1. Name Of The Medicinal Product
Fentazin 4mg Tablets
2. Qualitative And Quantitative Composition
Each tablet contains 4mg Perphenazine BP.
3. Pharmaceutical Form
Tablet
White, circular, biconvex, sugar-coated tablets, with a code on one face 2C.
4. Clinical Particulars
4.1 Therapeutic Indications
As an adjunct to the short term management of anxiety, severe psychomotor agitation, excitement, violent or dangerously impulsive behaviour, schizophrenia, treatment of symptoms and prevention of relapse, other psychoses especially paranoid, mania and hypomania, nausea and vomiting.
It may be of value in the control of intractable hiccough.
4.2 Posology And Method Of Administration
Adults:
4mg Fentazin three times a day
Dose may have to be adjusted upwards or downwards according to patient response.
Total daily dose should not exceed 24mg.
Treatment should be started and dosage increased under close supervision.
Treatment should be reviewed at intervals to avoid indiscriminate or unduly prolonged use.
Elderly
One quarter or one half of the recommended adult dosage.
Fentazin should be used with caution in the elderly, see section 4.4 for details.
Children
Fentazin should not be given to children under the age of 14 years.
Method of administration: Oral
Withdrawal symptoms seen on discontinuation of Fentazin:
Abrupt discontinuation should be avoided, see section 4.4 for details. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
4.3 Contraindications
Fentazin should not be administered to patients with leucopenia, or in association with drugs liable to cause bone marrow depression, or to patients in comatose states.
Fentazin should not be administered to patients with a known hypersensitivity to perphenazine or any of the other excipients.
4.4 Special Warnings And Precautions For Use
The possibility of suicide in depressed patient's remains during treatment and until significant remission occurs.
Fentazine should not be used alone when depression is predominant.
Fentazin should be used with caution in patients with liver disease; severe respiratory disease; renal failure; epilepsy and conditions predisposing to epilepsy such as alcohol withdrawal or brain damage; Parkinson's disease; patients who have shown sensitivity to other phenothiazines; personal or family history of narrow angle glaucoma; hypothyroidism, myasthenia gravis; phaeochromocytoma; or prostatic hypertrophy.
Fentazin should be used with caution in patient with cardiovascular disease, such as cardiac arrhythmias, congestive heart failure, and a personal or family history of QT prolongation.
The concomitant use of other neuroleptics should be avoided because of possible potentiation of effects.
Since temperature regulation may be impaired, care should be taken in extremely hot and in cold weather, especially in the elderly and frail because of risk of hypothermia.
Acute withdrawal symptoms including nausea, vomiting, sweating and insomnia have been described after abrupt cessation of antipsychotic drugs. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathesia, dystonia and dyskinesia) has been reported. Therefore gradual withdrawal is advisable.
Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Fenatzin and preventive measures undertaken
Increased Mortality in Elderly people with Dementia
Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.
Fenatzin is not licensed for the treatment of dementia-related behavioural disturbances.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Plasma concentrations of antipsychotics may increase when given with ritonavir or tricyclic antidepressants.
Metabolism of Fentazin is inhibited when taken with Paroxetine.
Kaolin or antacids may decrease the absorption of Fentazin.
Memantine may reduce the effects of Fentazin.
Interactions affecting other drugs
Fentazin may enhance the hypotensive effect of other antihypertensive medication
Risk of sedation and/or toxicity when Fentazin is administered with CNS depressants such as alcohol, antipsychotics, opioids, sedatives, and antihistamines. Tramadol when given with Fentazin may increase the risk of convulsions.
Risk of extrapyramidal reactions/anticholinergic effects when Fentazine is administered with Lithium, Metoclopramide, Fluoxetine.
Fentazin may antagonise the therapeutic effects of anticonvulsants
Fentazin may antagonise the therapeutic effects of drugs used for Parkinson's disease and other movement disorders.
Fentazin antagonises the hypoglycaemic effect of sulphonylureas
Phenothiazines may enhance the absorption of corticosteroids and digoxin
May affect action of anticoagulants and increase the bleeding time
Increased risk of toxicity when Fentazin is given with myelosupressive drugs.
Use with concomitant QT prolonging drugs, drugs inhibiting the metabolism of perphenazine, and with drugs causing electrolyte imbalance is not recommended. If the benefit is considered to out weigh the risk in the individual patient, co-administration should be undertaken with caution and ECG monitoring should be considered.(see section 4.4)
4.6 Pregnancy And Lactation
The safety of perphenazine in pregnancy has not yet been established.
Phenothiazines may be excreted in breast milk; breast feeding should be suspended during treatment.
4.7 Effects On Ability To Drive And Use Machines
Fentazin may impair alertness, particularly when treatment is started. This may be potentiated by alcohol.
Fentazin may cause sedation and patients should be advised not to drive or operate machinery.
4.8 Undesirable Effects
Not all the following side-effects have been reported with this specific drug. However pharmacological similarities with other phenothiazine derivatives require that each be considered. Many of the side effects may be prevented by a reduction in dosage. With the piperazine group (of which perphenazine is an example), the extrapyramidal symptoms like Opisthotonus, trismus, torticollis, retrocollis, aching and numbness of the limbs, motor restlessness, oculogyric crisis, hyperreflexia, dystonia, including protrusion, discoloration, aching and rounding of the tongue, tonic spasm of the masticatory muscles, tight feeling in the throat, slurred speech, dysphagia, akathisia, dyskinesia, parkinsonism and ataxia are more common, and others (e.g., sedation, jaundice, blood dyscrasias) are less frequent.
Frequencies of the ADRs is not defined, however the below mentioned ADRs have been reported.
Disorders of the Blood and the Lymphatic system
Agranulocytosis; Transient leucopenia.
Cardiac disorders
Tachycardia,Ventricular arrhythmias VF ,VT. Sudden unexplained death, cardiac arrest and Torsades de pointes, QT prolongation.
Endocrine disorders
Hyperprolactemia.
Disorders of the eye
Oculogyric crisis; Visual disorders including blurring of vision
Corneal and lens deposits; Pigmented retinopathy.
Gastrointestinal disorders
Nausea; Oral dryness and saliva altered.
Gastrointestinal atonic and hypomotility disorders including constipation, adynamic ileus
General disorders
Fatigue; Oedema, weight gain
Hepato-biliary disorders
Cholestasis and jaundice, Obstructive jaundice.
Disorders of the immune system
Antinuclear antibodies; Systemic lupus erythematous (SLE).
Investigations
Hyperglycemia, false positive pregnancy tests; Raised serum cholesterol
Neurological disorder:
Headaches; Choreiform movements of the extremities; Dyskinesias and movement disorders including akathisia, orofacial dyskinesia, extrapyramidal disorder and tardive dyskinesias; Dystonia; Hyperreflexia; Disturbances in consciousness including somnolence, stupor; Dizziness. Parkinsonism; Tremors; Epileptic fits; CSF protein abnormalities; Impaired regulation of body temperature. Neuroleptic malignant syndrome has been reported in patients treated with neuroleptic drugs. It is a relatively uncommon, potentially lethal syndrome, characterized by severe extrapyramidal dysfunction, with rigidity and eventual stupor or coma, hyperthermia and autonomic disturbances, including cardiovascular effects
Psychiatric disorders
Confusional state, Agitation; Excitement; Insomnia.
Renal and urinary disorders
Urinary hesitancy or urinary retention
Disorders of the Reproductive system and breast
Menstruation with decreased bleeding Amenorrhea; Erectile dysfunction; impaired ejaculation. Gynaecomastia; Galactorrhoea.
Respiratory, thoracic and mediastinal disorders
Nasal stuffiness.
Skin and subcutaneous tissue disorders
Photosensitivity; Rashes; Hyperhidrosis.
Vascular disorders
Hypotension.
Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs- Frequency unknown
4.9 Overdose
In patients who have overdosed, general supportive measures must be instituted.
Gastric lavage should be considered up to 2 hours after ingestion. Emetics are unlikely to be effective because Fentazin is a potent anti-emetic.
If hypotension is severe, fluid infusion may be needed.
Central nervous system depression is treated conservatively.
Temperature should be monitored to detect hypothermia, and this should be treated appropriately.
If convulsions occur, these should be managed by standard means.
Continuous monitoring of ECG should be instituted to detect any regularities of rhythm or QT interval for at least 48 hours.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Fentazin is a depressant which blocks dopamine receptors in the central nervous system.
5.2 Pharmacokinetic Properties
Fentazin is absorbed readily from the gastro-intestinal tract. It is distributed widely throughout the body, and crosses the placenta.
5.3 Preclinical Safety Data
No further relevant data.
6. Pharmaceutical Particulars
6.1 List Of Excipients
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6.2 Incompatibilities
None known
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Store below 30°C.
6.5 Nature And Contents Of Container
Cardboard cartons containing 10 strips of 10, 4mg Fentazin tablets packed in aluminium foil.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Goldshield Pharmaceuticals Limited
NLA Tower
12-16 Addiscombe Road
Croydon, Surrey
CR0 0XT
United Kingdom
8. Marketing Authorisation Number(S)
PL 12762/0211
9. Date Of First Authorisation/Renewal Of The Authorisation
24 January 1994
10. Date Of Revision Of The Text
12/02/2010
11 DOSIMETRY
(IF APPLICABLE)
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
(IF APPLICABLE)
