Medploz 5mg & 10mg FC tablet

MEDPLOZ is indicated for the short term treatment of insomnia. MEDPLOZ, is only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.

Treatment should be as short as possible. Generally, the duration of treatment varies from a few days to two weeks with a maximum, including the tapering off process, of four weeks. In certain cases, extension beyond the maximum treatment period may be necessary. If so, it should not take place without re-evaluation of the patientu2019s status. MEDPLOZ should be taken immediately before going to bed, or in bed.

Dose: The recommended daily dose for adults is 10 mg immediately before bedtime, or in bed. In elderly or debilitated patients who may be especially sensitive to the effects of zolpidem, and in patients with hepatic insufficiency who do not clear the agent as rapidly as normal individuals, a dose of 5 mg is recommended, which should be exceeded only under exceptional circumstances. The total dose of MEDPLOZ should not exceed 10 mg in any patient.

Hypersensitivity to the product.
Myasthenia gravis.
Sleep apnoea syndrome.
Acute and severe pulmonary insufficiency, as respiratory failure may be precipitated.
Severe hepatic insufficiency.
Children under the age of 18.
Concomitant administration with HIV protease inhibitors such as ritonavir as plasma concentrations may be increased and thus the risk of extreme sedation and respiratory depression.

Safety and efficacy in children under the age of 18 years have not been established.
Dependence and Abuse: Use of MEDPLOZ may lead to the development of physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment; it is also greater in patients with a history of alcohol or medicine abuse. These patients should be under careful surveillance when receiving hypnotics. Discontinuation of therapy may result in withdrawal or rebound phenomena.
Duration of treatment: The duration of treatment should be as short as possible and should not exceed 4 weeks, including the tapering off process. Extensions beyond these periods should not take place without re-evaluation of the situation. It may be useful to inform the patient when treatment is started that it will be of limited duration, and to explain precisely how the dosage will be progressively decreased.
Tolerance: After repeated use of MEDPLOZ for a few weeks, some loss of efficacy of the hypnotic effects may develop.
Depression: MEDPLOZ should not be used to treat depressive syndromes, or anxiety with depression as suicidal tendencies may be present.
Psychotic illness: MEDPLOZ should not be used as the primary treatment of psychotic illness.
History of alcohol and drug abuse: MEDPLOZ should not be used in patients with a history of alcohol or drug abuse.
Amnesia: MEDPLOZ may induce anterograde amnesia. The condition occurs most often several hours after ingesting the product and therefore, to reduce this risk, patients should ensure that they will be able to have an uninterrupted sleep of 7 to 8 hours (see Side u2013 effects).
Rebound Insomnia: A transient syndrome, whereby the symptoms that led to treatment with sedative/hypnotic agents recur in an enhanced form, may occur on withdrawal of hypnotic treatment. It may be accompanied by other reactions including mood changes, anxiety and restlessness. The syndrome is more likely to develop if the product is discontinued abruptly, and therefore treatment should be withdrawn gradually.

u2022 Concomitant intake with alcohol is not recommended. The sedative effect may be enhanced when the product is used in combination with alcohol. This affects the ability to use machines or drive.
u2022 Combination with CNS depressants: Enhancement of the central depressive effects may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, antiepileptic medicines, anaesthetics and sedative antihistamines. In the case of narcotic analgesics enhancement of the euphoria may also occur leading to an increase in psychological dependence.
u2022 The activity of MEDPLOZ may be enhanced by compounds which inhibit certain hepatic enzymes (particularly cytochrome P450). Zolpidem is metabolised via several hepatic cytochrome P450 enzymes: the main enzyme being CYP3A4 with the contribution of CYP1A2. The pharmacodynamic effect of MEDPLOZ is decreased when it is administered with rifampicin (a CYP3A4 inducer). However when zolpidem was administered with itraconazole (a CYP3A4 inhibitor) its pharmacokinetics and pharmacodynamics were not significantly modified. The clinical relevance of these results in unknown.
u2022 No significant pharmacokinetic interactions were observed when MEDPLOZ was administered with warfarin, digoxin or ranitidine.
u2022 HIV-protease inhibitors such as ritonavir may increase plasma concentrations of zolpidem with a risk of profound sedation and respiratory depression; use together is not recommended.

Safety in pregnancy has not been established. If MEDPLOZ is administered during the late phase of pregnancy, or during labour, effects on the neonate such as hypothermia, hypotonia and moderate respiratory depression, can be expected due to the pharmacological action of the product.
Infants born to mothers who take MEDPLOZ chronically during the latter stages of pregnancy may develop physical dependence and may be at some risk of developing withdrawal symptoms in the postnatal period.
Zolpidem should not be administered to breast-feeding mothers. Small quantities of zolpidem appear in breast milk.

Sedation, drowsiness, dizziness and vertigo may adversely affect the ability to drive or to use machines in patients taking MEDPLOZ. The likelihood of impaired alertness may increase if insufficient sleep duration occurs.

Nervous system disorders: Less frequent: Drowsiness during the day, confusion, headache, dizziness, ataxia and gait disturbances. Amnesia: Anterograde amnesia may occur using therapeutic dosages of MEDPLOZ, the risk increasing at higher dosages. Amnesic effects may be associated with inappropriate behaviour. The following side effects have been reported and frequencies are unknown: Reduced alertness, fatigue.
Psychiatric disorders: Less frequent: Depression: Pre-existing depression may be unmasked during the use of MEDPLOZ. Psychiatric and u201cParadoxicalu201d reactions: Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using MEDPLOZ. Should this occur, use of the product should be discontinued. These reactions are more likely to occur in children (see Contra-indications) and in the elderly. The following side effect has been reported and frequency is unknown: Numbed emotions.
Musculoskeletal, connective tissue and bone disorders: Less frequent: Muscle weakness.
Eye disorders: Less frequent: Double vision.
These phenomena mentioned above occur predominantly at the start of therapy and most frequently in elderly patients, but may disappear with repeated administration.
Gastrointestinal disorders: Less frequent: Gastro-intestinal disturbances, such as nausea, vomiting, diarrhoea, dry mouth, abdominal or gastric pain.
Skin and subcutaneous tissue disorders: Less frequent: Skin reactions.

Following an overdose with MEDPLOZ alone, impairment of consciousness may range from somnolence to light coma. Individuals have fully recovered from zolpidem doses of up to 400 mg. Overdose involving multiple CNS-depressant agents (e.g. alcohol), may result in more severe symptomatology, including fatal outcomes.
Treatment: General symptomatic and supportive measures should be used, along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Sedative medicines should be withheld even if excitation occurs. The value of dialysis in the treatment of overdose has not been determined, although haemodialysis studies in patients with renal failure receiving therapeutic doses have demonstrated that zolpidem is not dialysable. Where serious symptoms are observed, the use of benzodiazepine u2013 antagonists (e.g. flumazenil) may be considered. However, flumazenil administration may contribute to the appearance of neurological symptoms (convulsions). In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.