ANARACTIL

Posology Dosages should be low to begin with and gradually increased under close supervision until the optimum dosage for the individual is reached.

Schizophrenia, other psychoses, anxiety and agitation Adults:

Initially 25 mg three times daily or 75 mg at bedtime increasing by daily amounts of 25 mg to an effective maintenance dose. This is usually in the range 75 to 300 mg daily, but some patients may require up to 1 g daily.

Children under 1 year:

Do not use unless need is lifesaving. 5mg/kg bodyweight every 4 – 6 hours to a maximum recommended dose of 40 mg daily.

Children 6-12 years:

One third to half the adult dose to a maximum recommended dose of 75 mg daily.

Elderly or deliberated patients:

Start with one third to half the usual adult dose, with a more gradual increase in dosage. Hiccups Adults: 25 – 50mg three or four times a day. Nausea and vomiting of terminal illness Adults: 10 – 25 mg every 4 to 6 hours.

Children under 1 year:

Do not use unless need is lifesaving. 5mg/kg bodyweight every 4 – 6 hours to a maximum recommended dose of 40 mg daily. 5mg/kg bodyweight every 4 – 6 hours. The maximum daily dosage should not exceed 75 mg.

Elderly or debilitated patients:

Initially one third to half the adult dose. The physician should then use his clinical judgement to obtain control. Method of administration Oral: the tablets should be swallowed with a drink of water.

The following CIOMS frequency rating is used, when applicable: very common (≥1/10), common (y1/100 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).

) Parkinsonism (more common in adults and the elderly. 4), ST depression, U- Wave and T- Wave changes. Cardiac arrythmias, including ventricular arrhythmia and atrial arrythmias, A-V block, Ventricular fibrillation, Ventricular tachycardia, Torsade de pointes, Cardiac arrest have been reported during neuroleptic phenothiazine therapy, possibly related to dosage.

Pre-existing cardiac disease, old age, hypokalaemia and concurrent tricyclic antidepressants may predispose. 6) Reproductive system and breast disorders Priapism General disorders and administration site conditions Temperature regulation disorder Insomnia Agitation lmay be seen without evidence of clinical disease 2particularly at the start of treatment 3particularly during long term treatment; may occur after the neuroleptic is withdrawn and resolve after reintroduction of treatment or if the dose is increased.

4). 7the development of a metallic greyish-mauve coloration of exposed skin has been noted in some individuals, mainly females, who have received chlorpromazine continuously for long periods (4 - 8 years). 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.

Chlorpromazine tablets / Anaractil tablets should be avoided in patients with: • hypothyroidism, • phaeochromocytoma, • myasthenia gravis, • prostate hypertrophy. • known hypersensitivity to phenothiazines • a history of narrow angle glaucoma or agranulocytosis.

Except under exceptional circumstances, this drug must not be administered to patients with Parkinson’s disease. 5). 5).

Blood Disorders:

All patients must be advised that, if they experience fever, sore throat or any other infection, they should inform their physician immediately and undergo a complete blood count. Treatment will be discontinued if any marked changes (hyperleucocytosis, granulocytopenia) are observed in the latter.

As agranulocytosis has been reported, regular monitoring of the complete blood count is recommended. 8) and requires immediate haematological investigation. Neuroleptic malignant syndrome: treatment must be interrupted in the event of unexplained hyperpyrexia since this can be one of the signs of neuroleptic malignant syndrome (pallor, hyperthermia, disorders of autonomic function, altered consciousness, muscle rigidity).

Signs of autonomic instability, such as hyperhydrosis and irregular blood pressure, can precede the onset of hyperthermia and as such constitute premonitory signs of the syndrome. While this neuroleptic related effect can be of idiosyncratic origin certain risk factors such as dehydration and brain damage would seem to indicate a predisposition.

Withdrawal:

Acute withdrawal symptoms, including nausea, vomiting and insomnia, have very rarely been reported following abrupt cessation of high doses of neuroleptics. Relapse may also occur, and the emergence of extrapyramidal reactions has been reported.

Therefore, gradual withdrawal is advisable. In schizophrenia, the response to neuroleptic treatment may be delayed. If treatment is withdrawn, the recurrence of symptoms may not become apparent for some time.

1 • Bone marrow depression. • Risk of angle-closure glaucoma. • Risk of urinary retention related to urethroprostatic disorders. • History of agranulocytosis. 5). 6). 5)