Lexilium (Bromazepam) 3mg by SAMI Pharmaceuticals (pvt) ltd. 10 Tablets / Strip

LEXILIUM Tablets(Bromazepam)COMPOSITION:Each tablet contains: Bromazepam BP…..3mgINDICATIONS AND USAGE:LEXILIUM (Bromazepam) is useful for the short-term, symptomatic relief of manifestationsof excessive anxiety in patients with anxiety neurosis. Benzodiazepines are only indicatedwhen the disorder is severe, disabling or subjecting the individual to extreme distressEmotional disturbances: Acute tension and anxiety states. Difficulties in interpersonalcontacts, agitation, insomnia, agitated depressive reactionsi. Functional disturbances: Cardiovascular and respiratory systems: (Pseudoangina pectoris,precordial anxiety, emotiogenic hypertension trachycardia, dyspnea, hyperventilation)ii. Gastrointestinal system: Irritable bowel syndrome, epigastric pain, spasm, bloating, diarrhoea etc.iii. Genitourinary system: Frequency, irritable bladder and dysmenorrhoea:iv. Psychosis disorders: Psychogenic headache, psychogenic dermatosis, asthma, gastric andduodenal ulcer, ulcerative colitis, emotional reactions to chronic organic disease andadjuvant to psychotherapy in psychoneurosisDOSAGE & ADMINISTRATION:Average dose for ambulant therapy:1.5 – 3mg three times dailySevere cases especially in hospitals:6 – 12mg two to three times dailyThese are average recommendations and dosage should be individually determined.Treatment of ambulant patients in general begins with the lowest dose, gradually increasingif necessary to the optimum level. After about 8 to12 weeks, according to progress intherapy, dosage can usually be reduced gradually and then stoppedCONTRA-INDICATIONS:LEXILIUM (Bromazepam) is contra-indicated in-patients with known hypersensitivity tobenzodiazepines, myasthenia gravis, severe hepatic insufficiency, severe respiratoryinsufficiency or sleep apnea syndromeSPECIAL PRECAUTIONS:General Precautions:The patient should be checked regularly at the start of treatment in order to minimize thedosage and/or the frequency of administration and to prevent overdose due to accumulationUse in the elderly:Elderly and debilitated patients or those with organic brain syndrome, have been foundto be prone to CNS depression after even low doses of benzodiazepines. Therefore,medication should be initiated in these patients with very low initial doses and incrementsshould be made graduallyImpaired Hepatic or Renal Function:In patients with impaired hepatic or renal function, it is recommended to initiate therapy,if necessary, at a very low dose and to increase the dosage only to the extent that such anincrease is compatible with the degree of residual function of these organs. Such patientsshould be followed closely & have periodic laboratory assessmentWARNINGS:LEXILIUM (Bromazepam) is not recommended for use in patients with depressive disordersor psychosis. Patients should be advised against the concurrent use of alcohol and otherCNS depressant drugs. Patients with known or presumed dependence from alcohol ordrugs should not take benzodiazepines, except in rare situations under medical supervisionPaediatric Use:Because of the lack of sufficient clinical experience, Bromazepam is not recommendedfor use in patients less than 18 years of age Driving and Hazardous Activities:Since Bromazepam has a central nervous system depressant effect, patients should bewarned against driving, operating dangerous machinery or engaging in other hazardousactivities requiring mental alertness and physical co-ordination and should be cautionedthat the effects of alcohol on such activities may be increasedUse in Pregnancy:The safety of use of Bromazepam in pregnancy has not been established. Therefore,Bromazepam should not be used during pregnancyUse by Nursing Mothers:Bromazepam and its metabolites are probably excreted in human milk. Therefore, thisdrug should not be given to nursing mothersCONTRA-INDICATED ADVERSE EFFECTS:The most frequently repeated adverse reactions with Bromazepam have been drowsiness,ataxia and dizziness. Some other side effects such as irritability, excitability, restlessness,agitation, delusion, rages, nightmares, hallucinations, psychosis, inappropriate behaviorand other adverse behavioral effects are known to occur with the use of benzodiazepinesSTABILITY:See expiry on the packPRESENTATION:LEXILIUM 3mg tablet in pack of 30'sINSTRUCTIONS:Keep out of reach of childrenAvoid exposure to heat, light and humidityStore at 25ºC or belowImproper storage may deteriorate the medicineManufactured by:SAMI PHARMACEUTICALS (PVT) LTD.F-95, S.I.T.E., Karachi-Pakistan