If you forget to take Oxazepam tablets Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

If you stop taking Oxazepam tablets Do not stop taking your medicine without telling your doctor as he may wish to gradually reduce the number of tablets you take before stopping them completely. If you have been taking a high dose, you may occasionally experience confusion, convulsions, unusual behaviour derealisation feeling the world around you is not real or depersonalisation feeling your mind is becoming separated from your body , such as hypersensitivity to light, noise and physical contact, abnormally acute hearing and painful sensitivity to sound numbness and tingling of the extremities, hallucinations.

Treatment should be gradually withdrawn otherwise the symptoms you are being treated for may return more intense than before rebound insomnia and anxiety. The risk of this happening is greater when you stop taking Oxazepam suddenly. You may also experience mood changes, anxiety, restlessness or changes in sleep patterns. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Contact your doctor at once if the following symptoms occur: Tell your doctor if you notice any of the following side effects or notice any other effects not listed: This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. The active substance the ingredient that makes the tablet work is Oxazepam. Each tablet contains either 10mg or 15mg of the active ingredient. The other ingredients are colloidal silica, lactose, magnesium stearate, maize starch, microcrystalline cellulose E Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

Anxiety associated with depression is also responsive to Oxazepam therapy. This product has been found particularly useful in the management of anxiety, tension, agitation, and irritability in older patients.

Alcoholics with acute tremulousness, inebriation, or with anxiety, associated with alcohol withdrawal are responsive to therapy. The effectiveness of Oxazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.

Usual Dose Mild-to-moderate anxiety, with associated tension, irritability, agitation, or related symptoms of functional origin or secondary to organic disease. If necessary, increase cautiously to 15 mg, 3 or 4 times daily.

Alcoholics with acute inebriation, tremulousness, or anxiety on withdrawal. Absolute dosage for pediatric patients 6 to 12 years of age is not established. Capsules are supplied in unit dose packages of 10 x 10 NDC 15 mg — Each red opaque gelatin 4 capsule printed with logo and in black ink on both cap and body contains 15 mg of Oxazepam, USP.

Capsules are supplied in unit dose packages of 10 x 10 NDC 30 mg — Each maroon opaque gelatin 4 capsule printed with logo and in blue ink on both cap and body contains 30 mg of Oxazepam, USP. Capsules are supplied in unit dose packages of 10 x 10 NDC Distributed by: Anxiety associated with depression is also responsive to Serax oxazepam therapy.

Alcoholics with acute tremulousness, inebriation, or with anxiety associated with alcohol withdrawal are responsive to therapy. The effectiveness of Serax oxazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. Dispense in tight container.

Manufactured for Fauldino Laboratories Inc. Transient, mild drowsiness is commonly seen In the first few days of therapy. If it persists, the dosage should be reduced. In few instances, dizziness, vertigo , headache, and rarely syncope have occurred either alone or together with drowsiness. Other side effects occurring during oxazepam therapy include rare instances of nausea , lethargy , edema , slurred speech, tremor , altered libido , and minor diffuse skin rashes—morbilliform, urticarial, and maculopapular.

Such side effects have been Infrequent and are generally controlled with reduction of dosage. A case of an extensive fixed drug eruption also has been reported. Although rare, leukopenia and hepatic dysfunction including Jaundice have been reported during therapy. Periodic blood counts and liver-function tests are advisable. Ataxia with oxazepam has been reported in rare instances and does not appear to be specifically related to dose or age.

Although the following side reactions have not as yet been reported with oxazepam, they have occurred with related compounds chlordiazepoxide and diazepam: Transient amnesia or memory impairment has been reported in association with the use of benzodiazepines. Transient, mild drowsiness is commonly seen in the first few days of therapy. Mild paradoxical reactions, i. Other side effects occurring during oxazepam therapy include rare instances of nausea, lethargy , edema, slurred speech, tremor , altered libido , and minor diffuse skin rashes — morbilliform, urticarial, and maculopapular.

Such side effects have been infrequent and are generally controlled with reduction of dosage. Anxiety associated with depression is also responsive to Oxazepam therapy. This product has been found particularly useful in the management of anxiety, tension, agitation and irritability in older patients. Alcoholics with acute tremulousness, inebriation, or with anxiety associated with alcohol withdrawal are responsive to therapy.

The effectiveness of Oxazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient. Contraindications History of previous hypersensitivity reaction to Oxazepam. Oxazepam is not indicated in psychoses. Warnings Risks from Concomitant Use with Opioids: Concomitant use of benzodiazepines, including Oxazepam, and opioids may result in profound sedation, respiratory depression, coma, and death.

Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe Oxazepam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation.

In patients already receiving an opioid analgesic, prescribe a lower initial dose of Oxazepam than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking Oxazepam, prescribe a lower initial dose of the opioid and titrate based upon clinical response.

Advise both patients and caregivers about the risks of respiratory depression and sedation when Oxazepam is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined see Drug Interactions. As with other CNS-acting drugs, patients should be cautioned against driving automobiles or operating dangerous machinery until it is known that they do not become drowsy or dizzy on Oxazepam therapy.

Patients should be warned that the effects of alcohol or other CNS-depressant drugs may be additive to those of Oxazepam, possibly requiring adjustment of dosage or elimination of such agents. Physical and Psychological Dependence Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol convulsions, tremor, abdominal and muscle cramps, vomiting, and sweating , have occurred following abrupt discontinuance of Oxazepam.

The more severe withdrawal symptoms have usually been limited to those patients who received excessive doses over an extended period of time. Generally milder withdrawal symptoms e. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage-tapering schedule followed.

Addiction-prone individuals such as drug addicts or alcoholics should be under careful surveillance when receiving Oxazepam or other psychotropic agents because of the predisposition of such patients to habituation and dependence. Oxazepam, a benzodiazepine derivative, has not been studied adequately to determine whether it, too, may be associated with an increased risk of fetal abnormality.

Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered.

Patients should be advised that if they become pregnant during therapy or intend to become pregnant, they should communicate with their physician about the desirability of discontinuing the drug. Precautions General Although hypotension has occurred only rarely, Oxazepam should be administered with caution to patients in whom a drop in blood pressure might lead to cardiac complications. This is particularly true in the elderly patient.

Information for Patients To assure the safe and effective use of Oxazepam, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug. Drug Interactions The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration.

When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation. Pediatric Use Safety and effectiveness in pediatric patients under 6 years of age have not been established. Absolute dosage for pediatric patients 6 to 12 years of age is not established.

Geriatric Use Clinical studies of Oxazepam were not adequate to determine whether subjects aged 65 and over respond differently than younger subjects. Clinical circumstances, some of which may be more common in the elderly, such as hepatic or renal impairment, should be considered.

Greater sensitivity of some older individuals to the effects of Oxazepam e. Adverse Reactions The necessity for discontinuation of therapy due to undesirable effects has been rare. Transient mild drowsiness is commonly seen in the first few days of therapy.

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