TROPIUM

4). Treatment should be given for the shortest possible duration. Method of administration: oral When treatment is started it may be useful to inform the patient that treatment will be of limited duration and to explain precisely how the dosage will be progressively decreased.

Moreover, it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms should they occur while the medicinal product has been discontinued.

Anxiety Adults:

The starting dose should be 5 mg daily increasing to 100 mg daily, in divided doses adjusted on an individual basis. Treatment should always be as short as possible and should not normally exceed 8-12 weeks including tapering off process.

Extension should not take place without re-evaluation of the situation.

Elderly and debilitated patients:

Dosage should not exceed half the adult dose. The same applies to patients with impaired liver or renal function and steps should be taken to ensure that there is no accumulation of plasma chlordiazepoxide in these patients.

Children :

Not recommended. Insomnia associated with anxiety Adults: 10-30 mg before retiring. Treatment should be as short as possible and would normally vary from a few days to two weeks with a maximum, including tapering off, and should not exceed four weeks including tapering off process.

Where extension beyond the maximum treatment period may be necessary it should not take place without re-evaluation of the patients status.

Elderly and debilitated patients:

Dosage should not exceed half the adult dose. The same applies to patients with impaired liver or renal function and steps should be taken to ensure that there is no accumulation of plasma chlordiazepoxide in these patients.

Children :

Not recommended.

Common adverse effects include drowsiness during the day (when the product is used as a hypnotic it should be stated explicitly), numbed emotions, reduced alertness, confusion, fatigue, headache dizziness, muscle weakness, ataxia or double vision.

The phenomena occur predominantly at the start of therapy and usually disappear with repeated administration. Other adverse reactions like gastrointestinal disturbances, changes in libido or skin reactions have been reported occasionally.

Amnesia Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages. Amnestic effects may be associated with inappropriate behaviour. Depression Pre-existing depression may be unmasked during benzodiazepine use.

Psychiatric and paradoxical 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 benzodiazepines or benzodiazepine-like agents.

They may be quite severe with this product. They are more likely to occur in children and the elderly. 4) Use (even therapeutic doses) may lead to the development of physical dependence: discontinuation of the therapy may result in the withdrawal or rebound phenomena (see warnings and precautions).

Psychic dependence may occur. Abuse of benzodiazepines has been reported. 4 Special warnings and precautions). Symptoms reported following discontinuation of benzodiazepines include headaches, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, and the occurrence of “rebound” phenomena whereby the symptoms that led to treatment with benzodiazepines recur in an enhanced form.

These symptoms may be difficult to distinguish from the original symptoms for which the drug was prescribed. In severe cases the following symptoms may occur: derealisation; depersonalisation; hyperacusis; tinnitus; numbness and tingling of the extremities; hypersensitivity to light, noise, and physical contact; involuntary movements; hyperreflexia, tremor, nausea, vomiting; diarrhoea, abdominal cramps, loss of appetite, agitation, palpitations, tachycardia, panic attacks, vertigo, short-term memory loss, hallucinations/delirium; catatonia; hyperthermia, convulsions.

Convulsions may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the convulsive threshold such as antidepressants. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. .

4 Special warnings and Special precautions for use Tolerance Some loss of efficacy to the hypnotic effects of chlordiazepoxide may develop after repeated use for a few weeks. Drug dependence, tolerance and potential for abuse The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of alcohol or drug abuse.

Dependence may be physical or psychic. Drug addiction comprises behavioural, cognitive and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use and possible tolerance or physical dependence.

Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, which manifests as withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.

Addiction and dependence are related but distinct presentations and in discussing these themes, terminology that apportion blame to the individual should be avoided. For all patients, prolonged use of this product may lead to drug dependence and addiction but can occur with short-term use at recommended therapeutic doses.

, major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of drug misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.

Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of symptom control as initially experienced. Patients may also supplement their treatment with additional medications to achieve the same effect.

These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.

Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for treatment with Chlordiazepoxide should be reviewed regularly, with frequent assessments of patients being undertaken during the course of their treatment.

Drug withdrawal syndrome Prior to starting treatment with Chlordiazepoxide, a discussion should be held with patients to explain the risk of dependence, addiction, and drug withdrawal syndrome. A withdrawal strategy for ending treatment with Chlordiazepoxide should also be put in place with the patient before starting treatment (there may be exceptions to this in specific clinical situations such as symptom management in end of life palliative care).

Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take in excess of weeks or months.

Patients should be informed of this when the medication is first prescribed. The reduction schedule for a patient should be tailored to the individual and should be modified to allow intolerable withdrawal symptoms to improve before making the next reduction.

If using a published withdrawal schedule, apply it flexibly to accommodate the person’s preferences, changes to their circumstances and the response to dose reductions. Suggest a slow stepwise rate of reduction proportionate to the existing dose, so that decrements become smaller as the dose is lowered, unless clinical risk is such that rapid withdrawal is needed.

If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome.

Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.

Rebound insomnia and anxiety: a transient syndrome whereby the symptoms that led to treatment with a benzodiazepine recur in an enhanced form, may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness.

Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually. Duration of treatment The duration of treatment should be as short as possible and should not exceed four weeks for insomnia and 8-12 weeks in case of anxiety, including tapering off process.

Extension 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.

Patients should be made aware of the possibility of rebound phenomena; thereby minimising anxiety other symptoms should they occur while the product is being discontinued. There are indications that, in the case of benzodiazepines with a short duration of action, withdrawal phenomena can become manifest with the dosage interval, especially when the dosage is high.

When chlordiazepoxide is being used it is important to warn against […]

1; sleep apnoea syndrome; severe respiratory insufficiency; severe hepatic insufficiency; myasthenia gravis, acute pulmonary insufficiency.