DIPIPANONE/CYCLIZINE

4).

Adults:

The initial dose in all conditions is one tablet every 6 hours. It is unwise to exceed this dose in view of the difficulty in accurately predicting the initial central effects of dipipanone. Should this dose fail to provide adequate analgesia, as in severe intractable pain or when other potent opioids have been used, it may be increased by half a tablet every six hours.

e. 12 tablets in 24 hours).

Elderly:

There is no specific information on the use of Diconal in elderly patients. 4).

Paediatric population:

There is no specific information on the use of Diconal in children. Diconal is very rarely indicated in children and dosage guidelines cannot be stated.

Method of administration:

Oral

Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: Very common: (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known: cannot be estimated from the available data.

The following undesirable effects have been reported with a frequency of Not known.

Adverse reactions attributable to dipipanone include:

System Organ Class Frequency Adverse reactions Immune system disorders Not known Allergic reaction, anaphylactic reaction, anaphylactoid reaction. 4), decreased libido. Ear and labyrinth disorders Not known Vertigo Nervous system disorders Not known Somnolence, sedation, raised intracranial pressure, involuntary muscle contractions, dizziness, convulsions, hypertonia, paraesthesia, syncope, coma, headache, myoclonus, taste perversion.

Eye disorders Not known Miosis, visual disturbance. Cardiac disorders Not known Tachycardia, bradycardia, palpitations. Vascular disorders Not known Facial flushing, hypotension, hypertension, circulatory failure, orthostatic hypotension Respiratory, thoracic and mediastinal disorders Not known Respiratory depression, respiratory failure, bronchospasm, pulmonary oedema, cough decreased.

Gastrointestinal disorders Not known Constipation, nausea, vomiting, abdominal pain, ileus, dyspepsia, dry mouth, exacerbation of pancreatitis. Hepatobiliary disorders Not known Biliary pain, biliary spasm. Skin and subcutaneous tissue disorders Not known Hyperhidrosis, urticaria, rash, pruritus.

Renal and urinary disorders Not known Ureteric spasm, urinary retention, dysuria. Reproductive system and breast disorders Not known Amenorrhea, erectile dysfunction. General disorders and administration site conditions Uncommon Not known Drug withdrawal syndrome Asthenia, malaise, peripheral oedema, drug tolerance, hypothermia.

Investigations Not known Increased hepatic enzymes.

Adverse reactions attributable to cyclizine include:

System Organ Class Frequency Adverse reactions Blood and lymphatic system disorders Not known Agranulocytosis, leucopenia, haemolytic anaemia, thrombocytopenia. Immune system disorders Not known Hypersensitivity reactions, including anaphylaxis has occurred.

Metabolism and nutrition disorders Not known Decreased appetite Psychiatric disorders Not known Disorientation, restlessness or agitation, nervousness, euphoria, insomnia and auditory and visual hallucinations have been reported, particularly when dosage recommendations have been exceeded.

Ear and labyrinth disorders Not known Tinnitus Nervous system disorders Not known Effects on the central nervous system have been reported with cyclizine these include: somnolence, headache, dystonia, decreased consciousness, dyskinesia, extrapyramidal motor disturbances, restless leg syndrome, tremor, convulsions, dizziness, decreased consciousness, transient speech disorders, paraesthesia, generalised chorea, drowsiness, incoordination.

There have been rare case reports of patients experiencing depressed levels of consciousness/loss of consciousness. Eye disorders Not known Blurred vision, oculogyration. Cardiac disorders Not known Tachycardia, palpitations, arrhythmias.

Vascular disorders Not known Hypertension, hypotension. Respiratory, thoracic and mediastinal disorders Not known Bronchospasm, apnoea, nasal dryness, dry throat. Gastrointestinal disorders Not known Dryness of the mouth, nose and throat.

Constipation, increased gastric reflux, nausea, vomiting, diarrhoea, stomach pain. Hepatobiliary disorders Not known Hepatic dysfunction, including hepatitis due to hypersensitivity. Cholestatic jaundice, cholestatic hepatitis Skin and subcutaneous tissue disorders Not known Urticaria, drug rash, angioedema allergic skin reactions, fixed drug eruption, photosensitivity.

Musculoskeletal and connective tissue disorders Not known Twitching, muscle spasms. Renal and urinary disorders Not known Urinary retention. General disorders and administration site conditions Not known Asthenia, malaise 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.

Drug dependence, tolerance and potential for abuse For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. , major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of opioid 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 pain control as initially experienced.

Patients may also supplement their treatment with additional pain relievers. 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 analgesic treatment should be reviewed regularly. Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with dipipanone.

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 weeks to months.

The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.

If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome. Concomitant use of alcohol and Diconal tablets may increase the undesirable effects of Diconal tablets and should be avoided.

Diconal should be used with caution in the debilitated since they may be more sensitive to the respiratory depressant effects. 3). Should paralytic ileus be suspected to occur during use, treatment should be discontinued immediately.

Diconal is metabolised in the liver and excreted along with its metabolites in the urine. Where not contraindicated in patients with impaired hepatic and/or renal function, Diconal should be given at less than the usual recommended dose, and the patient's response used as a guide to further dosage requirements.

Cyclizine may cause a fall in cardiac output associated with increases in heart rate, mean arterial pressure and pulmonary wedge pressure. Diconal should therefore be used with caution in patients with severe heart failure. Cyclizine should be avoided in patients with porphyria.

Therefore use of Diconal should also be avoided in these patients. Because cyclizine has anticholinergic activity it may precipitate incipient glaucoma. It should be used with caution and appropriate monitoring in patients with glaucoma.

Extreme caution should be exercised when administering Diconal to patients with phaeochromocytoma, since hypertension has been reported in association with other potent opioids. Hyperalgesia Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain.

This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre- existing pain and less defined in quality.

Symptoms of hyperalgesia may resolve with a reduction of opioid dose. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1. Patients with respiratory depression, especially in the presence of cyanosis and excessive bronchial secretions. Patients with obstructive airway disease, during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.

Head injury and raised intracranial pressure. Acute alcohol intoxication. The anti-emetic properties of cyclizine may increase the toxicity of alcohol. Individuals receiving monoamine oxidase inhibitors, or within 14 days of stopping such treatment.

Patients with ulcerative colitis since in common with other narcotic analgesics it may precipitate toxic dilatation or spasm of the colon. Patients with paralytic ileus and delayed gastric emptying. Patients with spasm of the biliary or renal tract, particularly immediately after operative interventions on the biliary tract.

Pre-operative period or during the first 24 hours post operatively. Patients with severe hepatic impairment as it may precipitate hepatic encephalopathy or coma. Severe renal impairment. Diconal, in common with all narcotic analgesics, may precipitate coma or severe and prolonged respiratory depression.