional means to control the muscle convulsions in tetanus - up to 10 mg / kg body weight per day in nasoduodenal probe. The dosage should correspond to the severity of the disease , as originally suggested the application of the intravenous formulation of the product.
Control of tension and irritability in cerebral spasticity in some cases - to 40 mg per day in divided doses. As an additional means to control the muscle convulsions in tetanus - as in adults.
Addition to the treatment of certain forms of epilepsy
To 60 mg daily in divided doses .
The usual dose of 5 to 20 mg. children
Usual dose 10 mg.
Benzodiazepines should not be given to children without careful assessment of reading . The duration of treatment should be minimal.
Doses should not exceed half of the recommended under normal conditions. These patients should be closely controlled at the start of treatment in order to minimize the dose and / or frequency of administration in order to prevent overdosing , due to the effect .
Patients with impaired hepatic function
Patients with impaired hepatic function should receive a reduced dose.
Patients with impaired renal function
In renal insufficiency, the half-life of diazepam remained unchanged and therefore these patients do not require a dose adjustment .
If you have the impression that the effect of Diazepam Actavis is too strong or too weak, talk to your doctor or pharmacist !
If you take a large amount of the drug :
When taking a higher dose than prescribed immediately contact a doctor !
Overdose of benzodiazepines is usually manifested by the suppression of the central nervous system - from somnolence to coma ( loss of consciousness ) . In mild forms manifested by drowsiness, mental disorder , and lethargy (sleepiness , apathy , lethargy ) . In more severe forms appears gait disturbance , low blood pressure , respiratory depression , coma (rarely) , and death (very rare) .
When co-administered with centrally acting drugs, especially alcohol , the likelihood of overdose effects are more pronounced increases in the absence of supportive measures that can be fatal. Following overdose with oral benzodiazepines should be induced vomiting (up to 1 hour after dosing ) if the patient is conscious , if unconscious - to perform gastric lavage. If there is no stomach emptying of the expected beneficial effect to reduce the absorbance to be applied charcoal . Treatment is carried out in intensive care and special attention should be paid to respiratory and cardiac functions. Specific antidote intravenously administered in emergency situations annexation ( flumazenil ) . Patients requiring such treatment must be under constant observation in hospital . Special attention requires the application of annexation in epileptic patients treated with benzodiazepines .
In the event of no agitation must be used barbiturates .
If you forget to use Diazepam
If you forget to take the next dose then take the missed as soon as possible , but do not take the same time to the next .
4 . POSSIBLE SIDE EFFECTS
Like any other medicine, Diazepam can cause side effects
The most common side effects are fatigue, drowsiness and muscle weakness. This phenomenon usually occurs at the beginning of treatment and further application clears .
Can be observed more : ataxia ( gait instability ), confusion , constipation , depression, diplopia, gastrointestinal disturbances , headache, low blood pressure, incontinence , altered libido , nausea , dry mouth or increased saliva , skin reactions, drawl , tremor, urinary retention , dizziness and altered vision ; rarely increase in transaminases and alkaline phosphatase , as well as cases of jaundice.
Benzodiazepines may trigger anterograde amnesia ( memory impairment ) .
There is evidence for the development of paradoxical reactions such as anxiety , agitation, irritability , aggressiveness , disorientation , anger , nightmares , hallucinations, psychoses, inappropriate behavior and other behavioral responses .
Elderly patients are particularly sensitive to the effects of central depressant , which may cause confusion , especially in the presence of organic changes in the brain. In such patients, the dose of Diazepam Actavis should not exceed half the recommended for other adults .
Administration of benzodiazepines may trigger pre- depression. Prolonged use ( even at therapeutic doses) may lead to the development of physical and psychic dependence, discontinuation can cause addiction or signs of recurrence of complaints . There is evidence of abuse of benzodiazepines .
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5 . STORAGE CONDITIONS
At temperatures below 25 ° C.
Keep out of reach of children!
Do not use after the expiry date stated on the package !
Shelf life : 3 ( three) years